In the Matter of the Complaint Against INTRA-MEDIC FORMULATIONS, INC. 1110 West Sunrise Boulevard Ft. Lauderdale, Florida 33311-1337 and MITCHELL K. FRIEDLANDER 508 Bontona Avenue Ft. Lauderdale, Florida 33301-2422 and CUSTOMER SERVICE DISTRIBUTION CENTER, INC. 997 N.E. 11th Avenue Ft. Lauderdale, Florida 33311-1337 and CONNOR-FREEMAN LABORATORIES, INC. 1881 N.E. 26th Street, Suite 208 Ft. Lauderdale, Florida 33305-1416 and 1110 West Sunrise Boulevard Ft. Lauderdale, Florida 33311-1337 and 10100 Linn Station Road, Suite 102 Louisville, Kentucky 40223-3837 RESPONDENTS P.S. Docket No 19/182 09/10/85 Bernstein, Edwin S. APPEARANCES FOR COMPLAINANT: Sandra C. McFeeley, Esq.; Kenneth N. Hollies, Esq.; Consumer Protection Division, Law Department, U.S. Postal Service, Washington, D.C. 20260-1100APPEARANCES FOR RESPONDENTS: Lee H. Harter, Esq.; 2256 Van Ness Avenue, San Francisco, CA 94109-2513 Dale B. Hinson, Esq.; 1101 Fifteenth Street, N.W., Washington, DC 20005-5002 Mitchell K. Friedlander c/o The Robertson Taylor Company, 1110 West Sunrise Blvd. , Ft. Lauderade, Florida 33311-1337
On September 21, 1984, the Consumer Protection Division, United States Postal Service (Complainant) filed a Complaint alleging that Respondents Intra-Medic Formulations, Inc. and Mitchell K. Friedlander violated 39 U.S. Code § 3005 by selling Anorex-CCK, a purported weight loss product, through the use of the mail by false representations. The Complaint was amended by Orders of January 8, January 28 and May 23, 1985 to add Respondent Connor-Freeman Laboratories, Inc. and its three mailing addresses. The January 28 Order also permitted revised allegations of false representations, and confirmed an earlier Order that added Respondent Customer Service Distribution Center, Inc. (Tr. 396).
Paragraph 7 of the Amended Complaint alleged that Respondents falsely represent:
(a) Ingestion of Anorex-CCX in accordance with the label instructions will result in rapid, permanent weight loss.
(b) The weight loss results claimed for Anorex-CCX may be achieved without effort, calorie-restricted diets or exercise.
(c) Cholecystokinin (CCK), the primary active ingredient of Anorex-CCK, is responsible for causing rapid, permanent weight loss in users, without effort, calorie-restricted diets or exercise
(d) Reliable and competent scientific evidence demonstrates that the cholecystokinin in Anorex-CCK, orally ingested, is effective as described in 7(c) above.
(e) The bovine tissue in Anorex-CCK is the only naturally occurring source of cholecystokinin.
Respondents denied that they violated 39 U.S. Code § 3005. At Respondents' request, this case together with PS Docket Nos. 19/104 and 19/162 was scheduled for expedited hearing pursuant to 39 C.F.R. 952.17(a) (Judge Cohen's Order of February 1, 1985). I was designated Acting Judicial Officer for that purpose.
Commencing February 12, 1985 Complainant presented the testimonies of Richard C. Eastman, M.D., William R. Ayers, M.D., and Albert I. Mendeloff, M.D. Respondents presented the testimonies of Stephen C. Woods, Ph.D., Thomas M. S. Wolever, B.M., Dan Sarel, Ph.D., Lynda M. Maddox, Ph.D., and Ruth B. Smith, Ph.D. By Stipulation, Respondents' advertisements and various other exhibits as identified on Complainant's exhibit list were received in evidence (Tr. 2006-15).
During the hearing, Respondents offered as exhibits two collections of scientific articles which they designated as "Anorex-CCX (Cholecystokinin) Source Book" and "Guar Source Book." Upon no objection these source books were received into evidence, although they were not given exhibit numbers since the books were to be furnished later and some of the articles duplicated other exhibits (Tr. 4690J-O). The Anorex-CCX Source Book is hereby designated as RX3-54 and the Guar Source Book is hereby designated as RX3-55. The articles contained in the Anorex-CCK Source Book are listed in Appendix A to this decision.
Respondents offered as an exhibit the videotaped deposition of Joseph E. Morrow, Ph.D. Dr. Morrow conducted a survey and based upon that survey concluded that the money-back guarantee that Respondents offered was a crucial factor in persuading the majority of users surveyed to buy products. Although Complainant objected to the admission of this exhibit, I received it into evidence subject to a showing in post-hearing proposed findings and conclusions that the deposition is relevant (Tr. 4794-96). Respondents' post-hearing submissions have failed to show that the deposition is relevant. In view of the holdings in Farley v. Heininger, 105 F.2d 79, 84 (D.C. Cir. 1939); Borg-Johnson Electronics, Inc. v. Christenberry, 169 F. Supp. 746, 751 (S.D.N.Y. 1959) and other cases that a promise of a refund if a customer is dissatisfied will not dispel the effect of false advertisements, I find the deposition to be irrelevant and therefore inadmissible. The transcript and the videotape of the deposition are hereby designated as RX3-56 and RX3-56A respectively and will be retained as rejected exhibits.
At the hearing, Respondents also offered an affidavit and report of Kenneth W. Clarkson, Ph.D. Upon objection by Complainant, the affidavit and report were rejected as irrelevant (Tr. 5906-07, Conference on the Record of April 15, 1985, pp. 5-6). The affidavit and report are hereby designated as RX3-57 and will be retained as a rejected exhibit.
By Order of May 20, 1985 the parties were directed to submit proposed findings of fact, proposed conclusions of law, and memoranda. Proposed findings and conclusions were to be specific and supported by citations. The parties were directed to file reply submissions specifically stating agreement or disagreement with the opposing party's proposed findings and conclusions and providing supporting citations and alternate findings or conclusions where there was disagreement. Complainant filed 86 pages of proposed findings and conclusions on June 7, 1985. After requesting and being given a 10 day extension of time in which to file their submission, Respondents on June 18, 1985 filed a three page submission which contained no specific citations to evidence or legal authority. Complainant filed reply submissions on June 20 and July 12, 1985. Respondents filed a reply submission on July 8, 1985 (Respondents July 8 submission). All proposed findings, proposed conclusions and arguments have been considered. To the extent indicated, they have been adopted. Otherwise they have been rejected as irrelevant or not supported by the evidence.
I. The Use of the Mail
Mitchell K. Friedlander owns Intra-Medic Formulations, Inc. Intra-Medic wholly owns Customer Service Distribution Center, Inc. and Connor-Freeman Laboratories, Inc. A similar finding was made in the January 28, 1985 Decision and Order on Motion to Dismiss and this was not denied by Respondents in their July 8 submission.
Mitchell K. Friedlander is the president and principal decision-maker in Respondent corporations which he wholly owns and controls (January 28, 1985 Decision and Order on Motion to Dismiss). It was determined that there was a complete identity of interests between Mr. Friedlander and his corporations, despite Respondents' protests to the contrary. Therefore, Lee H. Harter, Esq. was considered to also represent Mr. Friedlander. Mr. Friedlander was permitted to personally participate in the hearing as a matter of courtesy and convenience to Respondents (Tr. 2176-77, my Memorandum For Record dated May 6, 1985).
The Complaint set forth Mitchell K. Friedlander's address as 2175 State Road 84, Dock 12, Ft. Lauderdale, Florida 33312-4839. However, in a May 1, 1985 Motion, Complainant requested that Mr. Friedlander's address be amended as 508 Bontona Avenue, Ft. Lauderdale, Florida 33301-2422. That part of the motion was denied due to Complainant's failure to cite evidence to support this change. Complainant's proposed finding no. 3 correctly asserted that this address was admitted in the response to Request for Admissions No. 8 filed by the corporate Respondents on January 29, 1985. Therefore, I grant the motion to amend Mr. Friedlander's address to 508 Bontona Avenue, Ft. Lauderdale, Florida 33301-2422. However, in accordance with Mr. Friedlander's request, service of papers will also be made to him c/o The Robertson-Taylor Company, 1110 West Sunrise Blvd., Ft. Lauderdale, Florida 33311-1337.
Respondent corporations solicit orders by mail in connection with the sale of Anorex-CCK. These orders are solicited for Intra-Medic at 1110 W. Sunrise Blvd., Ft. Lauderdale, Florida 33311 (CX3-33, 35, 36b); for Customer Service at 997 N.E. 11th Avenue, Ft, Lauderdale, Florida 33311-1337 (CX3-48, 50, 54); and for Connor-Freeman at 1881 N.E. 26th Street, Suite 208, Ft. Lauderdale, Florida 33305 (CX3-41, 42, 48, 56(e) and (f)); at 1110 W. Sunrise Boulevard, Ft. Lauderdale, Florida 33311 (attachments to May 1, 1985 Motion to Amend, granted by Order dated May 23, 1985); and at 10100 Linn Station Road, Suite 102, Louisville, Kentucky 40223 (CX3-51).
Respondents' advertisements appear in publications of general circulation (CX3-33, 42, 51, admitted in Respondents' July 8 submission).
Respondents are all part of a single enterprise directed by Mitchell K. Friedlander through various corporations using various advertisements for Anorex-CCK.
II. The Advertising Representations
Respondents' advertising materials, including product inserts accompanying reorder solicitations, make the representations alleged in subparagraphs 7(a), (b), (c) and (d) of the Complaint. However, the advertising materials do not make the representation alleged in 7(e). Specific reasons for these findings are as follows:
Respondents' July 8 submission did not dispute this proposed finding. The May 20, 1985 Order required each party to reply to the opposing party's proposed findings. The parties were advised that unless an opposing party's proposed finding was specifically denied with supporting citations and an alternate finding, that proposed finding would be deemed admitted. Respondents' statement, "no objection," is consequently deemed an admission. Therefore, I find that the representation was made. This finding is also based upon quotations from advertisements set forth in pages 7-14 of Complainant's proposed findings.
Respondents' July 8 submission also does not dispute this proposed finding. Respondents' only statement was "no objection." Accordingly, this finding is deemed admitted, and I find that the representation was made. This finding is also based upon quotations from advertisements set forth in pages 14-17 of Complainant's proposed findings.
With respect to 7(c), the language of Respondents' advertisements conveys the unmistakable message that it is CCK in Anorex-CCK that causes the claimed weight-loss effects. This idea is reinforced by use of the letters CCK in the product's name. The advertisements state:
Medical science has just dropped a long-awaited bombshell on the diet industry -- a powerful weight loss formulation with the tongue-twisting name of cholecystokinin.
* * * * *
What makes the discovery of cholecystokinin a real diet bombshell? Not only does the compound cause rapid weight loss, but its discovery literally exploded all previous theories about losing weight and the cause of obesity.
* * * * *
What intrigues researchers is that CCK overcomes the biggest obstacles to weight loss: diet and exercise. CCK puts the body in an anorectic state - a state in which the body rejects excess calories . . .
* * * * *
[O]nly Anorex-CCK contains the powerful weight loss compound extracted through a patented production process (CX3-33, p. 2).
EXPLOSIVE WEIGHT LOSS DISCOVERY
A significant weight loss breakthrough of unprecedented magnitude has just been revealed. A compound with the tongue-twisting name of cholecystokinin (CCK) that will soon become a household word for every American man and woman who wants or needs to lose weight and we mean lots of weight (10, 20, 30, 50 pounds or more) including YOU] This potent, powerful, isolated peptide actually eliminates the cause of fat formation. . . So QUICKLY and so EFFECTIVELY you will know from the very start why it has taken more than 15 years of research and over 200 medically documented studies to finally bring you ANOREX-CCK - THE ULTIMATE CURE FOR FAT.
WHY HAS IT TAKEN ANOREX-CCK SO LONG TO REACH THE MARKETPLACE?
The answer is really quite simple: while ANOREX-CCK was proven to cause weight loss, a natural source for the compound was not available. Now, after years of research and extensive experimentation, an independent laboratory with expertise in biotechnology finally uncovered a naturally-occurring source of CCK -- a source that could be taken orally in tablet form. This discovery was the key to making ANOREX-CCK available to the millions of overweight men and women who diet each year. But there's only one catch: ANOREX-CCK is expensive to produce (CX3-41, 3-56b, p. 2).
FACT: LABOTATORY ANIMALS INJECTED WITH CCK LITERALLY STARVED THEMSELVES TO DEATH (CX3-41).
CCK puts the body in an anorectic state - a state in which the body rejects excess calories (CX3-51, p. 2, 3-56b, p. 2).
The product labels and package insert instruction book reinforce the message that CCK is the active principle. The labels state:
CONTENTS: Each tablet provides: Bovine tissue (a natural source of Cholecystokinin-CCK) 350 mg . . . . (CX3-38, 3-45, 3-52)
Other advertisements of Respondents state:
All you need to lose weight is to take ANOREX-CCK as directed. That's it] Only ANOREX-CCK contains the single natural source of cholecystokinin (CCK, for short), the potent weight loss compound that not only exploded all outdated theories about abesity, but has made losing weight as easy as taking this miraculous agent. (CX3-47 p. 2, 3-53 p. 2).
... It's all because of ANOREX-CCK. That's right] Research published ... concluded the awesome weight loss powers of CCK are dose dependent. Your weight loss is regulated by the amount of CCK to put into your system therefore the more Anorex-CCK you take the more weight you will lose.
While CCK was proven to cause weight loss, a natural source for the compound was not available. Now. . . an independent laboratory ... finally uncovered a naturally-occurring source of CCK -- a source that could be taken orally in tablet form. This discovery was the key to making ANOREX-CCK available ...
The basic raw materials are expensive to produce and must be properly prepared and designed to insure the required absorption of CCK within the body -- absorption vital to produce the visible and measurable weight loss you demand and deserve.
The above language appeared in a copy of an advertisement attached as an exhibit to Complainant's May 1, 1985 Further Motion to Amend Complaint. Complainant alleged, and the advertisement and an attached affidavit of Postal Inspector Cantley indicated that the advertisement appeared in the New York Post on February 8, 1985. Respondents did not dispute the authenticity of this advertisement either in their May 22 written opposition to the motion or at any other time. Therefore, this advertisement will be considered as evidence.
With respect to 7(d), the advertisements represent:
. . . researchers have presented over 200 studies published in medical journals around the world demonstrating CCK's miraculous weight loss powers . . .
CCK has proven time and time again that it has the unique ability to cause rapid weight loss with little or no effort on the part of the dieter . . .
After years of research and a lot of detective work, a Wisconsin-based firm with expertise in biotechnology finally uncovered a naturally-occurring source of CCK -- a source that could be taken orally in tablet form (CX3-33 p. 2).
EXPLOSIVE WEIGHT LOSS DISCOVERY.
. . . it has taken more than 15 years of research and over 200 medically documented studies to finally bring you ANOREX-CCK - an ultimate cure for fat.
What intriqued researchers most is that CCK overcomes the two biggest obstacles to weight loss . . . this medically documented published report underlined the supreme and uncompromising powers of CCK (CX3-51, p. 1).
. . . it's all because of ANOREX-CCK. That's right] Research published in the American Journal of Clinical Nutrition (May 30, 1977, pp. 758-761) concluded the awesome weight loss powers of CCK are does dependent (CX3-51, p. 2).
This is truly a major breakthrough . . . N.J. Lester, Chief CCK Researcher, A.R.C. Medical Services (CX3-41, 3-51).
Respondents contend that representations about CCK alleged in subparagraphs 7(c) and (d) are not material. Respondents argue that consumers would purchase the product without relying upon representations about CCK. Respondents presented testimonies of three marketing experts. Dan Sarel, Ph.D., Professor of Marketing at the University of Miami, Florida, has been working in the area of consumer decision-making and advertising effectiveness for the past 10 years (RX3-45). He defined a material representation as one that has a significant impact on a person's decision (Tr. 5689). He concluded that representations 7(c) and (d) are not material (Tr. 5690, 5694). He gave no reason for the conclusion except that it was based upon his education and experience.
Ruth B. Smith, Ph.D., Assistant Professor of Marketing at the University of Maryland, has published several papers in the marketing field (RX3-46). She defined a material representation as that portion of an advertisement on which the consumer focuses and considers important (Tr. 5790). She also testified that representations 7(c) and (d) are not material. She based her opinion on her knowledge of the literature and "ad comprehension information processing" (Tr. 5791).
Lynda M. Maddox, Ph.D., is Associate Professor of Business Administration at George Washington University, Washington, D.C., where she teaches advertising and marketing. She is involved in research and publishing in her field (RX3-47). She defined a material representation as the principal criterion upon which a consumer makes a purchase decision (Tr. 5848). Her view is that representations 7(c) and (d) are not material because consumers would purchase the product for its overall effect, rather than because it contained the ingredient CCK (Tr. 5849). She based this opinion upon her training and experience (Tr. 5850).
Generally, I agree with these witnesses' definitions of materiality. Chaachou v. American Central Insurance Company, 241 F.2d 889, 893 (5th Cir. 1957), defined a material representation as one that would "cause the [other party] to do other than that which would have been done had the truth been told." Applying this definition, representations are material if they have the effect of helping to induce individuals to purchase the product.
Respondents' representations are directed at the ordinary consumer. It has been consistently held that a trier of fact is qualified to determine the effects of various representations on the minds of ordinary people and whether representations are material, regardless of the opinions of experts. Steinberg v. Indemnity Insurance Co. of North America, 364 F.2d 266, 274 (5th Cir. 1966); Vibra Brush Corp. v. Schaffer, 152 F. Supp. 461, 468 (S.D.N.Y 1957); rev'd on other grounds, 256 F.2d 681 (2nd Cir. 1958); Delta Enterprises, P.S. 14/72 (P.S.D. July 3, 1984).
I have carefully considered the views of these experts. I do not agree with their conclusions that the representations in 7(c) and (d) are not material. Although the word "cholecystokinin" is not one that the ordinary consumer would know, Respondents' advertisements elevate this ingredient to great importance. For example, the first paragraph of CX3-33, p. 2, after the heading "MEDICAL UPDATE: SCIENCE CONQUERS FAT, " states:
Medical science has just dropped a long-awaited bombshell on the diet industry - a powerful weight loss formulation with the tongue-twisting name of cholecystockinin.
In CX3-41 and 51, after headings of "FAT CURE REVEALED" and "Rare and Powerful Anorectic Agent UNCOVERED, " another conspicuous heading states:
FACT: LABORATORY ANIMALS INJECTED WITH CCK LITERALLY STARVED THEMSELVES TO DEATH]
After another heading, "EXPLOSIVE WEIGHT LOSS DISCOVERY," the advertisement continues:
A significant weight loss breakthrough of unprecedented magnitude has just been revealed. A compound with the tonque-twisting name of cholecystokinin (CCK) that will soon become a household word for every American man and woman who needs to loss weight and we mean lots of weight . . .
That same advertisement also states: "We stumbled across the substance that everyone's looking for . . ."
The fact that Respondents' product is named Anorex-CCK, after these advertisements have described choleystokinin as "rare and powerful," an "incredible diet breakthrough," a "fat cure," an "explosive weight loss discovery," and have identified CCK as being the initials for cholecystockinin, stresses the important role which the ingredient plays in accomplishing the product's represented results. Respondents' advertisements repeatedly refer to "cholecystokinin" or "CCK." The name "cholecystokinin" or its abbreviation "CCK" is mentioned approximately 24 times in CX 3-33, 15 times in CX3-41 and 15 times in CX3-51. Further, the product name which includes the initials is used approximately 14 times in CX 3-33, 24 times in CX3-41 and 46 times in CX3-51.
Respondent's experts did not indicate why the advertising lanquage about CCK would not impress the average consumer. They simply stated that generally, based upon their training and experience, the language about CCK was not material. For the reasons set forth herein, I find that the representations in 7(c) and (d) are material.
(e) The bovine tissue in Anorex-CCK is the only naturally occurring source of cholecystokinin.sing materials. Respondents correctly state that there is no reference to bovine tissue anywhere in their advertisements (July 8 submission). The term "bovine tissue" only appears on the label of the product itself. Therefore, Respondents did not make the representation alleged in 7(e).
III. Qualifications of the Scientific Witnesses
Medical doctors Richard C. Eastman, William R. Ayers and Albert I. Mendeloff testified for Complainant. Medical doctor Thomas M. S. Wolever and Stephen C. Woods, Ph.D., testified for Respondents.
Dr. Richard C. Eastman is Associate Professor of Medicine at the Georgetown University Medical School, Washington, D.C., and chief of the Division of Endocrinology and Metabolism, an area which includes the treatment of obesity. Dr. Eastman is consultant to Georgetown's Diet Management and Eating Disorders Program. He also consults directly with patients, some of whom have obesity problems. He is director for clinical research for the diabetes unit. He is a board certified internist (Tr. 2043-45, CX3-67). Dr. Eastman has impressive credentials, having published approximately 25 articles. I found Dr. Eastman to be highly knowledgeable about weight loss principles and about peptide chemistry. He testified in a sincere, forthright manner and carefully considered the questions in an effort to be helpful and truthful. I found him to be an extremely reliable witness.
Dr. William R. Ayers is Associate Professor of Internal Medicine and Associate Dean for undergraduate medical education at the Georgetown University Medical School (Tr. 2194). He is certified in internal medicine (Tr. 2195), a fellow in the American College of Physicians (Tr. 2198), and co-founder and former director of the Diet Management Clinic at the Georgetown University Hospital (Tr. 2199-2200). He has published articles on the management of obesity and on the use of computers in medicine (Tr. 2224, CX3-65). I found Dr. Ayers to be a credible witness. He demonstrated great expertise concerning principles of weight loss and diet management. He provided a logical analysis of scientific studies. However, as Dr. Ayers admitted, he is not a peptide chemist (Tr. 4447). His testimony about forms of peptides contained errors (Tr. 4447-48, 5159-61) and, therefore, was not reliable.
Dr. Albert I. Mendeloff is Professor of Medicine at Johns Hopkins University School of Medicine, Baltimore, Maryland (Tr. 2858). He is a gastroenterologist, a physician who specializes in digestive diseases and disorders of the digestive system. He is a fellow in gastroenterology, past president of the American Gastroenterological Association (Tr. 2859), Governor of the American College of Physicians for the State of Maryland (Tr. 2852) and editor of the American Journal of Clinical Nutrition (Tr. 2864, CX3-66). His research and practice interests encompass nutritional disorders, absorption and digestion, dietary fiber, diabetes and obesity (Tr. 2865-66). Respondents stated that Dr. Mendeloff "is eminently well qualified to testify and evaluate the studies" (Tr. 2867), and Respondents described him as "an expert's expert" (Tr. 2844). Dr. Mendeloff testified credibly and showed much expertise and care in his testimony. While more knowledgeable about guar, a substance involved in the companion cases, he demonstrated expertise concerning weight loss concepts, cholecystokinin and scientific studies. I found him to be an impressive and highly reliable witness.
Respondents accused Dr. Mendeloff of being untruthful and biased. They first argued that he misrepresented a guar study that he had conducted. Later they contended that he was biased because: (1) he was involved in a competing mail order business, (2) he may have incorrectly believed that Respondents delayed payment of his witness fee, and (3) he made negative comments about Respondents to Dr. Wolever. None of these accusations led me to conclude that Dr. Mendeloff testified untruthfully.
Dr. Mendeloff testified that he conducted a study using a grant from the United States Department of Agriculture for the purpose of determining guar's safety. Guar was experimentally administered in bars made by the National Biscuit Company. Placebo bars, which tested exactly the same were also developed and administered. Dr. Mendeloff stated that these were "fairly high calorie bars." At the end of the six month study, no differences in subjects' body weights were noted (Tr. 3090-94). He stated that this experiment demonstrated how tough it is to make people lose weight and that the subjects kept eating "even though they had all these extra calories we provided them" (Tr. 3093). Respondents contended that Dr. Mendeloff's co-researcher, Dr. Michael McIvor, contradicted several of Dr. Mendeloff's statements about the study in a recently taped telephone interview. Respondents were not permitted to introduce the recording of the conversation or the testimony of their interviewer, Mr. Lester, to prove the truth of Dr. McIvor's alleged statements, but they were permitted to call Dr. McIvor as a witness (Tr. 3199-3201, 3261-62). Dr. McIvor agreed to testify (Tr. 3351), but Respondents subsequently decided not to call him (Lee H. Harter's Fedruary 25 telegram). Therefore, Respondents never substantiated their accusation that Dr. Mendeloff did not testify credibly about the study.
Respondents also argued that Dr. Mendeloff was biased because, according to Mr. Friedlander, "We have been informed that Dr. Mendeloff is selling medication through the mail in direct competition with me" (Tr. 4937). Mr. Friedlander appeared to refer to a "mail order diet" allegedly distributed by the American Digestive Disease Society, a non-profit organization with which Dr. Mendeloff is associated (Tr. 4937-39, 4944, 4956-57, 5066-67). I found this accusation to be too far-fetched to constitute proof of bias (Tr. 4938, 4940). Dr. Mendeloff's association with the sale and distribution of diets by the American Digestive Disease Society does not place him in direct competition with Respondents, nor does it provide him a motive to testify falsely about Respondent's products and medical and scientific matters.
In a motion to strike testimonies of Drs. Ayers and Mendeloff filed June 12, 1985, Respondents argued that because of a postscript in a September 13, 1984 letter from Ms. McFeeley to Dr. Mendeloff referring to a "payment problem" which Respondents contended referred to a delay in their payment of Dr. Mendeloff's witness fee through no fault of theirs, Dr. Mendeloff became biased against Respondents. This accusation also seems absurd. I do not believe that a man of Dr. Mendeloff's stature would testify falsely because of a delay in payment of his bill.
The final accusation of bias relates to Dr. Wolever's testimony. Dr. Wolever testified that he telephoned Dr. Mendeloff on April 9, 1985, the evening after Dr. Wolever's first day of testimony in this hearing. Dr. Wolever stated that Dr. Mendeloff said that Respondents were crooks who, after one mail box was closed down, moved to another city and opened another one (Tr. 5606). Although this testimony indicates Dr. Mendeloff's negative view of Respondents as of April 9, Dr. Wolever's statements do not destroy Dr. Mendeloff's credibility. Dr. Mendeloff completed his testimony almost three weeks before this conversation with Dr. Wolever. Assuming the accuracy of Dr. Wolever's testimony, it is not clear whether Dr. Mendeloff's negative opinion formed by April 9 preceded any of his testimony or that these views effected his testimony. It would not be surprising, after the many incidents in which Respondents verbally attacked Dr. Mendeloff during his testimony, that Dr. Mendeloff subsequently formed a negative impression of Respondents.
Dr. Stephen C. Woods is Professor of Paychology, chairman of the Department of Psychology, and Adjunct Professor of Medicine at the University of Washington. Dr. Woods holds the Ph.D. in physiology, biophysics and psychology. He has worked in the field of endocrinology since the late 1960s and has authored more than 100 scientific articles, the majority of which deal with metabolism, food intake, and peptide hormones. Dr. Woods is the National Science Foundation's expert on food intake. He serves on the editorial boards of two peer review journals, American Journal of Physiology and Behavioral Neurobiology. He is organizer of the 1986 International Congress of Physiology of Food and Food Intake (Tr. 5113-15, RX3-36).
Although Dr. Woods' credentials were outstanding with respect to his work concerning CCK, I found him to be all too often assuming an advocate-like stance. Perhaps his personal involvement with CCK prevented him from being more objective. Dr. Woods' strong reaction to Dr. Ayers' statement that a satiating role for CCK has recently been fully disproved, (RX3-8, p. 7), which Dr. Woods apparently regarded as an affront to his entire life's work (Tr. 2126, 5160), may have caused him to become too much of an advocate for Respondents.
Dr. Thomas Wolever is a licensed physician in England and in Ontario, Canada (Tr. 5405-06). He is currently working toward a Ph.D. in the Department of Nutritional Sciences at the University of Toronto (RX3-39). His doctoral research involves nutrition in the treatment of diabetes and lipid problems (Tr. 5404). Dr. Wolever did not testify about Anorex-CCK. He mainly testified about guar, a product involved in another case, but some of his testimony also related to relevant issues concerning scientific method.
IV. Definition of Terms and Background Findings
Dr. Ayers stated, and Respondents accepted the definition, that obesity is the state of being 15 percent or more over the ideal weight for one's height, age and sex as defined by tables published periodically by, among others, the Metropolitan Life Insurance Company (Tr. 2201-02, Respondents' July 8 submission, p. 11, para. 20). As Drs. Ayers and Mendeloff testified, obesity is a complex problem that is not simple to treat. Nutrition, energy balance, exercise and behavior are important aspects of the problem (Tr. 2202-03, 2268-69, 2873-76). Dr. Wolever also characterized obesity as a complex problem (Tr. 5463). To lose weight, a person must create an energy or calorie deficit so that the body will use stored energy or fat to meet its current energy needs (Tr. 2203, 3134, 3684).
Satiety in humans is the sense of fullness that normally leads to cessation of eating. Dr. Ayers gave this definition (Tr. 4762-63), and Dr. Woods agreed that the definition was reasonable (Tr. 5215). Dr. Eastman's similar definition was "the sense of having had enough to eat, being full" (Tr. 2092). Satiety signals that cause a lean person to stop eating are not equally effective for obese persons. Dr. Ayers testified that satiety does not necessarily cause obese people to eat less, that there is no necessary relationship between increased satiety and weight loss, and that the normal satiety signals do not apply in obese people (Tr. 3381, 4128). When Dr. Woods was asked whether he believed "that producing the feeling of satiety in an obese person leads inevitably to weight loss for that person," he replied, "Certainly not." (Tr. 5289-90). Dr. Wolever agreed that just because a substance produces satiety does not necessarily mean that the substance also produces weight loss (Tr. 5462-63, 5415). Dr. Mendeloff emphasized that many patients who say they feel full in hunger-satiety ratings continue to eat, ignoring the feeling of fullness (Tr. 3841).
Permanent weight loss in obese people is extremely difficult to accomplish. Dr. Eastman stated that if a patient loses weight, remains thin and does not regain the weight for five years, the patient is considered cured of obesity. But the recidivism rate for obesity is extremely high, and 95-98 percent of people in weight loss programs regain their lost weight regardless of the program used (Tr 2084). Dr. Woods agreed that it is difficult to prevent regaining weight lost (Tr. 5291). He doesn't know if permanent weight loss exists, and prefers to redefine "permanent" to mean "continuous" (Tr. 5153). Dr. Mendeloff agreed that weight loss and weight gain are chronic problems (Tr. 3069). Dr. Wolever stated that even if weight is lost, the effect will not necessarily be long lasting (Tr. 5525, 5557).
As scientific experts for both sides testified, to establish a claim that a substance will be effective to achieve a particular result, the claim must be supported by sound scientific evidence (Tr. 2079-82, 2273, 3068, 5283, 5434, 5550-51). Dr. Ayers said that efficacy claims for Anorex-CCK must be treated as false in the absence of information to support them (Tr. 2972-74). Dr. Woods said that until a substance is tested using the mode of administration for which claims are made, there is no way to know how that substance will work (Tr. 5283). He stated that in the absence of data, a claim or hypothesis is an open question; there is simply no information (Tr. 5197-98). Dr. Wolever also indicated that data are required in order to support a medical opinion (Tr. 5434-35, 5550-51).
Formation of a scientific or medical consensus requires that results of studies be disseminated among members of the scientific community and be reviewed by others working in the field. Presentations of data at meetings and conferences lend themselves to that function, as do having papers reviewed by experts in the field prior to their publication in peer reviewed journals (Tr. 2270, 2956-57, 3072). Persons who perform work and follow work in a field are in positions to be aware of a consensus in that field. As Dr. Eastman indicated, the leading figures in CCK research are Drs. Stephen Woods, Gerard Smith and James Gibbs (Tr. 2109). Drs. Ayers, Eastman and Mendeloff also are qualified to testify about a consensus in the field of weight loss and about the ingredients in Anorex-CCK because of their training and experience in weight loss and their literature searches of these subjects.
V. The Truth or Falsity of the Representations
The parties disagree on the composition of Anorex-CCK. Complainant contends that it is proper to conclude that Anorex-CCK consists of two ingredients: (1) cholecystokinin, and (2) carboxymethylcellulose (CBC). Only these two ingredients are listed on labels found on Anorex-CCK containers which Complainant obtained in three separate test purchases (CX3-38, 3-45, 3-52). Respondents contend that there was a mistake in these labels and that Anorex-CCK also, includes guar gum, vegetable bran and caffeine and is, in fact, identical to a product called Appecurb manufactured by GenTrac, Inc. (Tr. 2439).
In order to prove the identical nature of Anorex-CCK and Appecurb, Respondents offered six documents as exhibits. Upon objection, these documents were not admitted into evidence. The six documents were found to be inadmissible hearsay evidence lacking sufficient guarantees of trustworthiness (Decision and Order dated June 10, 1985). Since the beginning of the hearing in Fedruary 1985, I have told Respondents that if they wished to prove that the product labels were in error, they should offer the testimonies of knowledgeable witnesses subject to cross-examination. I can find no justification for Respondents' failure to present such testimonies. Testimonies could have been scheduled in accordance with witnesses' other commitments, just as other witnesses were accomodated over the course of this lengthy hearing. Respondents went to great effort and showed unusual ingenuity in presenting other witnesses, including those from Canada and Florida. Complainant even suggested a confidentially agreement or a protective order to safeguard any proprietary information or trade secrets of Respondents' witnesses (Tr. 5739, 5897). Respondents' failure to present this testimony leads me to conclude that such testimony might not have been as favorable to Respondents as statements contained in the rejected exhibits, which are not subject to cross-examination
The first pages of Complainant's exhibits CX3-63 and 3-71 contain statements that Appecurb is the "primary ingredient" or "primary component" of Anorex-CCK. I find these statements no more reliable than those in the rejected exhibits, and in and of themselves insufficient to overcome the evidence of the Anorex-CCK labels. Therefore, in accordance with the three product labels, I find that Anorex-CCK consists of:
CONTENTS: Each tablet provides Bovine tissue (a natural source of cholecystokinin-(CCK) 350 mg., carboxymethylcellulose 650 mg.
A statement of contents on a product label is presumptive evidence of the product's ingredients. Sister Fannie Howard, P.S. 1/101 (I.D. July 10, 1972). In fact, even in cases of conflicting evidence, ingredients listed on product labels have been relied upon as correct. Carter-Ross Labs, P.S. 5/163 (I.D. July 25, 1977); Emil-John Research; P.S. 5/162 (I.D. July 21, 1977).
During the hearing Mr. Friedlander invited Dr. Mendeloff to call Respondents "if you have any doubts about the authenticity of the CCK formulation" (Tr. 3183). Dr. Mendeloff responded by telephoning Respondents' office requesting information. He received a bottle of Anorex-CCK along with a collection of articles about CCK. The product was labeled identically to the three labels received in evidence (Tr. 4013-15).
Carboxymethylcellulose (CBC) has not been established as a weight loss agent. Dr. Ayers described CBC as a fiber product which has been used as a filler or additive for a variety of products (Tr. 2305). Although it has sometimes been claimed that CBC causes satiety (Tr. 2306), Dr. Ayers stated that the quantities of CBC in Respondents' product would not cause weight loss (Tr. 2310). Dr. Mendeloff agreed that CBC is a filler which would have no effect on satiety or weight loss (Tr. 3107-08, 4990, 5008). In fact, Respondents denied claiming that CBC causes satiety (Tr. 2306).
Anorex-CCK's other ingredient is more controversial. During the hearing and in their post-hearing submission, Respondents contended that CCK "is not an isolated ingredient of Anorex-CCK, but rather one of many polypeptides contained in the freeze dried cranial tissue extract contained in Anorex-CCK" (July 8 submission, p. 5). However, as I have previously found in this decision, Respondents' advertisements fail to mention bovine tissue and repeatedly emphasize the sensational value of CCK in their product. They dramatically describe CCK as "rare and powerful," an "incredible diet breakthrough," a "fat cure," a "diet bombshell" dropped by medical science, an "explosive weight loss discovery" a "significant weight loss breakthrough of unprecedented magnitude," and having "awesome weight loss powers." These superlative descriptions of CCK itself with no mention of bovine tissue in the advertisements support the conclusion that it is CCK and not bovine tissue that is the product's claimed mechanism of action.
I also note that Dr. Woods' position changed from his pre-hearing affidavits emphasizing the role of CCK to his testimony during the hearing that it was perhaps the bovine tissue which produced weight loss results. The following is typical of his pre-hearing declarations:
The important and relevant aspect of the extracted bovine tissue is that the extraction is done in such a way as to insure a high yield of the naturally occurring peptide, cholecystokinin (CCK) as well as other biochemically related compounds (CX3-68, pp. 2-3) [Emphasis added].
Bovine tissue comes from the cow or ox family (Tr. 3106). Although Respondent's July 8 submission contends that Anorex-CCK contains freeze dried cranial tissue, there is no evidence in the record to support this assertion. Moreover, there is no evidence of any scientific theory that bovine tissue causes weight loss. Respondents' Anorex-CCK Source Book was introduced into evidence by Respondents as a compilation of 24 scientific articles in support of their case (Tr. 4690 J-O). All of these articles relate to CCK. I have been unable to find any emphasis upon bovine tissue in any of these articles or, except for the GenTrac study, in any other scientific article in evidence in this case. If bovine tissue caused weight loss, beefsteak, also bovine tissue (Tr. 5050), might become a diet product. Assays of Anorex-CCK do show that it contains CCK. In order to determine whether Anorex-CCK fulfills Respondents' claims, it is CCK which must be evaluated for weight loss properties.
CCK is a small peptide hormone that was discovered in 1943. It is composed of amino acids of varying chain links. For instance, CCK-4 has four amino acids; CCK-8 has eight (Tr. 2095, 3108). CCK is found in human tissue and in the tissue of all mammals that have been tested for CCK (Tr. 2097). It is released in the body when food enters the small intestine (Tr. 2108, RX3-12, 3-54(14), 3-54(15)). CCK was first identified as having two major functions: (1) emptying the gall bladder, and (2) stimulating the pancreas to secrete enzymes necessary for digestion (Tr. 2096, 3108). Dr. Eastman explained that in 1973 CCK was further identified as a substance which produces a feeling of satiety. To produce satiety, large amounts of CCK have been injected either intravenously or into the abdominal cavity (Tr. 2096-98). Dr. Mendeloff agreed that CCK so injected influences satiety and food intake (Tr. 3111).
However, orally administered CCK has not been shown to be effective to produce satiety. Although CCK is actively being studied by research scientists (Tr. 4768), none of the published literature reviewed or received in evidence involves administration other than by injection of infusion. No studies were reported in published literature in which CCK was given orally (Tr. 3110-11). All of Complainant's witnesses concluded that CCK given orally would be ineffective to produce satiety (Tr. 2958-59, 2109-10, 3130). Dr. Eastman testified:
In general, hormones that are peptides are not absorbed orally - nor are they effective orally, because they are digested by the peptide acids or digested enzymes which break down meat which is protein.
. . . .So that the consensus would be 99.9 percent of the people would predict that it's not effective orally.
. . . .
Some of the leading figures in the field feel it is not effective orally, have so written in print, and have even tried it. And, my opinion would side with the consensus in that regard. If one were going to give this hormone for this effect, one would not give it orally (Tr. 2109-10).
Dr. Eastman identified the leading figures in CCK research as Drs. Stephen C. Woods, Gerard P. Smith and James Gibbs (Tr. 2109). Dr. Mendeloff confirmed that there is not a single published article "in the vast literature on cholecystokinin which indicates that CCK has an effect when given orally" (Tr. 3010-11). Dr. Mendeloff testified that he had telephoned Dr. Smith "and asked him whether there was some new information which I wasn't privy to which stated that this material was effective by mouth and he said absolutely not" (Tr. 3113).
In a chapter written for a 1984 publication entitled "Gut Hormone Hypothesis of Postprandial Satiety," Dr. Gerard P. Smith confirmed that an extract of CCK, CCK-8, injected in the abdominal cavity will inhibit food intake in animals and people. Dr. Smith stated, "the fact that CCK-8 is not active when given orally is an additional therapeutic constraint" (CX 3-58, p. 72). Although Respondents argued that this statement applied only to CCK-8, there is no published scientific evidence that any form of CCK whatsoever is effective orally.
Dr. James Gibbs indicated similar reservations. In a draft of an article to be published in Dietary Treatment and Prevention of Obesity, Dr. Gibbs wrote, "The crucial questions for treatment - whether CCK or BBS [bombesin, another peptide] can reduce the excess body weight of obese patients when the peptides are repeatedly administered over extended periods, and whether they can do it safely - have not been tested yet" (CX 3-57, p. 102). Dr. Woods agreed with Dr. Gibbs' statement (Tr. 5295). Dr. Woods testified that there is an "absence of any data in animals or humans on giving CCK orally." However, Dr. Woods added, ". . . it may well be that that's the most efficient way to take the compound . . . I don't know" (Tr. 5333, RX 3-38, p. 2).
Dr. Ayers testified about his telephone conversation with Dr. Gibbs. Dr. Ayers stated that he and Dr. Gibbs agreed that orally administered CCK is not effective to cause weight loss in humans (Tr. 2976).
Further, the amounts of CCK in Anorex-CCK are far less than most studies of injected CCK have found to be efficacious to produce satiety and reduced food intake. Dr. Ayers asked Dr. Rosalyn Yalow to assay Anorex-CCK for cholecystokinin (Tr. 2111, 2991). Dr. Yalow won a Nobel prize for developing the radioimmunoassay method (Tr. 2110, 5136). Drs. Eastman and Mendeloff relied upon the assay in testifying (Tr. 2110-11, 3110), and Dr. Woods accepted it as reasonably accurate (Tr. 5278). Mr. Friedlander also stated that he had no problems at all with the Yalow assay (Tr. 2997).
At Dr. Eastman's request, Dr. Jerry Gardner of the National Institutes of Health performed a bioassay of Anorex-CCK (Tr. 2116). Dr. Eastman explained that a bioassay measures the ability of CCK in the product to stimulate cells in the pancreas, or the product's actual biological activity, whereas the radioimmunological assay measures the concentration of a hormone. As a result, it is quite possible to have wide discrepancies in CCK measurements between these two types of assays. Such discrepancies do not necessarily indicate that one of the assays is inaccurate. There may be large amounts of CCK in the radioimmunological assay which are not biologically active (Tr. 2116-17). As a result, the quantities of CCK found in the Yalow assay were 500 times greater than those found in the Gardner assay (Tr. 2117, 3110).
As Dr. Eastman testified without contradiction, based upon the quantities found in the Yalow assay, one would have to take anywhere from two to 65 tablets per minute during the course of a meal to obtain doses comparable to those which have produced satiety in humans by injection. Based upon the quantities found to be biologically active in the Gardner assay, one would have to take about 500 tablets per minute during the course of a meal. This assumes 100 percent effectiveness of CCK taken orally, an assumption lacking a scientific basis (Tr. 2117-18). Dr. Mendeloff agreed that the amounts of CCK found in Anorex-CCK by either assay are extremely small. He added that there is no evidence that even a large amount of CCK taken orally can be "absorbed from the gut" (Tr. 3110). Dr. Woods agreed that the dosage prescribed in the Anorex-CCK label, two tablets before each meal, is at most one-tenth of the required does of CCK shown to reduce food intake when CCK was injected (Tr. 5280).
Additionally, Dr. Ayers testified that the most potent natural stimulus to the production of CCK is food in the gut. Overweight people, who eat more than they should, produce CCK through the food that they eat. The fact that despite this they remain overweight is evidence that the CCK in their stomachs is not working for them to help them to lose weight (Tr. 2960-61, 3673).
Respondents argue that the GenTrac study (CX3-63) is sufficient evidence to overcome the consensus of medical opinion that CCK taken orally is not effective to cause satiety or weight loss.
I find the GenTrac study to be irrelevant. That study tested a product known as Appecurb which contained guar gum, vegetable bran and caffeine in addition to bovine tissue extract and CBC. Respondents have failed to show by competent, persuasive evidence that Appecurb is substantially similar to the product described on the labels of Anorex-CCK obtained in the three test purchases. The GenTrac study, therefore, is not pertinent to Respondents' Anorex-CCK product. Further, even if Respondents had shown that Appecurb and Anorex-CCK are identical products, this one in-house study does not overcome the consensus of informed scientific opinion that CCK taken orally will not result in weight loss.
GenTrac, Inc. studied 39 subjects who were recruited by newspaper advertisement and subsequently divided in two groups, a test group and a control group. After an initial random assignment, subjects were moved between groups to balance the average weight per subject. Over a four-week period the test group was given two tablets of Appecurb at a time, while the control group was given only one placebo tablet at a time. During the four-week period the subjects who took Appecurb lost an average of 12.05 pounds per subject, while the placebo group lost 2.15 pounds per subject (CX3-63, 3-71, 3-69 para 3c). The study has not been replicated (Tr. 2140), nor has it been published in a peer reviewed journal. Other than Dr. Woods, none of the witnesses have seen the underlying data on which the report at CX3-63 is based.
As previously stated, the experts agreed, and Respondents conceded (July 8 submission, p. 12), that to establish a claim that a substance will be effective to achieve a particular result, the claim must be established by sound scientific evidence (Tr. 2079-82, 2125, 2273, 3068, 5283, 5197-98, 5435, 5550-51). Whenever possible, controlled, double-blind studies should be conducted (Ayers Tr. 2273-74; Eastman 2081-82, 2754; Mendeloff 3067-71; Woods 5312; Wolever 5565). In a controlled, double-blind study the subjects are divided into two groups, one group receiving the test product, the other group receiving an inert placebo closely resembling the test product. In a double-blind study neither the subjects nor those administering the substances know which group is receiving the experimental substance or which group is receiving the placebo. If the subjects do not know who is getting which substance, but the administrators are aware of the difference, the study is only single-blind. A single-blind study is given less scientific weight because of its potential for bias (Tr. 2358, 3124). It is not clear from the evidence presented whether or not the GenTrac subjects were prevented from learning the difference between the experimental and control groups. Although Dr. Woods described the difference between receiving one pill and two as unimportant and trivial (Tr. 5147), Complainant's three experts' views that this difference challenges the study's credibility are more plausible (Tr. 2138, 2358, 3124). I find that the credibility of the study is weakened because of the difference in the number of tablets given the two groups and the strong possibility that the subjects were aware of the difference.
Another weakness was GenTrac's failure to monitor the subjects' dietary intake and exercise. A study should control for other variables which could effect its results. For a weight loss study such variables include diet and exercise (Eastman Tr. 2079-80, 2089, 2141, 2149; Mendeloff 3067, 3125-26; Woods 5297). Dor. Woods learned that GenTrac "wanted subjects who were on a low-calorie and/or weight-maintaining diet" (CX3-69, para 3B). In the absence of pre-study and continuing food intake records, there is no way to know what effect the subjects' dietary regimens had on results. Similarly, the subjects' exercise was not monitored. This too may have effected results.
The fact that the GenTrac study was an in-house manufacturer's study which was not submitted for peer-review scrutiny and not replicated also reduces the weight of its findings. As Dr. Ayers testified, in-house studies by pharmaceutical companies are not unusual. They produce preliminary data such as appropriate dosage schedules and information about side effects. These preliminary studies are used as a basis for further controlled, blind studies (Tr. 2964-65).
It is also important that results of studies be reviewed by scientists working in the field. Presentations of data at meetings and conferences are important, as are publications in peer reviewed journals (Tr. 2270, 3072). Journals that are peer reviewed require review of each submitted paper by two or more experts in the particular field (Tr. 2049-50, 2864-65, 2224-25). The author may be asked to provide additional data or rewrite portions of the paper before it is accepted for publication (Tr. 2864-65, 5339). One important function of peer reviewed journals is to enable members of the scientific Community to learn of new work in the field. Another function of publication, especially with respect to new or unexpected results, is to invite further investigations. Although Dr. Woods urged GenTrac to publish the study, GenTrac rejected his recommendation (Tr. 5339). When a study such as the one conducted by GenTrac produces results which conflict with the consensus of informed medical opinion and are thus new and unexpected, replication is especially required for those results to be accepted in the medical community.
Dr. Mendeloff testified that the medical community is not going to accept just one study of this type. The study would require replication by an independent source, at "least one other study, to reproduce this, before, I think, anyone would take it very seriously" (Tr. 3070-71). Dr. Ayers testified that "findings ... must be replicated in the hands of someone else so that any possible bias can be excluded ..." (Tr. 2270, 2301). Dr. Eastman explained that a single group's findings might be subjected to unknown biases and the findings would have to be confirmed before they would be widely accepted by the scientific community (Tr. 2140). Dr. Wolever also agreed that one single report is not enough to convince the scientific community that anything works, and replication is generally required for the results to be established (Tr. 5561-62). Dr. Woods also advocates replication for unexpected findings. He stated, "when they give me - bring me back findings that I think are unexpected, I have them do the study again." When asked to explain why he would require replication, Dr. Woods replied "because I'm a skeptic. And I would like to see if it comes out the same way. You have tremendous statistical power if you get the same results in two independent replications" (Tr. 5310).
According to Complainant's scientific experts, the GenTrac study produced new and unexpected findings and should have been replicated in order to gain acceptance in the medical and scientific communities. Dr. Wolever did not discuss the GenTrac study. Dr. Woods agreed that the results of the study are unique (Tr. 5305). However he disagreed that the study's weight loss results are unexpected because GenTrac expected Appecurb to produce weight loss rather than weight gain (Tr. 5311). I think that a more appropriate definition of "unexpected" would be results unexpected because they differ from an informed consensus in the medical and scientific community.
In summary, the informed consensus of medical and scientific opinion is that Anorex-CCK, consisting of the amounts of CCK and CBC listed in Respondents' product labels will not cause weight loss. The GenTrac study applies to a product which contains different ingredients. It is therefore, not relevant to Anorex-CCK. Even if the GenTrac study was relevant, it is insufficient evidence to overcome the informed consensus of medical and scientific opinion that CCK given orally will not cause satiety or weight loss. Cholecystokinin has potential value as an aid to a weight loss program. Unfortunately, science has not yet determined how to harness CCK's appetite-reducing properties in oral form. If that time comes, as demonstrated by valid scientific evidence, carefully-worded weight loss representations for such products will be valid. But based upon present scientific knowledge, Respondents' grandiose claims about Anorex-CCK are untrue. Therefore, I find that the following representations set forth in paragraph 7 subparagraphs (a) through (d) are materially false.
(a) Ingestion of Anorex-CCK in accordance with the label instructions will result in rapid, permanent weight loss.
(b) The weight loss results claimed for Anorex-CCK may be achieved without effort, calorie-restricted diets or exercise.
(c) Cholecystokinin (CCK), the primary active ingredient of Anorex-CCK, is responsible for causing rapid, permanent weight loss in users, without effort, calorie-restricted diets or exercise.
(d) Reliable and competent scientific evidence demonstrates that the cholecystokinin in Anorex-CCK, orally ingested, is effective as described in 7(c) above.
1. Postal Service False Representation Orders do not violate the First Amendment of the Constitution. Donaldson v. Read Magazine, 333 U.S. 178 (1948); Lynch v. Blount, 330 F. Supp. 689 (S.D.N.Y. 1971); Hollywood House International, Inc. v. Klassen, 508 F.2d 1276 (9th Cir. 1974); and United States Postal Service v. Beamish, 466 F.2d 804 (3d Cir. 1972). In the latter case, the Court held "Advertisers possess no constitutional right to disseminate false or misleading materials. Therefore, Congress has the power to prohibit such deceptions through appropriate legislation." p. 807. See also: Bolger v. Young's Drug Products Corp., 463 U.S. 60 (1983).
2. The Corporate Respondents solicit money through the mail in connection with their sale of Anorex-CCK at the addresses listed in the caption of this proceeding.
3. An advertisement must be considered as a whole and its meaning will be determined in the light of its probable effect on persons of ordinary minds. Donaldson v. Read Magazine, Inc., supra; Vibra Brush Corp. v. Schaffer, 152 F. Supp. 461 (S.D.N.Y. 1957). Rev'd on other grounds, 256 F.2d 681 (2d Cir. 1958).
4. The impression of promotional representations on the ordinary mind generally is a question for the judge to determine. Expert testimony on interpretation is not required, but it is within the discretion of the judge to permit such testimony. Vibra Brush Corp. v. Schaffer, supra. The impression of advertising on the ordinary mind may be determined by the trier of fact solely on the basis of the advertising itself. Vibra Brush Corp. v. Schaffer; Delta Enterprises, P.S. 14/72 et al, (P.S.D. July 3, 1984).
5. Express misrepresentations are not required. It is the net impression that the advertisement as a whole is likely to make upon individuals to whom it is directed that is important. Even if a solicitation is so worded as to not make an express representation, but is artfully designed to mislead those responding to it, the false representation statute is applicable. G. J. Howard Co. v. Cassidy, 162 F. Supp. 568 (E.D.N.Y. 1958); See also, Virginia State Board of Pharmacy v. Virginia Citizens Consumer Council, 425 U.S. 748 (1976), quoting United States v. 95 Barrels of Vinegar, 265 U.S. 438, 443 (1924): "It is not difficult to choose statements, designs and devices which will not deceive." In Vibra Brush Corp. v. Schaffer, supra, the Court stated:
It is not each separate word or a clause here and there of an advertisement which determines its force, but the totality of its contents and the impression of the entire advertisement upon the general populace. p. 465.
Similarly, in American Image Corp. v. United States Postal Srvice, 370 F. Supp. 964 (S.D.N.Y. 1974) the Court held: "The cases are clear that such advertisements are to be viewed not with a lawyer's eye to 'fine spun distinctions' but with an eye to their over-all effect on the average reader."
6. False representations may also be made in order verification letters and package insert materials since these may be relied upon in connection with reorders. Iso-Tensor Plan, P.S. Docket No. 3/30 (P.S.D. May 23, 1975).
7. Where an advertisement is ambiguous or capable of more than one meaning, if one of those meanings is false, the advertisement will be held to be misleading. Rhodes Pharmacal Co. v. Federal Trade Commission, 208 F.2d 382, 387 (7th Cir. 1953); Ralph J. Galliano, P.S. 19/15, (P.S.D. p. 9 May 2, 1985); Bruce Roberts Co., P.O.D. 3/78, (I.D., August 16, 1971); Moneymakers et al., P.S. 16/1, (I.D. June 20, 1983).
8. Applying the foregoing standards, the average person who reads Respondents' advertisements would interpret them substantially as characterized in subparagraphs 7 (a), (b), (c) and (d), but not (e) of the Complaint.
9. As expressed in Chaachou v. American Central Insurance Co., 241 F.2d 889, 893 (5th Cir. 1957), a representation is material if it would ". . . cause the [other party] to do other than that which would have been done had the truth been told." Applying the Chaachou test, the representations in subparagraphs 7(a), (b), (c), and (d) are material because they have the effect of inducing individuals to remit money through the mail to purchase Anorex-CCK.
10. A statement of contents on a product label is presumptive evidence of the product's ingredients. Sister Fannie Howard, P.S. 1/101 (I.D. July 21, 1972). In fact, even in cases of conflicting evidence, ingredients listed on product labels may be relied upon as correct. Carter-Ross Labs, P.S. 5/163 (I.D. July 25, 1977); Emil-John Research, P.S. 5/162 (I.D. July 21, 1977).
11. Complainant has established through qualified expert testimony that the informed consensus of scientific and medical opinion is that Respondents' representations are false. Where Complainant shows that representations in issue are not accepted as true by such a consensus, this showing establishes a prima facie case that the representations are in fact false. Cosvetic Laboratories, P.S. 8/160 (P.S.D. July 22, 1982). Once Complainant presents a prima facie case of falsity, the burden of going forward with evidence to rebut this showing (though not the burden of proof which always remains with Complainant) moves to Respondent who must adduce evidence either that the consensus does not exist or that the claim of effectiveness is true despite the lack of acceptance by the medical community. Peak Laboratories, Inc. v. United States Postal Service, 556 F. 2nd 1387 (5th Cir. 1977); Frank E. Bush, Inc. v. United States Postal Service, 84 Civ. 8756 (LBS) (S.D.N.Y. 1985); Cosvetic Laboratories, supra. Respondents have failed to rebut Complainant's prima facie case in either of these ways. Accordingly, the representations alleged in subparagraphs 7(a), (b), (c) and (d) are materially false as a matter of law.
12. Complainant has established its case by the preponderance of competent and probative evidence. Complainant's expert witnesses testified with substantial unanimity that representations made in Respondents' advertisements are false. These expert witnesses stated that their opinions reflected mainstream scientific thought, and each gave detailed bases, not only for his own opinion, but for the process by which a scientific consensus is formed. By contrast, Respondents' witness, Dr. Woods, relied solely upon the GenTrac study to support Respondents' claims.
13. Respondents relied upon Reilly v. Pinkus, 338 U.S. 269 (1949), frequently throughout the hearing (e.g. Tr. 2815-20). Respondents appear to believe that Reilly stands for the proposition that if, in a case brought pursuant to 39 U.S.C. § 3005, Respondents put forward evidence tending to show that their product performs as claimed, the Postal Service's case must necessarily fail. Reilly does not go so far as to change the standard of evidence from a preponderance to some higher one as Respondents suggest. Reilly's dictum cautioned the Postal Service to avoid crushing new or developing ideas. Reilly did not tell the agency to avoid proper enforcement actions where unproved ideas are promoted as established fact. Reilly stated:
In the science of medicine, as in other sciences, experimentation is the spur of progress. It would amount to condemnation of new ideas without a trial to give the Postmaster General power to condemn new ideas as fraudulent solely because some cling to traditional opinions with unquestioning tenacity. P. 274
The Court in Reilly was concerned with placing a "limitation upon findings of fraud under the mail statutes when the charges concern medical practices in fields where knowledge has not yet been crystalized in the crucible of experience." Knowledge in the areas of weight loss and peptide hormones have been sufficiently well scrutinized that one may state the long-established consensus with respect to several scientific facts: One cannot lose weight without adjustment of caloric balance. Evidence is necessary to support claims of efficacy. Neither CCK nor CBC, the specified ingredients of Anorex-CCK, are established by evidence to cause weight loss given orally in the amounts contained. Had Respondents produced evidence of properly conducted, replicated tests showing that Anorex-CCK performed as claimed, both as to results and to mechanism of action since advertisements make both kinds of claims, this case would have been subject to the cautions of the Reilly Court. However, no such "minority school of though" was established by Respondents' evidence.
14. A promise to refund if a customer is dissatisfied will not dispel the effect of false advertisements. Farley v. Heininger, 105 F.2d 79, 84 (D.C. Cir. 1939); Borg-Johnson Electronics, Inc., v. Christenberry, 169 F. Supp. 746, 751 (S.D.N.Y. 1959).
15. The Corporate Respondents in this proceeding are conducting a scheme for obtaining money or property through the mail by means of materially false representations within the meaning of 39 U.S. Code § 3005 through the sale of Anorex-CCK.
16. Mitchell K. Friedlander formulates, directs and controls the policies of the corporate Respondents. Therefore, it is necessary that the Cease and Desist Order includes Mitchell K. Friedlander, See: Federal Trade Commission v. Standard Education Society, 302 U.S. 112 (1937); Benrus Watch Company v. F.T.C., 352 F.2d 313, (8th Cir. 1965).
Accordingly, a False Representation Order and a Cease and Desist Order are issued herewith.