In the Matter of the Complaint Against BREWSTER PRODUCTS at P.O. Box 908, Madison Square Station, New York, New York 10010 INITIAL DECISION OF HEARING EXAMINER and 20 Branford Place, Newark, New Jersey 07102 P.O.D. Docket No. 3/79 August 30, 1971 H. Richard Hefner and Thomas A. Ziebarth, Esqs., Office of the General Counsel, U. S. Postal Service, for Complainant. Robert Ullman, Esq., Bass & Ullman, New York, New York, for Respondent. Before: John Lewis, Hearing Examiner.
This proceeding was initiated by the filing of a complaint by the General Counsel of the Post Office on March 11, 1971, charging the above-named Respondent with conducting a scheme or device for obtaining money or property through the mail by means of false representations, in violation of 39 U.S. Code, Section 4005, now Section 3005. In essence, said complaint charges Respondent with having made false representations concerning the nature of its product "FORMULA 11", and the ability of said product to cause obese persons to lose weight. Respondent appeared by counsel and filed answer denying, in substance, that it was conducting a scheme or device for obtaining money or property through the mail by means of false representations, and alleging as an affirmative defense the unconstitutionality of the statute involved in this proceeding.
Pursuant to notice duly given, a hearing for the reception of evidence was convened on May 17 and 18, 1971, in Washington, D.C. Both parties appeared by counsel and were afforded full opportunity to be heard, and to examine and cross-examine witnesses. Counsel for Complainant called two witnesses, (1) a postal inspector, through whom they sought to establish that Respondent's method of operation involved the obtaining of money through the mail by means of statements made in advertising and (2) a physician, through whom they sought to establish the falsity of the representations allegedly made in Respondent's advertising matter. Counsel for Respondent called a single witness, a user of Respondent's product, through whom counsel sought to establish the effectiveness of Formula 11 in weight loss.
During the course of the hearing on May 18, 1971, counsel for Respondent was advised by the Hearing Examiner that the record could be kept open so as to enable him to call additional witnesses, after counsel had informed the Examiner that certain witnesses had been delayed due to transportation problems. However, counsel for Respondent elected not to avail himself of such opportunity and the record was, accordingly, closed for the reception of evidence. The parties were granted until June 21, 1971, to file proposed findings of fact and conclusions of law, which date was subsequently extended until July 12, 1971, on motion of Respondent. Proposed findings of fact and conclusions of law have been filed on behalf of both parties.
After having carefully reviewed the evidence in this proceeding and the proposed findings and conclusions,1/ and based on the entire record, including his observation of the witnesses, the undersigned makes the following:
FINDINGS OF FACT
A. The Alleged Solicitation of Money Through the Mail
1. Respondent is engaged in selling a weight-reduction product and program to the general public designated as "FORMULA 11". Such plan involves the use of certain tablets described as "FORMULA 11 DIET PLAN TABLETS" or "CAPSULES", and a set of instructions designated as "FORMULA 11 PLAN" (CX 2 A-C, 3 A-c).2/
2. Public attention is attracted to Respondent's weight-control product and plan through advertisements placed in magazines of general circulation and by direct mail advertising (CX 1 A-E, 4; Tr. 8-11, 19-20, 111). As part of its advertisements, Respondent includes an order form to be used by the prospective purchasers for ordering Respondent's product through the mail. Such form requires the sending of cash, check or money order through the mail from customers who complete and mail the order form in payment of Respondent's product and plan (CX 1 F-G, 2 A-C; Tr. 11-19, 111). 3/
B. The Alleged Representations
3. Respondent's advertising matter contains various statements concerning its weight-reduction product and method (CX 1-C, 4). A copy of Respondent's advertising matter, by which it solicits money through the mail, is attached hereto as Appendix "A". Based on the portions of Respondent's advertisements quoted in the complaint and on other statements made therein (hereinafter set forth in parenthesis), it is the finding of the Examiner that Respondent has made the following representations, in substance and effect, to readers of said advertisements:4/
a. "FORMULA 11" will enable obese persons to reduce their body weight and size without restricting their daily intake of calories, and will enable said persons to lose substantial amounts of weight in relatively brief periods of time.
(e.g.,"NOTED New York physician showed patients how to BREAK
EVERY 'RULE IN THE BOOK' and still ... LOSE 7 pounds the
first 48 hours ... 12 pounds the very first week . . 34
pounds the very first month ... Yes, lose up to 71 pounds in
less than 3 months time]. *** I HAVE ... KEPT MYSELF
SLIM--AND WITHOUT DANGEROUS DRUGS, WITHOUT PUNISHING
EXERCISE, WITHOUT DANGEROUS DRUGS, WITHOUT STARVATION DIETS
*** SO EFFECTIVE ... I ACTUALLY LOST 4 LBS. IN THE FIRST 16
HOURS] You see every other method of losing weight
PERMANENTLY is doomed to failure simply because they are all
based on ... ridiculous exercises ... dangerous drugs ... or
diets that turn you into a 'carrot and lettuce addict.' ***
[Y]ou will see breathtaking results within the first 48
hours, and continue to see them day after day...")
b. "FORMULA 11" is generally recognized and employed by the medical doctors as a scientifically sound and effective means of overcoming treating and/or curing obesity.
(e.g., "I finally was told THE METHOD THAT IS ACTUALLY USED
BY DOCTORS THEMSELVES when they want to lose weight ...lose
it fast ... and lose it permanently. *** SO THAT'S WHAT
DOCTORS DO WHEN THEY WANT TO LOSE WEIGHT FAST] *** Yes, a
medically proven way to not only liquify and drain away any
existing fat that may be on your body today ... but even
more significant, a PROVEN METHOD to take the calories in
the food you eat ... and burn them...")
c. "FORMULA 11" will affect or alter the metabolism of an obese person, so as to result in the burning of fat and cause calories being ingested not to turn into fat.
(e.g., "Ever hear of the word METABOLIZE? NOT
CATABOLIZE...BUT METABOLIZE] Well, in a nutshell, that's
the entire secret ... AN INCREDIBLE WAY TO NEUTRALIZE THE
CALORIES IN THE FOOD YOU EAT AND TURN THEM INTO ENERBY
INSTEAD OF UGLY FAT. Yes, a medically proven way to not
only liquify and drain away any existing fat that may be on
your body today ... but even more significant, a PROVEN
METHOD to take the calories in the food you eat ... and burn
them ... liquidate them ... virtually destroy them before
they even have a chance to turn into fat.")
d. "FORMULA 11" is based on new or significantly different scientific principles which make it more effective than traditional methods of overcoming, treating and/or curing obesity.
(e.g., "You see every other method of losing weight
PERMANENTLY is doomed to failure simply because they are all
based on 75-year old 'rule book methods' that (A) either
demand ridiculous exercises ... (B) or dangerous drugs (like
thyroid, that the U. S. Gov't. has banned from public
sale)--(C) or diets that turn you into a 'carrots and
lettuce addict,' so that you simply give up on them. And as
for this year's colossal fad-failure ... the 'protein-kick'
... well, that's got to be the most ridiculous of all.")
e. "FORMULA 11" will enable the user to permanently overcome, treat and/or cure obesity.
(e.g., "This amazing capsule program called 'FORMULA 11',
helps get rid of unwanted, dangerous fat cells and tissues
in your body ... AND KEEPS THOSE POCKETS OF FAT OFF
PERMANENTLY.*** Is it any wonder that for the first time in
my adult life I really lost weight ... LOST IT
PERMANENTLY.")
f. "FORMULA 11" capsules or tablets contain ingredients which make them an effective aid in a program of weight reduction.
(e.g., "That with the use of this incredible capsule with
its medically structured regimen here is what happens. ***
This amazing capsule program called FORMULA 11, helps get
rid of unwanted, dangerous fat cells and tissues in your
body ... you simply take one wonder working capsule 3 times
a day, one before each mean--following the enclosed
regiment. That's all]] *** It is 12 midnight. 16 hours
have passed since you took your first capsule. You step on
the scale and lo and behold you are as much as 4 pounds
lighter] Don't be shocked... because what has happened to
you is exactly what medical science has proven MUST HAPPEN.
YOU, WITHOUT EVEN FEELING IT ... WITHOUT EVEN NOTICING IT
... WITHOUT THE SLIGHTEST HINT, have actually shed as much
as 4 pounds]")
C. The Alleged Falsity of the Representations
4. As heretofore noted, Complainant relies principally on the testimony of its medical witness, Dr. Lawrence E. Putnam, to establish the falsity of the representations made in Respondent's advertisements concerning Formula 11. Respondent offered no countervailing testimony by qualified medical witnesses. However, Respondent contends that certain studies by experts in the field, about which Dr. Putnam was interrogated on cross-examination, contradict his testimony and demonstrate his bias and lack of expertise in the field of weight reduction. Contrary to Respondent's position, the Examiner found Dr. Putnam to be highly qualified, lacking in bias and his testimony to be substantially worthy of credit.5/ Dr. Putnam adequately explained the reasons for his difference of opinion with the reports or studies about which he was interrogated by Respondent, none of which was offered into evidence by Respondent. The Examiner accepts Dr. Putnam;s "live" and highly persuasive testimony, in the absence of countervailing testimony by competent medical witnesses subject to the appropriate safeguards of cross-examination, as an appropriate basis for the findings hereinafter made. The testimony of the single lay witness called by Respondent in no way contradicts Dr. Putnam's testimony.
5. In essence, Respondent represents in its advertising that its Formula 11 will enable the users thereof to lose weight rapidly, permanently, and in substantial amounts. It claims that this is accomplished with ease by a new scientific method recognized and used by physicians, which involves a change in the metabolic process so as to "neutralize" and "burn" off calories before they turn to fat, and which dispenses with the need to follow traditional methods such as limiting calorie intake. The "wonder-working" Formula 11 tablets are claimed by Respondent to be the key element in its weight-reduction method. The credible testimony by Dr. Putnam clearly establishes, and it is so found, that Respondent's representations are contrary to fact and are false in all material respects, for the following reasons:
a. A person is considered obese if his weight is 10 per cent or more above the average for his or her height and sex. Obesity is caused by the taking in of more food than is needed by the individual for carrying on his daily activities. The basic remedy for obesity is to cut down on food and calorie consumption so that the individual is taking in less food than he needs for daily living, thus burning up excess fat which has been stored in the body. While there are drugs that can be used as appetite depressants to start patients off on a regimen of lessening food and calorie consumption, they soon lose their effectiveness. Unless the individual continues on a diet which involves taking in less calories than he requires he will soon regain his former weight (Tr. 25-6, 62).
b. The only ingredients in Respondent's tablets for which any weight loss potentiality is claimed are benzocaine, sodium carboxy methyle cellulose, and methyle cellulose, the latter two substances being substantially identical. However, according to Dr. Putnam's credible testimony none of these ingredients has any value or effectiveness in a weight-reduction program. The remaining ingredients in the tablets consist of various vitamins and minerals which may be useful in assuring that a person on a diet does not become deficient in these elements, but they have no effect on weight reduction (Tr. 29, 30-3, 36-7).
c. Benzocaine is used as a local anesthetic and is applied to the skin to relieve itching. An individual suffering from a slight irritation of the throat may obtain some relief from the anesthetizing effect of a throat lozenge containing benzocaine. However, according to Dr. Putnam's credible testimony benzocaine, in the quantities contained in Respondent's tablets or in any amount feasible for human consumption, would have no anesthetic effect on the stomach or cause a diminution of appetite (Tr. 29-30, 96-9). 6/ There are some drugs that depress appetite by stimulating the heart and blood pressure, but benzocaine is not one of these nor are there any such drugs in Formula 11 (Tr. 95). The only evidence cited by Respondent to contradict Dr. Putnam's testimony is that of a report used in connection with Dr. Putnam's cross-examination, but not offered in evidence, in which a Dr. Gould allegedly found that certain tablets ("Flavettes") containing benzocaine were effective in curbing appetite. However, the portion of the report quoted in the record indicates that the "Flavettes" were used in connection "with a diet low in fats and carbohydrates" (Tr. 103). According to Dr. Putnam's testimony, any loss of weight which may have occurred would be due to the diet and not to the use of benzocaine.
d. Methyle cellulose and sodium carboxy methyle cellulose are hydrophyllic substances, i.e., substances which attract water. In quantities much larger than those contained in Respondent's tablets they are used as bulk laxatives. However, according to Dr. Putnam's credible testimony these ingredients would have no value in curbing the appetite and causing a reduction in weight, either in the quantities contained in Respondent's tablets or in the larger quantities which are used in bulk laxatives (Tr. 30-2, 48). The principal evidence cited by Respondent to contradict Dr. Putnam's testimony is an article in a medical journal by a New York doctor (possibly the "Noted New York physician" referred to in Respondent's advertising) purporting to establish the utility of methyle cellulose in a weight-reduction program. The article (not offered in evidence) does not contain any conclusions by the author, but refers to a report by another group of physicians (likewise not offered in evidence) which states that: "Using methylcellulose, caloric restriction and patient selection to avoid compulsive eating, Brusch and Colleagues found an average weight loss of 46 grams per day" (Tr. 82). However, as noted by Dr. Putnam, the study involved a reduction in caloric intake, which alone could have produced a reduction in weight (Tr. 91). Absent more specific and reliable evidence concerning the nature of the basic study and of the qualifications of those who conducted it, no weight can be given to it in the face of Dr. Putnam's testimony that there are hundreds of studies showing contrary results and that he himself has used similar substances with many patients and found them to be without value in suppressing appetite (Tr. 73, 58, 83). Respondent also refers to another study mentioned in a medical journal (not introduced into evidence) in which methyle cellulose was used as a bulk laxative in the hope that it would depress the appetite. Not only do the garbled portions of the report which are referred to in the transcript not contain any conclusions as to the value of methyle cellulose as an appetite depressant, but the article contains the following illuminating conclusion: "From the foregoing it seems evidence that the only rational approach to obesity lies in psychotherapy." (Tr. 93).
e. The so-called "FORMULA 11 PLAN" enclosed with Respondent's capsules contains various dietary prescriptions. It advises the user to "Eat only food listed in your menu plan in quantities specific" (CX 2-C, 3-C). While there are certain contra- dictions in the advice given in the leaflet, persons following the recommended diets may achieve some reduction in weight. However, contrary to the claims made in Respondent's advertisements about "break[ing] every rule in the book" and ignoring diets, the dietary prescriptions in the plan are similar to traditional dietary regimens used to lose weight, which contain limitations on quantities and types of food that can be eaten. There is nothing new or revolutionary in it. Moreover, any weight loss which would be achieved would be the result of following the dietary prescription and would not be due to ingestion of the tablets. The latter have no value whatsoever in bringing about a reduction in weight (Tr. 45-8).
f. None of the ingredients in Formula 11 will affect or alter the metabolism of an obese person, so as to result in the burning up of fat or cause calories being ingested not to turn into fat. The only way in which a weight loss could be achieved through a change in the metabolic process would be to speed up the process so as to cause a person to burn up tissue faster than he can change food into living tissue. This occurs in the case of persons suffering from an overactive thyroid. However, a person not suffering from such a condition cannot affect his metabolism by tablets or medication. The only way in which he can affect his metabolism is to give it less work to do; i.e., by taking in less food (Tr. 41-3).
g. Formula 11 does not incorporate any new scientific principles for overcoming obesity. For a number of years a small number of people in the medical profession has claimed to have found some merit in the use of tablets containing various combinations of benzocaine or methyle cellulose as part of a regimen for weight reduction. However, the universality of medical opinion, based on hundreds of studies, is that such tablets have no effect on weight reduction. Insofar as the diet plan enclosed with Respondent's tablets is concerned, it contains nothing significantly new or different from other plans which seek to control weight by limitations on the kinds and quantities of food ingested (Tr. 43-6, 48, 80, 83).
h. The only affirmative evidence offered by Respondent that Formula 11 is effective in a weight-reduction program is the testimony of a single lay witness, who claimed that after following the diet plan and taking the capsules for six or seven weeks he reduced his weight by approximately 26 pounds (Tr. 113-6). Such testimony fails to establish that the Formula 11 capsules, upon which the thrust of Respondent's advertising claims is based, had any effect on his purported loss of weight. On the contrary, the witness's testimony indicates that as soon as he ceased following the diet strictly he gained six or seven pounds (Tr. 116). The testimony of this single lay witness is hardly sufficient to overcome the overwhelming weight of the expert testimony concerning the lack of merit of Respondent's Formula 11 capsules in a weight-reduction program.
CONCLUSION
Respondent is engaged in conducting a scheme or device for obtaining money or property through the mail by means of false representations, in violation of 39 U.S. COde 3005. It is accordingly recommended that an order in the form attached, as provided in 39 U.S. Code 3005, should be issued.
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1/ Proposed findings not herein adopted, either in the form
proposed or in substance, are rejected as not supported by the
evidence or as involving immaterial matters.
2/ The following abbreviations are used herein in referring
to evidence in the record: "Tr", for the transcript of testimony; "CX",
for Complainant's exhibits; "RX", for Respondent's exhibits. Such
references are to the principal parts of the record relied upon by
the Examiner, in support of particular findings, but are not intended
as an exhaustive compendium of the portions of the record reviewed
and relied upon by him.
3/ In its answer, Respondent admits the use of the
advertising material attached to the complaint and the use of the mails in the
operation of its business, but denies that it obtained money by false
representations. No proposed findings were submitted by Respondent
with respect to the issue of obtaining money through the mail
pursuant to the instructions given in its advertising matter.
4/ Respondent submitted no proposed findings concerning
the representations purportedly made in its advertisements, limiting its
proposed findings solely to the issue of the falsity of representations made in its advertisements.