February 1, 2012
As the recent news of 10 California District Attorneys reaching a settlement with the maker of two weight-loss dietary supplements banning the sale of those products and other weight-loss supplements in much of the state amply demonstrates—along with the seemingly endless stream of Federal Trade Commission (FTC) enforcement actions—the marketing of these products can be both a lucrative and high risk activity.
Compliance concerns arise primarily in two areas: (1) claims which are carefully mentored by the FTC, state Attorney Generals, and many local District Attorneys; (2) the presence of unauthorized ingredients that could cause the product to be an unapproved new drug and subject to enforcement action by the Food and Drug Administration (FDA). Careful consideration of most common issues in these areas can go a long way toward keeping a company marketing weight-loss supplements from becoming an easy target for regulators.
For much of the past two decades, weight-loss dietary supplements have been targeted by the FTC for special scrutiny due to the apparent tendency of marketers to exaggerate claims and prey on vulnerable consumers. In 1994, the Commission announced “Operation Waistline”; a decade later the Commission posted “Facts for Consumers: Weighing the Evidence in Diet Ads.” This latter document continues to provide valuable guidance to both consumers and marketers as it cites a series of claims the Commission considers “red flags” for enforcement action. These include: “lose weight without diet and exercise”; “lose weight and eat whatever you want”; “lose weight permanently and never have to diet again”; and “lose thirty pounds in 30 days.” Products making any of these—or similar claims—that come to the attention of the FTC, a State Attorney General, or a local District Attorney (especially one in California) are likely to attract much unwanted scrutiny. Two claims that should be avoided unless carefully screened include “clinically proven” (which generally must be supported by one or more long term, double blinded, placebo controlled, well-run studies in humans) and any type of unqualified percentage weight-loss claim (e.g., "users of our supplement lose 33% percent more body fat than anyone else”).
Reacting to an increasing number of reports of dietary supplements spiked with undeclared drug ingredients, on December 15, 2010 FDA and industry trade associations announced an initiative to target companies that put this type of adulterated product on the market. In a letter to the industry as a whole, FDA made it clear that products labeled as dietary supplements spiked with undeclared drug ingredients are legally classified as unapproved new drugs and would be treated as such. At the time of this announcement, FDA had already alerted consumers against using over 300 different spiked supplements. Along with body building supplements, the weight-loss category was identified as being particularly at risk. Drug ingredients frequently found in weight-loss supplements include appetite suppressants such as Meridia or diuretics such as sibutramine. Companies marketing weight-loss supplements need to be on guard against the adulteration of their products and ensure that their Good Manufacturing Practices protect against this kind of adulteration.
The weight-loss category remains a high priority area for enforcement authorities. Companies that do not take these very fundamental steps to guarantee product compliance place themselves at risk of an unwanted encounter with FDA, FTC, or state and local authorities.
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