P.S. Docket No. 19/104 and 19/162

In the Matter of the Complaint Against

W. G. Charles COMPANY
7770 West Oakland Park Boulevard
Landmark Bank Building Suite 210
Sunrise, Florida 33321-6729

and

3952 N. Southport
Chicago, Illinois 60613-2606

and

CUSTOMER SERVICE DISTRIBUTION CENTER, INC.
997 N.W. 11th Avenue
Ft. Lauderdale, Florida 33311-1337

and

MITCHELL K. FRIEDLANDER
508 Bontona Avenue
Ft. Lauderdale, Florida 33301-2422

and
HARRIS FRIEDLANDER
2175 State Road 84, Dock 12 #1
Ft. Lauderdale, Florida 33312-4839

and
MICHAEL MEADE
2615 N. E. 49th Street
Ft. Lauderdale, Florida 33308-4846,

RESPONDENTS

P.S. Docket No. 19/104;
P.S. Docket No. 19/162

09/10/85

Bernstein, Edwin S.

In the Matter of the Complaint Against

THE ROBERTSON-TAYLOR COMPANY
1110 West Sunrise Boulevard
Ft. Lauderdale, Florida 33311-1337

and

INTRA-MEDIC FORMULATIONS, INC.
7770 West Oakland Park Boulevard Suite 210
Sunrise, Florida 33321-6729

and

CUSTOMER SERVICE DISTRIBUTION CENTER, INC.
997 N.W. 11th Avenue
Ft. Lauderdale, Florida 33311-1337

and

MITCHELL K. FRIEDLANDER
508 Bontona Avenue
Ft. Lauderdale, Florida 33301-2422

and

HARRIS FRIEDLANDER
2175 State Road 84, Dock 12 #1
Ft. Lauderdale, Florida 33312-4839

and

MICHAEL MEADE

APPEARANCES FOR COMPLAINANT:
Sandra C. McFeeley, Esq.,
Kenneth N. Hollies, Esq.
Consumer Protection Division
Law Department
U.S. Postal Service
Washington, D.C. 20260-1100

APPEARANCES FOR THE CORPORATE RESPONDENTS and MITCHELL K. FRIEDLANDER:
Lee H. Harter, Esq.
2256 Van Ness Avenue
San Francisco, CA 94109-2153,

Dale B. Hinson, Esq.,
1101 Fifteenth Street, N.W.
Washington, DC 20005-5002,

Mitchell K. Friedlander
c/o The Robertson-Taylor Co.
1110 West Sunrise Blvd.
Ft. Lauderdale, FL 33311-1337

APPEARANCE FOR HARRIS FRIEDLANDER:
Harris Friedlander, Pro Se
c/o The Robertson-Taylor Co.
1110 W. Sunrise Blvd.
Ft. Lauderdale, FL 33311-1337

APPEARANCE FOR MICHAEL MEADE:
Michael Meade, Pro Se c/o
The Robertson-Taylor Co.
1110 W. Sunrise Blvd.
Ft. Lauderdale, FL. 33311-1337

POSTAL SERVICE DECISION

On July 3, 1984, the Consumer Protection Division, United States Postal Service (Complainant) filed a Complaint in Docket No. 19/104 alleging that W. G. Charles Company, Mitchell K. Friedlander, Harris Friedlander and Michael Meade violated 39 U.S. Code § 3005 by selling Intercal-SX, a purported weight loss product, through the use of the mail by false representations.

On August 31, 1984, Complainant filed a similar Complaint in Docket No. 19/162 alleging that The Robertson-Taylor Company, Intra-Medic Formulations, Inc., Mitchell K. Friedlander, and Harris Friedlander violated 39 U.S. Code § 3005 by selling Metabolite-2050, also a purported weight loss product, through the use of the mail by false representations. The product in each case consisted of guar gum tablets to be taken in divided doses totaling 15 grams daily.

On November 15, 1984, Complainant filed a motion to amend the captions of these cases and other cases, by adding Respondent,

Customer Service Distribution Center, Inc. at 997 N.W. 11th Avenue, Ft. Lauderdale, Florida 33311. Upon no opposition, the motion was granted (Tr. 394).

The Complaint in Docket No. 19/104 alleged that Respondents falsely represent:

(a) Ingestion of Intercal-SX will cause significant weight loss in virtually all users.

(b) Ingestion of Intercal-SX will cause significant weight loss without calorie restricted diets or exercise.

(d) The weight loss claims for Intercal-SX are supported by the results of scientifically sound clinical studies.

(e) Respondents have accurately reproduced an excerpt from Acta Medica Scandinavia, Vol. 208, pp. 45-48 in certain of its printed advertisements, including Exhibit 1.

The Complaint in Docket No. 19/162 alleged that Respondents falsely represent:

(a) Ingestion of Metabolite-2050 will cause significant weight loss in virtually all users.

(b) Ingestion of Metabolite-2050 will cause significant weight loss without willpower, calorie restricted diets or exercise.

(d) The weight loss claims for Metabolite-2050 are supported by the results of scientifically sound clinical studies.

(e) Respondents have accurately reproduced an excerpt from Acta Medica Scandinavia, Vol. 208, pp. 45-48 in certain of its printed advertisements, including Exhibit 1.

(f) An obese person who takes Metabolite-2050 may reasonably expect to lose weight while continuing to eat all he or she wants.

Respondents denied that they violated 39 U.S. Code 3005. At Respondents' request the cases, together with P.S. Docket No.19/182, were scheduled for expedited hearing pursuant to 39 C.F.R. 952.17(a) (Judge Cohen's Order of February 1, 1985). I was designated Acting Judicial Officer for that purpose. Harris Friedlander and Michael Meade did not attend the expedited hearing or appear by counsel. However, by notarized letter to me dated February 11 and filed February 13, 1985, Harris Friedlander consented to the expedited hearing and wrote, "The questions I would ask of Complainant's winesses re: Intercal and Metabolite have been furnished to Co-Respondents, and the evidence they plan to offer is acceptable to me on the products." By notarized letter to me also dated February 11 and filed February 13, 1985, Michael Meade made the same statements, but limited to Intercal-SX in Docket No. 19/104.

Commencing February 12, 1985 Complainant presented the testimonies of Richard C. Eastman, M.D., William R. Ayers, M.D., and Albert I. Mendeloff, M.D. Respondents presented the testimonies of Thomas M. S. Wolever, B.M., Stephen C. Woods, Ph.D., Dan Sarel, Ph.D., Lynda M. Maddox, Ph.D., and Ruth B. Smith, Ph.D. By stipulation, Respondents' advertisements and various other exhibits as identified in Complainant's exhibit list were received in evidence (Tr. 2006-15).

During the hearing, Respondents offered as exhibits two collections of scientific articles which they designated as "Anorex-CCK (Cholecystokinin) Source Book" and "Guar Source Book." Upon no objection these source books were received into evidence, although they were not given exhibit numbers since the books were to be furnished later and some of the articles duplicated other exhibits (Tr. 4690J-O). The Anorex-CCK Source Book is hereby

designated as RX3-54 and the Guar Source Book is hereby designated as RX3-55. The articles contained in the Guar Source Book are listed in Appendix A to this decision.

Respondents offered as an exhibit the videotaped deposition of Joseph E. Morrow, Ph.D. Dr. Morrow conducted a survey and based upon that survey concluded that the money-back guarantee that Robertson Taylor offered in the sale of Metabolite-2050 and other products was a crucial factor in persuading the majority of users surveyed to buy the products. Although Complainant objected to the admission of this exhibit, I received it into evidence subject to a showing in post-hearing proposed findings and conclusions that the deposition is relevant (Tr. 4794-96). Respondents post-hearing submissions have failed to show that the deposition is relevant. In view of the holdings in Farley v. Heininger, 105 F.2d 79, 84 (D.C. Cir. 1939); Borg-Johnson Electronics, Inc. v. Christenberry, 169 F. Supp. 746, 751 (S.D.N.Y. 1959) and other cases that a promise of a refund if a customer is dissatisfied will not dispel the effect of false advertisements, I find the deposition to be irrelevant and therefore inadmissible. The transcript and the videotape of the deposition are hereby designated as RX3-56 and RX3-56A respectively and will be retained as rejected exhibits.

At the hearing, Respondents also offered an affidavit and report of Kenneth W. Clarkson, Ph.D. Upon objection by Complainant, the affidavit and report were rejected as irrelevant (Tr. 5906-07, Conference on the Record of April 15, 1985, pp. 5-6). The affidavit and report are hereby designated as RX3-57 and will be retained as a rejected exhibit.

By Order dated May 20, 1985 the parties were directed to submit proposed findings of fact, proposed conclusions of law, and memoranda. Proposed findings and conclusions were to be specific and supported by citations. The parties were directed to file reply submissions specifically stating agreement or disagreement with the opposing party's proposed findings and conclusions, and providing supporting citations and alternate findings and conclusions where there was disagreement. Complainant filed 76 pages of proposed findings and conclusions on June 10, 1985. After requesting a 10 day extension of time, Respondents on June 18, 1985 filed a two-page submission which contained no specific citations to evidence or legal authority. Complainants filed reply submissions on June 19 and July 12, 1985. Respondents filed a reply submission on July 8, 1985 (Respondents' July 8 submission). All proposed findings, proposed conclusions and arguments have been considered. To the extent indicated, they have been adopted. Otherwise they have been rejected as irrelevant or not supported by the evidence.

DECISION ON MOTION FOR RECONSIDERATION AND

REVERSAL OF JANUARY 28, 1985 DECISION AND

ORDER ON MOTION TO DISMISS COMPLAINTS AGAINST

HARRIS FRIEDLANDER AND MICHAEL MEADE

After receiving and considering testimony and other evidence at a hearing in December 1984 and considering the parties' proposed findings of fact and conclusions of law, by Decision and Order dated January 28, 1985 I determined that Harris Friedlander was properly named a Respondent in Docket Nos. 19/104, 19/162 and other cases, and that Michael Meade was properly named a Respondent in Docket No. 19/104 and other cases. By Order dated May 17, 1985, Michael Meade was added as a Respondent in Docket No. 19/162, since Docket Nos. 19/104 and 19/162 involve identical products and the same evidence.

By Order dated May 20, Respondents Harris Friedlander and Michael Meade were advised that at the time set for filing proposed findings and conclusions, they could also file memoranda supporting reconsideration and reversal of the January 28 Decision. These memoranda were filed on June 12. Complainant filed a response on June 18. Upon reconsideration of the entire record and all of the briefs and memoranda, I find the January 28 Decision to be correct.

The memorandum urging reversal indicated no basis for reversal. In the separate memorandum urging reconsideration, Respondents con tended the decision should be reversed based upon their assertions that Postal Inspector Cantley lied in testifying, and that Complain ant did not comply with the Jencks Rule in connection with Inspector Cantley's testimony.

It is not necessary to determine whether Respondents' allegations are correct because the January 28 Decision and Order would have been factually and legally supported by the evidence even if Inspector Cantley had not testified. Inspector Cantley's November 1984 testimony, which relates to different issues, was not considered in connection with the January 28 Decision. His testimony at the December hearing was limited to: (1) describing locations of Respondents' business, and (2) describing several Postal Service forms and a letter by Lee H. Harter, Esq. The locations of Respond ents' business were not relevant to the issues addressed in the January 28 Decision. The Postal Service forms were under seal and, therefore, self-authenticating and independently admissible pursuant to Federal Rule of Evidence 902(1). Inspector Cantley's testimony about the various blocks on the forms was also not necessary to the

Decision. The importance of the forms was that two of them were signed by Harris Friedlander as vice president (CX3-7a and 7c); one was signed by Michael Meade as general manager (CX2-1a); two were signed by Mitchell K. Friedlander who referred to Harris Friedlander as vice president of W. G. Charles (CX2-1b) and Bio Technic Labs (CX2-6a); and the letter of Mr. Harter as attorney for Robertson-Taylor referred to Harris Friedlander as a responsible corporate representative (CX2-8). Not only were all of these exhibits under seal with the exception of Mr. Harter's letter, but Harris Friedlander and Michael Meade did not deny that they had signed the forms as vice president and general manager, respectively, and did not deny the authenticity of the signatures of Mitchell Friedlander and Lee H. Harter, also present at the hearing. Since this evidence was reliable and admissible without Inspector Cantley's testimony, issues as to Inspector Cantley's credibility are irrelevant.

Therefore, the January 28, 1985 Decision and Order is affirmed.

FINDINGS OF FACT

I. The Use of the Mail

Mitchell K. Friedlander owns Intra-Medic Formulations, Inc. Intra-Medic wholly owns W. G. Charles Company, The Robertson-Taylor Company and Customer Service Distribution Center, Inc. A similar finding was made in the January 28, 1985 Decision and Order on Motion to Dismiss and this was not denied by Respondents in their July 8 submission.

Mitchell K. Friedlander is the president and principal decision maker in Respondent corporations which he wholly owns and controls. (January 28, 1985 Decision and Order on Motion to Dismiss). It was determined that there was a complete identity of interests between Mr. Friedlander and his corporations, despite Respondents' protests to the contrary. Therefore, Lee H. Harter, Esq. was considered to also represent Mr. Friedlander. Mr. Friedlander was permitted to personally participate in the hearing as a matter of courtesy and convenience to Respondents (Tr. 2176-77; my Memorandum For Record dated May 6, 1985).

Mitchell K. Friedlander's residence address is 508 Bontona Avenue, Ft. Lauderdale, Florida 33310. (Response to Request for Admissions No. 8 in Docket No. 19/182 filed by the Corporate Respondents on January 29, 1985). However, in accordance with Mr. Friedlander's request, service of papers will also be made to him c/o The Robertson-Taylor Company, 1110 West Sunrise Blvd., Ft. Lauderdale, FL 33311-1337. Michael Meade and Harris Friedlander are properly named as individual Respondents in these cases (Orders of January 28 and May 17, 1985; Decision on Motion for Reconsideration and Reversal herein).

Harris Friedlander's residence address is 2175 State Road 84, Ft. Lauderdale, Florida 33312 (Tr. 1726). However, in accordance with Harris Friedlander's request, service of papers will also be made to him at 1110 W. Sunrise Boulevard, Ft. Lauderdale, Florida 33311 (Letter of Harris Friedlander to Judge Bernstein filed February 13, 1985).

Michael Meade's residence address is 2615 N.E. 49th Street, Ft. Lauderdale, Florida (Complainant's proposed finding no. 6, Tr. 1790). Therefore, the address in the captions for Michael Meade is amended to this address. However, in accordance with Mr. Meade's request, service of papers will also be made to him at 1110 W. Sunrise Boulevard, Ft. Lauderdale, Florida 33311 (Letter of Michael Meade to Judge Bernstein filed February 13, 1985).

Respondents solicit orders through the mail for Intercal-SX to W. G. Charles Company, 3952 N. Southport, Chicago, Illinois 60613. (C3-1, 2, 3b, c and g, 7, p. 3, 8d, f, g, 9, and 10; admitted in Respondents' July 8 submission).

Respondents solicit orders through the mail for Metabolite-2050 to The Robertson-Taylor Company at 1110 W. Sunrise Boulevard, Ft. Lauderdale, Florida 33311 (CX3-24, 25, 27b and e, 31c, and 32, admitted in Respondents' July 8 submission) and at 135 E. Oakland Park Boulevard, Ft. Lauderdale, Florida 33334 (CX 3-11, 12, 14b, 14c, 19, and 23c; admitted in Respondents' July 8 submission).

Any mail stop order for Docket Nos. 19/104 and 19/162 should also apply to Customer Service Distribution Center, Inc. at 997 N.W. 11th Avenue, Ft. Lauderdale, Florida 33311 since Respondents' products are received in packages using that return address. These packages contain packing slips which also use that name and address (CX3-6, 28 and 30). Therefore, customers may reasonably be expected to use the Customer Service address for inquiries, problems and reorders.

However, Complainant has not supported the inclusion of 7770 West Oakland Park Boulevard, Landmark Bank Building, Suite 210, Sunrise, Florida 33321-6729 as an address for which mail to W. G. Charles Company should be stopped in Docket No. 19/104, or as an address for which mail to Intra-Medic Formulations, Inc. should be stopped on Docket No. 19/162. Respondents' advertisements appear in publications of general circulation (CX3-9, 10, 11, 17, 24, and 32; admitted in Respondents' July 8 submission).

Respondents are all part of a single enterprise directed by Mitchell K. Friedlander through various corporations using various advertisements for Intercal-SX and Metabolite-2050.

II. The Advertising Representations (P.S. Docket No. 19/104)

Respondents' advertising materials, including product inserts accompanying reorder solicitations, make the representations alleged in subparagraphs 8 (a), (b), (c), (d), and (e) of the Complaint. Specific reasons for these findings are as follows:

(a) Ingestion of Intercal-SX will cause significant weight loss in virtually all users.

CX3-1, 8f and 10
LOSE WEIGHT WITHOUT DIETING]

Works from within your body to form a protective coating around the foods you eat, reducing the total number of calories BEFORE THEY CAN BE TURNED INTO POCKETS OF STORED FAT]

INTERCAL-SX is a powerful, bio-active formula that "NEUTRALIZES" EXCESS CALORIES from within your body. INTERCAL-SX actually absorbs excess fats and carbohydrates AFTER YOU HAVE EATEN THEM, preventing their further conversion into pockets of unsightly, figuredestroying stored fat.

No matter how overweight you are, no matter how many "diets" you've tried before, no matter how many weeks, months, or years you have been trying to lose excess pounds and inches of stubborn fat, flab and cellulite just to be frustrated by "diet programs" that are impossible to live with. No matter how many times you have failed before, (believe us, you are not alone) this time will be different. THIS TIME YOU ARE GUARANTEED SUCCESS WITH INTERCAL-SX.

YES] Everyone who used INTERCAL-SX lost weight]

EVERYONE]

The results are medically documented.

Use of words such as "highly significant decrease in body weight," "powerful," and "neutralizes excess calories" conveys the impression that this product causes significant weight loss. Language such as "everyone," and "GUARANTEED SUCCESS," represents that the weight loss this product causes can be expected by virtually all users.

CX-3c, 8d, and 9

Guaranteed weight loss without dieting

LOSE UP TO 68 POUNDS WITHOUT DIETING

At last, the scientific community has developed what can only be called the "miracle" weight loss compound a potent and powerful compound that is specifically designed for tough, adult weight loss problems. That's right] No matter how long you've been overweight, no matter how hard you've tried to lose those embarrassing excess pounds and inches only to fall short of your goal, now there is a scientifically-developed, medically-verified answer to your adult weight loss problem -- INTERCAL-SX

NEVER BE FAT AGAIN]

The language, "Lose up to 68 pounds without dieting" conveys the impression to the average reader that the results can reasonably be expected. See: Weider Distributors, Inc., P.S. Docket No. 3/27

(P.S.D. Nov. 4, 1974); Iso-Tensor Plan, P.S. Docket No. 3/30 (P.S.D. May 23, 1975); The New Body Boutique, Inc., P.S. Docket No. 10/169 (P.S.D. July 7, 1982).

Quantification of expected weight loss results, combined with representations that the product has been medically verified, conveys the impression that significant weight loss results may be expected by the user. Those assertions, together with the claim that any user, regardless of past experience with diet products, can expect to lose weight, convey the impression that the signifi cant weight loss results can be expected by virtually all users.

Also the warning emphasizes the product's great effectiveness. It states, "NOTICE: Intercal-SX is an extremely powerful potent and effective weight loss compound."

CX3-3b, a product insert, reads:

With INTERCAL-SX you will be beginning a most REVOLUTIONARY WEIGHT LOSS program. This caloric "neutralizing" formulation has the industry buzzing because INTERCAL-SX lets you LOSE WEIGHT EFFORTLESSLY -- WITHOUT DIETING, CALORIE COUNTING AND EXERCISE. You can forget about failure, no matter how many times you have tried to lose weight only to abandon your intentions out of frustration. INTERCAL-SX will help you reach YOUR GOAL so quickly, you won't have time to become discouraged. And that's GUARANTEED. But don't take our word for it -- or the medically documented double-blind study that conclusively proved that EVERYONE who took the INTERCAL-SX formulation LOST SIGNIFICANT AMOUNTS OF WEIGHT -- see for yourself. We're confident that you will be amazed at the results.

The claims that this is a "revolutionary" weight loss product, that there are no "failures," that the product "neutralizes," that the effects are "medically documented," and that "everyone" lost significant amounts of weight, convey the impression that virtually all users will lose significant amounts of weight.

CX3-7, an instruction booklet that accompanies Intercal-SX, states: WITH THE EXCLUSIVE INTERCAL-SX YOU WILL LOSE ALL OF THE WEIGHT YOU WANT TO LOSE -- AUTOMATICALLY. for the serious dieter who needs to lose more than 20 pounds, INTERCAL-SX eliminates any chance for you to fail.

There is no chance of failure because INTERCAL-SX does it all-scientifically.

Medical studies have documented the amazing success of this wonderful weight loss formulation. In a medically documented, double-blind study performed at a major university, it was conclusively shown that everyone who used the INTERCAL-SX formulation -- Yes 100 percent of those who undertook the study -- lost weight .... this same guaranteed weight loss is yours.

Because INTERCAL-SX is so powerful, and its weight loss effects are automatic, you can quit worrying about ever again being fat.

The claims that users can lose "all" the weight they wish, that this program is for users who wish to lose "more than 20 pounds," that there are no "failures," that the effects are medically documented, and that the effects are "guaranteed" and "automatic" with this "powerful" product together convey the impression that the product causes significant amounts of weight loss in virtually all users.

(b) Ingestion of Intercal-SX will cause significant weight loss without calorie restricted diets or exercise.

CX3-1, 8f and 10

LOSE WEIGHT WITHOUT DIETING]

Works from within your body to form a protective coating around the foods you eat, reducing the total number of calories BEFORE THEY CAN BE TURNED INTO POCKETS OF STORED FAT]

INTERCAL-SX is a powerful, bio-active formula that "NEUTRALIZES" EXCESS CALORIES from within your body. INTERCAL SX actually absorbs excess fats and carbohydrates AFTER YOU HAVE EATEN THEM, preventing their further conversion into pockets of unsightly, figure-destroying stored fat.

This revolutionary new concept not only eliminates dieting, eliminates calorie counting, eliminates strenuous exercise, but most importantly eliminates fat, flab and ugly cellulite so easily, so effectively and so efficiently that you will soon know exactly why the entire diet industry is talking about this exciting breakthrough discovery.

By claiming that users will lose weight without the need for "calorie counting," and that Intercal-SX "eliminates dieting," the advertisements represent that users can lose weight "without dieting."

CX3-3c, 8d and 9

Guaranteed Weight Loss Without Dieting ...

Without Strenuous Exercise ... Without Giving Up

The Foods You Love To Eat.

LOSE UP TO 68 POUNDS WITHOUT DIETING

NEVER BE FAT AGAIN]

This revolutionary new concept not only eliminates dieting, eliminates calorie counting ...

By claiming that users will "never" be fat again, regardless of attention to diets, without giving up foods they love to eat, Respondents convey the impression that the product causes significant weight loss in users without the need for calorie-restricted diets.

CX3-3b

LOSE WEIGHT EFFORTLESSLY -- WITHOUT DIETING,

CALORIE COUNTING AND EXERCISE.

The representation of significant weight loss in users without calorie-restricted diets or exercise is expressed in the above language.

CX3-7

INTERCAL-SX eliminates any chance for you to fail. This special formulation works by itself, WITHOUT dieting, WITHOUT calorie counting . . . This advertisement represents that the user need only ingest the product to lose weight, since it "works by itself." Further, users do not need to adjust their caloric balances by dieting.

CX3-1, 8f and 10

Works from within your body to form a protective coating around the foods you eat, reducing the total number of calories BEFORE THEY CAN BE TURNED INTO POCKETS OF STORED FAT]

INTERCAL-SX is a powerful, bio-active formula that "NEUTRALIZES" EXCESS CALORIES from within your body. INTERCAL-SX actually absorbs excess fats and carbohydrates after you have eaten them, preventing their further conversion into pockets of unsightly, figure-destroying stored fat.

These quotations describe the mechanism of action; the product blocks the absorption of calories by forming a "protective coating" around calories or by "absorbing " them, thereby "preventing" their conversion into stored fat.

CX3-3c, 8d and 9

Now you can eat all you want and still lose weight] INTERCAL-SX actually bonds with ingested foods, thereby altering the time contact is made with the intestinal membrane.

INTERCAL-SX was developed and tested for adults only (anyone over 18 years of age) because the adult metabolism requires a very special weight loss formulation -- a powerful action-specific compound that helps to "short circuit" the fat building cycle BEFORE your body turns excess calories into figure-destroying fat.

These advertisements claim that Intercal-SX "bonds" with food, alters the food's contact with the intestinal wall, and "short circuits" the fat building cycle before the body turns excess calories into fat. In this way, the advertisements convey the impression that ingestion of Intercal-SX prevents foods from being converted into stored fat.

CX3-7

This proven, powerful formulation works from WITHIN to limit your system's ability to absorb excess fat-creating calories.

INTERCAL-SX is the proven automatic caloric "neutralizing" compound.

This advertisement also represents that the product "limits" the body's ability to "absorb ... calories" and describes Intercal-SX as a caloric-neutralizing compound.

(d) The weight loss claims for Intercal-SX are supported by the results of scientifically sound clinical studies.

This proposed finding was not disputed in Respondents' July 8 submission. The May 20, 1985 Order required each party to reply to the opposing party's proposed findings. The parties were advised that unless an opposing party's proposed finding was specifically denied with supporting citations and an alternate finding, it would be deemed admitted. Respondents' comment, "no objection," is consequently deemed an admission. Therefore, I find that this representation was made. This finding is also based upon quotations from advertisements set forth in pages 15-18 of Complainant's proposed findings.

(e) Respondents have accurately reproduced an excerpt from Acta Medica Scandinavia, Vol. 208, pp. 45-48 in certain of its printed advertisements, including Exhibit 1.

CX3-1, 8f, and 10

Finally a weight loss compound that delivers exactly what it promises. But don't take our word for it. The results are medically documented. Published in Acta Medica Scandinavia (Volume 208, pages 45-48), this amazing study was uncovered by a team of U.S. researchers during a computer search of Excerpta Medica and Medicine (2 major medical data bases). What follows is a word for word excerpt from the actual medical abstract ...

"A highly significant decrease in body weight (62.9 + 2.1 vs. 60.4 + 2.4 kg. p is less than 0.0005, paired comparison) was seen in subjects receiving cyamopsis tetragonolobus (INTERCAL-SX) whereas body weight remained constant in the other two groups IT IS CONCLUDED THAT THE DAILY INGESTION OF 15 MG. sic OF INTERCAL-SX RESULTS IN PERMANENT WEIGHT-LOSS..."

III. The Advertising Representations (P.S. Docket No. 19/162)

Respondents' advertising materials, including product inserts accompanying reorder solicitations, make the representations alleged in subparagraphs 8(a), (b), (c), (d), (e), and (f) of the Complaint.

Specific reasons for these findings are as follows:

(a) Ingestion of Metabolite-2050 will cause significant weight loss in virtually all users.

The theme and central message of Respondents' advertisements is "Weight Loss]" See headline of CX3-17 p. 2, CX3-19. In CX3-24, a full-page advertisement in the July 1984 Cosmopolitan, the weight loss theme is expressed in the headline as "THE ULTIMATE CURE FOR FAT." The promise of "significant" weight loss is found in CX3-17, p. 1. when you need to lose 15 pounds or more, take METABOLITE-2050 . . . .

The text below that headline contains two references to the prospective customer's need to lose more than 15 and up to 40 pounds. In that paragraph, and again in the last paragraph on page 1 where it is in bold print, are references to "tough weight-loss problems." The same references are repeated in the package insert material, (CX3-23b and 31b), which also includes reorder forms, (CX3-23c and 31c). In the centered and boxed print on page 2 of CX3-17 and in CX3-19 is a reference to "highly significant decrease in body weight." The ordinary reader would understand "significant" in its usual sense rather than as it is technically used in a statistical sense. That usual meaning is "important, of consequence" Random House Dictionary of the English Language (1967) or "having meaning, full of import, weighty, notable" Webster's Third New International Dictionary (1968).

In the lower portion of the boxed text and in bold print is the language,

The research RESULTS ARE STAGGERING . . .

EVERYONE LOST SUBSTANTIAL WEIGHT PERMANENTLY.

On page 1 of CX3-17 at bottom center is the subheading

"I lost 31 pounds so far without even dieting]"

The message that the user will lose significant amounts of weight is repeated twice in CX3-32, a two-page advertisement in the September 1984 Playgirl. Under the large headline of "EAT ALL YOU WANT AND STILL LOSE WEIGHT," the text tells the reader,

There has truly been a major breakthrough in the science of dramatic and permanent weight loss. Science has produced a new, medically-documented weight loss compound specifically for those who need to lose a large amount of weight . . ."

Under "THE ULTIMATE CURE FOR FAT" headline in CX3-24 appears,

If you need to LOSE WEIGHT, and we mean LOTS OF WEIGHT - 10 pounds, 15 pounds, 20 pounds, 30 pounds, 50 pounds and more - . . .

InCX3-32, as in CX3-24, the photograph of a slender woman wearing extremely large shorts emphasizes "significant" weight loss by the use of Metabolite-2050. The "before" and "after" photographs on page 1 of CX3-17 also represent that significant amounts of weight will be lost by taking Metabolite-2050.

That everyone will experience the promised weight loss with Metabolite is represented by the bold subheading, "FACT: EVERYONE LOST WEIGHT: TESTS PROVE 100% SUCCESS," followed by language which repeats and reinforces that message.(CX3-11 p.2, CX3-17 p. 2, CX3-19, CX3-24, CX3-32 p.2).

(b) Ingestion of Metabolite 2050 will cause significant weight loss without willpower, calorie restricted diets or exercise.

The advertisement at CX3-17 emphasizes:

AUTOMATIC WEIGHT-LOSS

NO calorie counting]

NO dieting]

NO food restrictions]

NO expensive fat clinics]

NO exercise]

In the same advertisement, the product is described to as "The powerful Scandinavian SUPERPILL]" -- an indication that the pill alone is responsible for an automatic weight loss. In the text near the middle of page 1, the message is repeated:

METABOLITE-2050 works by itself, without dieting, without calorie counting, without special foods, without powdered mixes, without strenuous exercise, without anything else at all. For the first time, we can truly say there is now a compound that will produce AUTOMATIC WEIGHT-LOSS.

The automatic, i.e., effortless, achievement of weight loss is repeated in one sub-headline:

FACT: "EAT AS MUCH AS YOU WANT AND STILL

LOSE POUNDS & INCHES OF EXCESS FAT]

The Randee N. testimonial in CX3-17 says "you don't have to change your life style at all." On page 2 of that advertisement, the message is repeated:

WHAT DOES THIS MEAN IN ENGLISH? Now you can eat all you want and still lose weight, without will power and without dieting,automatically.

The same message is repeated in the product inserts, CX3-23b and 31b.

CX3-24 and 32 also represent weight loss without effort or diet. The headlines read, "EAT AS MUCH AS YOU WANT AND STILL LOSE WEIGHT] NEVER DIET AGAIN]" This is followed in CX3-24 by the subheadings:

NO CALORIE COUNTING.

NO STRENUOUS EXERCISE]

NO MORE WILLPOWER]$

NO MORE DIETING]

CX3-11 reads at page 2:.

FACT: THE SECRET IS THE FORMULA METABOLITE-2050 has definitely been determined to increase satiety through its binding action to ingested food stuffs. WHAT DOES THIS MEAN IN ENGLISH? Now you can eat all you want and still lose weight ..."

The nearly identical message appears in the package insert received with the Metabolite ordered from CX3-11 (CX3-16, p. 2). In other

advertising materials, Respondents add just after "ingested food stuffs:"

. . . thereby altering gastric emptying time, decreasing the normal caloric absorption rate and in effect lowering total caloric capacity (CX3-17 p. 1, 3-19, 3-23b).

In other advertisements, Respondents represent in a sub-headline:

FACT: METABOLITE-2050 RENDERS FAT CALORIE FREE]

(CX3-24, 3-32).

(d) The weight loss claims for Metabolite-2050 are supported by the results of scientifically sound clinical studies.

(e) Respondents have accurately reproduced an excerpt from Acta Medica Scandinavia, Vol. 208, pp 45-48 in certain of its printed advertisements, including Exhibit 1.

This proposed finding also was not disputed in Respondents' July 8 submission. Respondents' only comment similarly was "no objection." Therefore, the finding is deemed admitted and I find that this representation was made. This finding is also based upon a quotation from advertisements set forth in page 26 of Complainant's proposed findings.

(f) An obese person who takes Metabolite-2050 may reasonably expect to lose weight while continuing to eat all he or she wants.

This proposed finding also was not disputed in Respondents' July 8 submission. Respondents' only comment was "no objection." Therefore, the finding is deemed admitted and I find that the representation was made. This finding is also based upon quota tions from advertisements set forth in page 27 of Complainant's proposed findings.

IV. Qualifications of the Scientific Witnesses

Medical doctors William R. Ayers, Albert I. Mendeloff, and Richard C. Eastman testified for Complainant. Medical doctor Thomas M. S. Wolever and Stephen C. Woods, Ph.D., testified for Respondents.

Dr. William R. Ayers

Dr. William R. Ayers is Associate Professor of Internal Medicine and Associate Dean for undergraduate medical education at the Georgetown University Medical School, Washington, D.C. (Tr. 2194). He is certified in internal medicine (Tr. 2195), a fellow in the American College of Physicians (Tr. 2198), and co-founder and former director of the Diet Management Clinic at the Georgetown University Hospital (Tr. 2199-2200). He has published articles on the manage ment of obesity and on the use of computers in medicine (Tr.2224, CX3-65). I found Dr. Ayers to be a credible witness. He demon strated great expertise concerning principles of weight loss and diet management. He also testified logically in his analysis of scientific studies. Dr. Ayers' testimony in Docket No. 19/182, which was heard together with these cases, indicated

misunderstandings with regard to peptide chemistry. However, Dr. Ayers' testimony demonstrated a good understanding about the state of scientific knowledge concerning guar.

Dr. Albert I. Mendeloff

Dr. Albert I. Mendeloff is Professor of Medicine at the Johns Hopkins University School of Medicine, Baltimore, Maryland (Tr. 2858). He is a gastroenterologist, a physician who specializes in digestive diseases and disorders of the digestive system. He is a fellow in gastroenterology, past president of the American Gastro enterological Association (Tr. 2859), Governor of the American College of Physicians for the State of Maryland (Tr. 2852) and editor of the American Journal of Clinical Nutrition (Tr. 2864). His research and practice interests encompass nutritional disorders, absorption and digestion, dietary fiber, diabetes and obesity (Tr. 2865-66). Respondents stated that Dr. Mendeloff "is eminently well qualified to testify and evaluate the studies" (Tr. 2867), and described him as "an expert's expert" who is "one of the world's greatest authorities on guar" (Tr. 2844). Dr. Mendeloff demon strated great expertise concerning the product at issue in these cases. I found him to be an extremely credible and reliable witness. He also testified knowledgeably and persuasively about weight loss concepts and scientific studies.

Respondents accused Dr. Mendeloff of being untruthful and biased. They first argued that he had misrepresented a guar study that he conducted. Later they contended that he was biased because: (1) he was involved in a competing mail order business, (2) he may have incorrectly believed that Respondents delayed payment of his

witness fee and, (3) he made negative comments to Dr. Wolever about Respondents. None of these accusations led me to conclude that Dr. Mendeloff testified untruthfully.

Dr. Mendeloff testified that he conducted a study using a grant from the United States Department of Agriculture for the purpose of determining guar's safety. Guar was administered in the form of bars made by the National Biscuit Company. Placebo bars which tasted exactly the same were also developed and administered. He stated that these were "fairly high calorie bars." At the end of the six month study, no differences in subjects' body weights were noted (Tr. 3090-94). He stated that this demonstrated how tough it is to make people lose weight, and that the subjects kept eating "even though they had all these extra calories we provided them" (Tr. 3093). Respondents contended that Dr.Mendeloff's co-researcher, Dr. Michael McIvor, contradicted several of Dr. Mendeloff's statements about the study in a recently taped telephone interview. Respondents were not permitted to introduce the recording of the conversation or the testimony of their interviewer, Mr. Lester, to prove the truth of Dr. McIvor's statements, but they were permitted to call Dr. McIvor as a witness (Tr. 3199-3201, 3261-62). Dr. McIvor agreed to testify (Tr. 3351), but Respondents subsequently decided not to call him as a witness (Lee H. Harter's February 25 mailgram). Thus Respondents never substantiated their accusation that Dr. Mendeloff did not testify credibly about the study.

Respondents also argued that Dr. Mendeloff was biased, because according to Mr. Friedlander, "We have been informed that Dr. Mendeloff is selling medication through the mail in direct compe tition with me" (Tr. 4937). Mr. Friedlander appeared to refer to a "mail order diet" allegedly distributed by the American Digestive Disease Society, a non-profit organization with which Dr. Mendeloff is associated (Tr. 4937-39, 4944, 4956-57, 5066-67). I found this accusation to be too far-fetched to constitute proof of bias (Tr. 4938, 4940). Dr. Mendeloff's association with the sale or distribu tion of diets by the American Digestive Disease Society does not place him in direct competition with Respondents, nor does it provide him a motive to testify falsely about Respondents' products and medical and scientific matters.

In a motion to strike testimonies of Drs. Ayers and Mendeloff filed June 12, 1985, Respondents also argued that because of a post script in a September 13, 1984 letter by Ms. McFeeley to Dr. Mendeloff referring to a "payment problem," which Respondents' contended referred to a delay in their payment of Dr. Mendeloff's witness fee through no fault of theirs, Dr. Mendeloff became biased against Respondents. This accusation also seems absurd. I do not believe that a man of Dr. Mendeloff's stature would testify falsely because of a delay in payment of his bill.

The final accusation of bias relates to Dr. Wolever's testi mony. Dr. Wolever testified that he telephoned Dr. Mendeloff on April 9, 1985, the evening after Dr. Wolever's first day of testimony in this hearing. Dr. Wolever stated that Dr. Mendeloff

said that Respondents were crooks who, after one mail box was closed down, moved to another city and opened another one (Tr. 5606). Although this testimony indicates Dr. Mendeloff's negative view of Respondents as of April 9, Dr. Wolever's statements do not destroy Dr. Mendeloff's credibility. Dr. Mendeloff completed his testimony almost three weeks before this conversation with Dr. Wolever. Assuming the accuracy of Dr. Wolever's testimony, it is not clear whether Dr. Mendeloff's negative opinion formed by April 9 preceded any of his testimony, or that these views effected his testimony. It would not be surprising after the many incidents in which Respondents verbally attacked Dr. Mendeloff during his testimony, that Dr. Mendeloff subsequently formed a negative impression of Respondents.

Dr. Richard C. Eastman

Dr. Richard C. Eastman is Associate Professor of Medicine at the Georgetown University Medical School, and chief of the Division of Endocrinology and Metabolism, an area which includes the treatment of obesity. Dr. Eastman is consultant to Georgetown's Diet Manage ment and Eating Disorders Program. He also consults directly with patients, some of whom have obesity problems. He is director for clinical research for the diabetes unit. He is a board certified internist (Tr. 2043-45, CX3-67). Dr. Eastman has impressive credentials, having published approximately 25 articles. I found Dr. Eastman to be highly knowledgeable about weight loss principles and about peptide chemistry. He testified in a sincere, forthright manner and carefully considered the questions in an effort to be helpful and truthful. I found him to be an extremely reliable witness although he did not testify specifically about guar.

Dr. Thomas M. S. Wolever

Dr. Thomas Wolever is a licensed physician in England and in Ontario, Canada (Tr. 5405-06). He is currently working toward a Ph.D. in the Department of Nutritional Sciences at the University of Toronto. His doctoral research involves nutrition in the treatment of diabetes and lipid problems (Tr. 5404). Dr. Wolever has excel lent credentials and substantial expertise with regard to guar. Dr. Wolever was an extremely interesting and highly informative witness. However, on several critical issues, I found his testimony less reliable than that of Dr. Mendeloff. Dr. Mendeloff testified consistently despite lengthy cross-examination. Although Dr. Wolever demonstrated candor in condemning Respondents' advertising language, his testimony at other times was unbelievable and contradicted by his subsequent testimony.

Dr. Stephen C. Woods

Dr. Stephen C. Woods is Professor of Psychology, chairman of the Department of Psychology, and Adjunct Professor of Medicine at the University of Washington. Dr. Woods holds the Ph.D. in physiology, biophysics, and psychology. He has worked in the field of endocri nology since the late 1960s and has authored more than 100 scienti fic articles, the majority of which deal with metabolism, food intake, and peptide hormones. Dr. Woods is the National Science Foundation's expert on food intake. He serves on the editorial boards of two peer review journals, American Journal of Physiology and Behavioral Neurobiology. He is organizer of the 1986 Inter national Congress of Physiology of Food and Food Intake (Tr. 5113-15, RX3-36). Dr. Woods did not testify about guar. He

30testified mainly about a product involved in another case, but some of his testimony related to relevant issues concerning scientific method. I found his credentials to be impressive. V. Definition of Terms and Background Findings

Dr. Ayers stated, and Respondents accepted the definition, that obesity is the state of being 15 percent or more over the ideal weight for one's height, age and sex as defined by tables published periodically by, among others, the Metropolitan Life Insurance Company (Tr. 2201-02, Respondents' July 8, 1985 submission, p. 8, para 44).

As Dr. Ayers and Dr. Mendeloff testified, obesity is a complex problem that is not simple to treat. Nutrition, energy balance, exercise and behavior are important aspects of the problem. (Tr. 2202-03, 2268-69, 2873-76). Dr. Wolever also characterized obesity as a complex problem (Tr. 5463). To lose weight, a person must create an energy or calorie deficit so that the body will use stored energy or fat to meet its current energy needs (Tr. 2203, 3134, 3684). Satiety in humans is the sense of fullness that normally leads to cessation of eating. Dr. Ayers gave this definition (Tr. 4762-63), and Dr. Woods agreed that the definition was reasonable (Tr. 5215). Dr. Eastman's similar definition was, "the sense of having had enough to eat, being full" (Tr. 2092). Satiety signals that cause a lean person to stop eating are not equally effective for obese persons. Dr. Ayers testified that satiety does not necessarily cause obese people to eat less, that there is no necessary relationship between increased satiety and weight loss,

and that the normal satiety signals do not apply in obese people (Tr. 3381, 4128). When Dr. Woods was asked whether he believed "that producing the feeling of satiety in an obese person leads inevitably to weight loss for that person," he replied, "Certainly not" (Tr. 5289-90). Dr. Wolever agreed that just because a substance produces satiety does not necessarily mean that the substance also produces weight loss (Tr. 5462-63, 5415, 5557). Dr. Mendeloff emphasized that many patients who say they feel full in hunger-satiety ratings continue to eat, ignoring the feeling of fullness (Tr. 3841, 3880).

As scientific experts for both sides testified, to establish a claim that a substance will be effective to achieve a particular result, the claim must be established by sound scientific evidence (Tr. 2079-82, 2273, 3068, 5283, 5434, 5550-51). Dr. Ayers said that efficacy claims for Anorex-CCK, a product involved in the companion case, must be treated as false in the absence of information to support them (Tr. 2972-74). Dr. Woods said that until a substance is tested using the mode of administration for which claims are made, there is no way to know how that substance will work (Tr. 5283). He stated that, in the absence of data, a claim or hypo thesis is an open question; there is simply no information (Tr. 5197-98). Dr. Wolever also indicated that data are required in order to support a medical opinion (Tr. 5434-35, 5550-51).

Formation of a scientific or medical consensus requires that results of studies be disseminated among members of the scientific community and be reviewed by others working in the field. Presenta tions of data at meetings and conferences lend themselves to that

function as do having papers reviewed by experts in the field prior to their publication in peer reviewed journals (Tr. 2270, 2956-57, 3072). Persons who perform work and who follow work in a field are in positions to be aware of a consensus in that field.

VI. The Truth or Falsity of the Representations

Intercal-SX and Metabolite-2050 each consists of tablets of cyamopsis tetragonolobus (CX3-5, 3-15, 3-29). The only difference between Intercal-SX and Metabolite-2050 tablets, other than their names, seems to be the quantities of liquids which the user is told to take with tablets when ingesting three daily doses. Test purchases of Intercal-SX and Metabolite-2050 each contained 1,500 mg of cyamopsis tetragonolobus per tablet (CX3-5, 3-15). A later test purchase of Metabolite-2050 contained 750 mg of cyamopsis tetragonolobus per tablet but required the user to take twice the number of tablets (CX3-29).

Cyamopsis tetragonolobus is the latin name for guar, a product made from seeds of the cluster plant. Guar is a dietary fiber. A dietary fiber is the portion of food obtained from plants which is not digested by the enzymes of the gastrointestinal tract (RX3-40, p. 1). When guar is mixed with water it swells and becomes gelatinous. It is used as a thickening agent for such foods as ice cream and salad dressings. It is also used to thicken skin creams and lotions, for baking to give better loaf quality to bread, and in oil wells to thicken sludge (Tr. 2878-79, 3073, 3075-76, 5413). Guar is grown and commonly used in India (Tr. 5414, 2880). Dr. Wolever testified that guar "is a very old part of the diet. People have been eating guar for many hundreds or even thousands of years. It's a staple" (Tr. 5414). Although guar is tasteless, when it

combines with saliva in the mouth, it quickly forms a gel, swells and becomes unpleasant and bitter tasting. Like other fibers, guar adds bulk to the intestinal tract. It is believed that guar and other fibers may be helpful in treating diabetes since they have been shown to lower blood sugar levels (Tr. 2206, 2880, RX3-40, pp.1-2). Guar also slows gastric emptying and lowers cholesterol levels (Tr. 3850-52. RX3-40. p. 2). Guar was discussed at an international fiber conference held in Washington, D.C. in the Spring of 1984 and attended by Drs. Mendeloff and Wolever (Tr. 5596).

On February 15, the fourth day of the hearing, Respondents presented a new issue. Respondents stated that they wished to fill all existing orders for Intercal-SX and Metabolite-2050 with lej guar, a granulated form of guar manufactured by the Lej Pharmaceutical House in Sweden (Tr. 2901-03, 3010). Mr. Friedlander explained:

"In the ads and the coupons and orders that are being held, it says a three week supply of Metabolite-2050. If I had my mail, I would supply them with a three week supply of Metabolite-2050. No one is going to be able to tell me that these people know what they are going to get when they order the product other than a three week supply of Metabolite-2050" (Tr. 2908-09).

Mr. Harter said that lej guar would be taken in amounts of 20 grams per day in two 10 gram doses. The guar in tablet form provided only 15 grams per day. Mr. Harter stated that Respondents would no longer sell guar in tablet form (Tr. 3013). The parties considered a consent agreement with respect to guar tablets, but were unable to reach agreement (Tr. 3049, 5452).

It is proper to determine falsity issues with respect to both the guar tablets and the guar granules within these proceedings.

With respect to guar in tablet form, United States v. W. T. Grant Co., 345 U.S. 629, 632 (1953) instructs that "voluntary cessation of allegedly illegal conduct does not deprive the tribunal of power to hear and determine the case, i.e., does not make the case moot .... A controversy may remain to be settled in such circumstances ... The defendant is free to return to his old ways. This, together with a public interest in having the legality of the practices settled, militates against a mootness conclusion" Citations to other cases omitted . The parties agreed to litigate the truth or falsity issues and presented evidence regarding the lej guar products, and the Postal Service decisions prohibiting the issuance of advisory opinions do not bar decisions regarding these products.The decisions -- Paul Harvey, P.S. Docket No. 8/10 (P.S.D. on Appl. for Mod. of Mail Stop Order, August 29, 1980) and George Ernst, Jr., P.S. Docket No. 13/88 (P.S.D. in Motion to Revoke False Representa tion Orders, May 1, 1984) -- apply to requests for opinions where advertising representations have not been formulated and orders have not been received. In the present cases, there are existing adver tisements and orders which Respondents desire to implement with lej guar products.

Although Respondents allege that lej guar represents an improve ment over guar in tablet form, I find that there is no difference between these forms of guar in their effects upon weight loss. Dr. Mendeloff testified that guar may vary in grades of purity, particle size, palatability, concentration, and effects of temperature, but these variations do not effect the metabolism of food or nutrient

absorption (Tr. 3075-77). With respect to the differences in effect between the guar tablets and lej guar granules, Dr. Mendeloff explained:

The first effect of guar, as it's customarily used, is in contact with water or "liquous" components so that granules would be in the mouth, subject to immediate swelling on contact with the secretions of saliva and the natural moisture that's in the mouth.Therefore, if you started swallowing guar as granules in the mouth, it would start swelling up. It might be unpleasant, because it's sticky stuff and it's hard to swallow. Therefore, the use of a capsule would mean that the material would not begin to swell until it reached the stomach, when the capsule dissolves and the material inside then goes out into the stomach secretions and begins to swell at that point. So the difference I would say has nothing to do with its actions in the stomach. It would have to do primarily with whether you want to avoid actions in the mouth, which is not really what you are trying to produce (Tr. 3073).

Dr. Wolever, Respondents' only witness concerning guar, wavered on this point. He stated that "possibly the type of guar and the way it is given may be important" (Tr. 5563) and "Guar is not guar is not guar" (Tr. 5547), but on cross-examination Dr. Wolever could not support the conclusion that the form of guar would effect its weight loss properties. He testified:

Q. When you said the formulation is important, what exactly do you mean?

A. I mean whether the guar is the type of presentation, in other words whether it is a tablet, a capsule, mini capsule, granulated, whatever, powder, and how it is taken with respect to meals. In other words, do you mix it on your food, do you take it before the meal, after the meal, is it incorporated into the food and so on.

Q. Which is better for the purposes of producing weight loss?

A. That I don't know because this sort of experience is the sort of experience you get and from this data I would say the lej guar seems to be the one that is most effective (Tr. 5549-50)

The data to which Dr. Wolever referred is a guar study by Dr. Marcin Krotkiewski of Sweden, the only known study using lej guar (CX3-64).

When pressed on the subject of formulation, Dr. Wolever testified:

Q. So you think if powdered or granulated guar is mixed with water and drunk down immediately before a meal it is likely to have more effect on weight loss than administered some other way?

A. I have no comment to make there, I don't know.

Q. You stated before formulation and administration were important. I am trying to find out what formulation and what mode of administration will produce weight loss.

A. I am telling you there has not been enough study (Tr. 5550-51).

There is very little scientific evidence relating to guar's effect upon weight loss. Most studies with respect to guar relate to its potential use for the treatment of diabetes and the treatment of heart disease (Tr. 3862, 5425).

Dr. Wolever testified that he knew of only one study which had specifically used guar to produce weight loss and had shown it to do so. That was a 1975 study reported by Evans and Miller entitled "Bulking Agents In The Treatment of Obesity" (RX3-21; Tr. 5462, 5543). Evans and Miller conducted a two-week study in which guar and methylcellulose were each given to 11 subjects for one week. They concluded that guar and methylcellulose were equally effective to produce weight loss. But reported weight losses with both substances were small and the two week time period was extremely short. The report concluded, "The indication that these agents are more effective in obese subjects than non-obese subjects is

interesting and needs further investigation" (RX3-21, p. 203). Dr. Mendeloff said that he report "indicated a pious hope that this would be a very good way ofreducing weight" (Tr. 4925).

In a 1980 Finnish study of guar's effect on cholesterol levels, the study that Respondents emphasized and quoted from in many of their advertisements (CX3-1, 3-8(f), 3-10, 3-11, 3-17, p. 2, 3-17), the investigators found no change in cholesterol levels, but noted that subjects lost weight (CX3-59). The weight loss was statistic ally significant but not clinically significant, being only 5.5 lbs in four months (Tr. 2882, 3287-88, 5493). Several of the report's authors indicated that the observed weight loss could possibly be explained by seasonal variations in diet and/or inadequate dietary instructions (CX3-60, p. 114-15). Drs. Ayers, Mendeloff and Wolever agreed that the 1980 study was not designed to reveal whether guar caused the weight loss (Tr. 3289-90, 2881-82, 5495-96).

Groups of researchers, including some of those involved in the 1980 study, conducted three follow-up studies using guar (CX3-60, 61, 62). None of these studies found significant weight loss with guar administration. A 1983 report of a study of 12 obese hyper cholesterolemics indicated that subjects actually gained weight while on guar treatment, though not a statistically significant amount (CX3-60, p. 114). One group of Finnish investigators concluded, "it seems to us that guar gum alone cannot control body weight, but could probably be of importance as a part of a more comprehensive weight-control programme" (CX3-60, p. 115).

The only known study of lej guar's effect on body weight, and the one upon which Respondents rely to support efficacy claims for

their products, was reported in the British Journal of Nutrition in 1984. It is entitled "Effect of Guar Gum on Body Weight, Hunger Ratings and Metabolism in Obese Subjects" and was written by Dr. Marcin Krotkiewski, a Swedish scientist (CX3-64).

The report involved two studies -- experiment 1 and experiment 2. In experiment 1, nine obese female subjects were studied. They were recruited to the obesity outpatient clinic for weight reduction. Subjects were given 10 grams of lej guar twice daily for eight weeks. The study was designed to evaluate guar's effects on blood glucose levels. Cholesterol and triglyceride levels and body weight were also measured. The mean weight loss for the nine subjects was about 1.1 pounds per week. Although this is a small weight loss, it is considered statistically significant (Complainant's proposed finding no. 71).

As Dr. Krotkiewski reported, "Since the obese patients in Expt 1 lost weight (see Table 3) and several patients spontaneously reported an increased satiety during guar gum treatment a second experiment was carried out" (CX3-64, p. 99). For Experiment 2, 21 obese subjects were recruited from the obesity outpatient clinic. Patients were given either 10 grams of lej guar or 10 grams of wheat bran twice daily mixed in water. The experiment was designed to last 10 weeks with the subjects taking guar and wheat bran during alternating weeks. Subjects were weighed weekly and were asked to rate their hunger on a scale of one to nine. All subjects continued in the study for 6.6 weeks but then 14 subjects discontinued hunger ratings, and weight loss statistics were thereafter reported for

only nine subjects in one table (Table 5) and for seven in another (Table 4). As Dr. Krotkiewski reported, the mean body weights were significantly less after 10 weeks (P. 102). The subjects lost an average of approximately 1.5 pounds per week (Tables 4 and 5, p.103). Dr. Krotkiewski concluded:

The results of the present study clearly demonstrate that guar gum taken in conjunction with meals leads to a reduction in hunger as compared with wheat bran taken in the same way. This effect seems to be long-lasting and could still be demonstrated after a 10-week period.

The study acknowledged, "Previous studies have usually reported that guar gum treatment did not significantly influence body-weight, although this has been found in some investigations" (P. 104).

As the witnesses testified, although the Krotkiewski study of lej guar reported weight loss, there are a number of problems with the study. First, the two experiments involved very small numbers of subjects. Dr. Mendeloff testified that although this study's P value of .05 is highly significant in statistics (Tr. 2894) many would consider a seven-subject experiment with an .05 level of significance insufficiently rigorous from a statistical viewpoint (Tr. 3082, 3848). To the same effect, Dr. Wolever testified "it is not the P value that gives me caution, it is the smaller number of people that gives me caution" (Tr. 5633).

The Krotkiewski report presented other problems. Experiment 1 had no control group. Therefore, it was not a blind study. Another concern is the study's failure to explain why between 12 and 14 of the 21 subjects did not complete Experiment 2. Both Drs. Ayers (Tr. 3373, 3510-19) and Mendeloff (Tr. 3078) felt that this greatly reduced the study's value. I agree. Did they drop out because they

achieved poor results and become discouraged? Dr. Mendeloff acknowledged that it is not unusual for subjects to drop out. How ever, he stated "But to have two-thirds of the people drop out is really a serious matter. And the fact that there's no explanation here makes it extremely difficult to understand what's going on here" (Tr. 3078). Dr. Wolever agreed that the reasons why they discontinued the study should have been explained. That would have been good scientific practice (Tr. 5502, 5505).

Drs. Ayers, Mendeloff and Wolever agreed that the Krotkiewski study was not designed to show the mechanism of action, whether guar caused the weight loss. Rather, the study was designed to look at hunger (Tr. 3479, 3080, 5460, 5509, 5512). Dr. Wolever also acknowledged that reduced hunger is not necessarily the reason why the patients lost weight; it is merely a plausible explanation (Tr. 5415).

Drs. Ayers and Mendeloff pointed out that Experiment 2 involved two subjects who lost much more weight than the other five. Without these two, the group weight loss would have been much less (Tr. 3374-76, 3081-82, Table 4). Also, Drs. Ayers and Mendeloff observed that subjects had been selected from new referrals to an obesity clinic. Thus, it would have been important to know what they had been eating and whether they were already losing weight (Tr. 3498, 4930-35, 4990-93). Dr. Mendeloff also testified that wheat bran has not been shown to cause weight loss. Weight loss observed during the bran treatment in Experiment 2 was not of significant statis tical difference from that reported during guar treatment (Tr. 5009)

Another weakness in the Krotkiewski study was its failure to monitor subjects' diets and exercise. A study should always control for other variables which could effect its results. Such important variables for a weight loss study include diet and exercise (Eastman Tr. 2079-80, 2089, 2141, 2149; Ayers 3308, 3479; Mendeloff 3125-26, 4930-31; Woods 5297). In Experiment 1, the subjects "were asked not to alter their normal diet or energy intake during the trial period." However, it is not clear whether they followed this direction. The report also indicated that, "Diet records (4d) before and during guar gum treatment suggested that no qualitative difference in dietary habits occurred" (P. 99). However, qualitative refers only to kinds of foods, as contrasted with amounts of food. Therefore, it is not clear whether there were quantitative changes in diet (Tr. 3371-72, 5512-13, 5594-95). Also the study did not indicate whether subjects' exercise patterns were determined to make sure that after the study began they did not increase their exercise. Experiment 2 was completely silent about diet and exercise, making it unclear whether these important factors were controlled in that experiment.

Dr. Mendeloff testified that, of course, the medical community is not going to accept just one study of this type. The study would require replication by an independent source, "at least one other study, to reproduce this, before, I think, anyone would take it very seriously" (Tr. 3070-71). Dr. Ayers testified that "findings ... must be replicated in the hands of someone else so that any possible bias can be excluded ..." (Tr. 2270, 2301). Dr. Eastman explained that a single group's findings might be subjected to unknown biases and that findings would have to be confirmed before they would be

widely accepted by the scientific community (Tr. 2140). Dr. Woods also advocates replication for unexpected findings. He stated, "when they give me - bring me back findings that I think are unexpected, I have them do the study again." When asked to explain why he would require replication, Dr. Woods said "because I'm a skeptic. And I would like to see if it comes out the same way. You have tremendous statistical power if you get the same results in two independent replications" (Tr. 5310). Dr. Wolever stated that "One paper alone on anything is not enough to convince the scientific community that anything works." He agreed that replication would be required to establish these results (Tr. 5561-62).

With regard to the Krotkiewski study, Dr. Wolever testified as follows: He telephoned Dr. Krotkiewski a few days before he testified and learned that Dr. Krotkiewski now puts virtually everybody in his obesity clinic on guar. Dr. Krotkiewski told Dr. Wolever that he has over 200 patients in his obesity clinic whom he has studied for 50 weeks using guar. He reported that as a result of the patients' use of guar, they are more compliant with the weight loss program, lose more weight, and still feel less hungry even after a year (Tr. 5415-16). By "compliant," Dr. Wolever thought that Dr. Krotkiewski meant continuing in the obesity clinic rather than dropping out (Tr. 5455). Dr. Wolever also testified that Dr. Krotkiewski's patients are not necessarily specifically instructed on diets. Therefore, a subject may or may not be on a diet during the study (Tr. 5457-58). Dr. Wolever said that Dr. Krotkiewski's findings would soon be published (Tr. 5416). Dr. Wolever stated that he felt a lot happier about testifying in this

proceeding after having talked to Dr. Krotkiewski about Dr. Krotkiewski's additional work. Dr. Wolever said that if he only had the one study of a few patients CX3-64 to go on he would be a lot less happy about saying the things he has said at the hearing (Tr. 5593).

Soon after Dr. Wolever testified, Complainant recalled Dr. Ayers as a rebuttal witness. Dr. Ayers testified as follows: He telephoned Dr. Krotkiewski after being informed of Dr. Wolever's testimony. Dr. Krotkiewski confirmed that he had done subsequent work with guar, that a paper describing some of his work had been presented at the International Fiber Conference in Washington, DC in the spring of 1984 and that Dr. Ayers could most easily obtain a copy of the paper from Dr. George Vahouny, a co-director of the fiber conference, at the George Washington University in Washington, D.C. (Tr. 5918-19). Dr. Krotkiewski told Dr. Ayers that patients had better compliance with the program when they used guar and that the program included a 1000 calorie-a-day diet (Tr. 5923-23, 5964). After the telephone conversation, Dr. Ayers called Dr. Vahouny and obtained a copy of the Krotkiewski paper (Tr. 5917-19). The paper confirmed that in the Krotkiewski program guar helped patients comply with their 1000 calorie-a-day diets (CX3-73).

After introductory statements, the paper discussed the study at CX3-64 and then discussed Dr. Krotkiewski's subsequent work, begin ning with the following language:

An additional study was made of seven patients on a low calorie regimen supplemented with guar gum. One patient succeeded in losing 62 kg over a period of one year. (The other six lost and sic average of 22.5 kg + SD) (CX3-73, p. 7) [Emphasis added].

hepaper continued:

After the completion of the above studies, 68 patients routinely obtained guar gum as a supplement to their 800 to 1000 Kcal diet recommendation. Of those who followed the programme (and had a check-up every five weeks), 58% reported good tolerance and an appetite-suppressing effect. Only 67% of those initially included in the study followed the treatment after eight months, but of these 74% belonged to the guar users. Sixty-nine percent reported a persistent appetite-suppressing effect and 61% a laxative effect of the guar (CX3-73, p. 8) [Emphasis added].

This language specifically contradicts Dr. Wolever's testimony about his telephone conversation with Dr. Krotkiewski. Dr. Wolever testified:

Q. In the follow-up work that you and he discussed on the phone, do you know whether those patients who had been taking the guar, as you said, for 50 weeks had been given a diet to follow, a diet plan?

A. No. He says that they are specifically -- they are not instructed to keep -- they are just instructed to keep their regular diet and encouraged to keep their regular activities.

Q. When you say "he says," do you mean in this paper?

A. No. Over the telephone, he stated to me that his patients are not instructed specifically on diets necessarily. Some of them go on to diets, and some of them don't. So it's not necessary for the patients to go on to specific diets. They can get weight loss just by maintaining their normal everyday life and not making any special efforts (Tr. 5457-58).

After Dr. Ayers testified on rebuttal, Respondents requested and were given additional time to present the testimony of either Dr. Krotkiewski, Dr. Wolever or a Dr. Kristokis as a surrebuttal witness (Tr. 6126-27). However, Respondents subsequently decided not to present surrebuttal testimony. In the absence of any contradictory

evidence, I find that CX3-73 is an authentic report of Dr. Krotkiewski and I have no reason to question the truthfulness of the statements contained in the report. Therefore, I find that Dr. Wolever's testimony in this critical area is inaccurate.

The follow-up report confirms Dr. Krotkiewski's concluding statement in CX3-64:

In summary, the present results document some effect of granulated guar gum on carbohydrate and lipid metabolism in obese individuals. These effects would appear of particular importance in obesity considering the known associations with diabetes and lipid disorders. In addition, guar gum reduces hunger when taken with meals and may thus be an important adjunct to other treatments of obesity.[Emphasis added].

Dr. Wolever was Respondents' only scientific witness with respect to guar. On direct examination Dr. Wolever was asked if the representations referred to in subparagraphs 8(a), (b), (c), and (d) of Docket No. 19/104 and subparagraphs 8(a), (b), (c), (d), and (f) of Docket No. 19/162 were true or false. He testified that all these representations were true (Tr. 5427-29). However, these conclusions were contradicted by the testimonies of Drs. Mendeloff and Ayers, the weight at the credible evidence and some of Dr. Wolever's own testimony. I find that the representations alleged in Paragraphs 8 of the Complaints in Docket Nos. 19/104 and 19/162 are false for the following reasons:

(a) Ingestion of Intercal-SX (or Metabolite-2050) will cause significant weight loss in virtually allusers.

Dr. Wolever at first supported Respondents on this issue, testifying that "virtually every obese person has lost weight just 46taking guar." However, this testimony was contradicted by Dr. Wolever's later testimony and by other evidence. Later, Dr. Wolever acknowledged that (1) there is conflicting evidence as to whether everyone who takes guar loses weight (2) that a "good proportion" of persons who take guar will lose weight, and (3) that a majority or a high majority of persons who take guar will lose weight (Tr. 5558-59, 5549, 5592). I find Dr. Mendeloff's conclusions to be more plausible. Dr. Mendeloff stated that his review of the scientific literature for various forms of guar revealed inconsistent weight loss results and that only about 25 percent of the people reported in guar studies lost weight (Tr. 3961, 3988, 5031). Dr. Mendeloff concluded that "some people lose weight and most people don't" on guar administration (Tr. 4924-25). The results of the very few studies of guar's effects on weight loss are inconsistent. Three of the four Finnish studies showed no significant weight loss while taking guar; one showed weight gain. In the one Finnish study where there was weight loss (CX3-59) the weight loss was statistically significant but not clinically significant. In the Evans and Miller study the weight loss also was small. Dr. Krotkiewski's statement in CX3-64 also supports Dr. Mendeloff's conclusion. Dr. Krotkiewski stated, "Previous studies have usually reported that guar gum treatment did not significantly influence body weight, although this has been found in some investigations" (P. 104). The Krotkiewski study, in view of its small sample, unexplained drop outs, and the other problems discussed, and without replication, does not overcome the other evidence that guar will not cause significant weight loss in virtually all users.

Guar does appear to cause a feeling of fullness and satiety and may cause weight loss in some users. Dr. Mendeloff explained that almost all dietary fibers that have been tested, including carrots, cabbage and a great number of foods, produce the effect of increased satiety (Tr. 3880). However, as the scientific experts agreed, satiety signals are not as effective for obese people and satiety does not necessarily cause obese people to eat less and lose weight (Tr. 3381, 3880, 4128, 5289-90, 5462-63, 5415).

(b) Ingestion of Intercal-SX (or Metabolite-2050) will cause significant weight loss without willpower, calorie restricted diets or exercise.

Dr. Mendeloff testified that the consensus of informed medical opinion is that this representation is false (Tr. 3096). The evidence supports that conclusion. Several of the authors of the Finnish studies concluded, "it seems to us that guar gum alone can not control body weight, but could probably be of importance as part of a more comprehensive weight loss programme" (CX 3-60, P.115). Dr. Krotkiewski agreed, stating that guar "may thus be an important adjunct to other treatments of obesity," such as the 800 to 1,000 calorie diet that Dr. Krotkiewski supplements with guar (CX3-64, 3-73, p. 8). Dr. Wolever, in complaining about exaggerations found in Respondents' advertising materials stated that it would be more accurate to describe guar as "an aid to slimming." "In other words, used as a part of a calorie controlled diet and in the program of diet and exercise" although he then qualified his testimony by stating, "The fact that they can lose weight and even if they don't try to diet and don't alter their diet, that may be true" (Tr. 5556-57, CX3-40, p. 2).

Dr. Mendeloff stated his opinion that this representation is false and that his opinion is consistent with the consensus of informed medical opinion (Tr. 3096). I agree. Dr. Mendeloff testified that guar has no effect on the metabolism of food. Guar's only effect is to cause the lining of the small intestine to be covered by a thickened layer which overlies every absorbing cell. Guar has no effect on the amount of nutrients absorbed, but does influence their rate of absorption (Tr. 3077). Dr. Wolever did not disagree with these assertions, and I find them to be accurate and to reflect the consensus of informed medical opinion.

At the hearing Respondents contended that an increase in fecal fat supports their representation that guar prevents food from being converted into stored fat (Tr. 3935-36) and offered scientific articles which they contended supported this argument (Tr. 3938-40). However, Respondents never indicated how the articles supported their position and the articles do not appear to support Respondents' claim. Moreover, the testimony of the expert witnesses indicates that the use of guar results in miniscule increase of fecal fat and I so find. In addition, the testimonies of Drs. Mendeloff and Wolever on this subject demonstrate why I found Dr. Mendeloff's testimony more reliable than that of Dr. Wolever where they differed. Dr. Mendeloff's testimony was clear and unequivocal despite many days of cross-examination. He stated, "The effect of guar on fecal excretion of most metabolites is minimal to nothing." When pressed on cross-examination with the question "Guar in large

doses, though, has been shown to increase fecal fat, not in all studies, but in some?" Dr. Mendeloff adhered to his previous testi mony stating, "It is generally considered to be a trivial result" (Tr. 3861). In contrast, Dr. Wolever's initial testimony appeared misleading, and he later retracted some of that testimony. At first, Dr. Wolever stated that guar increases bile acid excretion in the stool and "this has implications in the way that fat itself is metabolized and absorbed" (Tr. 5422-24). Later he said, "Bile can be made from cholesterol, which can be made from stored fat, if you like, metabolicaly. So I guess that it could possibly come from stored fat" (Tr. 5463-64). Still later, Dr. Wolever admitted, "Well, bile acids are not fat, they don't get metabolized in the way of fat but they are fatty materials so there is not a great deal of calories there." He admitted that "we are talking about milligrams of fat" and agreed that one gram (1,000 milligrams) of fat equals only nine calories (Tr. 5571-72). Later when asked, "So if there were an alleged binding action on food that is ingested by guar in order to promote its excretion in the stool, it would be miniscule, if at all, would it not?" Dr. Wolever agreed, replying "I think from a physiological point of view, yes, it would be small" (Tr. 5572).

(d) The weight loss claims for Intercal-SX (or Metabolite-2050) are supported by the results of scientifically sound clinical studies.

Respondents did not dispute that this representation was made. The following are typical of Respondents' advertising language that made the representation:

INTERCAL-SX CERTIFIED GUARANTEE. The INTERCAL-SX Caloric "Neutralizing" compound has been proven in double-blind studies to create dramatic weight loss for all who used this unique formulation.

MEDICALLY DOCUMENTED FACT: EVERYONE WHO USED INTERCAL-SX EXPERIENCED A SIGNIFICANT LOSS OF WEIGHT] (CX3-1, 3-8(f) and 3-10).

At last, the scientific community has developed what can only be called the "miracle" weight loss compound, a potent and powerful compound that is specifically designed for tough, adult weight loss problems... now there is a scientifically-developed,medically-verified answer to your adult weight loss problem -- (CX3-3c, 8-8d and 3-9).

FACT: EVERYONE LOST WEIGHT]

TESTS PROVE 100% SUCCESS]

Yes, that's right] Scientific documentation confirmed that EVERY PERSON who used METABOLITE-2050 LOST WEIGHT] The research RESULTS ARE STAGGERING. In a Scandinavian double-blind study, DOCTORS TESTED a number of overweight women and in the group that took METABOLITE-2050, EVERYONE LOST SUBSTANTIAL WEIGHT PERMANENTLY. This is not a marketing fantasy. This is a scientific fact documented by PUBLISHED MEDICAL FINDINGS from the Public Health Laboratory of Finland. This is the most DIRECT, unequivocal MEDICAL DOCUMENTATION of weight loss that can be published (CX3-11, 3-17).

In CX3-11, 3-17 and 3-32, a serious looking, bearded man in a white coat identified as Dr. G. K. Knowlton, stated:

After reviewing all the available European studies, I can say, without a doubt, that cyamopsis tetragonolobus (METABOLITE-2050) is the only product I have seen that has worked for everyone who has used it. . .

For the reasons that I state in this decision, Respondents' weight loss claims - subparagraphs 8(a), (b), and (c) of both Complaints and 8(f) of the Complaint in Docket No. 19/162 - are not supported by the results of scientifically sound scientific studies..

(e) Respondents have accurately reproduced an excerpt from Acta Medica Scandinavia, Vol. 208, pp. 45-48 in certain of its printed advertisements, including Exhibit 1.

This representation is also false in both Docket Nos. 19/104 and 19/162. The advertisements for Intercal-SX in Docket No. 19/104 read:

But don't take our word for it. The results are medically documented. Published in Acta Medica Scandinavia (Volume 208, pages 45-48), this amazing study was uncovered by a team of U.S. researchers during a computer search of Excerpta Medica and Medicine (2 major medical data bases). What follows is a word for word excerpt from the actual medical abstract..."A highly significant decrease in body weight (62.9 + 2.1 vs. 60.4 + 2.2 kg.p - 0.0005, paired comparison) was seen in subjects receiving cyamopsis tetragonolobus (INTERCAL-SXTM) whereas body weight remained constant in the other two groups. IT IS CONCLUDED THAT THE DAILY INGESTION OF 15MG, OF INTERCAL-SXTM RESULTS IN PERMANENT WEIGHT LOSS..." (CX3-1, 3-8(f), 3-10) [Emphasis added].

The advertisements for Metabolite-2050 in Docket No. 19/162 read:

Actual Excerpt from original Medical Abstract (Published in Vol. 208 of Acta Medica Scandinavia, pages 45-48). "A highly significant decrease in body weight (62.9 + 2.1 vs. 60.4 + 2.2 kg.p - 0.0005, paired comparison) was seen in subjects receiving cyamopsis tetragonolobus (METABOLITE-2050TM), whereas body weight remained constant in the other two groups. IT IS CONCLUDED THAT THE DAILY INGESTION OF 15MG. OF METABOLITE-2050TM RESULTS IN PERMANENT WEIGHT-LOSS...." (CX3-11, 3-17, p. 2, 3-19) Emphasis added.

The excerpt from the quoted report (CX3-59, p. 1) actually reads:

A highly significant decrease in body weight (62.9 + 2.1 vs. 60.4+ 2.2 kg, p - 0.0005 paired comparison) was seen in subjects receiving guar gum, whereas body weight remained constant in the other two groups.It is concluded that the daily ingestion of 15 g of guargum results in a permanent weight loss. [Emphasis added].

Although most of the language in the report is quoted accurately in Respondents' advertisements, Respondents have substituted "cyamopsis tetragonolobus" and the names of their products for "guar gum." These substitutions render false Respondents' representations

that "what follows is a word for word excerpt" and that each advertisement is an "actual excerpt." Furthermore, the substitutions convey the false impressions that Respondents' actual products were subjected to the reported test and that the report specifically concluded that the products themselves result in permanent weight loss.

(f) An obese person who takes Metabolite-2050 may reasonably expect to lose weight while continuing to eat all he or she wants (Docket No. 19/162).

This representation is false. As previously stated, to lose weight one must create an energy or calorie deficit so that the body will use stored energy or fat to meet its current energy needs (Tr. 2203, 3134, 3684). Although guar may cause satiety in some individuals, satiety does not necessarily cause overweight people to eat less (Tr. 3381, 4128). Thus Dr. Mendeloff stated, "There are plenty of people who tell you they are full while eating their fourth meal in five hours (Tr. 2889). Clearly a representation to such indiv iduals that they can expect to lose weight while stuffing themselves with food is false. Dr. Wolever expressed this view on cross examination as follows:

Q. Which effect of the product is exaggerated and to what degree by this ad?

A. For instance, the statement "Eat as much as you want and still lose weight, never diet again," that seems to imply that people will be able to stuff themselves with ice cream and chocolate cake and all that sort of stuff and in fact they will be able to eat all the sorts of food that they like which are bad for them and lose weight (Tr. 5555).

Although guar may have weight loss attributes, the evidence is clear that it does not fulfill the exaggerated claims of Respondents' advertisements. Dr. Wolever expressed his disapproval

of these advertisements. He testified in answer to Mr. Friedlander's questions:

Q. What do you think of the ads in general?

A. These ads?

Q. Yes.

A. I think they're sensational. They go along with the sort of ads that I usually see in the rag-mags for slimming products which generally I don't feel work. And this puts guar into a category, in my mind of material similar to that, which I find offensive, because I feel guar should have more respect than that (Tr. 5427). Dr. Wolever also stated, "Neither can I endorse the advertisements made as they seem to me to be sensational and able to be interpreted such that the effects of the product are exaggerated" (RX3-40, p. 2, Tr. 5553).

The issue is not whether guar has value. It is whether the public is being mislead by untrue advertising claims.

As the Supreme Court stated in Leach v. Carlile, 258 U.S. 138, 139 (1922), "it is sufficient to say that the question really decided by the lower courts was, not that the substance which appellant was selling was entirely worthless as a medicine, as to which there were some conflict in the evidence, but that it was so far from being the panacea which he was advertising it through the mails to be, that by so advertising it he was perpetrating a fraud upon the public."

CONCLUSIONS OF LAW

1. Postal Service False Representation Orders do not violate the First Amendment of the Constitution. Donaldson v. Read Magazine, 333 U.S. 178 (1948); Lynch v. Blount, 330 F. Supp. 689

(S.D.N.Y. 1971); Hollywood House International, Inc. v. Klassen, 508 F.2d 1276 (9th Cir. 1974); and United States Postal Service v. Beamish, 466 F.2d 804 (3d Cir. 1972). In the latter case, the Court held "Advertisers possess no constitutional right to disseminate false or misleading materials. Therefore, Congress has the power to prohibit such deceptions through appropriate legislation." p. 807. See also: Bolger v. Young's Drug Products Corp., 463 U.S. 60 (1983).

2. With the exception of 7770 West Oakland Park Boulevard, Landmark Building, Suite 210, Sunrise, Florida 33321-6729 as an address for W. G. Charles Company in Docket No. 19/104 and for Intra-Medic Formulations, Inc. in Docket No. 19/162, the Corporate Respondents solicit money through the mail in connection with their sales of Intercal-SX and Metabolite-2050 at the addresses listed in the captions of these proceedings.

3. An advertisement must be considered as a whole and its meaning will be determined in the light of its probable effect on persons of ordinary minds. Donaldson v. Read Magazine, Inc., supra; Vibra Brush Corp. v. Schaffer, 152 F. Supp. 461 (S.D.N.Y. 1957). Rev'd on other grounds, 256 F.2d 681 (2d Cir. 1958).

4. The impression of promotional representations on the ordinary mind generally is a question for the judge to determine. Expert testimony on interpretation is not required, but it is within the discretion of the judge to permit such testimony. Vibra Brush Corp. v. Schaffer. The impression of advertising on the ordinary mind may be determined by the trier of fact solely on the basis of the advertising itself. Vibra Brush Corp. v. Schaffer; Delta Enterprises, P.S. 14/72 et al, (P.S.D. July 3, 1984).

5. Express misrepresentations are not required. It is the net impression that the advertisement as a whole is likely to make upon individuals to whom it is directed that is important. Even if a solicitation is so worded as to not make an express representation, but is artfully designed to mislead those responding to it, the false representation statute is applicable. G. J. Howard Co. v. Cassidy, 162 F. Supp. 568 (E.D.N.Y. 1958); See also,Virginia State Board of Pharmacy v. Virginia Citizens Consumer Council, 425 U.S. 748 (1976), quoting United States v. 95 Barrels of Vinegar, 265 U.S. 438, 443 (1924): "It is not difficult to choose statements, designs and devices which will not deceive." In Vibra Brush Corp. v. Schaffer, supra, the Court stated:

It is not each separate word or a clause here and there of an advertisement which determines its force, but the totality of its contents and the impression of the entire advertisement upon the general populace. p. 465. Similarly, in American Image Corp. v. United States Postal Service, 370 F. Supp. 964 (S.D.N.Y. 1974) the Court held: "The cases are clear that such advertisements are to be viewed not with a lawyer's eye to 'fine spun distinctions' but with an eye to their over-all effect on the average reader."

6. False representations may also be made in order verification letters and package insert materials since these may be relied upon in connection with reorders. Iso-Tensor Plan, P.S. Docket No. 3/30 (P.S.D. May 23, 1975).

7. Where an advertisement is ambiguous or capable of more than one meaning, if one of those meanings is false, the advertisement will be held to be misleading. Rhodes Pharmacal Co., Inc. v.

Federal Trade Commission, 208 F.2d 382, 387 (7th Cir. 1953); Ralph J. Galliano, P.S. Docket No. 19/15, (P.S.D. p. 9, May 2, 1985); Bruce Roberts Co., P.O.D. Docket No. 3/78, (I.D., August 16, 1971); Moneymakers et al., P.S. Docket No. 16/1, (I.D., June 20, 1983).

8. Applying the foregoing standards, the average person who reads Respondents' advertisements would interpret them substantially as characterized in paragraphs 8 of the Complaints in Docket Nos. 19/104 and 19/162.

9. As expressed in Chaachou v. American Central Insurance Co., 241 F.2d 889, 893 (5th Cir. 1957), a representation is material if it would ". . . cause the other party to do other than that which would have been done had the truth been told." Applying the Chaachou test, the representations are material because they have the effect of inducing individuals to remit money through the mail to purchase Intercal-SX and Metabolite-2050.

10. A statement of contents on a product label is presumptive evidence of the product's ingredients. Sister Fannie Howard, P.S. Docket No. 1/101 (I.D. July 21, 1972). In fact, even in cases of conflicting evidence, ingredients listed on product labels may be relied upon as correct. Carter-Ross Labs, P.S. Docket No. 5/163 (I.D. July 25, 1977); Emil-John Research, P.S. Docket No. 5/162 (I.D. July 21, 1977).

11. Complainant has established through qualified expert testimony that the informed consensus of scientific and medical opinion is that Respondents' representations are false. Where Complainant shows that the representations in issue are not accepted as true by such a consensus, this establishes a prima facie case

thatthe representations are false. Cosvetic Laboratories, P.S. Docket No. 8/160 (P.S.D. July 22, 1982). Once Complainant presents a prima facie case of falsity, the burden of going forward with evidence to rebut this showing (though not the burden of proof which always remains with Complainant) moves to Respondents who must adduce evidence either that the consensus does not exist or that the claim of effectiveness is true despite the lack of acceptance by the medical community. Peak Laboratories, Inc. v. United States Postal Service, 556 F. 2nd 1387 (5th Cir. 1977); Frank E. Bush, Inc. v. United States Postal Service, 84 Civ. 8756 (LBS) (S.D.N.Y. 1985); Cosvetic Laboratories, supra. Respondents have failed to rebut Complainant's prima facie case in either of these ways. Accordingly, the representations alleged in subparagraphs 8(a), (b), (c), (d) and (e) in Docket No. 19/104 and 8(a), (b), (c), (d), (e) and (f) in Docket No. 19/162 are materially false as a matter of law.

12. Respondents relied upon Reilly v. Pinkus, 338 U.S. 269 (1949) frequently throughout the hearing (e.g. Tr. 2041-42, 2815-20). Respondents appear to believe that Reilly stands for the proposition that if, in a case brought pursuant to 39 U.S.C. § 3005, Respondent produces evidence tending to show that their products perform as claimed, the Postal Service's case must necessarily fail. Reilly does not change the standard of evidence from a preponderance to some higher standard as Respondents suggest. Reilly's dictum cautioned the Postal Service to avoid crushing new or developing ideas. Reilly did not tell the agency to avoid

enforcementactions where unproved ideas are promoted as established fact. Reilly stated:

In the science of medicine, as in other sciences, experimentation is the spur of progress. It would amount to condemnation of new ideas without a trial to give the Postmaster General power to condemn new ideas as fraudulent solely because some cling to traditional opinions with unquestioning tenacity P. 274.

The Court in Reilly court was concerned with placing a "limita tion upon findings of fraud under the mail statutes when the charges concern medical practices in fields where knowledge has not yet been crystalized in the crucible of experience." Knowledge in the areas of weight loss and fiber has been sufficiently well scrutinized that one may state the consensus with respect to several scientific facts: One cannot lose weight without adjustment of caloric balance. Guar appears to cause satiety in some people but not virtually all people. The reported weight loss with guar alone and no diet regimen is generally not clinically significant. Satiety does not necessarily lead to weight loss. There is evidence, however, that guar assists persons to comply with reduced calorie diets, with resultant weight loss. Had Respondents produced evidence of properly conducted replicated tests showing that their product in tablet or granule form performed as claimed, this case would have been subject to the cautions of the Reilly Court. However, no such "minority school of thought" was established by Respondents' evidence.

13. A promise to refund if a customer is dissatisfied will not dispel the effect of false advertisements. Farley v. Heininger, 105 F.2d 79, 84 (D.C. Cir. 1939); Borg-Johnson Electronics, Inc., v. Christenberry, 169 F. Supp. 746, 751 (S.D.N.Y. 1959).

14. The Corporate Respondents in this proceeding are conducting a scheme for obtaining money or property through the mails by means of materially false representations within the meaning of 39 U.S. Code § 3005 through their sales of Intercal-SX and Metabolite-2050.

15. Mitchell K. Friedlander formulates, directs and controls the policies of the corporate Respondents. Therefore, it is necessary that Cease and Desist Orders include Mitchell K. Friedlander.Because of the significant involvement of Harris Friedlander and Michael Meade in the business activities of the corporate Respondents, it is necessary that Cease and Desist Orders also include Harris Friedlander and Michael Meade. See: January 28, 1985 Decision and Order on Motion to Dismiss; Federal Trade Commission v. Standard Education Society, 302 U.S. 112 (1937); Benrus Watch Company v. F.T.C., 352 F.2d 313, (8th Cir. 1965).

Accordingly, False Representation Orders and Cease and Desist Orders are issued herewith.

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