In the Matter of the Complaint Against EVERYWOMAN'S WATER PILL, P. O. Box 1344 and P. O. Box 1347 at Hallandale, FL 33009 P.S. Docket No. 6/113 October 31, 1978 Quentin E. Grant Administrative Law Judge Appearance for Complainant: H. Richard Hefner, Esq. Consumer Protection Office Law Department U. S. Postal Service Washington, D.C. 20260 Appearance for Respondent: Joel Heim 1420 Diplomat Parkway Hollywood, FL 33019
In a complaint filed on June 28, 1978, complainant charged respondent with engaging in the conduct of a scheme for obtaining money through the mail in violation of 39 U.S.C. 3005.
Specifically, the complaint alleges that by means of advertising matter distributed to the public which is calculated and intended to induce readers thereof to remit money or property through the mails, respondent expressly or impliedly represents to the public in substance and effect, that:
"(a) Everywoman's Water Pill is an effective means for the reduction of body fat. (e.g., "Leave the fat behind" "[T]here is a pill that works as a reducing aid that will literally let you flush unwanted fat and fluids from your body..." etc.)
(b) Everywoman's Water Pill is an effective remedy for obesity. (e.g., "The plan is designed so each woman can control the dosage that is exactly right for her. If you wish to lose 10 lbs. Your problem is different from a woman who wants to lose 50 lbs." "LEAVE THE FAT BEHIND]" "You can answer the call of the THIN woman within you that is crying out to be released." etc.)
(c) Everywoman's Water Pill is an effective way to lose body weight without dieting. (e.g., ""YOU DO NOT HAVE TO DIET-you can continue to eat the foods you have always eaten. YOU WILL LOSE WEIGHT]" etc.)
(d) Everywoman's Water Pill is effective in promoting weight loss that is not transitory. (e.g., "Now, you can be that thin, chic woman of your dreams" "every day you take your pill you will be wringing out excess water from your body." etc.)
(e) Everywoman's Water Pill is a special formulation for women. (e.g., "Now there is a MILD, non-prescription (diuretic) water pill that is MADE EXPRESSLY FOR WOMEN." "Remember this pill was designed FOR WOMEN ONLY."
(f) Everywoman's Water Pill will "flush out" only excess body fluids. (e.g., "When we take a water pill it helps remove EXCESS body fluids." etc.)
(g) Everywoman's Water Pill does not have harmful side effects. (e.g., "[M]ild enough not to have harmful side-effects when used as directed." "If you've had a history of kidney disorder, consult your doctor before using. He will probably approve of this mild, safe diuretic formula." etc.)
(h) Everywoman's Water Pill may be used to reduce particular areas of the body. (e.g., "If you want to lose weight from flabby thighs, your problem is different from the woman who wants to shed pounds from her upper body and arms." "They will remove excess fluids from legs, thighs, rear, stomach, sagging breasts and arms primarily." etc.)
(i) Everywoman's Water Pill is medically recognized and accepted as an effective diuretic. (e.g., "These pills have been medically proven to work." etc.)
Further, complainant alleges that such representations are materially false as a matter of fact.
Respondent filed an answer to the complaint dated July 19, 1978, in which it denies the allegations quoted above and raises a number of purported constitutional objections. The answer did not deny the allegations of the complaint as to its engagement in a scheme employing advertising matter, copies of which were attached to the complaint (Cplt., Parags. I and II).
By document filed on October 16, 1978, long after the hearing held in Miami on August 17, 1978, respondent sought to amend its answer to deny all allegations of the complaint. My order of October 24, 1978, disallowed the proposed amendment as untimely.
At the hearing on August 17 in Miami, respondent raised numerous objections to the proceeding all of which were denied on the record. The hearing proceeded. Complainant presented its evidence. Respondent was given the opportunity to present evidence but declined to do so for various reasons stated by Mr. Heim on the record. The parties were directed to file proposed findings of fact and conclusions of law which were originally due to be filed on September 29, 1978. At respondent's request the time for filing was extended to October 20, 1978. Respondent has requested additional extension of time which has been denied in my orders dated October 13 and October 24, 1978. Complainant's proposed findings and conclusions were filed on October 20. Respondent's proposed findings and conclusions were not filed by the due date and have not been filed to date.
The matter stands ready for decision.
1. Based on Complainant's exhibits CX-1 through CX-3b and the testimony of Postal Inspector Owen J. Broadwater concerning a test purchase by him of respondent's product (Tr. 34-57) I find that respondent is engaged in a scheme for obtaining money or property through the mails for its product, Everywoman's Water Pill (hereinafter sometimes called the "product").
2. A fair reading of respondent's advertisements discloses that they contain representations concerning the product substantially as characterized in the complaint (as quoted above).
3. The product involved in this proceeding is called "Everywoman's Water Pill" (CX-2a). It comes in a plastic container containing 60 tablets with a label stating that it is "a mild diuretic." The label lists the content of each tablet as follows:
"PO EXT. Buchu 32.4 mg.
PO EXT. Uva ursi 32.4 mg.
Corn silk 32.4 mg.
PO EXT. Juniper 16.2 mg.
Caffeine 16.2 mg."
4. Direction for use appearing on the label read as follows:
"ADULT DOSE: One tablet upon arising in morning. Can take additional tablet before noon meal and before evening meal. Maximum dose 3 tablets per day. CAUTION: Not to be used in any kidney disorder or when any organic or systemic disease is present."
5. Furnished with the tablets is a small brochure or leaflet (CX-2b) entitled "Instructions and Diet Guide." This brochure states that use of the product as directed will result in daily weight losses without any change in eating habits. It provides a diet guide for purchasers who "wish to lose weight even faster."
6. Complainant produced as an expert witness William J. Evans, a medical doctor employed by the Food and Drug Administration (FDA) who practiced for 22 years in the field of obstetrics and gynecology and who was an assistant professor, and later an associate professor, of clinical gynecology, at Georgetown University School of Medicine. Dr. Evans since 1960 has been employed by the FDA in various capacities. At the time of the hearing Dr. Evans was serving as Special Assistant to the Associate Director of the Bureau of Drugs. In his private practice, Dr. Evans was particularly concerned with control of weight of female patients, the associated problem of edema, defined as the abnormal accumulation of fluid in the body tissues (Tr. 135-139) and the use of diuretics to control edema (Tr. 142). Dr. Evans was well-qualified to testify as to the matters at issue in this case.
7. Dr. Evans defined obesity as the excessive accumulation of fat in a patient due to excess intake of calories and stated that the basic accepted medical treatment for obesity is reduction of caloric intake (Tr. 142, 143) accomplished by use of a well-balanced diet of protein, carbohydrate, and fat (Tr. 144).
8. Dr. Evans used diuretics frequently in his practice but not for weight loss. He testified that the conditions of obesity or overweight are not related to edema (Tr. 144, 145).
9. In Dr. Evans' opinion, taking into consideration all the ingredients of the product, it would be no more effective as a diuretic than a placebo (Tr. 151, 152) and would certainly not cause any loss of body fat (Tr. 156, 157).
10. Based on the uncontradicted opinions expressed by Dr. Evans, which according to his testimony are in conformity with the consensus of informed medical and scientific opinion (Tr. 175), I find that the product is not an effective remedy for obesity, is not an effective means to lose body weight without diet (Tr. 161), is not an effective means for promoting weight loss that is not transitory (Tr. 161, 162), is not a special formulation for women (Tr. 163-165), is not an effective means of reducing weight in particular areas of the body (Tr. 171) and is not medically recognized and accepted as an effective diuretic (Tr. 172, 173).
11. Complainant's proof does not support the falsity of the representation alleged in paragraph III(f) of the complaint.
12. Since loss of body fat is a matter of great concern to a large proportion of the population, I find that the representations made by respondent, as alleged in the complaint, are material.
1. Respondent is engaged in the conduct of a scheme for obtaining money or property through the mails by means of representations substantially as characterized in the complaint.
2. Complainant failed to prove the falsity of the representation alleged in paragraph III(f) of the complaint but as to the other representations I find them to be materially false in fact based on the testimony of complainant's expert witness, Dr. Evans.
3. The federal courts have upheld the constitutionality of 39 U.S.C. 3005 under attacks similar to those set forth in the answer. See, for example, Hollywood House v. Klassen , 508 F.2d 1276 (1974).
4. An order pursuant to 39 U.S.C. 3005 in the form attached should be issued against respondent.