Weider FTC Weight Loss Charges Settled For $400,000

Weider Nutrition Internatl. has agreed to pay $400,000 to settle Federal Trade Commission charges the firm misrepresented the science supporting weight loss and safety claims for its Schiff PhenCal products.

In a complaint filed Oct. 5, FTC takes issue with claims made in newspaper ads and an information brochure. In the materials, PhenCal and PhenCal 106 are represented as being safe and effective in comparison to the Rx combination therapy phen-fen (phentermine and fenfluramine).

Advertising and promotional materials referring to PhenCal as the "natural alternative to Phen-Fen" and deeming it "safe without a prescription" were criticized in a 1998 FDA "courtesy letter" that also questioned the safety of L-5-hydroxytryptophan, one of the compound's ingredients.

Earlier in 1998, Weider received a warning letter from the agency that deemed the products unapproved new drugs - FDA said the weight-loss claims amounted to drug claims for the treatment of obesity. In November 1997, the agency had issued a broad prohibition against "herbal Phen-Fen" products.

PhenCal ads appeared in the New York Times, Washington Post, USA Today and other major newspapers during the summer and autumn of 1997. One ad carried the tagline: "You no longer need to choose between the dangers of being overweight and the dangers of diet drugs."

The commission charges Weider did not have sufficient scientific evidence to support advertising claims that PhenCal is "proven: effective as prescription treatments," "proven: to decrease food cravings," "proven: safe without a prescription" and "proven: safe and effective in clinical trials."

Two clinical trials supposedly proving the products' efficacy are cited in a PhenCal brochure: a 90-day trial showing an average loss of 27 lbs. and a two-year trial showing sustained weight loss.

All claims in question were accompanied in small print by the standard dietary supplement disclaimer.

"In truth and in fact," FTC says in its complaint, "respondent did not possess and rely upon a reasonable basis that substantiated the representations," making them "false and misleading."

Salt Lake City-based Weider may not promote PhenCal with the disputed claims and must back future claims for all products with "competent and reliable scientific evidence," according to the terms of the settlement.

Such evidence "shall mean tests, analyses, research, studies or other evidence based on the expertise of professionals in the relevant area, that have been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results," FTC states in the consent order.

Weider also must make available for FTC inspection all ads, promotional material and research data on every product it markets for the next five years. The $400,000 charge will be directed to consumer redress, with any remainder to be kept by the government.

The commission voted 5-0 to accept the settlement; there will be a public comment period through Nov. 6 following FTC's publication of the decision in the Federal Register.

The Weider settlement marks the latest in a series of FTC actions against companies marketing dietary supplements with weight loss claims. The effort is part of the commission's "Operation Waistline," which began three years ago.

Enforma Natural Products agreed to a $10 mil. fine in April related to ad claims for Fat Trapper and Exercise In A Bottle. A second complaint was filed in August against Enforma spokesperson and former baseball player Steve Garvey and others (¹ (Also see "Enforma To Cease Deceptive Weight Loss Claims, Pay $10 Mil. -FTC" - Pink Sheet, 1 May, 2000.) and ² (Also see "Enforma Weight Loss Ads Thrown Second Strike By FTC" - Pink Sheet, 11 Sep, 2000.)).

Rexall Sundown has been charged in an FTC complaint for claims made regarding its Cellasene cellulite reducer (³ (Also see "Rexall Sundown Cellasene Claims Cited In FTC Complaint" - Pink Sheet, 24 Jul, 2000.)). In addition, the Home Shopping Network settled FTC charges last year that arose in response to a variety of products marketed on the TV retail outlet, including several diet products (⁴ (Also see "Home Shopping Network Settles FTC Unsubstantiated Ad Claims Case" - Pink Sheet, 19 Apr, 1999.)).

The FTC settlement is Weider's second recent response to a complaint about its advertising. Last year, the company halted ads for NuStart Breast Health Formula to comply with the National Advertising Division of the Council of Better Business Bureaus (⁵ (Also see "Weider NuStart Breast Health Print Ad Discontinued Following NAD Inquiry" - Pink Sheet, 15 Nov, 1999.)).