In the Matter of the Complaint Against

AMERICAN RESEARCH LABS,
Post Office Box 369 at
Taylor, Michigan 48180

P.S. Docket No. 5/159

07/21/77

Sobernheim, Rudolf Administrative Law Judge

APPEARANCES:
Thomas A. Ziebarth, Esq.
Consumer Protection Office
Law Department U. S. Postal Service
Washington, D. C. 20260 for Complainant

Mr. Richard Wiesend American Research Lab.
P.O. Box 369
Taylor, Michigan 48180 for Respondent

INITIAL DECISION

This is a proceeding by complainant against respondent under 39 USC 3005 which authorizes action against respondent on evidence satisfactory to the Postal Service that respondent is "engaged in conducting a scheme or device for obtaining money or property through the mails by means of false representations." Complainant alleges that respondent is engaged in such a scheme in the sale of a Diet Pill. Specifically complainant alleges in paragraphs (2) and (3) of the complaint that respondent through the use of an advertisement (Compl. Ex. 1) makes representations, directly or indirectly, in substance and effect, whether by affirmative statements, omission or implication, as follows:

"(a) The DIET PILL is 300% more potent than any other diet pill available to the public without prescription;

(b) This DIET PILL is available because the federal government 'lifted the ban on the sale of an increased dosage of the strongest diet pill ingredient available to the public without a prescription';

(c) The DIET PILL contains a scientifically proven fat-melting formula and energizer;

(d) The DIET PILL 'works from within to command your body to burn calories off faster than they are consumed;' and

(e) The weight loss achieved through the use of the DIET PILL will be permanent."

Complainant further alleges in paragraph (4) of the complaint that these representations are false and materially so.

Respondent filed an answer to the complaint in effect admitting the use of the advertisement a copy of which was annexed to the complaint and denying that any representations therein made were false.

Stating that it would be unable to appear at the hearing, set for 16 June 1977, respondent in its answer made a detailed reply to each of the charges made in paragraph (3) of the complaint.

As to the charge in paragraph (3)(a) of the complaint it claimed that the total weight in milligrams of the diet pill's major ingredients:

Phenylpropanolamine           75 mg
Methylcellulose                     50 mg
Niacine                                  20 mg
Benzocaine                          15 mg
                                           160 mg

exceeds by three times the milligram content of "any other diet products available today."

As to the charge in paragraph (3)(b) of the complaint respondent claimed that some years ago the federal Food and Drug Administration (FDA) lifted a ban on dispensing more than 25 mg of phenylpropanolamine in any product--meaning presumably without prescription--and raised the limit to 75 mg. Respondent's product "Wate Controll" is said to contain 75 mg of that drug.

As to the charge in paragraph (3)(c) of the complaint respondent asserts that its reference in the advertisement to a "scientifically proven fat-melting formula" refers to the combined action of the ingredients of the pill and its formula plan sent out with every order for the pill. Respondent considers the formula "scientifically proven," since it was tested on four overweight couples for a 3-month period and those who followed the formula-plan lost more weight than those who did not. Finally, it alleges in respect of paragraph (3)(c) of the complaint that its product contains vitamins in unstated quantity and 250 mg of caffeine; that the latter is a stimulant and can be called an energizer since "energy" is according to Rogets Thesaurus a synonym of words such as "pep, vim, drive, strength" and caffeine boosts mental and physical performance through psychic stimulus.

As to the charge of paragraph (3)(d) of the complaint respondent asserts that its diet pill works from within since it is swallowed and reduces craving for food by drying the mouth and numbing the taste buds and giving a full feeling in the stomach and a feeling of stimulation.

As to the charge made in paragraph (3)(e) of the complaint respondent denies that it makes the representation charged and asserts that it is the body of the user and not the pill itself which creates a permanent weight loss and that that is the representation which it makes. Respondent also attaches to its answer photocopies of lay testimonials but these cannot be received in evidence as proof of the efficacy or quality of appellant's diet pill, sold through the mails. See 39 CFR 952.18(f).

A hearing was held at which complainant in accordance with the rule set forth in 39 CFR 952.11(b) offered proof in support of the complaint through evidence of a test purchase of the diet pills (T 2-6) and through expert medical testimony of a well-qualified physician who is employed by the FDA as a medical officer and assigned by it as Postal Collaborative Officer (see Compl. Ex. 3).

FINDINGS OF FACT

1. Richard Wiesend is engaged in business at Taylor, Michigan 48180, under the firm name and style of American Research Lab and advertises its products under the name "American Research Labs" (see Compl. Ex. 1).

2. Richard Wiesend signed the answer for respondent on letterhead of American Research Lab.

3. Respondent advertised a Diet Pill in 1977 as follows (Compl. Ex. 1):

          DIET PILL:  Potency
                            Boosted
-------------------------------------------------------------
         Fat-Melter + Energizer Added
-------------------------------------------------------------

After over a decade, the federal government lifted the ban on the sale of an increased dosage of the STRONGEST DIET PILL ingredient available to the public without prescription.

And American Research Labs has combined that ingredient with an ENERGY BOOSTER to create a pill 300% more potent than any other diet pill available today.

Containing a scientifically proven FAT-MELTING formula, the pill works from within to command your body to burn calories off faster than they are consumed. Your body becomes a FAT-SHEDDING system, resulting in fast and permanent weight loss.

There's no risk. Use the pills for 15 days. If you are not satisfied, return unused portion for full refund.

Order today. For a limited time, 30 pills only $6.95 and 60 pills for a REAL SAVINGS of $11.95. Send payment with this ad to American Research Labs, P. O. Box 369, Taylor, Mich.

48180. Canadians add 30 cents.

4. Respondent uses the mails in the sale of its product and has received money through the mail in connection therewith.

5. Respondent admits making and does make the representations charged to it in paragraph (3)(a) through (d) of the complaint.

6. Respondent's denial that it does not make the representation charged to it in paragraph (3)(e) of the complaint is not acceptable. A statement in the advertisement that "the pill works from within to command" the body to burn off calories and that the body becomes a fat-shedding system resulting in permanent weight loss states to the ordinary person that taking the diet pill will result in permanent weight loss. Prospective purchasers are asked to buy the diet pill to attain this to them desirable result. Accordingly I find that respondent makes the representation charged in paragraph (3)(e) of the complaint.

7. As a result of his test purchase the postal inspector received a bottle with thirty capsules labelled as follows (Compl. Ex. 2, Label):

"PENATROL REDUCING PLAN

with Phenylpropanolamine

ONE CAPSULE WORKS ALL DAY

30 CAPSULES

Distributed by AMERICAN RESEARCH LABS

Taylor, Michigan 48180

Phenylpropanolamine . . . is part of the

following effective formula and plan

Each Capsule Contains

Phenylpropanolamine Hc1 75 mg

Caffeine Anhydrous 140 mg

ADULT DOSAGE: One capsule in the early morning

or as directed by physician."

8. With the bottle the postal inspector received a small pamphlet, entitled "ONE DAILY REDUCING PLAN", which provides diet plans for 1,000, 1,200 and 1,500 calorie diets and directions for use of its diet supplement which contains "the proven ingredient PHENYLPROPANOLAMINE an appetite suppressant, plus BENZOCAINE, one of Medical Science's most useful and safe topical anesthetics which quiets hunger sensations, both dispersed daily over a twelve hour period." (Compl. Ex. 2, Pamphlet, p. 3).

9. The quoted pamphlet makes clear that the diet pill's alleged effectiveness required observation of a diet cutting down caloric intake substantially (see Compl. Ex. 2, Pamphlet, passim).

10. The label on the bottle also states that individuals with high blood pressure, heart disease, diabetic or thyroid disease should use the product only as directed by a physician (see Compl. Ex. 2, Label).

11. The ingredients and name of the diet pill conflict with respondent's description thereof in its answer and the statement on the letterhead of Pharmecon, Inc., of Farmington, Mich., attached thereto. The diet pill sold the postal inspector who responded to the advertisement (Compl. Ex. 1) was referred to on the label as "Penatrol", while the diet pill referred to in the answer is called "Wate Controll". The only active weight-reducing ingredient listed on the bottle label is phenylpropanolamine, while the answer and attached statement include among them also methylcellulose, niacine and benzocaine. The action of the latter is also referred to in the diet pamphlet, as quoted above. See Compl. Ex. 3, Pamphlet. Methylcellulose and niacine are not mentioned therein. On this record I find that the only alleged weight-reducing agent in the diet pill advertised by respondent is phenylpropanolamine, with a weight of 75 mg.

12. Respondent in its answer asserts that its product contains 250 mg of caffeine. The label states a quantity of 140 mg of anhydrous caffeine as part of its content and I find that the statement on the label must be accepted as correct. This is the equivalent of about two cups of coffee (T 12).

13. Respondent's product is a time-release pill which releases its phenylpropanolamine content over 12 hours or at the rate of 6 1/2 mg per hour and its caffeine content at the rate of a sip of coffee per hour (T 8-9, 15).

14. The effect of taking an adequate dose of phenylpropanolamine, i.e. 25 mg (T 18), is to dry out the mouth. Respondent's time-release capsule fails, however, to provide that dosage.

15. Phenylpropanolamine does not produce a feeling of full stomach or suppress a feeling of hunger (T 17-8). It is also not an appetite-depressant although much used in diet pills in the belief that drying out the mouth makes a person less desirous to eat. However, the statement of Pharmecon, Inc., annexed by respondent to its answer, says that " t esting of Phenylpropanolamine's use as an appetite depressant has not been concluded." Loc. cit., p. 2. Complainant's medical witness also testified that the only effective weight reduction drug known to him was dextroamphetamine which reduces appetite by action on the brain (T 17). On this record I cannot and, hence, do not find that phenylpropanolamine has any effect as a diet-control or weight-reducing drug.

16. The quantity of phenylpropanolamine contained in respondent's once-a-day time release capsule is not substantially greater than that of other diet pills using phenylpropanolamine as an active ingredient (T 15).

17. While it is not necessary in arriving at this initial decision to do so I take judicial notice of the fact that other over-the-counter diet pills do not contain substantially lesser dosages of phenylpropanolamine than respondent's. Indeed, pills providing an immediate dosage of 25 mg of this substance before each meal provide a stronger dosage than respondent's pill (T 9).

18. There has been no recent change in the quantity of the dosage of phenylpropanolamine which may be used in over-the-counter weight reduction products (T 10). Hence, I find respondent's reference in its advertisement to the lifting of a ban on increased dosages of its diet pill ingredient false as a matter of fact and, hence, a false representation to the ordinary reader of its product.

19. Caffeine is one of a class of chemicals, known as xanthines. Its ingestion or injection provides various degrees of stimulation to the central nervous system or the heart and is so used in medical practice. Ingested in reasonable quantity, it relieves drowsiness, stimulates mental and physical activity, and increases the user's alertness.

20. The energy of the body, once partly spent, is restored only by renewed caloric intake, i.e., consumption of food, or if there is fatigue by rest (T 12-13). A stimulus to the brain, such as caffeine causes, does not add to the energy which the body uses in performing whatever activity it is engaged in.

21. While words such as "energy", "vim", "vigor", etc., may at times be interchangeably used in ordinary speech, respondent's advertisement does not so use the word "energizer". By advertising that it has "added" an "energy booster" (Compl. Ex. 1) to its diet pill respondent advertises to the ordinary reader not nervous stimulus but a substance added to the pill which restores the user's physical vigor which the dieting effort has consumed. To speak of caffeine as an energizer balancing the effect of weight loss is grossly misleading and amounts to a false representation.

22. On the basis of all of the foregoing I find that complainant has adduced ample proof that the representations charged to respondent in paragraph 3 of the complaint have been made by respondent, that they are false, and that they are materially false. For they falsely assert uniqueness, novelty and effectiveness of the diet pill as well as the nature of its action. Such are the properties, however, which attract and are important to purchasers and falsity in their description is a material falsity.

CONCLUSIONS OF LAW

1. Respondent makes the representations which are set forth in paragraph (3) of the complaint. The text of the advertisement bears for the ordinary reader the meaning which complainant has set forth in its complaint. See Donaldson v. Read Magazine, 333 U.S. 178, 189 (1948). These representations are materially false as a matter of law.

2. The record discloses other misrepresentations, such as the failure of the advertisement to disclose that persons suffering from certain ailments should use the diet pill only with the consent of their physician (see Midwest Health Aids, P.S. Docket No. 2/151), but since they are not made the basis of false representation charges by complainant, they are not given consideration here.

3. Respondent is engaged in a scheme or device to obtain money through the mails by means of false representations in violation of 39 U.S.C. 3005.

4. Accordingly, an order, as provided in 39 U.S.C. 3005 and in the form annexed hereto, should issue.