In the Matter of the Complaint Against EMIL-JOHN RESEARCH, Post Office Box 369 at Taylor, Michigan 48180 P.S. Docket No. 5/162 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 Richard Wiesend Emil John Research P. O. Box 369 Taylor, Michigan 48180 for Respondent
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 "SHAPE-UP DAY Reducing Plan with Phenylpropanolamine." Specifically complainant in paragraphs (2) and (3) of the complaint alleges that respondent through the use of advertisements (Compl. Ex. 1 and 2) makes representations, directly or indirectly, in substance and effect, whether by affirmative statements, omission or implication, as follows:
"(a) The capsules furnished with the '24-Hour Diet Kit' will, in and of themselves, cause a loss of weight in the user;
(b) The 'night capsule' will 'dissolve unsightly fat' while the user sleeps; and
(c) The 'day capsule' will 'boost energy' during the day."
Complainant further alleges in paragraph (4) of the complaint that these representations are false and materially so.
Respondent in its answer admits using the advertisements, copies of which are attached to the complaint, and making the representations which are charged to it in paragraph (3) of the complaint but asserts that the same are true. A statement of its alleged supplier Pharmecon, Inc. as to the ingredients of the capsule forming part of its reducing plan with phenylpropanolamine as well as lay testimonials are attached to the answer. Such lay testimonials are not, however, admissible as proof as the efficacy or quality of the reducing plan with phenylpropanolamine sold by respondent (39 CFR 952.18(f)).
Respondent in its answer stated that it was unable to attend the hearing set for 16 June 1977 and it did not appear at the hearing. Under the rule set forth in 39 CFR 952.11(b) complainant thereupon proceeded to present the testimony in support of the complaint, to wit: testimony of a postal inspector regarding a test purchase of respondent's product as part of which respondent received the purchase price (money) through the mails and expert medical testimony in support of the asserted falsity of respondent's representations.
FINDINGS OF FACT
1. Respondent, the principal of which also is engaged in business under the trade name and style of American Research Labs (P.S. Docket Nos. 5/159, 5/160) and which is the supplier of the pep pill "ALIVE" sold by American Research Labs to the public (P.S. Docket No. 5/160), is engaged in the sale of a reducing plan with phenylpropanolamine by use of advertisements copies of which are attached to the complaint as exhibits 1 and 2.
2. In the sale of this product respondent receives money through the mail as shown by the postal inspector's test purchase previously mentioned (T 5-7).
3. a. The advertisements used by respondent are headed either "24-HOUR DIET KIT" or "DIET KIT" followed by either one or the other of two punch lines:
"BOOSTS ENERGY BY DAY
MELTS FAT BY NIGHT"
or
"PEPS-U-UP BY DAY
MELTS FAT BY NIGHT"
b. The text of some advertisements represents that the user should take one capsule at night to dissolve unsightly fat while the user sleeps or that the user should take two capsules for pepping-up during the day and melting pounds away at night during restful sleep.
c. None of the advertisements refer to reduced or regulated food intake and state that the "diet kit consists of two capsules guaranteed to" accomplish an energy boost or pepping-up during the day and fat-melting during nocturnal sleep.
4. Comparing the text of the advertisements and the representations, charged to respondent in paragraph (3) of the complaint, I find that the representations, admitted by respondent, are indeed made to the readers of its advertisements.
5. In response to the test purchase the postal inspector received two bottles with 30 capsules each labelled (Compl. Ex. 3, pp. 1, 2):
"SHAPE-UP DAY
Reducing Plan
With Phenylpropanolamine
ONE CAPSULE
WORKS ALL DAY
30 CAPSULES
Distributed by
Advance Nutrient Products
Southgate, Michigan 48195"
and
"SHAPE-UP-NIGHT" also distributed by Advance Nutrient Products.
6. a. The day capsules contain according to the label 25 mg phenylpropanolamine, 100 mg caffeine, 100 mg sodium carboxymethylcellulose, and 3.5 mg benzocaine. In addition, each capsule contains an assortment of vitamins, with quantities noted on the label for three capsules together. The totals are stated as a percentage of the minimum daily requirement and, hence, a single day capsule contains less than the daily minimum requirement except for vitamin B-1.
b. The day capsules are to be taken one per day but "for extra effectiveness" another capsule may be taken late in the afternoon. The label further warns against use of the capsule if high blood pressure, heart, kidney, diabetic, thyroid or other disease is present.
c. The night capsules contain 19 grs of lecithin in pure soy bean oil as a carrier and unstated quantities of vitamin B complex substances and esters or acids. They are described as a " f ood supplement for dietary purposes only", to be taken one capsule at a time.
7. Advanced Nutrient Products, the distributor of the product sold by respondent, is the respondent in a proceeding, docketed as P.S. Docket No. 5/164, involving the sale of another diet capsule.
8. Respondent has furnished an analysis of the day capsules by Pharmecon, Inc., which deviates in some respects from that shown on the label of their bottle. The major divergence is that Pharmecon states a larger quantity of benzocaine and there are variants in respect of the vitamins. To the extent of such variations the statement on the label is accepted as giving the correct composition.
9. In addition to the capsules the test purchaser received a copy of a testimonial (Compl. Ex. 3, p. 5), a re-order blank (id., p. 4) and a "slimtime reducing plan" (id., p. 3). The latter states on page 3 that, to "lose weight, it is important that the intake of foods with high caloric value" be "reduced". The plan then refers to the need of avoiding loss of vitamins as well as the need for bulk in the digestive organs, for quieting hunger sensation, aid in dieting and a slight perk-up in feelings. The vitamins in the day capsules, methylcellulose, benzocaine, phenylpropanolamine and caffeine, contained in the day capsules, are said to fulfill these requirements. The remainder of the slimtime pamphlet contains weight charts and diet plans. As to the latter, the label on the day capsule bottle urges the purchaser to follow the suggested menus "every day" as he loses weight (Compl. Ex. 3, p. 1).
10. The testimony of respondent's well-qualified expert medical witness, a medical officer in the federal Food and Drug Administration assigned as Postal Collaborative Officer (see Compl. Ex. 4) convincingly refutes the medicinal claims made by respondent in its answer.
a. He testified that 25 mg of phenylpropanolamine, time-released over 6 or 8 hours would be insufficient to dry out the mouth (T 11, 14) but that even if all of it were released at once and the mouth became dry, this phenomenon would not kill the appetite (T 11, 15) and it is obvious that drinking of liquids with or before the meal will overcome the effect of dryness.
b. He conceded that methylcellulose, if swelling up in the stomach, would give an appetite-restricting feeling of fullness. The dosage necessary for such result would, however, be 2 to 6 grams (T 11, 16) and respondent's 100 mg dosage was totally inadequate to reach the desired result. The same was true of the benzocaine, a topical anesthetic for the skin surface, which would in no way quiet hunger feelings or, if ingested with the capsule into the stomach, numb the taker's taste buds (T 12, 15).
c. The caffeine content of the day capsule amounts to one extra cup of coffee during the day and has no effect on the user's "energy" during the day. Moreover, caffeine is a cerebral stimulant and adds nothing to the physical resources of the body. For detailed findings on this point see American Research Labs, P.S. Docket No. 5/159 (init. dec.).
d. Lecithin, the night capsule ingredient, is known to keep fat in the gall bladder and liver in liquid state but has no known effect, metabolic or otherwise, on body tissue fat and does not emulsify it (T 12).
e. The witness testified that his testimony represented the consensus of informed medical opinion (T 13).
11. Based on the foregoing detailed findings of fact and the record as a whole I find that the representations, charged to respondent in paragraph (3) of the complaint and made by it, are false and that the ingredients of its capsules have no medical effect on obesity whatever even if commonly marketed with claims of such effect (see T 10).
12. These representations are materially false in that they claim effectiveness in weight reduction, desired by prospective purchasers, and thus lead them to buy respondent's capsules.
CONCLUSIONS OF LAW
1. Respondent is engaged in a scheme or device to obtain money through the mails by means of false representations in contravention of 39 USC 3005.
2. Accordingly, an order as provided for in 39 USC 3005 and in the form annexed should be issued against respondent.