In the Matter of the Complaint Against SLIM-QUIK Box 893 Metuchen, NJ 08840 and DOCTOR'S CAPSULE PLAN P. O. Box 398 Bronxville, NY 10708 and BEAUTY BOUTIQUE 1 Wolf's Lane Pelham, NY 10803 and DOCTOR'S CAPSULE PLAN 1255 Post Street San Francisco, CA 94109 P.S. Docket No. 10/172; 10/28/81 Cohen, James A. APPEARANCE FOR COMPLAINANT: Hilda Rosenberg, Esq. Consumer Protection Division Law Department United States Postal Service 475 L'Enfant Plaza West, S.W. Washington, DC 20260-1100 APPEARANCE FOR RESPONDENTS: Lee H. Harter, Esq. 2256 Van Ness Avenue San Francisco, CA 94109 BEFORE: Judge Edwin S. Bernstein
Complainant alleged and Respondents denied that Respondents are conducting a scheme to obtain money through the mail by means of false representations in violation of 39 United States Code § 3005.
I held a hearing in Washington, D.C., on June 24, l981. Dr. Sorrell L. Schwartz and Dr. William R. Ayers testified for Complainant. No witness testified for Respondents.
I find that Respondents solicit money through the mail in connection with the sale of their product which is the subject of this proceeding. Respondents' counsel stipulated to this at the hearing (Tr. 2-3). Additionally, many of Complainant's exhibits substantiate this finding (CX 1-3, 6b-9, 10b-12 and 14).
I further find that Respondents' advertisements make the representations alleged in Paragraphs 3 of the Complaints in Docket Nos. 10/173, 10/174 and 11/31. CX-7 is an advertisement used by Doctor's Capsule Plan in Bronxville (10/173). That advertisement is almost identical to one used for Beauty Boutique (10/174, CX-6) and Doctor's Capsule Plan in San Francisco (CX-10, 11/31). The only difference between the advertisements, other than the different addresses, is that the advertisements in CX-6 and CX-10 state in their heading "Melt Away Fat Forever" while the hearing for CX-7 reads "Lose the Fat Forever." The representations alleged in the Complaints for Doctor's Capsule Plan in Bronxville, New York, Doctor's Capsule Plan in San Francisco, California, and Beauty Boutique are identical. The representations alleged in the Complaints for Docket Numbers 10/173, 10/174 and 11/31 and the reasons for my findings are as follows:
1. Doctor's Capsule will cause the average overweight individual to lose five pounds in one day; seven pounds in two days; and 12 pounds in one week.
This is substantiated by the statement in the first column, second paragraph of CX-6, 7 and 10 which reads, "Yes, now medical science makes it possible to lose as much as 5 pounds the very first day . . . 7 pounds in just 48 hours . . . 12 pounds in only 7 short days" and also by the testimonial of Mrs. Jane R. in the lower portion of the second column, which states "My weight dropped unbelievably fast." The word "possible" does not nullify the impression conveyed by this language that the average person will achieve these results just as the words "up to" did not nullify the impression that the stated results would not be unusual in Weider Distributors, Inc., P.S. Docket No. 3/27 (1974). See also: Iso-Tensor Plan, P.S. Docket No. 3/30 (1975).
2. Doctor's Capsule will cause the average overweight individual to lose, within 14 days: five inches off his/her tummy; five inches off his/her hips; five inches off his/her thighs; five inches off his/her waist; and six inches off his/her backside.
That representation is contained in the language at the bottom of the first column in CX-6, 7, and 10, which states:
"Yes, in an amazingly short time, you can --
Lose up to 5 Inches Off Your Tummy]
Lose up to 6 Inches Off Your Waist]
Lose up to 6 Inches Off Your Backside]
Lose up to 5 Inches Off Your Hips]
Lose up to 5 Inches Off Your Thighs]"
The holding in Weider Distributors, Inc., supra, similarly applies to this language.
3. Doctor's Capsule (Slim-Quik) allows you to lose weight without your having to diet, exercise or exert any willpower.
4. Doctor's Capsule (Slim-Quik) allows you to lose weight without your ever feeling hungry.
At the hearing, Respondents moved to dismiss subparagraphs 3 and 4 of Paragraph III of all Complaints (Tr. 127). I reserved decision on the motion. Respondents relied upon the Initial Decision in Joe Weider, P.S. Docket No. 2/74 (1974). In that case, the administrative law judge dismissed charges in a Postal Service complaint which alleged that Respondent represented that its product "permits" or "will allow." The judge found that these words resulted from careless draftsmanship and since there was nothing about the product which would inhibit weight loss, the product would allow the purchaser to "slim down" and permit the loss of weight and the purchaser to trim inches off his body.
While I have great respect for that administrative law judge's views, after careful consideration, I reach a different conclusion.
It is a canon of statutory construction that remedial statutes are to be liberally applied to advance the remedies intended. See 3 Sands, Sutherland Statutory Construction § 60.01. T he purpose of mail fraud orders is . . . prevention of future injury to the public by denying the use of the mails to aid a fraudulent scheme." Donaldson v. Read Magazine, 333 U. S. 178, 184 (l948). In evaluating such fraud, the overall impression of the language on the public must be determined. Vibra-Brush Corp. v. Schaffer, 152 F. Supp. 461 (1957). I believe that claims that a product will "allow" or "permit" the purchaser to achieve claimed results would be interpreted by the average, unsophisticated consumer as a representation that the product will cause or produce these results. Thus, I believe that an adherence to the Joe Weider holding would permit advertisers to make such false representa tions with immunity from enforcement proceedings through the use of such misleading language.
Despite my personal views, I consider the Weider determination, which was not modified on appeal, binding precedent. Therefore, I grant the motion to dismiss subparagraphs 3 and 4 of Paragraph III of the Complaints.
5. Once you have lost weight by using Doctor's Capsule you will never gain the weight back.
This representation is made in the advertisements' headings "Lose The FAt Forever" and "Melt Away Fat Forever." It is also made by the words in the first paragraph "Now, perhaps for the first time in your life you can finally achieve total freedom from the basic cause of fat"; at the end of the second paragraph "Most important of all, you will never gain it back again as long as you live] Think of it . . . Lifetime protection from fat - Once a dream - Now an actual reality"; in the heading in column 1 "The Sure Easy Way To Take It Off and Keep It Off"; and in Mrs. Jane R's testimonial "It's such a wonderful feeling to know I will be slim for the rest of my life."
6. Doctor's Capsule is not a drug and contains only natural ingredients.
This representation is made in column two of the advertisement by the words "Without harmful side effects - Without habit forming drugs] The Doctor's Capsule in 100% natural. It utilizes the body's natural chemistry. . ."
7. By speeding up your body's natural calorie-burning system, Doctor's Capsule will cause fat and other food components to liquify and be drained out of your body.
This representation is made in the fourth paragraph by the words "The Doctor's Capsule contains a safe ingredient that gently speeds up your body's natural calorie burning system so it is able to quickly melt excess fat. This same fat destroying process also breaks up existing layers of fat, liquifies them and drains them out of your body. It is this incredible, medically proven anti-fat process that will enable you to take off unwanted pounds and inches."
8. Doctor's Capsule is a safe reducing aid for overweight persons.
This representation is made in the advertisement's first paragraph, "This doctor-tested, clinically-tested, proven formula is so reliable that it was found safe and effective by a U. S. Govern ment-sponsored panel of medical and scientific experts."
The proposition that this capsule is safe is also stated in the fourth paragraph: "The Doctor's Capsule contains a safe ingredient." That same paragraph, towards the end: "This incredible, medically-proven anti-fat process will enable you to take off unwanted pounds and inches safely". Then in larger print, set off by two lines in the second column towards the middle, the advertisement states: "The ingredients found in the Doctor's Capsule have been proven remarkably safe."
With respect to Slim-Quik, Docket No. 10/172, Respondent's advertisement (CX-1), except for subparagraphs 3 and 4, makes the representations alleged in Paragraph III of the Complaint for the following reasons:
1. Slim-Quik will cause all persons to lose a minimum of eight to ten pounds after the first week of use.
This claim is made by the words "In fact, you must lose at least 8 to 10 pounds by the very first week or your money back." As held in Waist Trimmer, P.S. Docket No. 2/7 (I.D. 1973) at page 6, a guarantee constitutes a representation that the stated results can be reasonably expected within the specified time period.
5. Quik-Slim is a safe reducing aid for overweight persons.
This representation is made by the words in CX-1 "You can lose these embarrassing extra pounds quickly and safely" and "Become healthier." Additionally, Respondents' counsel admitted that this representation was made (Tr. 181).
I further find that Respondents' foregoing advertising representations are materially false. My conclusions are largely based upon the testimony of Complainant's two expert witnesses. Doctor Ayers has impressive credentials in the field of obesity and weight management, as does Dr. Schwartz in the field of pharmacology. Both witnesses testified persuasively and without contradiction. I accept their testimony that their views are in accordance with the consensus of informed opinion in their respective fields of expertise (Tr. 46, 109). The reasons for my findings are as follows:
1. Doctor's Capsule will cause the average overweight individual to lose five pounds in one day; seven pounds in two days; and 12 pounds in one week (10/173, 10/174 and 11/31).
2. Doctor's Capsule will cause the average overweight individual to lose, within 14 days: five inches off his/her tummy; five inches off his/her hips; five inches off his/her thighs; six inches off his/her waist; and six inches off his/her backside (10/173, 10/174 and 11/31).
1. Slim-Quik will cause all persons to lose a minimum of eight to ten pounds after the first week of use (10/172).
2. Slim-Quik will cause the average overweight person to lose five pounds after the first day; 12 pounds after the first week; and 20 pounds after the first two weeks (10/172).
The identical product is sold by all Respondents. It is a capsule that consists of 75 mg. of Phenylpropanolamine ("PPA") and 140 mg. Caffeine (CX-4). Doctor Schwartz described Caffeine as a central nervous system stimulant which has anti-sleep affects. It also stimulates gastric acid secretions and for that reason is contraindicated for patients with ulcers (Tr. 17). It also has a mild diuretic activity. He stated that it has not been shown to have anorectic properties (Tr. 19). He stated that PPA has some central nervous system stimulating properties (Tr. 20).
Doctor Schwartz testified that PPA does not exercise weight reduction activity by increasing metabolism (Tr. 29) and without a diet PPA would have no effect on weight loss (Tr. 30). Doctor Ayers testified to the same effect (Tr. 103). Furthermore, although the drug acts as an appetite suppressant, a tolerance to PPA develops rapidly in a matter of several days to a few weeks (Tr. 31). Respondents urge their customers to follow a 1,000 calorie diet which they furnish (CX-5). Doctor Ayers testified that even if this diet were followed most people would not lose five pounds in one day, seven pounds in two days, 20 pounds in two weeks (Tr. 107), or 12 pounds in the first week (Tr. 110). He stated that while such losses are theoretically possible, very few people would experience water losses during the first two days of dieting and the body's balance mechanisms soon replenish such water losses (Tr. 108).
Thus, I find that the product will not affect weight in the absence of a diet and even with its accompanying diet the claimed weight losses and inch losses are false.
5. Once you have lost weight by using Doctor's Capsule, you will never gain the weight back (10/173, 10/174 and 11/31).
I found persuasive Dr. Ayers' testimony that "Unless people make a long-term commitment to . . . their eating behavior and allow time for this change in eating behavior . . . to take hold of them" they will go back to their old poor eating habits and quickly regain the lost weight (Tr. 103). Moreover, the tolerance that users develop to PPA means that the drug's appetite suppressant effects will not help the user when he reverts to past poor eating practices.
6. Doctor's Capsule is not a drug and contains only natural ingredients (10/173, 10/174 and 11/31).
Doctor Schwartz testified without contradiction that Doctor's Capsule's two ingredients, PPA and Caffeine, are both drugs and PPA is not a natural substance (Tr. 17).
7. By speeding up your body's natural calorie-burning system, Doctor's Capsule will cause fat and other components to liquify and be drained out of your body (10/173, 10/174 and 11/31).
Doctor Schwartz testified that fats in the body are in a transition point between solid and liquid phases. They are not so liquid that they can be poured and not so solid that they can be chipped with a chisel (Tr. 23). He stated that metabolism involves the conversion of solid fat into its molecular components and PPA does not increase metabolism except for its increase of the heart rate. He explained that the increase of the heart rate is an adverse affect and not a weight reduction activity (Tr. 28, 29).
8. Doctor's Capsule is a safe reducing aid for overweight persons (10/173, 10/174 and 11/31) and 5. Slim-Quik is a safe reducing aid for overweight persons (10/172).
I find that Respondents' product is unsafe for a significant group of potential users and that in failing to adequately warn these users, Respondents have falsely represented the product's safety.
Both Dr. Schwartz and Dr. Ayers testified that PPA increases blood pressure in many users, that this can result in a health hazard, and, therefore, PPA is dangerous to overweight persons (Tr. 34, 35, 95, 96). Complainant introduced exhibits that supported this contention. CX-16, a January 1980 article in The Lancet which Dr. Schwartz characterized as a highly reliable British medical journal, tested two PPA preparations and found that high dose (50-85 mg.) PPA is "potentially hazardous and there is a case for increasing restrictions on such preparations." (p. 61.) CX-17, a note in the December 1979 issue of The Lancet, concluded "Since psychic disturbances, including psychotic episodes, seem to be a problem, the prescribing of drugs containing PPA should be more restricted." CX-18, an article in the February 13, l981, issue of Journal of American Medical Association, recommended that PPA pro ducts contain warnings about central nervous system effects. CX-19, an August 1979 issue of The Medical Letter, a publication that Dr. Schwartz described as a sort of Consumer Reports on drugs (Tr. 36), recommends that PPA not be used by patients who have heart disease, hypertension, hyperthyroidism or diabetes.
In opposition, Respondent introduced two exhibits. RX-1, an article in the June 1975 issue of Current Therapeutic Research, a publication that Dr. Schwartz called a respected authoritative work, stated "In this clinical study employing a well-motivated group of exogenously obese adults, phenylpropanolamine was found to be a safe and effective anorexiant." The study found that side effects were negligible, that no central nervous system stimulation was reported and that indicated a "lack of abuse potential from PPA." (p. 541.)
RX-2 is a December 1978 report entitle "Tentative Findings of the Advisory Review Panel on OTC Miscellaneous Drug Products." This panel was appointed by the Food and Drug Administration (FDA). How ever, as CX-20, a FDA publication, indicates, the FDA has not yet evaluated the panel's report. The report concluded that PPA and CAffeine are safe when doses do not exceed 50 mg. for a single dose or 100 mg. for daily divided doses (p. 43). However, the report also stated "because of its adverse reactions phenylpropanolamine is contraindicated for persons with hypertension, heart disease, diabetes or thyroid disease." (p. 37.)
The report was quite concerned about labeling. It stated:
"In order for any labeling to be acceptable, it must include (a) the indication(s) for use, (b) pertinent warnings and contraindications, (c) the recommended dosage range. Only those indications and warnings listed under Category I are generally recognized to be acceptable at this time.
"The Panel believes that all labeling should be clear, concise, and easily read and understood by most consumers. It has followed this concept in the development of all Category I labeling. The Panel is also concerned about the size and color of the print used in labeling of these and all drug products, and recommends that the industry make the necessary effort to design labeling which can be read easily by consumers.
One of the primary functions of this Panel is to attempt to eliminate confusing labeling claims. Some of the labeling on currently marketed weight control drug products tends to be overly complicated, vague, unsupported by scientific data, and in some cases false and misleading.
"The indications for use should be simply and clearly stated, the directions for use should provide the user with enough information for safe and effective use of the product, and the label should include the statement that the product is intended only for the temporary reduction of obesity. The Panel has defined temporary as no more than a three month period for ingestion of any weight control drug product to aid in the control of appetitite and this definition must be clearly stated on the product's label." (p. 29.)
The report recommended that labels for PPA contain these specific warnings:
(i) "Do not exceed recommended dosage."
(ii) "If nervousness, dizziness, or sleeplessness occur, stop the medication and consult your physician."
(iii) "If you have high blood pressure, heart disease, diabetes, or thyroid disease, or are being treated for high blood pressure or depression, do not take this product except under the supervision of a physician."
(iv) "If you are taking another medication containing phenylpropanolamine, do not take this product." (p. 41.)
"Caution: Do not exceed recommended dose since side effects may occur." (p. 44.)
Thus, even Respondents' Exhibit 2 emphasizes PPA's dangers and qualifies its findings of safety by also finding that persons who suffer from high blood pressure, heart disease, diabetes or thyroid disease might be harmed by the product and should be clearly and emphatically so warned.
In contrast to these recommendations the advertisement for Slim-Quik (CX-1) contains no safety warning and the advertisements for Doctor's Capsule (CX-6b, 7b and 10b) contain a warning in print so small that it is virtually illegible without a magnifying glass. That warning reads:
"Everyone's body chemistry is not the same, therefore the rate and quickness of weight loss may vary with the individual. However, we encourage you to show this remarkable plan to your Doctor. If he doesn't agree it is the most sensible most medically sound approach to achieving permanent, rapid weight loss, your money will be refunded without question.
"If you suffer from High Blood pressure, Diabetes, Thyroid or Heart disease check with your physician before beginning this or any reducing program."
The product's label (CX-4) states: "CAUTION: Individuals with high blood pressure, heart disease, diabetes or thryroid disease, should use only under directions of a physician."
I find that these warnings, which fall far short of those urged by the FDA Panel, are inadequate to warn of the drug's potential dangers. See: Manuel Garcia Imports, P.S. Docket No. 5/127 (1977), Initial Decision at p. 5, para. 8, P.S. Decision at p. 5; Uxbridge Products Company, P.S. Docket No. 2/199 (1974); P.S. Decision at p. 9, para. 6(d) and p. 26, para. 30(d); and Calhoun Collector's Society, Inc., P.S. Docket No. 5/24 (1976), Initial Decision at pp. 27 and 28. Therefore, because Respondents have failed to adequately warn persons who suffer from high blood pressure, heart disease, diabetes and thyroid diseases about the dangers of PPA to them, as marketed Respondents' product is unsafe, at least to these persons.
1. Since Respondents have sought remittances of money through the mail, the jurisdictional requirement of 39 U.S.C. § 3005 has been fulfilled.
2. The representations made by an advertisement are considered to be those that the purchaser to whom it was directed, presumed to be of ordinary intelligence, would understand from viewing the advertisement as a whole. What has been omitted and what may be reasonably implied from the advertisement are considered in assessing its meaning. Donaldson v. Read Magazine, Inc., supra.
Except for subparagraphs 3 and 4 of the Complaints which are dismissed, I conclude that the average overweight person would interpret Respondents' advertisements as characterized in the remaining subparagraphs of Paragraphs III of the Complaints.
4. 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. l939); Borg-Johnson Electronics, Inc. v. Christenberry, 169 F. Supp. 745, 751 (S.D.N.Y. 1959).
5. Except for subparagraphs 3 and 4, the representations in all subparagraphs of Paragraphs III of the Complaints are materially false.
Therefore, I conclude that Respondents are engaged in conducting a scheme for obtaining money through the mail by false representa tions in violation of 39 U.S.C § 3005 and that a mail stop order, substantially in the form attached, should be issued against Respondents.
Edwin S. Bernstein
Administrative Law Judge