In the Matter of the Complaint Against

 MCKENZIE-ROBERTS,
 P.O. Box 510028 at Miami, FL 33151 and MCKENZIE-ROBERTS, P.O. Box 4914 at Hollywood, FL 33083

 P.S. Docket No. 10/85
 
 June 10, 1981
 
 Edwin S. Bernstein Administrative Law Judge

 APPEARANCE FOR COMPLAINANT:
 Kevin B. Rachel, Esq.
 Sandra C. McFeeley, Esq.
 Law Department
 United States Postal Service
 Washington, D.C.  20260

 APPEARANCE FOR RESPONDENT:
 Ms. Daveen Bersch,
 President Davinol Products, Inc. 
 D/B/A McKenzie-Roberts
 6532 S. W. 23rd Street
 Miramar, Florida 33023

 BEFORE: Judge Edwin S. Bernstein

In a Complaint filed on January 27, 1981, Complainant alleged that 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 Section 3005.

By Order dated March 27, 1981, the hearing was scheduled for April 9, 1981. Respondent failed to appear at the hearing and I received Complainant's evidence. At the hearing, I granted Complainant's motion to amend the complaint by (1) adding an additional address for Respondent to the caption and (2) adding the following additional alleged false representation as subparagraph 3(f):

"Respondent will make a full refund of the purchase price of Nilamine upon request and return of the unused portion of the product."

I find the following to be facts pursuant to Respondent's admissions in answer to Complainant's Requests for Admissions:

(1) The active ingredient in Nilamine is 75 mgs. per tablet of Phenylpropanolamine Hydro- chloride (PPA) in a time release formula.

(2) The Food and Drug Administration has not approved for the purpose of weight control Nilamine, the active ingredient found in Nilamine, or PPA.

(3) There is no final government report on the use for weight control of Nilamine, the active ingredient found in Nilamine, or PPA.

(4) PPA has been on the market as a diet drug for many years prior to the marketing of Nilamine.

(5) The marketing of Nilamine is directed towards overweight persons.

At the hearing, Dr. Sorrell L. Schwartz and Postal Inspector Michael Flynn testified for Complainant. Dr. Schwartz is a Pro- fessor of Pharmacology at Georgetown University Schools of Medicine and Dentistry, who has outstanding expertise in Pharmacology and has written extensively in that field. He testified that PPA, the only ingredient in Nilamine, is an adrenergic drug that simulates some activities of adrenalin. It constricts the blood vessels and has been used as a nasal decongestant. (Tr. 9) It was considered useful as an appetite depressant. However, studies show that individuals who take this drug have an increased weight loss of two to four pounds during four to six weeks and then develop a tolerance for the drug which causes weight loss to discontinue. (Tr. 9,10) Professor Schwartz stated that an advisory panel on over-the-counter miscellaneous drug products appointed by the Food and Drug Administration reported in December 1978 that PPA is safe and effective as a anorexic agent. However, the Food and Drug Administration questioned these conclusions and has not accepted the report. (Tr. 11-15)

Dr. Schwartz personally believes and stated that the prevailing professional opinion is that PPA is unsafe because it constricts blood vessels all over the body and can cause a hypertensive crisis in individuals who have high blood pressure. Many people are not aware that they have high blood pressure or hypertension. (Tr. 13,14) Also, obese people are more likely to have high blood pressure. PPA also could be a hazard to individuals who have diabetes. (Tr. 14)

Dr. Schwartz stated that PPA has been used for weight control since the early 1960's. He testified that although Nilamine is labeled as a time release product, there is no data to indicate that its time release functions effectively. This product is labeled as containing 75 mgs. of PPA. Dr. Schwartz testified that an individual should take no more than 50 mgs. of PPA at a time, and no more than 100 mgs. in a day. However, there is no evidence to indicate that this product will release no more than 50 mgs. at a time. (Tr. 16,17)

Although Dr. Schwartz stated that there is disagreement in the scientific community as to whether PPA is effective at all as an appetite suppressant, he testified that there is no dispute that it is inaccurate, as contended in Respondent's advertisement, that you can lose up to 60 pounds in just 12 weeks. He stated that PPA simply is not effective to produce that degree of weight loss. (Tr. 21)

Dr. Schwartz testified that the FDA panel was not a research panel. It did no research. (Tr.15) He emphasized that the Food and Drug Administration issued a letter specifically not accepting the panel's report. (Tr.26) Additionally, the panel did not consider the effect of time release preparations. (Tr. 29) He stated that the panel's tentative findings met with considerable criticism in the scientific community. (Tr.12) He further testified that his expert opinion on the safety and efficacy of PPA is in accordance with prevailing scientific thought concerning the drug. (Tr.15)

Inspector Flynn is an inspector with the Postal Service's Special Investigations Division who investigates for medical fraud. He testified that the Postal Service uses test names or fictitious names and addresses through which it receives publications. He stated that the Postal Service received an advertisement for the product (Exhibit 3) under its test name of Sara Velte. It ordered the product by completing a coupon in another test name, Tim Lindsley. (Exhibit 3, p. 3). It received the product, and Exhibit 9 is an accurate transcription of the label on the product that the Postal Service received. (Tr. 35-41)

Inspector Flynn further testified that the post office box used by Respondent was receiving approximately eight to ten letters daily. On April 2 and 8, 1981, he was informed by an official from the post office in which the box was located that Respondent was receiving postal due parcels, that Respondent's president, Ms. Daveen Bersch, had been notified about this, and these parcels were not being collected. These parcels appeared to have been opened and resealed. This indicated that they were parcels mailed by Respondent to various addressees who returned the parcels. Ms. Bersch had refused those items and failed to pay postage due charges. When these parcels were not collected, about ten were sent to the dead letter office. When they were opened there, it was found that they contained Nilamine. (Tr. 47-49)

Complainant also introduced into evidence an August 10, 1979 issue of The Medical Letter (Exhibit 2). This letter stated the conclusion, "There is no good evidence that phenylpropanolamine, oral benzocaine or any other drug can help obese patients achieve long-term weight reduction. The only satisfactory treatment for obesity is a life-long change in patterns of food intake and physical activity."

I

I find that Respondent solicits money and property through the mail in its promotion of Nilamine. The testimony of Inspector Flynn and the exhibits introduced in connection with his testimony prove that Respondent's advertisements solicited orders by mail, enclosed a business reply envelope and the product was delivered by mail. Respondent also rented a post office box for its business, and its advertisements were transmitted through the mail.

II

I further find that Respondent makes the representations alleged in paragraphs (3) (a) thru (f) of the Complaint, as amended. The representations and the reasons for my findings are as follows:

(a) "A U.S. Government research team has approved the active ingredient in Nilamine for weight control in the amount and with the labelling found on the product." Respondent's advertisement (Exhibit 3, p.2) makes this representation several times. The heading states "U.S. GOV'T RESEARCH TEAM AGREES 100%]] THERE IS A SAFE AND EFFECTIVE DIET FORMULA." The second column of the advertisement states "The drug formula found in 'NILAMINE' works] The formula has been O.K'd by a select panel of leading Scientists, working for the United States Government."

Another advertisement used by Respondent (Exhibit 11, p.3) also supports this allegation. It states "The United States government selected a panel of medical and scientific experts to test a diet control formula. After lengthy study and painstaking research they all agreed, there is, taken as directed, a safe and effective diet pill formula that helps control your appetite. This approved appetite control formula is contained in 'NILAMINE'."

(b) "The active ingredient in Nilamine has the approval of the Food and Drug Administration for use in weight control."

This representation is made in Exhibit 3, p.2. In column 1, para.1, the advertisement states "United States Government's Panel of Experts say that there is a diet pill formula that does help people lose weight] These findings have been acknowledged by the Food and Drug Administration." Additionally, at column 2, para.1, the advertisement states, "After many years of research, the results were given to the United States Food and Drug Administration. When taken as directed, 'NILAMINE' is safe and effective. The diet pill actually does help people to lose weight]]" These representations, and especially the words "acknowledge" and "given" indicated to the reader that Nilamine and its active ingredient PPA, have U.S. Food and Drug Administration approval.

(c) "The active ingredient in Nilamine is being made available for weight control for the first time." Exhibit 3, states at the fifth line of the headline, "NOW]] AVAILABLE FOR THE VERY FIRST TIME]]" and in column 2, the caption to the right of the picture states, "1st TIME EVER OFFERED TO THE PUBLIC."

(d) Nilamine will make the user feel good or "up" rather than down or depressed. Exhibit 3, p.2, states in column 1, para.1, "Don't be down or depressed, feel good, and feel 'up' with the 'NILAMINE' Program". The headline in the middle of column 1 of that exhibit states, "FELL GOOD...FEEL 'UP'". Also, Exhibit 11, p.3 states in the last paragraph "'Nilamine' is an appetite depressant that keeps you in an 'up' mood."

(e) Nilamine will cause weight loss . Both Exhibit 3, page 2 and Exhibit 11, page 2 have a number of representations which substantiate this allegation. For example, in column 2, para.1, of Exhibit 3, p.2, the advertisements state "This diet pill actually does help people to lose weight]]" And in the seventh line of the headline "LOSE UP TO 60 LBS IN 12 SHORT WEEKS]]]" The same statement also is found in the headline of Exhibit 11, p.2.

(f) Respondent will make a full refund of the purchase price of Nilamine upon request and return of the unused portion of the product. Both of Respondent's advertisements substantiate this allegation. Exhibit 3, p.3, states "SATISFACTION IN 7 DAYS OR PURCHASE REFUNDED.", and the top of the coupon at Exhibit 11, p.2, reads "GUARANTEE...THIS IS A 14 DAY TRIAL 'NO RISK OFFER'. IF YOU DO NOT EXPERIENCE RESULTS THE VERY FIRST WEEK (7 DAYS) RETURN UNUSED PORTION FOR A COMPLETE REFUND OF YOUR PURCHASE PRICE". There are a number of other statements to the same effect in both advertisements.

III

I find that the representations alleged in paragraphs (a) through (f) of the Complaint, as amended are materially false and misleading. The representations and the reasons for my conclusions are as follows:

(a) A U.S. Government research team has approved the active ingredient in Nilamine for weight control in the amount and with the labelling found on the product.

As testified to by Dr. Schwartz, there is only one government panel that has issued a report on PPA as an aid to weight control. This is an advisory review panel of the Food and Drug Administration. It is not a research panel. The panel did not approve PPA. To date, it has issued only tentative findings. This panel only has authority to recommend. It cannot make a final decision for the Food and Drug Administration or the United States Government. Respondent's advertising misleads the public into thinking that its product has the stamp of approval of the U.S. Government, an important selling point, especially in the marketing of drugs. Additionally, the panel did not specifically evaluate Nilamine. Nilamine consists of 75 mgs. of PPA in a time release formula to be taken once a day. The panel's report did not consider the efficacy of PPA in a time release preparation. Finally, the panel's recommendation was made subject to certain labelling being made on the product containing PPA. None of these warnings appear on Respondent's pre-purchase promotional materials.

(b) The active ingredient in Nilamine has the approval of the Food and Drug Administration for use in weight control.

As Dr. Schwartz testified, the Food and Drug Administration has not approved PPA for weight control. The Advisory Review Panel has only the authority to recommend, and its finding are only tentative at this point.

(c) The active ingredient in Nilamine is being made available for weight control for the first time.

Respondent admitted this was not true in its letter of February 25, 1981. Additionally, Dr. Schwartz testified that PPA has been discussed as a possible appetite suppressant for many years.

(d) Nilamine will make the user feel good or "up' rather than down or depressed.

While Dr. Schwartz did testify that PPA had a stimulative effect on the central nervous system, he stated that this effect is undesirable. Respondent thus materially misleads the public by claiming as a benefit that which is really a detriment.

(e) Nilamine will cause weight loss.

Respondent's advertising represents that its pill will cause massive weight loss in very short periods of time. While Dr. Schwartz testified that there is some disagreement in the scientific community on the question of whether PPA is effective at all as an appetite suppressant, he stated that there is no disagreement, including the findings of the panel's report, that PPA is not so effective that it can cause the massive amounts of weight loss suggested by Respondent's advertising. Furthermore, Dr. Schwartz testified that PPA was normally not effective past the initial six week period. Thus, Respondent's advertising to the effect "Lose up to sixty pounds in just twelve weeks" is materially misleading and false. Furthermore, Dr. Schwartz testified that although PPA can be dangerous to individuals who have high blood pressure, heart, kidney, diabetes, thyroid or other diseases, there was no such warning in Respondent's solicitation and pre-purchase literature. Dr. Schwartz stated that the threat to individuals who have these problems can be dangerous. Especially in the case of hypertension, many individuals do not know that they have this problem. PPA can cause a hypertensive crisis, including a stroke or heart attack, to such individuals.

(f) Respondent will make a full refund of the purchase price of Nilamine upon request and return of the unused portion of the product.

Inspector Flynn testified that Respondent was not accepting various postage due packages returned to its post office box. The evidence indicates that at least some of these packages were returns of the unused portions of the product. Therefore, customers who attempted to return the unused portion of the product to Respondent were being denied promised refunds.

It is the impact of an advertiser's promotional material upon those to whom it is directed, the totality of its stated and implied content, and the impression of the entire oral and written solicitation upon the general public that determines whether the material contains false representations within the meaning of 39 U.S.C. Section 3005. Vibra Brush Corp. v. Schaffer , 152 F. Supp. 461 (S.D.N.Y. 1957); Donaldson v. Read Magazine , 333 U.S. 178 (1948); Borg-Johnson Electronics, Inc. v. Christenberry , 169 F. Supp. 746 (S.D.N.Y. 1959).

The average person reading Respondent's promotional materials would interpret the material substantially as characterized in paragraph 3 of the Complaint, as amended. Therefore, I conclude as a matter of law that Respondent is engaged in conducting a scheme or device for obtaining money or property through the mail by means of false representations within the meaning of Section 3005 of Title 39, U.S. Code. Accordingly, a mail-stop order substantially in the form attached should be issued against Respondent.