In the Matter of the Complaint Against

BODYSCIENCE, INC.
20 Medford Avenue
at Patchogue, NY 11772

and
2105 Lakeland Avenue
at Ronkonkoma, NY 11779

and
Post Office Box 4228
at Springdale, CT 06907

P.S. Docket No. 12/123;

07/22/82

Grant, Quentin E.

APPEARANCE FOR COMPLAINANT:
Thomas A. Ziebarth, Esq.
Consumer Protection Division
Law Department
United States Postal Service
Washington, DC 20260

APPEARANCE FOR RESPONDENT:
Lee H. Harter, Esq.
2256 Van Ness Avenue
San Francisco, CA 94109

INITIAL DECISION

In a Complaint filed on November 3, l981, Respondent was alleged to be in violation of 39 U.S.C. § 3005 by seeking remittances of money through the mail by means of eleven false representations concerning its product DMG-15. The specific alleged false represen- tations, together with a twelfth added by amendment to the Complaint (i.E., "DMG-16 is safe to use"), are set forth in the findings of fact, below.

Respondent admits its use of the advertisements annexed to the Complaint but denies making the alleged false representations except that as to safety. The Answer filed by Respondent raised affirmative defenses discussed below in my conclusions of law.

A hearing was held in New York City on February 3, 4, and 5, 1982 january filing of post-hearing briefs and proposed findings of fact and conclusions of law was delayed until early June, 1982 due mainly to the poor quality of the transcript of the hearing for February 3 and 4. Corrections proposed by the parties and allowed in my Order of June 15, l982, covered but a small fraction of the errors in the transcript.

All proposed findings, conclusions, and arguments contained in briefs have been considered in reaching this decision. To the extent indicated they have been adopted. Otherwise they have been rejected as irrelevant, immaterial or contrary to the law or the evidence.

At the hearing Complainant introduced into evidence without objection by Respondent (2/5, Tr. 29) a product currently being furnished by Respondent called simply DMG, rather than DMG-15. Therefore, I am treating the Complaint as amended to include the product labeled DMG wherever DMG-15 is mentioned therein.

FINDINGS OF FACT

1. Respondent, Bodyscience, Inc., at the addresses set forth in the caption hereof, through advertisements appearing in publications of general circulation, seeks remittances of money or property through the mail for its products DMG-15 and DMG. (CX-1 through 4; 2/3, Tr. 7)

2. The product received by Postal Inspector G. L. Borta when he ordered DMG-15 from Respondent was labeled as follows (in pertinent part):

aangamik 15

Calcium Gluconate

&

N, N-Dimethylglycine

50 Mg. Equimolar Mixture

DMG 15 TM

100 Tablets

Distributed by:

FoodScience Laboratories

At One Executive Drive

So. Burlington, Vermont 05401

The Original Formula -

First In America DMG 15 TM

Suggested use: 3 to 6 tablets daily.

Contents:

Microcrystalline Cellulose (Vegetable origin),

Dicalcium Phosphate, Calcium Gluconate

N,N-Dimethylglycine, Tricalcium Phosphate

(CX-5)

3. At the time of the hearing the product furnished by Respondent bore the following label:

DMG

N,N-Dimethylglycine

60 tablets - 90 mg each

distributed by: BodyScience, Inc.

2105 Lakeland Avenue

Ronkonkoma, N.Y. 11779

(CX-8)

4. It is probable that the dimethylglycine (hereinafter sometimes Dmg) in both products (CX-5 and CX-8) is dimethylglycine hydrochloride because Dmg as furnished by chemical suppliers is always the hydrochloride (2/3, Tr. 24, 25).

5. Employing the principles of interpretation of advertising applicable to proceedings under 39 U.S.C. § 3005 (see Conclusions of Law, below) I find that Respondent's advertising material makes the representations alleged in paragraph 3 of the Complaint. Such representations are set forth below (underscored) followed by the language of Respondent's advertisements in which I find them to be made. Quotations labeled "Original Advertisements" are found in CX-1 or CX-2. Those labeled "Revised Advertisements" are found in CX-3 or CX-4.

(a) DMG-15 (N, N-Dimethylglycine) is a supernutrient pill that can significantly improve the user's life by providing increase energy, stamina and endurance.

" . . .

With DMG-16, the Supernutrient Pill that Can Significantly improve Your Life and give you energy, stamina and endurance at work, at play, or at night with your spouse]"

(Original advertisements)

New super-food pills:

"3 hours later, I was still bouncing around. I felt terrific]" with DMG, the supernutrient pill. Will you, too, have more energy and stamina at work, at play, at night with your spouse?

I Can only tell you what it has done for me and others. * * * how our stamina and endurance have improved remarkably;

(Revised advertisements)

(b) DMG-15 can add years to the user's life.

...even add years to your life]

The true story of how DMG-15 gave Mr. and Mrs. William Link the most precious gift of all --TIME]

"All I can tell you is that it gave my husband new life for 4 years...and if it could give a dying man life, imagine what it could do for a healthy person."

(Original Advertisements)

Can DMG help prevent disease, even add years to your life?

Jaye Robertson says DMG revitalized her dying husband]

"All I can tell you is that it gave my husband new life for four years, and if it could give a dying man life, imagine what it could do for a healthy person."

(Revised Advertisements)

(c) DMG-15 can enhance the user's sexual abilities and capacity for sexual enjoyment.

And, what a night] I was convinced that the sexual enhancing effects that I felt were from the DMG-15 and not just my beautiful companion.

In fact, my husband was feeling so good, our

(d) DMG-15 can enhance the utilization of oxygen by every cell in the user's body.

Probably the single most important thing that DMG-15 does is enhance the utilization of oxygen by every cell in your body --including heart, muscle, brain and nerve cells --every single one.

(Original Advertisement)

Moreover, DMG may help you increase your uptake and efficient utilization of oxygen.

In other tests, doctors demonstrated that DMG enhances oxygen utilization.

When rabbits exposed to severe surgical stress were given DMG, their uptake and utilization of oxygen increased, leaving blood pressure and respiration completely normal.

When fed DMG under controlled laboratory conditions, rats were shown to increase oxygen uptake in low oxygen environments.

These findings suggest that DMG may allow the cells to continue normal functioning even under adverse (low oxygen) conditions. This shows that DMG may benefit athletes who experience pain, muscle cramping, and fatigue; individuals undergoing surgery or suffering from degenerative diseases; and others who require greater oxygen efficiency.

Increase oxygen efficiency at the cellular level has a significant impact on the performance of the mind and body. I've been using DMG now for several months with unbelievable results]

(Revised Advertisements)

(e) DMG-15 is effective in the prevention, alleviation, treatment or cure of such_ diseases or conditions as:

(i) hypertension,

(ii) gout,

(iii) arthritis

(iv) angina,

(v) arteriosclerosis.

It seems particularly beneficial to patients with angina and atherosclerosis (hardening of the arteries).

This may help you sidestep such maladies as hypertension, gout and aggravated arthritis.

"Two weeks after he started taking the DMG-15 formula he was doen to 5-7 angina attacks a day. Failed Fifth week, no more angina. It was indeed, a miracle] He was reborn. Life had been given back to him....And he even told me his arthritis was better. Since I had a touch of arthritis myself, I thought it wouldn't hurt if I tried some of his DMG-15 formula to see what it could do. Sure enough, it cleared up my arthritis, and my joints are limber and young to this day."

(Original Advertisements)

Can DMG help prevent disease...?

Form 50 angina attacks a day to "a perpetual honeymoon."

SCIENTIFIC PROOF]

University tests in Los Angeles and Charleston indicate that DMG may help your body prevent infection and disease as well as speed recovery time.

We read about DMG, a new nutrient called a metabolic enhancer, which could sometimes assist in easing arteriosclerosis by delivering more oxygen to the bloodstream.

...how it has helped protect against illness and improve recovery.

(Revised Advertisements)

(f) DMG-15 can maintain glycogen in the user's muscle tissue.

DMG-15 maintains muscle glycogen, a kind of reserve fuel in your muscle tissue.

(Original Advertisement)

(g) DMG-15 can prevent lactic acid buildup in the user's blood and muscles.

Another property of this fantastic nutrient is its ability to prevent lactic acid buildup in the blood and uscles --a major cause of fatigue and muscle cramps.

(Original Advertisement)

DMG lowered the concentration of lactic acid in the blood of animals under severe mental and physical stress. Lactic acid is formed by the tissues under low-oxygen conditions, such as extreme exercise, or when the body is in shock, or during the stress of surgery.

(Revised Advertisement)

(h) DMG-15 will help maintain normal blood serum levels of cholesterol, triglycerides and uric acid in the user's body.

DMG-15 is helpful in maintaining a normal blood serum level of cholesterol, triglycerides and uric acid --especially during times of stress when they are most prevalent.

(Original Advertisement)

(i) DMG-15 can produce a noticeable improvement in the user's immune system by increasing the production of antibodies and lymphocytes.

Another study by immunologist, Dr. C. D. Graber at the Medical University of South Carolina, Charleston, reports a noticeable improvement of the immune system in patients using DMG. By increasing both antibody and lymphocyte (white blood cell) production, the body as an increased ability to stave off infection and disease: and, in many patients with lowered immune response (such as those on chemotherapy or burn patients), it can make a significant difference in recovery time.

(Original Advertisement)

In one controlled double-blind study, doctors confirmed that DMG in humans enhances the body's immune responses. This human study, as well as earlier animal studies, confirms DMG's impact on both parts of the immune system. Antibody production is increased (these are molecules which help neutralize infections and harmful bacteria) and lymphocyte generation is also increased (these are white blood cells which are primarily responsible for the destruction of foreign --disease causing --substances).

In this study, lymphocytes from normal individuals and those with diabetes and sicle cell anemia were tested for their ability to induce the immune response. All three groups who used DMG showed a significant increase in lymphocyte (white blood cell) production as compared to the control group who did not use DMG.

(Revised Advertisements)

(j) DMG-16 can improve the user's mental processes by allowing the user to concentrate better, think more clearly and remember better.

My thinking and concentration abilities were as keen as I can remember them in years.

I can only tell you what it has done for me and others. ***how many of use feel we can concentrate better, think more clearly and remember better...

(Original Advertisements)

(k) The advertising claims made for DMG-15 as described in subparagraphs (a) through (j) are supported by"=be to with disputant an Scientific and medical studies or clinical trials.

SCIENTIFIC PROOF]

But there's more. Indeed, if anything, researchers are first truly beginning to fully comprehend just how intricately DMG-15 works within the complex structure of the human body. Research by Dr. J. W. Meduski at the USC School of Medicine, Los Angeles, indicates that the increased oxygen efficiency produced by using DMG may be of par ticular value to patients undergoing surgery and persons suffering from chronic degenerative diseases. It seems particularly beneficial to patients with angina and atherosclerosis (hardening of the arteries).

Another study by immunologist, Dr. C. D. Graber at the Medical University of South Carolina, reports a noticeable improvement of the immune system in patients using DMG. By increasing both antibody and lymphocyte (white blood cell) production, the body has an increased ability to stave off infection and disease; and, in many patients with lowered immune response (such as those on chemotherapy or burn patients), it can make a significant difference in recovery time.

(Original Advertisements)

But then, they hadn't yet seen the published research reports of doctors and immunologists in California and South Carolina.

SCIENTIFIC PROOF]

University tests in Los Angeles and Charleston indicate that DMG may help your body prevent infection and disease as well as speed recovery time. Moreover, DMG may help you increase your uptake and efficient utilization of oxygen.

...

In one controlled double-blind study, doctors confirmed that DMG in humans enhances the body's immune responses. This human study, as well as earlier animal studies, confirms DMG's impact on both parts of the immune system. Antibody production is increased (these are molecules which help neutralize infections and harmful bacteria) and lymphocyte generation is also increased.

...

In this study, lymphocytes from normal individ uals and those with diabetes and sickle cell anemia were tested for their ability to induce the immune response. All three groups were used DMG showed a significant increase of lymphocyte (white blood cell) production as compared to the control group who did not use DMG.

...

This study shows that DMG, like other nutrients such as Vitamins A and C and the mineral zinc, is beneficial for any individual with a low immune response activity.

In other tests, doctors demonstrated that DMG enhances oxygen utilization. DMG lowered the concentration of lactic acid in the blood of animals under severe mental and physical stress.

...

When rabbits exposed to severe surgical stress were given DMG, their uptake and utilization of oxygen increased, leaving blood pressure and respiration completely normal.

When fed DMG under controlled laboratory conditions, rats were shown to increase oxygen uptake in low oxygen environments.

These findings suggest that DMG may allow the cells to continue normal functioning even under adverse (low oxygen) conditions. This shows that DMG may benefit athletes who experience pain, muscle cramping, and fatigue; individuals undergoing surgery or suffering from degenerative diseases; and others who require greater oxygen efficiency.

(Revised Advertisements)

6. Respondent admits in its post-hearing brief that it repre sents in its advertising that DMG-15 is safe to sue (BR. p. 8).

7. In a small box at the bottom of Respondent's revised advertisements (CX-3, 4) appears the following:

IMPORTANT NOTICE FROM BODYSCIENCE, INC.

This article includes published reports, notarized sworn testimonials, and the opinion of many experts that may not yet be scientific dogma. You see, BodyScience, Inc. is in the forefront of research into alternative methods of increasing your body's natural capabilities. Our goal is to take the latest in nutritional science, and combine them to give you freedom of choice and an iron-clad gurantee. If your're not satisfied with how DMG--or any of our products --enhances the quality of your life, just return the unused portion--even the empty bottle or package--for a prompt refund of your purchase price]

8. Each party called only one witness at the hearing. Testify ing as an expert witness for Complainant was Victor Herbert, M.D., J.D. He received his medical degree at the Columbia University College of Physicians and Surgeons in 1952 and his J.D. degree at Columbia University School of Law in 1974. He is board certified in Internal Medicine (1959) and Nutrition (1967). H is Director, Division of Hematology and Nutrition, Bronx V.A. Hospital, New York, Clinical Professor of Medicine at the College of Physicians and Surgeons, Columbia University, and Professor and Vice Chairman of Medicine, State University of New York (Downstate Medical Center, Brooklyn, NY). He is a member of the Food and Nutrition Board, National Research Council, National Academy of Science. He is a member of 21 professional societies. He serves on the editorial board of 3 peer-reviewed scientific journals and has published 446 scientific articles and books (CX-6, 6A).

Dr. Herbert has done original research on the mutagenicity of dimethylglycine (CX-12) and has written extensively on the subject matter of this proceeding (CX-9, 10).

Dr. Herbert testified that the views he expressed on the issues in this proceeding are consistent with the informed medical and scientific consensus (Tr. 62).

(All references to Dr. Herbert's testimony are from the tran script of Feb. 3, l982 unless otherwise indicated).

9. Respondent's witness was Garry F. Gordon, M.D., a graduate of the Chicago College of Osteopathy with a D.O. degree (RX-26). His M.D. degree is honorary from the state of California (Tr. 67). He is present medical director of Nutrilab, Hayward, CA., (engaged in computerized diet analysis) and laboratory director of Mineralab, Inc., Hayward, CA (engaged in trace mineral analysis.

(All references to Dr. Gordon's testimony are from the transcript of Feb. 4, l982).

Dr. Gordon is a founder and has been the occupant of the top offices in the American Academy of Medical Preventics, is a founding member of the American Holistic Medical Association, and a board member of the International Academy of Holistic Health and Medicine (RX-26).

Dr. Gordon has not conducted any studies involving Dmg. The basis for his views on the matters in issue is his reading of the literature and what he has learned from colleagues (Tr. 97, 98).

Dr. Gordon stated that his views are the consensus of informed medical experts (Tr. 65). On cross-examination he stated that the consensus he expressed was that of doctors who wish to be nutriclaimed the to an, which which it Informed (Tr. 80).

10. I find that Dr. Herbert's qualifications to testify on the medical and scientific issues in this proceeding are superior to those of Dr. Gordon and I find Dr. Herbert's testimony more persuasive than that of Dr. Gordon. Consequently, the following findings on the falsity issues are based largely on Dr. Herbert's testimony and exhibits relied on by him.

11. The advertising claims made for the product as described in subparagraphs (a) through (k) of paragraph 3 of the Complaint (see Finding of Fact No. 5, supra) are not supported by competent, scientific and medical studies or clinical trials (Tr. 38).

12. Dimethylglycine is an amino acid the sole nutrient value of which, ingested as a pill, is four calories per gram (or eleven of Respondent's 90 mg. tablets). It is not an essential amino acid (Tr. 33). Note: In the following findings, reference to Respon dent's product (or DMG) includes both products involved in this proceeding unless otherwise indicated .

13. DMG is not a super-nutrient pill that can significantly improve the user's life and give increased energy, stamina, and endurance. Its only nutrient value is four calories per gram (Tr. 33, 34). If taken as directed on the label (3 to 6 tablets of DMG-15, (CX-5) or 1 to 2 tablets of DMG (CX-8) the daily energy increase provided would be a minuscle 1/3 calorie to 2 calories per day.

14. The product cannot add years to the user's life (Tr. 34).

15. The product cannot enhance the user's sexual abilities and capacity for sexual enjoyment (Tr. 34).

16. The product cannot enhance the utilization of oxygen by every cell in the user's body. It consumes oxygen in the body instead of delivering it (Tr. 34, 35).

17. The product is not effective in the prevention, allevia tion, treatment or cure of hypertension, gout, arthritis, angina, or arteriosclerosis (hardening of the arteries) (Tr. 35, 36).

18. The product cannot maintain glycogen in the user's muscle tissue (Tr. 36).

19. The product cannot prevent lactic acid buildup in the user's blood and muscles (Tr. 36, 37).

20. The product will not help maintain normal blood levels of cholesterol, triglycerides, and uric acid (Tr. 37).services 21. The product will not produce a noticeable improvement in the user's immune system by increasing the product of antibodies and lymphocytes (Tr. 37, 38).

22. The product will not improve the user's mental processes by allowing the user to concentrate better, think more clearly and remember better (Tr. 38).

23. With regard to the representation that the product is safe to use, Complainant introduced the report of a controlled scientific study performed by Dr. Herbert and others (CX-12) which, employing the Ames Test, showed dimethylglycine alone is not mutagenic but when preincubated with sodium nitrite to simulate exposure to salivary and gastric nitrites, and tested using appropriate controls, demonstrated a dose-related mutagenic effect. Mutagenicity is the ability to transform a cell by giving it a property it did not previously have or taking away a property it previously had. Mutagenicity by the Ames Test correlates in nine cases out of ten with the ability to cause cancer (Tr. 40).

24. Complainant also placed in evidence a decision in a case in the U. S. District Court for the Northern District of Illinois, United States v. An article of food...labeled in part...Aangamik 15 Calcium Pangamate etc. ... FoodScience Laboratories, Inc. (Consoli dated cases 77 C 662, et al.), in which it was held that N, N-Dimethylglycine as a food additive found in Aangamik 15 tablets, distributed by FoodScience Laboratories, Inc., is unsafe within the meaning of 21 U.S.C. § 342(a)(2)(c). As of the time of the hearing in the instant matter this case was on appeal to the Circuit Court of Appeals.

25. Many of the studies referred to by Respondent's witness Dr. Gordon, as supporting certain of the representations found above, were not identified by him (Tr. 35, 52, 53, 55, 56, 67, 59, 106). Thus, there is no way on this record to evaluate their scientific validity.

26. Several studies, or reports or abstracts of studies, were placed in evidence by Respondent. Based on the testimony of Complainant's expert, Dr. Herbert, and other evidence as indicated, I make the following findings concerning such exhibits:

a. Respondent's Exhibit 27 is an article entitled Immunomodulating Properties of Dimethylglycine in Humans, published in The Journal of Infectious Diseases (Jan. l981). The article reports on a double-blind study in 20 human volunteers purportedly employing Dmg administered orally. According to the abstract at the head of the article, the results of the sLdy suggest that DMG enhances both humoral and cell-mediated immune responses in humans. The study was made by Charles D. Graber and others. Graber is a Ph.D. and professor at the Medical University of South Carolina. This study is flawed and lacks scientific validity in that the test material used contained calcium, in the form of calcium gluconate, which would have accounted for some of the results reported, and several other substances including dicalcium phosphate and tricalcium phosphate. In fact, it contained the same material as the tablet (Aangamik 15) which was the subject of the federal court action mentioned in Finding of Fact No. 24, supra (Tr. 46, 47, 95, 100).

b. Respondent's Exhibit 28 is an abstract relating to the report of the Graber study (RX-27), and appended public relations material presented to an annual meeting of the Southeastern and

South Carolina branches of the American Society for Microbiology. It is subject to the same infirmities as RX-27 (see a., above) (Tr. 47, 48).

c. Respondent's Exhibit 29 is an article by Peter W. Stacpoole, of the Vanderbilt University School of Medicine, entitled Pangamic Acid ('Vitamin Ba5'), A Review. It was published in the World Review of Nutrition and Dietetics which operates out of Jamaica and according to Dr. Herbert, "accepts for publication everything which is sent to them." The article was rejected as incompetent and scientifically inadequate by the peer-reviewed American Journal of Clinical Nutrition for numerous reasons set forth in Dr. Herbert's book, Nutrition Cultism, Facts and Ficitions (CX-10) at page 109 (Tr. 48).

d. Respondent's Exhibit 30 is an article by researchers in a Polish laboratory in furtherance of requirements for a doctoral degree in pharmacology. It is entitled Alpha Adrenergic Blocking Effect Exerted by Vitamin B15. It deals with calcium pangamate (Calgam, the Bukin product) and has nothing to do with Dmg. Thus, it is not relevant to Respondent's product (Tr. 49-51).

e. RX-31 is an article, apparently by a Russian scientist named E. A. Posokhova, entitled Effect of Orotic Acid, Calcium Pangamate, and Lipamide on Ultrastructural Changes in Hepatocytes in Toxic Hepatitis. It does not mention Dmg. Calcium pangamate, according to Herbert, can be any chemical a seller chooses to put into a bottle. The name above does not describe any specific chemical. Thus, this exhibit does not appear to be relevant to Dmg (Tr. 51).

f. RX-32 is the curriculum vitae of Jerzy W. Meduski by which he represents himself to be an M.D., a Ph.D., and an assistant professor at the University of Southern California, School of Medicine.

g. RX-33 is an abstract of a study by J. W. Meduski and others at the Nutritional Research Laboratory, USC School of Medi cine, entitled Decrease of Lactic Acid Concentration in Blood of Animals Given N,N-Dimethylglycine. According to Dr. Herbert, there is no Nutritional Research Laboratory at USC School of Medicine. An abstract is a statement by a proponent of a conclusion from alleged data. It does not contain data adequate to form an opinion as to the validity of the conclusion stated. It is not scientifically valid proof of the conclusions stated. At most it is suggestive (Tr. 53, 54).

h. RX-34, a report dated December 11, l979, is entitled Nutritional Evaluation of the results of the 157-day subchronical estimation of N,N-dimethylglycine toxicity carried out in the Nutritional Research Laboratory, University of Southern California School of Medicine by J. W. Meduski, MD, PhD, Head of the Laboratory, etc. Dr. Meduski's opinion, stated in the report, was that subchronical tests made on 240 rats did not reveal any toxicological effects of 180 various dosages of Dmg-HC1 given to the rats. The report is addressed to DaVinci Laboratories, S. Burlington, Vermont.

This report is not persuasive as to the non-toxicity of the product in question for the following reasons:

157 days in an inadequate period to assess cancer causing ability which requires studies over the lifetime of rats. Also the test material Dmg-HC1 was, unlike Respondent's product, neutralized to eliminate the acid of the HC1. Further, the study goes to sub chronic toxicity; cancer-causing ability is chronic toxicity (Tr. 55, 56).

i. RX-35, entitled Vitamin B15 (Pangamic Acid) Properties, Functions and Use, is a collection of articles said to be transla tions from Ussian of various studies carried out by the U.S.S.R. Academy of Sciences on pangamic acid (Vitamin B 15) and on one of its analogs, Dipan. The publication refers to the Russian formula tion, calcium pangamate, not to Dmg and, thus, is not relevant to Dmg (Tr. 57).

j. RX--39 is an unpublished study by Jerzy W. Meduski, M.D., Ph.D., entitled LD 50 Determination of N,N-Dimethylglycine on Swiss-Webster Albino Mice by Subcutaneous Injection. This study, involving toxicity of injected Dmg-HC1 is irrelevant to oral tablets containing Dmg-HC1 (Tr. 58).

k. RX-49 is an unpublished study, unidentified as to source, entitled The Acute Oral LD 50 of Dimethylglycine Hydro chloride in Rats. It shows that if rats ingest sufficient Dmg-HC1 it will kill them (Tr. 58).

l. RX-41 is an article appearing in the Journal of the American Osteopathic Association (Aug. 1960) entitled Transmethylation in cardiopathies: The role of pangamic acid (vitamin B 15 , written by A. L. Pettigrew, D.O. The study reported in the article involved pangamic acid identified by a formula containing 8 methyl groups. Dmg contains only two methyl groups. Therefore, the article is irrelevant to Dmg (Tr. 59).

m. Rx-42 is a report prepared by Bioassay Systems Corporation entitled A Mutagenicity Analysis of N,N-Dimethylglycine Hydrochloride. It was prepared for Food Science/DaVinci Laboratories of Burlington, Vermont, the firm that supplied the original formulation sold by Respondent as DMG-15 (CX-5). This study purports to reproduce the work of Drs. Herbert, Colman, et al. (CX-12). But, as shown in Herbert's testimony, it is a sloppy study and not, in fact a reproduction because the Bioassay controls were in the hundreds, rather than the thousands, which means that Bioassay had toxicity in its plates that precluded findings of utagenicity (2/5, Tr. 135, 136). Further Bioassay, unlike Herbert, Colman, et al., failed to incubate the Dmg with an amount of nitrite that Dmg would be exposed to in the mouth and the stomach by eating it day-after-day for years. The Bioassay study also did not foreclose the possibility that the volunteer subjects were taking Vitamin C which would preclude nitrite formation in the saliva (Tr. 60, 61). The defects noted preclude giving any weight to RX-42).

n. RX-43 is an NMR (nuclear magnetic resonance) comparative report by FoodScience Laboratories, Inc., purporting to compare its product Aangamik 15 (Spectrum #3), with other pro ducts, reported to be B-15 or calcium pangamate, for the presence or absence of specific organic compounds. The report asserts that Aangamik 15 contains free Dmg whereas in an earlier report, using allegedly identical procedures, FoodScience claimed that their product was an ester of Dmg and gluconic acid. According to Dr. Herbert, a stable ester cannot be formed from straight chain gluconic acid and Dmg (Tr. 76, 77, 103; 2/5, Tr. 168). The report difference in conclusion reached therein from that reached in the earlier report (Tr. 62).

CONCLUSION OF LAW

1. Respondent, using the name and addresses set forth in the caption of this proceeding, solicits remittances of money through the mails for tablets advertised as DMG-15 and DMG.

2. The meaning of advertising representations is to be judged from a consideration of an advertisement in its totality and the impression it would most probably create in ordinary minds. Donaldson v. Read Magazine, 333 U.S. 178 (1948); Vibra-Brush Corp. v. Schaffer, 152 F. Supp. 461 (S.D.N.Y. 1957); Borg-Johnson Electronics v. Christenberry, 169 F. Supp. 746 (S.D.N.Y. l959). Express representations are not required. It is the net impression which the advertisement is likely to make upon purchasers to whom it is directed which is important, and even if an advertisement is so worded as not to make an express representation, if it is artfully designed to mislead those responding to it the mail fraud statutes are applicable. G. J. Howard v. Cassidy, 162 F. Supp. 568. See, also, Virginia State Board of Pharmacy v. Virginia Citizens Council, 425 U. S. 748 (1976). The foregoing principles of interpretation were employed in arriving at the findings of representation con tained in Finding of Fact No. 5, supra.

3. Respondent argues that the alleged representations are only testimonials or opinions and, as such, cannot be construed as representations made by Respondent. It is true that about 90% of the content of Respondent's advertisements is in the form of quotations, principally of one Douglas Laurence, identified in the ads as a nutrition writer and holistic health expert whose reputation as an authority and consultant on nutrition, vitami and minerals (according to his statement) have, until DMG-15 and DMG came along, kept him from allowing his name to be used by a client to promote a nutritional product. I find that in utilizing these opinions and testimonials as an integral and major part of its advertisements Respondent has obviously adopted the assertions of efficacy con- tained in the small box at the bottom of its revised advertisements (F. of F. No. 7, supra) is cleverly couched in language which I find would tend to encourage, rather than discourage, the reliance of the ordinary mind on the impressive claims asserted in the body of the ads. Further, it has been held that dislcaimers are ineffective to rebut misrepresentations. Gottlieb v. Schaffer, 141 F. Supp. 7 (S.D.N.Y. 1956); Cates v. Haderlein, 189 F.2d 369 (1951) and that the effect of false representations is not dispelled by a money-back guarantee. Borg-Johnson Electronics v. Christenberry, supra.

4. I cannot accept Respondent's argument that this case represents a "McAnnulty - Pinkus" situation, involving two widely held schools of opinion as to the efficacy of Dmg to product the results claimed by Respondent. (American School of Magnetic Healing v. McAnnulty, 187 U.S. 94 (1902); Reilly v. PPinjus, 338 U.S. 269, 274 (l949)). The record here reflects only one widely held school of opinion, the informed medical and scientific consensus expressed by Complainant's expert Dr. Herbert, based on knowledge developed from serious concern with the subject of Dmg as evidenced by his research, writing and participation in an earlier federal court action involving the safety of Aangamik 15. The sharers of the opposite consensus which Respondent's expert, Dr. Gordon purported to express, of "doctors who wish to be nutritionally informed," are too ill-defined a group, in nature and number, for me to find that their opinion is widely held in the medical and scientific communi ties. Moreover, if that consensus is based on the same irrelevant and scientifically suspect studies, reports, and literature as relied on by Dr. Gordon, I find it unpersuasive.

5. Respondent argues that Dr. Herbert's testimony should carry no weight because of obvious bias against Respondent and its products. Dr. Herbert has strong feelings about the claims Respon- dent makes for these products and about some of the sources Respon dent relies on to support such claims. Dr. Herbert was a difficult witness. His strong feelings produced many gratuitous comments and statements, including some of an ad hominem nature, which did not enhance his appearance as a witness the to But they did not damage, in my view, the essential scientific soundness of his relevant testimony.

6. It would be inappropriate for me to decide the falsity issue with regard to the representation that Respondent's products are safe to use in view of the pendency of that issue in the federal court case, brought under the Federal Food, Drug, and Cosmetic Act, mentioned in Finding of Fact No. 24, supra. Therefore, I do not decide that issue.

7. On the basis of the testimony of Dr. Herbert and exhibits introduced through him, I find that all the other representations found to have been made by Respondents are false in fact. Their materiality, i.e., their tendency to persuade readers to purchase the products, is obvious.

8. Respondent's post-hearing memorandum raises four, what it terms, "due process" arguments against issuance of an order under 39 U.S.C. 3005.

a. Respondent says that I violated the provisions of the Administrative Procedure Act (APA) in requiring Respondent, during the hearing, without authority, to produce the product with which it was fulfilling orders at the time of the hearing.

Respondent has not pointed to any provision of the APA which barred my directopm for production and the direction was consistent with my authority under § 952.21(j) of the Rules of Practice to order the production of objects and documents.

b. Respondent says that I violated the APA and constitu tional due process by requiring Respondent to proceed with its case-in-chief prior to the conclusions of Complainant's case-in chief. Again Respondent cites no particular provision of the APA or the Constitution.

It was a witness problem that gave rise to this attack. Due to a previous commitment, Dr. Herbert, Complainant's expert, and sole, witness had to leave New York at 3 P.M. on February 3, the first day of the hearing, after approximately 1 hr. and 45 minutes of cross-examination. It was announced that Dr. Herbert would not return to New York and be available for more cross-examination until about 1 P.M. on Friday, February 5. With the agreement of Complain ants Counsel that he waived redirect examination of Dr. Herbert, I ordered Respondent to commence presentation of its case on February 4 which it did, under protest. It is apparent on the record (Tr. 107-112) that Respondent's Counsel was aware several days in advance of the hearing of Dr. Herbert's prior commmitment but, instead of moving for a continuance on that basis prior to hearing, elected to proceed to hearing as scheduled, hoping that Complainant's Counsel and Dr. Herbert would arrange to change that commitment. Respon dent's Counsel has shown no more than a failure of the proceeding to follow the normal sequence and then, only in respect of his cross-examination of Dr. Herbert being discontinuous. There is no showing of any real prejudice to Respondent in the conduct of that examination or in the presentation of its own case.

c. Respondent says that lack of subpoena power in the Rules of Practice governing these proceedings denied due process to Respondent, disabling it from securing the testimony of Dr. Jerzy Meduski. However, Dr. Meduski's curriculum vitae and reports of studies made by him were received in evidence. Presumably, Respondent would have elicited expert testimony from Dr. Meduski.

It has been repeatedly held that 39 U.S.C. § 3005 (including its predecessor statute) and the procedures adopted pursuant thereto are constitutional. Lack of subpoena power thereunder has never been held to be a deprivation of due process. Moreover, it has not been shown that the procedures adopted by any of the federal courts provide for, or allow, expert witnesses to be subpoenaed.

d. Respondent says that my failure to grant an eight-week continuance of the hearing to allow it to conduct a marketing study as to the interpretation of its advertisements constituted a denial of due process. This argument is not persuasive. A presiding administrative law judge in this type of proceeding has long been held above to determine the probable effect of advertisements on the ordinary reader without benefit of market studies or expert testi mony. Moreover, I would feel compelled to give little weight to a market study showing an interpretation of Respondent's advertise ments varying significantly from that conveyed by the plain wording thereof of found above.

9. Respondent is engaged in a scheme to obtain money or property through the mails for its products DMG-15 and DMG by means of representations materially false in fact.

10. An order in the form attached should be issued against Respondent.