RCT Spells Requirement For Lipidryl, Shrinking Beauty Weight Loss Claims

Add the marketers of Lipidryl and Shrinking Beauty weight loss products to the list of firms the Federal Trade Commission is requiring to support future consumer health care claims with at least two randomized clinical trials.

Although FTC orders for RCTs to substantiate claims are criticized by some industry stakeholders, the agency routinely includes the burden of clinical trials in settlements with firms found to conduct false and misleading advertising for consumer health products, particularly in the weight loss area.

FTC’s latest settlements to resolve complaints against marketers of weight loss products – targeting Bioscience Research Institute LLC and Solace International Inc. in one and [DERMADoctor Inc.] in the other – also reflects the agency’s interest in investigating cases revealed through industry self-regulation. FTC noted in its Dec. 23 announcement that the Council of Better Business Bureaus’ National Advertising Division referred Solace International’s claims for DermaTend lotions to the agency after the firm failed to respond to a NAD review (Also see "In Brief" - Pink Sheet, 14 Nov, 2011.).

Additionally, FTC pointed out FDA issued a warning letter to Solace and regulatory agencies in 10 California counties received complaints about the firm.

“These companies made outrageous claims,” Jessica Rich, Director of FTC’s Bureau of Consumer Protection, said in a same-day statement. “The common thread for all of these claims was the fundamental lack of scientific evidence.”

Mango Seed Extract Claims

According to FTC, Bioscience Research charged $129.99 for a three-month supply of Lipidryl, which contains African mango seed extract. The firm claimed the ingredient is clinically proven to cause substantial weight loss and reduce users’ waistlines.

Solace promoted DermaTend skin cream for do-it-yourself removal of moles, skin tags, and warts, with claims including, “Mole Removal Cream Makes Surgery Obsolete!”

Solace sold a 1.7-ounce container of DermaTend for $39.95 and a 3.4-ounce container for $69.95, and included in each package an emery board with instructions directing consumers to file down their mole, skin tag, or wart with the emery board before applying the product, which contains the botanical bloodroot and zinc chloride. DermaTend ads touted a “97 percent success rate” and claimed the product worked in a very short amount of time, caused little or no scarring and was safe – even for children.

FTC’s settlement with the companies, both of Reno, Nev., and owner/operator Aaron Lilly, requires future claims for DermaTend and other products promoted for removing skin lesions be supported by “high-quality human clinical testing,” and future claims for Lipidryl or other weight loss products be supported by “at least two well-done human clinical studies.”

The order, filed in the U.S. District Court for the District of Nevada on Dec. 10, requires the defendants to pay $402,338 and to provide FTC with the proceeds from the sale of four homes in Texas, and prohibits Lilly and the firms from making a number of specific unsubstantiated representations; requires disclosure if endorsers are compensated; and requires monitoring of affiliate marketers.

The FTC enforcement capped a year in which Solace International recalled DermaTend lotions to resolve FDA’s July warning that the products are unapproved drugs and are misbranded. In its August recall announcement, Solace International said “DermaTend is not FDA approved,” and “Using these DermaTend products instead of seeking medical attention could result in delayed diagnosis of conditions such as cancer” (Also see "DermaTend Firm Faces Re-Labeling To Keep Lotions On Market" - Pink Sheet, 3 Sep, 2014.).

‘Lobster Weight Loss Inspired’

FTC’s complaint said DermaDoctor and its majority owner, Audrey Kunin, a physician, made deceptive claims about Photodynamic Therapy Liquid Red Light Anti-Aging Lotion and Eye Lift Lotion products and Shrinking Beauty body-slimming lotion, which was marketed as a “firming, sculpting & toning lotion with lobster weight loss inspired technology.”

The Kansas City, Mo., firm since December 2012 marketed Shrinking Beauty, with a retail price of $58 for a 5.5-ounce tube, with claims the product would improve the appearance of cellulite, smooth and tighten skin, and that the results were “clinically proven to reduce measurements up to one inch in two weeks.”

Since October 2010 the firm sold Photodynamic Therapy lotions with extract of the noni fruit, promoted as capturing UV light and transforming it into visible red light with purported anti-aging effects on the skin, for $85 for 1-ounce bottles.

The settlement, filed in the U.S. District Court for the Western District of Missouri, Western Division, on Dec. 23, requires a payment of $12,675. It also requires DermaDoctor to have competent and reliable scientific evidence to support future anti-aging and cellulite-reduction claims, and “at least two randomized, double-blind, placebo-controlled human clinical studies to support claims relating to weight loss or reduction of body size.

POM Takes Point On RCT Opposition

Perhaps the most notable FTC requirement for RCTs to support consumer health product claims came in the agency’s order against [POM Wonderful LLC]’s variety of claims, including disease prevention and cure, for its pomegranate-containing juices and pills. The Los Angeles firm’s appeal of the FTC order in U.S. Court of Appeals for the District of Columbia Circuit is pending (Also see "Trade Groups, Emord Rip FTC Interpretation Of POM Wonderful Ads" - Pink Sheet, 23 Aug, 2013.).

POM, which appealed the order to protect its investments in pomegranate health research and potentially to hold off the agency from seeking consumer restitution, argues that requiring full RCTs to support nutrient health claims deprives consumers of useful information and violates the First Amendment.

Relying on RCTs to support nutrient health claims is a virtual impossibility “because of overwhelming scientific, economic and ethical barriers to conducting such studies on food products,” the firm said in a brief filed with its appeal.

Although questions about some of POM’s claims were widespread in the nutritional products space, the Consumer Healthcare Products Association and the Council for Responsible Nutrition submitted an amicus curiae brief in the case, questioning FTC’s “rigid insistence” on RCTs. Requiring at least two RCTs from POM to support any disease-related product claim going forward “is more likely to suppress truthful information than to prevent deception,” the trade groups said.

In a separate amicus brief for Alliance for Natural Health-USA and think tank TechFreedom, attorney Jonathan Emord said FTC’s requirement for RCTs reflects a new rule adopted outside the notice-and-comment rulemaking process, in violation of the Administrative Procedure Act.

FTC officials say there is no such rule and substantiation requirements are decided on a case-by-case basis, but Emord pointed to what he says is evidence that FTC functionally is operating under such a standard promulgated through consent orders.

Emord, president of Clifton, Va.-based Emord & Associates, blasted the two-RCT requirement as arbitrary, capricious and overly restrictive, with the potential to chill future health claim advertising that otherwise would educate consumers about healthy dietary choices.