Weider Nutrition International, Inc., based in Salt Lake City, Utah, has agreed to settle Federal Trade Commission charges that it made unsubstantiated efficacy and safety claims in its advertisements for dietary supplement products called "PhenCal" and "PhenCal 106." The ads claim that PhenCal and PhenCal 106 (collectively, "PhenCal") were proven to cause weight loss and to prevent the regaining of lost weight. Under the terms of the proposed consent agreement, Weider would be required to pay $400,000 to the FTC for consumer redress. In addition, Weider must possess competent and reliable scientific evidence when it makes any weight loss, safety, disease benefit, or comparative claim in the promotion of its products or programs.
Weider is a leading manufacturer and marketer of nutritional supplements, vitamins and sports nutrition products. Weider sold PhenCal as an alternative to a combination of prescription diet drugs (phentermine and fenfluramine) commonly known as "Phen-Fen."
Weider advertised in major newspapers across the United States. Its newspaper ads touted PhenCal as a safe alternative to diet drugs: "YOU NO LONGER NEED TO CHOOSE BETWEEN THE DANGERS OF BEING OVERWEIGHT AND THE DANGERS OF DIET DRUGS." The ads also contained express claims that PhenCal's efficacy and safety have been clinically proven with statements such as: "Proven Safe Without a Prescription" and "Proven: Effective as Prescription Treatments." In its promotional brochure, Weider compared PhenCal to Phen-Fen and made similar claims that scientific studies proved PhenCal's efficacy and safety.
According to the FTC's complaint, Weider did not have a reasonable basis to substantiate its claims that PhenCal and PhenCal 106:
- cause significant weight loss;
- significantly increase a person's ability to maintain a reduced calorie diet and exercise regimen;
- significantly reduce food cravings and eating binges;
- prevent the regaining of lost weight;
- are as effective as the prescription weight loss treatment Phen-Fen; and
- are safe when used to promote or maintain weight loss.
The complaint further alleges that Weider's claims that scientific studies prove that PhenCal is effective and safe are false.
The proposed consent agreement, announced today for public comment, would prohibit Weider from making the specific unsubstantiated claims alleged in the complaint. The proposed settlement also would require Weider, when advertising any food, drug, dietary supplement, or program, to have adequate scientific evidence before making claims relating to:
- the safety of such product or program;
- the effect of such product or program on any disease; or
- the comparative or superior health benefit of such product or program.
In addition, the proposed settlement would prohibit Weider from misrepresenting the existence, contents, validity, results, conclusions or interpretations of any test, study or research. The settlement would allow Weider to make claims on labels for drugs or other products that have been approved by the Food and Drug Administration.
Further, the proposed settlement would require the respondent to pay $400,000 to the Commission. The funds will be used for consumer redress or, if that is impractical, the funds will be paid to the U.S. Treasury.
Finally, the settlement contains various recordkeeping provisions designed to assist the FTC in monitoring the respondent's compliance.
The Commission vote to accept the proposed consent agreement for public comment was 5-0. An announcement regarding the proposed consent agreement will be published in the Federal Register shortly. The agreement will be subject to public comment for 30 days, until November 6, 2000, after which the Commission will decide whether to make it final. Comments should be addressed to the FTC, Office of the Secretary, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580.
NOTE: A consent agreement is for settlement purposes only and does not constitute an admission of a law violation. When the Commission issues a consent order on a final basis, it carries the force of law with respect to future actions. Each violation of such an order may result in a civil penalty of $11,000.
Copies of the complaint, the proposed consent agreement and analysis of the agreement to aid public comment are available from the FTC's web site at http://www.ftc.gov and also from the FTC's Consumer Response Center, Room 130, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580; 877-FTC-HELP (877-382-4357); TDD for the hearing impaired 1-866-653-4261. To find out the latest news as it is announced, call the FTC NewsPhone recording at 202-326-2710.
Office of Public Affairs
Richard Cleland or Lemuel Dowdy
Bureau of Consumer Protection
202-326-3088 or 202-326-2981
(FTC File No. 982 3035)