In the Matter of the Complaints Against

W. G. CHARLES COMPANY
7770 West Oakland Park Blvd.
Landmark Bank Building
Sunrise, FL 33321-6729, et al

P.S. Docket No. 19/105; P.S. Docket No. 19/161; P.S. Docket No.20/32

09/30/85

Mason, Randolph D.

APPEARANCES FOR COMPLAINANT:
Anne Gallant, Esq.;
Kenneth N. Hollies, Esq;
Sandy McFeeley, Esq.;
Hilda Rosenberg, Esq.;
Consumer Protection Division,
Law Department,
United States Postal Service,
Washington, DC 20260-1112

APPEARANCES FOR THE CORPORATE RESPONDENTS AND MITCHELL K. FRIEDLANDER:
Lee H. Harter, Esq.;
2256 Van Ness Avenue,
San Francisco, CA 94109-215

Mitchell K. Friedlander
c/o The Robertson-Taylor Co.,
1110 West Sunrise Blvd.,
Ft. Lauderdale, FL 33311-133

APPEARANCES FOR HARRIS FRIEDLANDER MICHAEL MEADE:
Harris Friedlander, pro se,
Michael Meade, pro se
c/o The Robertson-Taylor Co.,
1110 W. Sunrise Blvd.,
Ft. Lauderdale, FL 33311-133

POSTAL SERVICE DECISION

The proceeding in Docket No. 19/105 was initiated on July 3, 1984, when the General Counsel filed a Complaint against the following Respondents: W.G. Charles Company at 7770 West Oakland Park Boulevard, Landmark Bank Building, Suite 210, Sunrise, Florida 33321-6729, and at 3952 N. Southport, Chicago, Illinois 60613-2606; and Mitchell K. Friedlander at 2175 State Road 84, Ft. Lauderdale, Florida 33312-4839; and Harris Friedlander at 2175 State Road 84, Dock 12 #1, Ft. Lauderdale, Florida 33312-4839; and Michael Meade at 3952 N. Southport, Chicago, Illinois 60613-2606. On August 31, 1984, the General Counsel filed a Complaint in Docket No. 19/161 against the following Respondents: The Robertson-Taylor Company at 1110 West Sunrise Boulevard, Ft. Lauderdale, Florida 33311-1337; Intra-Medic Formulations, Inc. at 7770 West Oakland Park Boulevard, Suite 210, Sunrise, Florida 33321-6729; and Mitchell K. Friedlander and Harris Friedlander at the addresses set forth for them above.

A Complaint was also filed on November 16, 1984 in Docket No. 20/32 againsts the following Respondents: J.F. Pharmaceuticals, Inc. at 7770 W. Oakland Park Blvd., Suite 210, Sunrise, Florida 33321-6729; and at 10 Bay Street, Suite 119, Westport, Connecticut 06880-4315, and at 3317 Montrose, Suite 1210, Houston, Texas 77006-3946; Intra-Medic Formulations, Inc. at the address set forth for it above; Mitchell K. Friedlander at 508 Bontona Avenue, Ft. Lauderdale, Florida 33301-2422; W.G. Charles Company at 7770 West Oakland Park Blvd., Suite 210, Sunrise, Florida 33321-6729; and Customer Service Distribution Center, Inc., at 997 NW 11th Avenue, Ft. Lauderdale, Florida 33311-1337

The Complaints in Docket Nos. 19/105 and 19/161 were also amended on September 14, 1984, to allege that Harris Friedlander was active in the conduct of Respondents' business. On December 11, 1984, all Complaints were amended to include Customer Service Distribution Center as a Respondent (Tr. 394-396, December 11, 1984). Also, by Order dated May 24, 1985, Harris Friedlander was added as a Respondent in Docket No. 20/32 and Michael Meade was added as a Respondent in Docket Nos. 19/161 and 20/32. Finally, on June 6, 1985, all Complaints in the instant cases were amended to correct typographical errors and propose different language for the Cease and Desist Orders. In addition, the Complaint in Docket No. 19/105 was amended to delete P8(b) which had alleged that the product would cause a "measurable increase" in size and weight of the female user's breast.

The Complaints alleged that Respondents are engaged in conducting a scheme or device for obtaining money or property through the mails by means of false representations concerning the following products in violation of 39 USC § 3005: Macrocell-D58 Liquid Concentrate (Docket No. 19/105); Mamralin-BX2 (Docket No. 19/161); and Breast Formula XP-39 (Docket No. 20/32). Respondents deny that any violation of the statute has occurred. The Complaints alleged in each case that Respondents falsely represent, directly or indirectly, in substance and effect, whether by affirmative statements, implication or omission that:

"Topical application of [the product] will cause a noticeable enlargement of the female user's breasts."

The instant cases are part of a group of 11 related cases. n1 In December of 1984, Administrative Law Judge Edwin S. Bernstein conducted a six-day evidentiary hearing in the eleven cases to determine, in part, whether Michael Meade and Harris Friedlander had been properly named in various complaints. Thereafter, Respondents requested that Docket Nos. 19/104, 19/162, and 19/182 be severed from the group and heard on an expedited basis by Judge Bernstein as Acting Judicial Officer. This had the effect of postponing the trial of the instant cases (Judicial Officer's Order dated February 1, 1985).

n1 P.S. Docket Nos. 19/103, 19/104, 19/105, 19/161, 19/162, 19/179, 19/182, 19/183, 19/184, 20/16, and 20/32.

In April of 1985 Respondents requested that the instant cases also be heard on an expedited basis and that the final agency decisions be issued by any of the Administrative Law Judges. The undersigned Administrative Law Judge was later designated to serve as Acting Judicial Officer to process, hear and issue the final agency decision in the captioned cases (Judicial Officer's Order dated April 19, 1985).

A survey of the record in the expedited cases before Judge Bernstein revealed an unduly burdensome and protracted record caused, in part, by repetitive and argumentative questions and a multitude of dilatory motions and surprises. In order to streamline the trial of the instant cases, a comprehensive pre-trial order was issued on May 8, 1985 by the Acting Judicial Officer. This order provided, in part, that: (a) all motions that may reasonably be expected to arise during trial shall be filed no later than 10 days before trial; (b) direct and rebuttal testimony shall be filed in writing no later than 20 days and 13 days, respectively, before the trial; (c) the parties shall exchange detailed proposed findings of fact and conclusions of law no later than 20 days prior to the trial; and, (d) upon receipt of these proposed findings, each party shall underline the findings and conclusions that are disputed, put brackets around the findings that are admitted, and leave unmarked the findings which are admitted but deemed irrelevant. In addition to the above "underlining" procedure, the parties were required to critique the other parties' proposed findings. The parties were instructed that in order to eliminate surprise or prejudice, parties who had not identified their facts, witnesses, and physical or documentary exhibits in their proposed findings shall, except upon a showing of good cause, be precluded from offering such proof at trial. Finally, in order to prevent unduly long, repetitive, and argumentative cross-examination, the parties were required to file in writing all reasonably anticipated cross-examination questions with the Acting Judicial Officer (without service on opposing parties) no less than 7 days before the hearing. It was stated that additional questions may be allowed in the interest of justice if they could not reasonably have been anticipated. Finally, all exhibits had to be exchanged no later than 20 days prior to the hearing. In order to accommodate the parties, the May 8 pre-trial order was amended on May 24 and May 29, 1985.

On May 24, 1985, the Acting Judicial Officer designated Lee Harter, Esq., to conduct all examinations of witnesses, make all motions, arguments, and objections at trial, and file all documents required by pre-trial orders on behalf of Respondent Mitchell Friedlander and the corporate Respondents. In the proceedings before Judge Bernstein, Mitchell Friedlander was unable to present his case in a manner consistent with a fair and orderly proceeding. The record is replete with instances in which Mr. Harter represented Mr. Friedlander. Mitchell wanted to represent himself on scientific matters and to be represented by Mr. Harter on legal, procedural, and evidentiary matters. The designation of Mr. Harter is in accordance with Brasier v. Jeary 256 F.2d 474 (8th Cir. 1958), cert. denied, 358 U.S. 867 (1958), which held that a party has no right to conduct his own case and have the aid of counsel to speak and argue for him at the same time. Thereafter, Mr. Harter continued to insist that he was only representing the "corporate Respondents," which are wholly owned by Mitchell Friedlander. All such filings have been treated as being, in substance, also filed on behalf of Mitchell.

In accordance with the critique and underlining procedure set forth in the May 8th pre-trial order, on June 12, Respondents filed a marked copy of Complainant's Proposed Findings of Fact and Conclusions of Law (See attachment to Respondents' Critique). Complainant had filed separate proposed findings in each of the captioned docket numbers; however, Respondents indicated that the only disputed sentences in the proposed findings for all three cases were those sentences which it had underlined in Complainant's proposed findings for Docket No. 20/32. All Respondents stipulated that all of Complainant's proposed findings in Docket Nos. 19/105 and 19/161 are admitted (or admitted but considered irrelevant) except for those sentences which are identical to the underlined (disputed) portions of Complainant's proposed findings in Docket No. 20/32. (Memorandum of Telephone Conversations dated June 18, 1985; Tr. 52, June 20, 1985).

After taking into consideration the alleged financial difficulties of the Respondents and all other factors presented, medical emergencies dictated that a portion of the trial be held in Washington, DC on June 17 and 18, 1985. Respondents refused to attend, and for a variety of reasons stated by the Acting Judicial Officer on the record, were deemed to have waived their right to cross-examine the Complainant's expert witnesses. Accordingly, the direct testimony of Peter H. Wendschch, M.D.; Estelle R. Ramey, M.D.; and Yvonne T. Maddox, M.D., were taken ex parte. This testimony had previously been submitted by Complainants as written direct testimony under the pre-trial procedure. The remainder of the hearing took place on June 20, 1985 in Ft. Lauderdale, Florida. Appearances were made by Lee Harter, Esq., and Mitchell K. Friedlander; however, no appearances were made by or on behalf of Harris Friedlander n2 or Michael Meade. Dr. Wendschuh appeared again at this hearing and was cross-examined by Mr. Harter. Although nominally appearing only for the corporate Respondents, Mr. Harter continually represented Mitchell Friedlander throughout these proceedings (June 20 Tr. 94, 106, 109, 110, 212-214, 222).

n2 Harris attended a portion of the June 20 hearing but declined to participate.

Michael Meade and Harris Friedlander failed to participate in these cases in a meaningful way. With the exception of proposed findings filed on May 29, 1985, consisting of four sentences, Michael Meade and Harris Friedlander failed to file pre-trial submissions required by the May 8 pre-trial order; they made no appearance at either hearing location. They appeared to be relying upon the presentation made by Mr. Harter to defend their cases (See, e.g., "Response of Michael Meade of May 8 Order to Show Cause," at p. 5, filed May 20, 1985; same adopted by Harris on May 21, 1985). It is noted that they also failed to appear in the lengthy main hearing on the false representation issues before Judge Bernstein in the related cases.

Complainant's unopposed motion to correct the transcript filed on July 9, 1985, is hereby granted.

The pre-trial procedure and the conduct of the trial itself afforded the parties a full opportunity to be heard, adduce relevant evidence and examine and cross-examine witnesses. Respondents chose not to present their purported "courtroom demonstration" of three women using the product and elected not to cross-examine two of Complainant's three expert witnesses. After the hearing, Complainant filed post-trial proposed findings of fact and conclusions of law on July 19, 1985 which have been duly considered. Due to withdrawal of counsel, Respondents were given until September 6, 1985, to file their post-trial brief. No such brief was filed.

During the trial Respondents made a motion to stay the proceedings based on an alleged criminal investigation being conducted by the Postal Service. Respondents argued that they should not be required to proceed with their case because it would violate their 5th Amendment right to remain silent and that Complainant might abuse the civil process to gain evidence for the alleged criminal investigation. I denied this motion at the trial; I hereby reaffirm this ruling for the reasons which I previously stated on the record (Tr. 79-82, June 20, 1985), and for the additional reasons set forth below.

In summary, Respondents failed to submit any evidence which tended to prove the existence of a Postal Service criminal investigation. The notations, abbreviations, and boilerplate language on USPS documents offered by Respondents (RX-1) do not even make one suspicious. In contrast, Complainant's counsel represented that there was no USPS criminal investigation (Tr. 42-43). In addition, even if such an investigation had existed, Respondents failed to show how they would be prejudiced by going forward with their case. In this regard, the pre-trial order asked Respondents to submit their entire case in writing prior to the oral hearing. The only evidence that they planned to submit was the product demonstration and the testimony of the three women subjects, which was described in detail and presented verbatim in the pre-trial submissions. Thus there was little that Complainant would discover by requiring Respondents to go forward. All exhibits had been received before trial. With regard to the demonstrative evidence, itself, Respondents' alleged preference to present this to a jury does not constitute a valid reason to stay these proceedings. Moreover, there is no secret to the demonstration; it could be independently performed by the government without the benefit of any evidence herein.

Finally, the stay was properly denied because the public interest protecting consumers from the false representations in these cases outweighs any damage to Respondents that might arguably have occurred by going forward with the civil proceedings. In this regard, Respondents have shown no special circumstances in which the nature of these proceedings demonstrably prejudices any substantial rights. SEC v. Dresser Industries, Inc., 628 F.2d 1368 (D.C. Cir. 1980), cert. denied 449 U.S. 993 (1980); United States v. Kordel, 397 U.S. 1, at 11-13 (1970).

To the extent indicated below, proposed findings and conclusions have been adopted; otherwise they have been rejected as irrelevant or contrary to the evidence. Based on the entire record herein, including my observation of the witnesses and their demeanor, the exhibits, stipulations, and other relevant evidence adduced at the hearing, I make the following Findings of Fact and Conclusions of Law:

FINDINGS AND CONCLUSIONS
REGARDING MICHAEL MEADE AND HARRIS FRIEDLANDER AS RESPONDENTS

In December of 1984, Administrative Law Judge Edwin S. Bernstein held a 6-day evidentiary hearing to determine whether Harris Friedlander and Michael Meade were properly named as Respondents in one or more of the instant cases plus the eight related cases. After hearing all of the evidence and considering the parties' briefs, Judge Bernstein issued a Decision on January 28, 1985. He found that these two Respondents held important, responsible positions and are deeply involved in the Respondent corporations' business activities. Accordingly, he held that they had been properly named as Respondents and that any orders issued should be applied to them.

Subsequent to the decision of the Administrative Law Judge, Complainant moved, inter alia, to amend two of the instant complaints, requesting that Meade and Harris be added as Respondents in Docket No. 20/32 and that Meade be added in Docket No. 19/161. Both Meade and Harris objected to these amendments on the ground that the January 28 Decision of the Administrative Law Judge was incorrect. By Order of May 24, 1985, the Acting Judicial Officer included Meade and Harris as Respondents but gave them the opportunity to incorporate their exceptions to the January 28 Decision in their pre-trial documents and in any post-trial briefs.

In paragraphs 9 and 10 of Complainant's pre-trial proposed findings of fact, it was alleged that Harris, vice president of W. G. Charles and Intra-Medic (the parent company) and Meade, the corporations' general manager, both hold important, responsible positions in the corporate Respondents and are deeply involved in their business activities. Complainant cited the January 28 Decision at pages 4-7, and 15. Although Harris and Meade did not file responses as required by the pre-trial orders of May 8 and 24, 1985, the "corporate respondents" disputed paragraphs 9 and 10 in their marked copy filed June 12, 1985. Respondents' critique of the same date simply disputes these findings "for the reasons set forth in Harris Friedlander and Michael Meade's Attorney's Memorandum of Law [filed before the January 28 Decision]" and their Motion to Reconsider the January 28 Decision filed on June 12 in Docket Nos. 19/104, 19/162, and 19/182.

After carefully reviewing the January 28 Decision of the Administrative Law Judge, and the underlying record, it is concluded that the findings of fact are fully supported by a preponderance of the evidence of record and that the conclusions of law are correct. In reaching this conclusion, the credibility determinations with respect to both Meade and Harris Friedlander are sustained since the Administrative Law Judge was in the best position to judge their demeanor. NLRB v. Florida Medical Center, Inc., 576 F.2d 666, 671 (5th Cir. 1978).

The record fully supports the finding that Harris Friedlander and Meade hold important, responsible positions and are deeply involved in the cororations' business activities. Harris is the vice president of several of the corporations. He and his brother Mitchell have a relationship of close mutual trust. Harris supervises workers and is the only person who opens the mail and removes the cash that is received in the mail. Further, he made complaints to the Postal Service on behalf of the corporations regarding cash losses (See citations in January 28, 1985 Decision).

Michael Meade is the corporations' General Manager, and had a salary of $52,000 per year (Tr. 1853, Dec. 19, 1984). In view of the small size of the companies, he is significantly involved in the management of the corporation Respondents.

Orders should be issued against both Harris Friedlander and Michael Meade in order to reduce the threat of evasion of any cease and desist orders issued against Mitchell Friedlander. Federal Trade Commission v. Standard Education Society, 302 U.S. 112 (1937). Moreover, where individuals are engaged in an egregious practice which is designed to mislead the public, the nature of the violation further justifies the imposition of orders on company officials. Bartlett Carpet Mills, Inc. v. Consumer Product Safety Comm., 635 F.2d 299 (4th Cir. 1980). The evidence of record supports a finding that the sale of a product purporting to enlarge breasts is, in fact, an egregious practice.

Finally, in their Motion for Reconsideration of the January 28 Decision, Respondents contended that the decision should be reversed based upon their assertions that Postal Inspector Cantley lied in testifying, and that Complainant did not comply with the Jencks rule in connection with Cantley's testimony. This argument is rejected because Cantley's testimony was either irrelevant or unnecessary for the purpose of deciding the instant issues. The Postal Service forms which he identified were under seal and therefore independently admissible under Federal Rule of Evidence 902(1). These forms revealed the positions held by Harris and Meade (CX2-7a and 7c; CX2-1a; CX2-1b; CX2-6a). Since Cantley's testimony was unnecessary to the January 28, 1985 Decision, Cantley's credibility is irrelevant. This conclusion is in accord with the related case of W. G. Charles Company, P.S. Docket No. 19/104, 19/162 (P.S.D. September 10, 1985 at pp. 7-9).

Accordingly, Harris Friedlander and Michael Meade are proper Respondents and orders will be issued against them individually.

REMAINING FINDINGS OF FACT

Most of the remaining findings were stipulated by Lee Harter, Esq., for the so-called "corporate Respondents" (and, in substance, Mitchell Friedlander) in the underlined copy of Complainant's pre-trial Proposed Findings of Fact filed as an attachment to Respondents' Critique on June 12, 1985. The other Respondents failed to respond to Complainant's pre-trial proposed findings, and are accordingly deemed to admit those findings. See Order of May 24, 1985, emphasizing the importance of a response by every Respondent. However, all findings are fully supported by the transcript and exhibits and citations to the record have been made below.

ADDITIONAL FINDINGS FOR DOCKET NO. 19/105

1. Respondent W.G. Charles Company ("W.G. Charles") is a corporation organized and doing business under and by virtue of the laws of the State of Florida (CX2-26).

2. Respondent Customer Service Distribution Center, Inc. ("Customer Service") is a corporation organized and doing business under and by virtue of the laws of the State of Florida (CX2-27).

3. The corporate Respondents have their principal place of business at 1110 West Sunrise Blvd., Ft. Lauderdale, Florida (CX2-28).

4. Respondent Mitchell K. Friedlander, an individual, wholly owns the corporation Intra-Medic Formulations, Inc. ("Intra-Medic") which, in turn, is the sole owner of Respondents W.G. Charles and Customer Service (CX2-28).

5. Respondent Mitchell K. Friedlander is the sole director and president of W.G. Charles and Customer Service (January 28 Decision; Ans., Dec. 31, 1984; CX2-1(b)).

6. As the sole director and president of the corporate Respondents, Mitchell Friedlander is in a position to formulate, direct and control both the policies and the daily operations of the corporate Respondents, and, in fact, does so (CX2-4, p. 3; Jan. 28 Decision; See additional citations in Complainant's proposed findings).

7. Respondent Mitchell K. Friedlander is responsible for decisions concerning the advertising to be used for the products that W.G. Charles sells (December Tr. 1735; CX2-4 at p. 3).

8. Respondent Harris Friedlander, vice-president of W.G. Charles and Intra-Medic, holds an important, responsible position in the corporate Respondents and is deeply involved in their business activities (See pp. 10-13, supra).

9. Respondent Michael Meade, the corporations' general manager, holds an important, responsible position in the corporate Respondents and is deeply involved in their business activities (See pp. 10-13, supra).

10. Respondent W.G. Charles advertises the product Macrocell-D58 for sale (CX-27, 33, 36, 38, 41, 45, 46).

11. Consumers may purchase the product Macrocell-D58 by sending payment through the United States mails (Id.).

12. Payment and orders for Macrocell-D58 are directed to: The W.G. Charles Company, 3952 North Southport, Chicago, Illinois 60613 (Id.)

13. Respondent Customer Service Distribution Center, Inc. ships the product Macrocell-D58 to customers, handles inquiries and correspondence concerning the product, and processes payment and orders for the product (CX-30, 34, 43, 46).

14. Payment and orders for Macrocell-D58 are also directed to: Customer Service Distribution Center, Inc., 997 N.W. 11th Avenue, Fort Lauderdale, FL 33311. In particular, when the product is shipped to customers who have not remitted full payment for it, such customers are directed to remit the balance due to Customer Service at this address (CX-46).

15. Macrocell-D58 is labeled to contain the following ingredients: Water, Aloe Extract, Cucumber Extract, Niacin, Glycerin, Comfrey Extract, Sodium PCA, Polysorbate 20, Octoxynol-9, Chamomile Extract, Propylene Glycol, Collagen Amino Acids, Ginseng Extract, Isopropyl Alcohol, Carbomer 940, Allantoin, Panthenol, Imidazolidinyl Urea, Methyl Paraben, Menthol, TEA, Fragrance (CX-31, 44).

16. Instructions for use of Macrocell-D58 are substantially similar to those for use of Breast Formula XP-39 and are nearly identical to those for use of Mamralin-BX2. These instructions are:

"STEP 1. After thoroughly cleansing your breasts with mild soap or cleansing cream, shake bottle well and then dispense a half dropper full of MACROCELL-D58 into the palm of your hand.

STEP 2. Apply MACROCELL-D58 with your fingertips to the entire breast area. Massage vigorously for 3 to 5 minutes.

STEP 3. Soak a clean towel in hot (not scalding) water and hold it firmly to your breasts until it cools. Remove wet towel and pat dry.

. . .

Use Elan Vital's MACROCELL-D58 4 to 7 times weekly until results are maximized. Then use 2 to 4 times a week to retain your breasts new, radiant, magnetic glow (CX-33, 45).

17. Macrocell-D58 is advertised in national magazines (CX-26, 27, 35-37).

18. At least two different formats are used in magazine advertisements for Macrocell-D58 (CX-26, 35).

19. Macrocell-D58 is also offered for sale to consumers in the instructions brochure accompanying the product (CX-33, 45).

20. Macrocell-D58 may also be ordered by consumers from the order coupon appearing in a letter notifying consumers that an order of Macrocell-D58 has been received by W.G. Charles (CX-41).

21. Respondents' promotional materials make the representation alleged in P8(a) of the Complaint, that "topical application of Macrocell-D58 Liquid Concentrate will cause a noticeable enlargement of the female user's breasts." The following excerpts from Respondents' promotional materials for the product demonstrate that they make the above representation:

(a) Exhibits CX-26, 27, 35, and 36

1. "A breakthrough for Women Who Want More] LARGER BREASTS GUARANTEED.

2. LARGER BREASTS WITHOUT SURGERY.

At last, a REVOLUTIONARY approach to breast enlargement. A highly sophisticated formulation verified by research chemists and unsurpassed in its ability to expand the cellular substructure of the female breast.

That's right] Now you can INCREASE the size of the BREAST itself, not just the bustline, but your ACTUAL CUP SIZE, where it really counts]

MACROCELL-D58 CREATES CELLULAR EXPANSION.

MACROCELL-D58 is a powerfully effective, scientific formulation that has the ability to penetrate deep into the outer layers of breast tissue preparing the breast's cellular sub-structure for ACCELERATED GROWTH. In simple terms, the cells of your breast will now have the capacity to ABSORB ADDITIONAL VOLUME similar to the way a sponge absorbs water. As this absorbtion [sic] begins, your breasts INCREASE in both SIZE and weight. Your breasts will develop a new satisfying feel of FULLNESS as the entire breast EXPANDS to magnificent new proportions right before your eyes AND THAT'S GUARANTEED.

3. INCREASE YOUR ACTUAL CUPSIZE]

4. NOTICE: Because MACROCELL-D58 causes the breasts to become both larger and heavier, MACROCELL-D58 is fortified with tissue strengtheners to help prevent the possibility of sagging due to accelerated growth. MACROCELL-D58 is not to be used by pregnant or lactating women.

5. You know how much ATTENTION women with large breasts demand from men. And you also know how it feels to see OTHER WOMEN get all that attention just because their breasts are larger than yours. Now you can fight back with MACROCELL-D58 , the ultimate breast enhancer.

6. MACROCELL-D58 creates "MACRO-CELLULAR" absorbtion [sic] over the entire breast area. Visible expansion begins with the very first application.

I understand that if I am not totally satisfied with the visible increase in my breast size, I will get a complete refund including the $2.00 for postage and handling.

(b) Letter to purchaser with order coupon (CX-41):

"With MACROCELL-D58 you will begin a REVOLUTIONARY APPROACH to breast enlargement - Not just an increase in your bustline, but a NOTICEABLE increase in your actual cup size. From the very first application, your breasts will develop a new SATISFYING FEELING OF FULLNESS and your NEW APPEARANCE AND CONFIDENCE will be the eye-catching envy of other, less well-endowed, women.

The MACROCELL-D58 formulation is the culmination of research in the growing field of macro-cellular expansion - the SCIENTIFIC METHOD of breast development that makes creams, weight gain powders and exercise contraptions totally obsolete. Now you will experience the breasts of your dreams and know the PERSONAL SATISFACTION and confidence of women with large breasts.

MACROCELL D-58 will PRODUCE VISIBLE RESULTS with your very FIRST APPLICATION. In fact, we are so positive that this PENETRATING breast enlarging compound will be all that you've dreamed about, that we are proud to offer you a FULL 20% DISCOUNT ON YOUR NEXT PURCHASE OF MACROCELL-D58 ."

(c) The Macrocell-D58 instruction booklet and order form (CX-33 and CX-45):

"AN EXCITING NEW EXPERIENCE FOR YOUR BREASTS

You will feel your breasts come alive as MACROCELL-D58 tightens, smooths, enlarges and firms the breasts, producing visible results so dramatic that . . . well, you'll see. A proven formulation from the cosmetic chemists at Elan Vital.

MACROCELL-D58 is a unique blend of natural skin salts, collagen, amino acids, herbal plants, flower extracts that regenerate the outer layers of the breast tissue to work the formulations magic."

ADDITIONAL FINDINGS FOR DOCKET NO. 19/161

1. Respondents, The Robertson-Taylor Company ("Robertson-Taylor"), Intra-Medic Formulations, Inc. ("Intra-Medic"), Customer Service Distribution Center, Inc. ("Customer Service") are corporations organized and doing business under and by virtue of the laws of the State of Florida (CX2-25; CX2-24; CX2-27).

2. Respondents Robertson-Taylor and Customer Service are subsidiaries of Respondent Intra-Medic (CX 2-28 at pp. 1-2; CX-6, 7, 12, 17, 18, 19, 21, 22).

3. The corporate Respondents all have their principal place of business at 1110 West Sunrise Blvd., Ft. Lauderdale, Florida (CX2-28 at p. 2).

4. Respondent Mitchell K. Friedlander, an individual, wholly owns Respondent Intra-Medic which, in turn, is the sole owner of Respondents Robertson-Taylor and Customer Service (CX2-28 at p. 2; See, Decision of Jan. 28, 1985).

5. Respondent Mitchell K. Friedlander is the sole director and president of Robertson-Taylor, Customer Service, and Intra-Medic (Decision of 1/28/85 at p. 3; CX2-24, 25, 27; CX2-4 at p. 2; Answer of corporate Respondents of December 31, 1984 at p. 4; CX2-11).

6. As the sole director and president of the corporate Respondents, Mitchell Friedlander is in a position to formulate, direct and control both the policies and the daily operations of the corporate Respondents, and, in fact, does so (Decision of 1/28/85 at pp. 3 and 15; CX 2-4 at p. 3).

7. Respondent Mitchell Friedlander is responsible for decisions concerning the advertising to be used and the products that Intra-Medic and Robertson-Taylor sells (December Tr. 1735; CX2-4 at p. 3).

8. Respondent Harris Friedlander, vice-president of Robertson-Taylor and Intra-Medic, holds an important, responsible position in the corporate Respondents and is deeply involved in their business activities (See pp. 10-13, supra).

9. Respondent Michael Meade, the corporations' general manager, holds an important, responsible position in the corporate Respondents and is deeply involved in their business activities (See pp. 10-13, supra).

10. Respondent Robertson-Taylor advertises the product Mamralin-BX2 for sale (CX-1, 2, 4, 7, 12, 14, 16, 18, 22, 24).

11. Consumers may purchase the product Mamralin-BX2 by sending payment through the United States mails (Id.).

12. Payment and orders for Mamralin-BX2 are directed to: The Robertson-Taylor Company, 1110 W. Sunrise Blvd., Ft. Lauderdale, Florida 33311 (Id.).

13. Respondent Customer Service ships the product Mamralin-BX2 to customers, handles correspondence concerning the product and processes payments and orders for the product (CX-9, 13, 20, 23) (envelopes in which products were sent and packing slips accompanying product).

14. Payment and orders for Mamralin-BX2 are also directed to: Customer Service Distribution Center, Inc., 997 N.W. 11th Avenue, Fort Lauderdale, Florida 33311. In particular, when the product is shipped to customers who have not remitted full payment for it, such customers are directed to remit the balance due to Customer Service at this address (CX-13, 23) (packing slips accompanying product).

15. Mamralin-BX2 is labeled to contain the same ingredients as Breast Formula XP-39 and Macrocell-D58 with the following exception: Mamralin-BX2 is labeled to contain two additional ingredients, F.D.&C. Red #33 and F.D.&C. Red #4 (CX-10, 21).

16. Instructions for use of Mamralin-BX2 are nearly identical to those for Macrocell-D58 and substantially the same as those for Breast-Formula XP-39 (CX-12, 22).

17. Mamralin-BX2 is advertised in national magazines (CX-1-3, 14-16, 24).

18. At least three different formats are used in magazine advertisements for Mamralin-BX2 (CX-1, CX-14 and CX-24).

19. Mamralin-BX2 is also offered for sale to consumers in the instructions brochure accompanying the product (CX-12, 22).

20. Mamralin-BX2 may also be ordered by consumers from the order coupon appearing on a letter notifying consumers that their order of Mamralin-BX2 has been received by Robertson-Taylor (CX-7, 18).

21. Respondents' promotional materials make the representation alleged in paragraph 8 of the Complaint that "topical application of Mamralin-BX2 will cause a noticeable enlargement of the female user's breasts." The following excerpts from Respondents' advertisements and instructions booklet for the product demonstrate that they make the above representation:

(a) Advertisement which appeared in the June 1984 issue of Cosmopolitan magazine (CX-1 and 2):

"FACT: Every woman has the ability to increase the size of her breasts. Including you] Increase in the actual cup size, not just the size of your back. (Face it, if you are a size 32AA or a 38AA you still have the problem of small breasts.) But now there is MAMRALIN-BX2 .

MEDICAL EXPERTS HAVE PRODUCED LARGER BREASTS FOR THOUSANDS OF LUCKY WOMEN]

According to most medical experts, the only way for you to permanently increase the size of your breasts is to undergo expensive and sometimes dangerous breast augmentation surgery. But you don't have to give up]

NOW YOU HAVE A CHOICE]

What if you could find a treatment which will produce attention-grabbing, larger, firmer breasts without expensive surgery? What if this exclusive, scientifically developed treatment was not only enjoyable to apply but worked with incredible speed? What if you were able to obtain this treatment now without prescription or embarrassment? Furthermore, what if this formula was guaranteed to work for you or it costs you nothing? Would you be interested? Of course you would] And you're not alone]

FIRST TIME AVAILABLE FOR NON-CLINICAL USE]

MAMRALIN-BX2 was formulated during ongoing research at The Robertson-Taylor Co., a division of Intra-Medic Formulations, Inc. Our research team engaged in the development of biotherapeutic treatments, had a goal: create a formula which could channel specific body mass to designated areas of the body capable of naturally induced expansion. The breasts, (because of the extraordinary properties of breast tissue) are capable of this type of expansion and the MAMRALIN-BX2 FORMULA can trigger the precise mechanisms which will produce larger, more sensual breasts. And do this fast, safely, and without the permanence or scarring you gamble with if you undergo breast augmentation surgery."

(b) "A WINNING FIGURE WILL MAKE YOU A WINNER] NEW] MAMRALIN-BX2 .

MAMRALIN-BX2 is a new effective scientific compound that is capable of channeling added amounts of body mass to specific areas of the body that are capable of naturally induced expansion. The breasts (because of the extraordinary properties of breast tissue) are capable of this type of expansion, and the MAMRLIN-BX2 FORMULA can trigger the precise mechanisms which will produce larger, more sensitive, sensual breasts, and do it fast, safely and without the permanence or scarring you gamble with if you undergo breast augmentation surgery.

THE SECRET IS THE EXCLUSIVE MAMRALIN-BX2 FORMULA

The MAMRALIN-BX2 FORMULA is a precise blend of compounds that, when massaged into the breasts, will create a series of biological actions that will, simply stated, expand the capacity of the breast to accept additional body mass.

The application of the MAMRALIN-BX2 FORMULA is both soothing and pleasant. Your breasts will "tingle" with a new sensuous warmth that will tell you the MAMRALIN-BX2 FORMULA is going to work. In a few short moments you will actually see and feel the difference. And that's guaranteed]

YOU NO LONGER HAVE TO FEEL SHORT-CHANGED]

Face it, women with beautiful breasts seem to always be surrounded by men. Instead of making flimsy excuses (like -- "I wouldn't want breasts that size") take the positive step. Order MAMRALIN-BX2 today and see how it feels to be the center of attention instead of the one left standing alone making flimsy excuses.

BE A WINNER]

Forget what you have heard about 'powdered drinks' that make you gain weight all over or ineffective exercise contraptions that do nothing but build up your back muscles. MAMRALIN-BX2 is the one for you. MAMRALIN-BX2 is applied directly to the breast where it goes to work directly on the breast" (CX-14).

(c) Instruction Brochure and Order Form (CX-12 and 22):

"MAMRALIN-BX2 WILL ACTUALLY INCREASE YOUR CUP SIZE . . . FROM THE VERY FIRST APPLICATION]

Get ready] You are about to experience a wonderful transformation . . . the result of a medical breakthrough that literally expands the capacity of your breasts to accept additional mass. The result? You can now have larger, firmer, more sensual breasts, and you will see and feel the difference right from the start.

The research teams of the Robertson-Taylor Co. have developed the breast expanding MAMRALIN-BX2 formulation -- a potent blend of tissue expanding compounds that will enlarge your breasts and give you the eye-catching figure of your dreams. With the first application, you will feel the MAMRALIN-BX2 tingle -- the sensual warmth that lets you know that the powerful tissue-expanding compounds are working their breast-enhancing magic. Yes, MAMRALIN-BX2 is the intelligent alternative to dangerous, permanent breast augmentation therapy.

Now look in the mirror. How does it feel to have larger, more sensual breasts. They said it couldn't be done, but now the proof is right before your eyes."

ADDITIONAL FINDINGS FOR DOCKET NO. 20/32

1. Respondents Intra-Medic Formulations, Inc. ("Intra-Medic"); W.G. Charles Company ("W.G. Charles"); J.F. Pharmaceuticals, Inc. ("J.F. Pharmaceuticals"); and Customer Service Distribution Center, Inc. ("Customer Service") are corporations organized and doing business under and by virtue of the laws of the State of Florida (CX2-22; CX2-26; CX2-27; CX2-24; CX2-28).

2. Respondents W.G. Charles, J.F. Pharmaceuticals and Customer Service are subsidiaries of Respondent Intra-Medic (CX2-28 at pp. 1-2).

3. The corporate Respondents all have their principal place of business at 1110 West Sunrise Blvd., Ft. Lauderdale, Florida (CX2-28 at p. 2).

4. Respondent Intra-Medic wholly owns Respondents W.G. Charles, J.F. Pharmaceuticals and Customer Service (CX2-28 at p. 3; See Decision of 1/28/85 at p. 3).

5. Respondent Mitchell K. Friedlander, an individual, wholly owns Intra-Medic (CX2-28 at p. 2; Decision of 1/28/85 at p. 3).

6. Mitchell K. Friedlander is the sole director and president of Intra-Medic, W. G. Charles, J.F. Pharmaceuticals and Customer Service (CX2-22, 24, 26, 27; See Decision of 1/28/85 at p. 3; CX2-4 at p. 2; Ans. of 12/31/84 at p. 4; CX2-1(b); CX2-6(b); CX2-11).

7. As the sole director and president of the corporate Respondents, Mitchell Friedlander is in a position to formulate, direct and control both the policies and the daily operations of the corporate Respondents, and, in fact, does so (See Decision of 1/18/85 at pp. 3 and 15; CX2-4 at p. 3; See additional citations in Complainant's brief).

8. Respondent Mitchell K. Friedlander is responsible for decisions concerning the advertising used for the products that Intra-Medic and W.G. Charles sell (Tr. 1735; CX2-4 at p. 3).

9. Respondent Harris Friedlander, vice-president of W.G. Charles and Intra-Medic, holds an important, responsible position in the corporate Respondents and is deeply involved in their business activities (See pp. 10-13, supra).

10. Respondent Michael Meade, the corporations' general manager, holds an important, responsible position in the corporate Respondents and is deeply involved in their business activities (See pp. 10-13, supra).

11. Respondents J.F. Pharmaceuticals and W.G. Charles (CX-66) advertise the product Breast Formula XP-39 for sale (CX-47, 48, 50, 55, 57, 58, 60, 64, 66).

12. Consumers may purchase the product Breast Formula XP-39 by sending payment through the United States mails (Id.).

13. Payment and orders for Breast Formula XP-39 are directed to: J.F. Pharmaceuticals, Inc., at 3317 Montrose, Suite 1210, Houston, Texas 77006 and at 10 Bay Street, Suite 119, Westport, CT 06880 (CX-48, 55, 58, 64, 66).

14. Respondent Customer Service distributes the product Breast Formula XP-39 and processes payments and orders for the product (CX-53, 63; CX-56, 65).

15. Payment and orders for Breast Formula XP-39 are also directed to: Customer Service Distribution Center, Inc., 997 N.W. 11th Avenue, Fort Lauderdale, FL 33311. In particular, when the product is shipped to customers who have not remitted full payment for it, such customers are directed to remit the balance due to Customer Service at this address (CX-56, 65).

16. Breast Formula XP-39 is labeled to contain: Water, Aloe Extract, Cucumber Extract, Niacin, Glycerin, Comfrey Extract, Sodium PCA, Polysorbate 20, Octoxynol-9, Chamomile Extract, Propylene Glycol, Collagen Amino Acids, Ginseng Extract, Isopropyl Alcohol, Carbomer 940, Allantoin, Panthenol, Imidazolidinyl Urea, Methyl Paraben, Menthol, Tea, Fragrance (CX-53, 54, 63).

17. Instructions accompanying the product are substantially the same as instructions for Macrocell-D58 and Mamrolin-BX2, supra (Additional FOF #16 for Docket No. 19/105) (CX-55; CX-64).

18. Breast Formula XP-39 is advertised in national magazines (CX47-49, 57-59, 66-67).

19. At least three different formats are used in magazine advertisements for Breast Formula XP-39 (CX-47, 57, 66).

20. Breast Formula XP-39 is also offered for sale to consumers in the Instructions Brochure which accompanies the product (CX-55, 64).

21. Respondents' promotional materials make the representation alleged in P6 of the Complaint that, "topical application of Breast Formula XP-39 will cause a noticeable enlargement of the female user's breasts." The following excerpts from Respondents' advertisements and re-order booklet for the product demonstrate that they make the above representation.

(a) "Thermal Infusion Technique Developed for Women Who Have Dreamed About LARGER BREASTS:

Can you imagine actually watching and feeling your bust increase in size right before your eyes. At last you will be able to experience the POWER and CONFIDENCE you know larger breasted women always seem to use to their advantage.

EXPERIENCE ALL THAT YOU'VE BEEN MISSING For those times when beautiful breasts make a difference, you'll be glad you have Breast Formula XP-39 on hand. WHAT ARE YOU WAITING FOR? You have nothing to lose and everything to gain. Breast Formula XP-39 is guaranteed to work for you just as it has for thousands of women who once thought that having a larger bust was only a dream. Order Right Now]" (CX-47, 48; CX-57, 58).

(b) "Thermal Infusion Technique Developed Especially for Women Who Have Always Dreamed About Terrific Breasts.

Are you concerned about your breasts and would you like to quickly, easily and safely create a fullness that will change your entire outward image? NOW you can, with the exclusive Breast Formula XP-39.

EXPERIENCE ALL THAT YOU'VE BEEN MISSING For those times when beautiful breasts make a difference, you'll be glad you have Breast Formula XP-39 on hand. WHAT ARE YOU WAITING FOR? You have nothing to lose and everything to gain. Breast Formula XP-39 is guaranteed to work for you just as it has for thousands of women who once thought that having a larger bust was only a dream. Order Right Now]" (CX-66).

(c) Breast Formula XP-39 Instructions Brochure and Order Form (CX-55 and 64):

"With BREAST FORMULA XP-39 you will notice the difference immediately -- and so will everyone else. BREAST FORMULA XP-39, with its proven Thermal Infusion Technique, is the confidence builder that has literally worked wonders for thousands of women who once thought that larger breasts were only for the fortunate few. Now, you too will know the power, confidence and sensual beauty of fuller, larger breasts with your very first application.

You will love the immediate feeling of fullness and sensual warmth as your breasts undergo the XP-39 transformation. This easy to use formulation delivers tissue-expanding compounds deep into the breast itself. In just a few minutes you will see your breasts become fuller and feel your breasts become more sensitive to the touch. You will finally know what has been missing in your life for so many years."

FURTHER FINDINGS OF FACT FOR ALL CASES

A. The Witnesses

1. Peter H. Wendschuh, M.D.

Dr. Wendschuh received his M.D. degree from the University of Miami in 1978. Prior to that time, as a National Science Foundation fellow, Dr. Wendschuh had earned a Ph.D. in organic chemistry from the University of California at Berkeley in 1971. Dr. Wendschuh completed an internship in internal medicine in 1979 at the Jackson Memorial Medical Center in Miami; he completed a residency in dermatology in 1982, also at the Jackson Memorial Medical Center in Miami. He also earned board certification in the specialty of dermatology in 1982 (CX-68; CX-72, p. 1 (Written direct testimony filed May 31, 1985)).

Since earning his board certification in dermatology, Dr. Wendschuh has engaged in private practice in dermatology. He is currently on the staffs of eight hospitals in the greater Miami area. He is also an Assistant Clinical Professor at the University of Miami Department of Dermatology (CX-68; CX-72, p. 1). Dr. Wendschuh keeps current in the field of dermatology by attending medical conferences at which current developments in dermatology are discussed, and by personal contacts with other physicians specializing in dermatology. In addition, he regularly reads several medical journals, including Archives of Dermatology, Journal of the American Medical Association, Journal of the American Academy of Dermatology, Capsules and Comments on Dermatology and Skin Allergy News. (CX-72 pp. 1-2).

As a dermatologist, Dr. Wendschuh is well qualified to testify as an expert on the effects Respondents' products have when topically applied to a user's skin. (CX-68; CX-72; June 17 Tr. 35-36). Dr. Wendschuh's opinion regarding the effects of Respondents' product when topically applied to a female user's breasts is in conformity with the informed consensus of medical and scientific opinion (CX-72, pp. 2-4; June 17 Tr. 35-37). Dr. Wendschuh's testimony was forthright and credible.

2. Estelle R. Ramey, Ph.D.

Dr. Ramey received her Ph.D. in physiology, with special training in endocrinology, in 1950 from the University of Chicago. At that time, she was awarded a U.S. Public Health Service Postdoctoral Fellowship in Endocrinology to work at the Michael Reese Hospital Research Institute in Chicago. The selection process for this fellowship was highly competitive: applicants were sponsored by their universities, and only one in fifty applicants was awarded funding. Dr. Ramey became an Assistant Professor in the Department of Physiology at the University of Chicago School of Medicine in 1950. For the next six years, she taught endocrinology to medical students and trained several Ph.D. candidates in endocrinology. During those years, she also did research in the relationship of glands and the nervous system to stress responses, as well as in the field of diabetes mellitus (CX-70; CX-71, p. 1 (Written direct testimony filed May 31, 1985).

In 1956, Dr. Ramey joined the staff of the Georgetown University Medical School where, since 1965, she has been a full professor in the Department of Physiology and Biophysics. At Georgetown, she has continued her endocrine research and teaching of medical, dental and graduate students (CX-70; CX-71, pp. 1-2).

Dr. Ramey has received numerous academic and civic awards during the course of her career, including election to the Phi Beta Kappa Society. She was honored as the Mergler Scholar in Physiology at the University of Chicago, which is a scholarship awarded periodically to the University's outstanding student in physiology. In 1973, she was named Outstanding Alumna from the University of Chicago. Every year, Phi Beta Kappa chooses approximately eight outstanding scholars on a nationwide basis to be its "Visiting Scholars," an honor which entails lecturing at universities throughout the country on the scholars' various areas of expertise. Dr. Ramey was chosen as a Visiting Scholar by Phi Beta Kappa for the academic year 1981-82. She holds honorary degrees from nine universities, including Georgetown University and Emory University (CX-70; CX-71, p. 2).

Dr. Ramey has authored or co-authored approximately one hundred scientific papers or abstracts for publication in peer-review professional publications or for presentation to professional meetings in the areas of physiology and endocrinology (CX-70; CX-71, p. 2). Throughout her career, Dr. Ramey has participated in research

Dr. Ramey regularly attends, and has lectured at, meetings of the American Physiological Society, the Endocrine Society, and the American Diabetes Association. She has also chaired sessions at these organizations' meetings. She has also presented papers at meetings of the international Endocrine Society, and the International Physiological Society. Last year, the National Science Foundation sponsored her attendance at an International Conference on Science Education (CX-71, p. 3).

Dr. Ramey regularly reads, and has published in, the American Journal of Physiology and the Journal of Endocrinology. She also regularly reads the Journal of Clinical Endocrinology and the New England Journal of Medicine. From 1978 through 1982, Dr. Ramey was a member of the Advisory Committee to the Director of the National Institute of Health (CX-71, p. 3).

Dr. Ramey is well qualified to testify as an expert in physiology and endocrinology, and thus on the effects of Respondents' product when applied to a female user's breasts (CX-70; CX-71; June 17 Tr. 17-18). Dr. Ramey's opinion regarding the effects of Respondents' product when topically applied to a female user's breasts is in conformity with the informed consensus of medical and scientific opinion (CX-71, p. 4; June 17 Tr. 17-18).

3. Yvonne T. Maddox, Ph.D.

Dr. Maddox received her Ph.D. in physiology from Georgetown University in 1981. At that time, she was awarded a Post Doctoral Fellowship by the National Institute of Health to pursue research in cardiovascular physiology in the Department of Physiology at Georgetown University. Since 1983, she has been a Research Assistant Professor in the Department of Physiology at the Georgetown University Medical Center, where she currently teaches. She also currently holds a position as research

Dr. Maddox has authored or co-authored over thirty-five papers or abstracts for publication in peer-review professional publications. She has also participated in numerous research

Dr. Maddox helps organize the Winter Prostaglandin Conference, membership in which is considered highly desirable by the scientific community and is by invitation only. Every third year, the conference is international. She also regularly attends meetings of the Reticuloendothelial Society, a national organization of researchers who study the cells involved in the immune system, and the Society for Gerontology (CX-73, p. 2).

She regularly reads, and has published in, the Journal of Pharmocology and Experimental Therapeutics, and Nature. She also regularly reads the American Journal of Physiology and the Journal of Endocrinology (CX-69; CX-73, p. 3).

Dr. Maddox is well qualified to testify as an expert in physiology and endocrinology, and thus on the effects of Respondents' product when applied to a female user's breasts (CX-69; CX-73, pp. 1-3; June 18 Tr. 6). Dr. Maddox's opinion regarding the effects of Respondents' product when topically applied to a female user's breasts is in conformity with the informed consensus of medical and scientific opinion (CX-73, pp. 3-4; June 18, Tr. 6).

The Truth or Falsity of the Representations

The following findings of fact are based upon the testimony of Drs. Wendschuh, Maddox and Ramey, whose testimony represents the informed consensus of medical and scientific opinion with respect to the issues to which their testimony relates.

1. Dermatology is the medical specialty concerned with the skin (CX-72, p. 2). Physiology is the study of body systems and how they work. Endocrinology is the study of hormones and their function within the body (CX-71, p. 4; CX-73, p. 4).

2. The female breasts are major secondary sex characteristics that appear at puberty. The human female's chromosomes direct the hypothalamus to release factors that signal the pituitary gland to release the hormone estrogen in the pubescent girl. Before menarche, both males and females have mammory glands that consist of only a few ducts surrounded by connective tissue. A male's mammary glands remain this way. In females, however, at the onset of puberty, the duct tissue is stimulated by the hormone estrogen to elongate and branch out. The connective tissue proliferates and becomes infiltrated with fat, and the breast begins to assume the shape of the mature female gland. When the female's ovulation cycle begins, the hormone progesterone is secreted by the pituitary and the characteristic structure of the breast during childbearing years is developed (CX-71, pp. 4-5).

3. Breast development is caused by hormonal activity within the individual's body. To trigger the hormonal activity, the brain must be stimulated by chromosomal information to activate the pituitary gland, which in turn, will release the hormones. All women have approximately the same amount of mammary gland tissue -- about a teaspoonful. Difference in breast size and shape are completely determined by the amounts of fatty and connective tissue each woman has. How much fatty and connective tissue a woman has is determined by her genetic composition, and by how much excess body fat she may acquire through life. In other words, every female is genetically unique as to how much her body will respond -- i.e., what the size and shape of breasts will be -- to the estrogen secreted by the pituitary gland at puberty (CX-71, pp. 5-6; June 17 Tr. 18-19). Moreover, a woman's breasts are not identical in size. Normally, most women have one breast that is slightly larger than the other (June 17 Tr. 19, 3-31; June 18 Tr. 11).

4. In addition to fat and connective tissue, the breast is composed of the nipple, where the ducts converge, and alveoli (the dark pigmented areas surrounding the nipples). The alveoli-nipple area is the only part of the breast that contains muscle fiber. This area is extremely sensitive, and, because of the muscle tissue in it, can become erect if touched or exposed to heat or cold. The breast is attached by connective tissue to the underlying chest muscles, the pectorals (CX-71, p. 6).

5. Once the female's ovulatory cycles have begun, and her breasts have developed into their mature shape, two aspects of her life cycle will sufficiently stimulate the brain to cause hormonal activity to alter the size and shape of her breasts (CX-71, p. 6).

6. Tissue changes occur in the female breast with each menstrual cycle (roughly a 28-day period). During the first half of the cycle, high levels of ovarian estrogens in the blood stimulate the reproduction of cells in the glandular ducts and the alveoli (the dark pigmented area surrounding the nipple). Increasing amounts of progesterone cause the ducts to dilate and alveolar cells to differentiate from secretory cells. Once ovulation occurs, there is also increased bloodflow to the breasts. In the week before menstruation, some women experience fluid retention in the breasts. The increased cellular growth caused by the ovarian estrogens in the blood, the enlarged duct diameters and newly formed alveoli cells caused by the increased progesterone levels, all contribute to this engorgement. Once menstruation ceases, the proliferate tissue begins to regress and is reabsorbed (CX-71, pp. 6-7; June 17 Tr. 19; June 18 Tr. 7)

7. Breast enlargement also occurs during pregnancy and lactation. The changes to the breast that occur during pregnancy are much greater than those that occur premenstrually. Each breast gains nearly a pound in weight by the end of the pregnancy. The increased size and weight are due to the glandular cells being partially filled with secretion, an increased number of blood vessels, and increased amounts of connective tissue and fat. The hormones that stimulate and prepare the breasts during pregnancy are the sex steroids from the ovaries and placenta. Other placental, pituitary and metabolic hormones also contribute to the duct and alveoli growth and differentiation into secreting cells (CX-71, p. 7; June 17 Tr. 19-20).

8. Once the baby is born, prolactin, a hormone from the anterior pituitary, causes the glandular cells to secrete large quantities of milk. As long as nursing continues, the mother will produce milk, and her breasts will accordingly remain enlarged (CX-71, p. 7).

9. Puberty, menstruation, pregnancy and lactation, and times of overall body weight gain, are the only times healthy breasts become noticeably enlarged. With the exception of overall body weight gain, all of these are due to complex hormonal activities within the female body. The extent to which the hormonal activity produces physiological changes in the woman is determined by her inherited genetic make-up (CX-71, pp. 7-8; CX-73, p. 6; June 17 Tr. 20-22).

10. Accordingly, not topically applied cream or lotion will cause a woman's breasts to become noticeably larger (CX-71, p. 8; CX-73, p. 6; June 17 Tr. 23; June 18 Tr. 7).

11. Consequently, at this point in time, the only medically and scientifically acceptable method to enlarge the female breast is by surgical implantation (CX-71, p. 8; June 17 Tr. 23-24; June 18 Tr. 7-8).

12. The ingredients in Respondents' product are not capable of producing a noticeable enlargement of the female user's breasts. This is because, as stated before, only complex hormonal activity and subsequent physiological reactions by the body, can cause breast enlargement (CX-71, p. 8; CX-73, p. 7).

13. Respondents' product, if topically applied, may cause a slight blush to spread over the area to which the product is applied. This is due to the presence of niacin in the products (CX-73, p. 5). Niacin, when topically applied, does penetrate the skin, causing its surface capillaries to increase their blood flow (CX-72, p. 4; CX-73, p. 5; June 17 Tr. 37-38; June 18 Tr. 9). This activity, however, would not cause a noticeable enlargement of the breast, if applied thereto (CX-72, p. 4; CX-73, p. 5; June 17 Tr. 37-38; June 18 Tr. 9). Just as a person's face does not get larger if she blushes, a woman's breasts would not get larger because of the blush that would occur there as a result of topically applying niacin to her breasts (CX-73, p. 5; June 17 Tr. 37).

14. Most of the remaining ingredients in the products are either aromatic or softening agents. Allantoin helps heal wounds and stimulates the growth of healthy tissue at the wound site. However, its ability to penetrate intact skin has not been demonstrated, and there is no evidence that it will stimulate the growth of normal breast tissue or in any other way enlarge the breast. Panthenol is taken orally to increase intestinal peristalsis and tone. Again, there is no evidence that it will penetrate the skin. Collagen is the major structural protein of the dermis; there is no evidence that the major amino acids in collagen can penetrate the skin if topically applied (CX-72, p. 4; CX-73, pp. 5-6).

Little is known about the medical effects of the remaining active ingredients. Aloe extract has been used as a purgative. Comfrey extract has been used to heal ulcers -- it is a potential carcinogen. Chamomile extract has been used as an emetic, and may be anti-inflamatory. Cucumber extract is an astringent and has a cooling effect on the skin (CX-72, pp. 4-5; CX-73, p. 6). There are anecdotal reports that ginseng, if taken orally, may cause hypertension and mastalgia, a condition of painful breasts (CX-72, p. 5; CX-73, p. 6).

The remaining ingredients essentially comprise the vehicle by which the applied ingredients discussed above are applied to the skin. One of them, methyl paraben, can cause contact dermatitis (CX-72, p. 5; CX-73, p. 6).

15. Placing a hot towel on one's breasts, as per Respondents' directions for use of the products, may cause a slight edema to occur. The subject might flex her pectoral muscles in reaction of the heat. This would occur whether or not the person placing and hot towel on her breasts also applied Respondents' product to her breasts. Moreover, repeatedly placing a hot towel on her breasts could cause considerable irritation, and possibly, pain (CX-71, p. 8; CX-72, p. 5; CX-73, p. 8; June 17 Tr. 26, 31).

16. After having conducted searches of the medical literature in the area of breast growth and development, as well as on the ingredients in Respondents' products, neither Doctor Wendschuh nor Doctor Maddox discovered any medical or scientific study linking any of these ingredients to healthy breast development or enlargement (CX-72, pp. 3-4; CX-73, pp. 4-5; June 17 Tr. 22-23; 36; June 18 Tr. 6, 13).

17. Dr. Wendschuh conducted extensive computer searches of the referenced medical and scientific literature in Medline as far back as 1966. He also searched the Toxicology Data Base, Chemline and a pharmacological data base. He also reviewed the Merck Index and various biochemistry and pharmacological textbooks. Dr. Wendschuh found no reports or studies which linked the ingredients in Respondents' product in any way to breast enlargement (CX-72, pp. 3-4; June 17 Tr. 36, 37).

18. Dr. Maddox conducted extensive computer searches of the referenced medical literature in both the Index Medicus and Med Line, going back to the early 1960s in her searches. In addition, she reviewed standard medical textbooks, the Merck Index, and a dictionary of Cosmetic Ingredients. Dr. Maddox found no reports or studies which linked the ingredients in Respondents' product in any way to breast enlargement (CX-73, pp. 4-5; June 18 Tr. 6).

19. Each of the doctors who testified on behalf of Complainant is well qualified to testify on the quality and type of evidence required to establish a product's or formula's efficacy (CX-71, pp. 1-3, 8-9; CX-72, pp. 1-2, 5; CX-73, pp. 1-3, 7; June 17 Tr. 17-18; June 18 Tr. 6).

For a product's efficacy to be accepted by the scientific and medical communities, clinical trials should be administered. These trials should be "double blind," that is, neither the administrators of the tests nor the subjects should know the purpose behind the test or the product involved. In addition, there should be at least one "control" group, that is, a group to which a placebo is administered. Again, neither the subjects of this group nor the administrators should know what the product is or whether it is a placebo. In addition, the group receiving the placebo should, at some appropriate point in the experiment, receive the actual drug and vice versa. Again, no one involved with the test should be aware of the change. The tests should be designed so that all body systems are involved; for example, there should be dermatological studies, vascular studies, and endocrinological studies (CX-71, p. 9; CX-72, p. 6; CX-73, pp. 7-8; June 17 Tr. 24-26; June 18 Tr. 9-10).

20. If any such study had been conducted on Respondents' product, or any ingredient therein, that demonstrated that the product caused breast enlargement, that study would have been discovered by Dr. Wendschuh and Dr. Maddox in their research of the medical and scientific literature. Moreover, it would be well known by Drs. Maddox, Ramey and Wendschuh because it would be a revolutionary development in their areas of expertise, endocrinology, physiology and dermatology. The lack of such a study indicates that Respondents' product does not cause a noticeable enlargement of the female user's breast (CX-71, pp. 9-10; CX-72, pp. 6-7; CX-73, p. 8; June 17 Tr. 22-23, 35-37; June 18 Tr. 13).

21. Anecdotal reports are unreliable indicia of a formula's efficacy. In the instant case, in an unscientific demonstration where lay users would have applied Respondents' product as directed, any apparent change in the size of their breasts would not be due to the product. Rather, it would be due to the effects of the hot towel, simple changes in posture, or flexing of the pectoral muscles, and the possible erection of the alveoli-nipple area due to exposure to heat and rubbing. Moreover, the demonstration would fail to overcome the fact that no scientific or medical studies have been conducted which establish that the product can achieve such a result (CX-71, p. 10; CX-72, p. 7; CX-73, pp. 8-9; June 17 Tr. 26-28, 30-31; June 18 Tr. 8-9, 11-12).

22. The foregoing findings of fact establish that Respondents' representation is materially false as a matter of fact.

CONCLUSIONS OF LAW

1. Where an individual, in this case Mitchell K. Friedlander, is the sole owner, director, and president of the corporate Respondents and this individual is in a position to control, formulate and direct the policies and daily activities of the corporations, and in fact, does so, he may be named in his individual capacity in the cease and desist order. Cf., FTC v. Standard Education Soc., 302 U.S. 112 (1937); United States v. Johnson, 541 F.2d 710, 713, (8th Cir. 1976) cert. denied, 429 U.S. 1093 (1977); Sunshine Art Studios, Inc. v. FTC, 481 F.2d 1171, 1175 (1st Cir. 1973); Bruhn's Freezer Meats, Inc. v. United States Dept. of Agriculture, 438 F.2d 1332, 1343 (8th Cir. 1971).

2. Where there is evidence that the individual, here Mitchell K. Friedlander, was responsible for the advertising used by the corporate Respondents -- and misrepresentations in such advertising form the crux of the statutory violation -- it is imperative that the individual be bound in his personal capacity in order to make the cease and desist order fully effective. Cf., Tractor Training Service v. Federal Trade Com., 227 F.2d 420 (9th Cir. 1955), cert. denied, 350 U.S. 1005 (1956); FTC v. Standard Education Soc., supra.

3. Respondents Michael Meade and Harris Friedlander should be named in their individual capacities in the cease and desist orders issued (Findings and Conclusions, supra, pp. 10-13).

4. The meaning of a solicitation's representations is to be judged from a consideration of the advertisement in its totality and the impression it would most probably create in ordinary minds. Donaldson v. Read Magazine, Inc., 333 U.S. 178 (1948); Borg-Johnson Electronics, Inc. v. Christenberry, 169 F. Supp. 746 (S.D.N.Y. 1959); Vibra-Brush Corp. v. Schaffer, 152 F. Supp. 461 (S.D.N.Y. 1957), Rev'd on other grounds, 256 F.2d 681 (2nd Cir. 1958).

5. Applying the above criteria to Respondents' promotional materials, it is evident that Respondents' promotional materials submitted into evidence in this proceeding make the representation alleged in each of the Complaints. Moreover, Respondents admitted making the representations in their pre-trial submissions.

6. The person of ordinary mind would interpret Respondents' promotional materials as making the representations alleged in paragraphs 8(a), 8, and 6 of the Complaints in Docket Nos. 19/105, 19/161, and 20/32, respectively.

7. Respondents' brochures which accompany the products when purchased, are part of the promotional materials employed by Respondents in the sale of their products. The brochures make the above representations alleged in the Complaints. These brochures reinforce the original ads and result in reorders; moreover, there is no basis to assume that the original deception would be cleared up before the reorder form was put to use. Iso Tensor Plan, P.S. Docket No. 3/30, (P.S.D. May 23, 1975, pp. 27-28).

8. A money back guarantee does not dispel the effect of an advertisement's representations. Farley v. Heininger, 105 F.2d 79 (D.C. Cir. 1939), cert. den. 308 U.S. 587 (1939); Borg-Johnson Electronics, Inc. v. Christenberry, 169 F. Supp. 746 (S.D.N.Y. 1959). Accordingly, Respondents' motion to admit the "Morrow deposition" is denied. Moreover, Respondents failed to mention this evidence and argument in their submissions pursuant to the May 8 pre-trial order, and are deemed to have abandoned this motion. The same motion was also denied in W.G. Charles Co., P.S. Docket Nos. 19/104, 19/162 (P.S.D. Sep. 10, 1985 at 6) and Intra-Medic Formulations, Inc., P.S. Docket No. 19/182 (P.S.D. Sep. 10, 1985 at 4).

9. The representations found to have been made by Respondents are material representations since they would induce a consumer to purchase the product.

10. The jurisdiction of the Postal Service under 39 U.S.C. § 3005 is established when it is shown that a Respondent has solicited money through the mails. Respondents' advertisements seek money through the mail, and proof of actual receipt of remittances through the mail by a Respondent is not required. IAAIC, P.S. Docket No. 13/173 (P.S.D. December 29, 1982). Moreover, the June 12 submission by the "corporate respondents" stipulates to such use of the mails.

11. The fact that a medical expert witness has not personally used or tested a product does not in any way discredit his testimony. Original Cosmetics Products, Inc. v. Strachan, 459 F. Supp. 496 (S.D.N.Y. 1978), aff'd mem. no. 78-6165 (2nd Cir. April 30, 1979); Feil v. Federal Trade Com. 285 F.2d 879, 893 (9th Cir. 1960).

12. Complainant has established its case by a preponderance of the competent, reliable and probative evidence of record. S.E.C. v. Savoy Industries, 587 F.2d 1149, 1168 (D.C. Cir. 1978).

13. The representations alleged to be false in the Complaints, as amended, are materially false as a matter of fact.

14. Respondents are engaged in conducting a scheme for obtaining money or property through the mails my means of materially false representations. Accordingly, a False Representation Order and Cease and Desist orders under 39 U.S.C. § 3005 are issued herewith.