Regulation: Claim making and claim taking

Add to that strong interest among the non-overweight and obese from the likes of the athletic community and body-shape conscious men and women and you have a diverse, multi-billion dollar sector.

But this vibrant market of calorie-burning, botanical-bearing beverages, satietysupporting supplements and calorie cutting food items is faced with an enormous problem – weight management claims are almost universally prohibited. The category also suffers from an obesity-sized credibility problem that is doing it no favours in its attempts to win legitimate and science-driven health claims.

Not a single weight management claim has been approved by the US Food and Drug Administration (FDA) or the European Food Safety Authority (EFSA), and nor are any approved in any other major markets. In the US at least, companies can take their chances with structure/function claims.

The state of play hasn’t stopped companies being creative with the law and launching products making all manner of unauthorised claims that inevitably like the herbal extract ephedrine in the US, also cause health problems and even deaths. Ephedrine alkaloids have been banned in most uses in the US since 2004.

As Tom Vierhile, director of product launch analytics, at market researcher, Datamonitor, notes, the category has been a “wild west” for a long time.

“Consumers are jaded about claims that are made anyway, so I am not sure if increased regulation is really going to make much of a short-term difference as there are long-term credibility issues,” he said, noting increased FDA activity under the Obama administration.

Crack down

Such claim making is dominated by, but not exclusive to, smaller supplement companies that employ methods such as guerrilla marketing, online selling and testimonials to get their weight loss messages across.

Much of this kind of claim-making has been cracked down on, with the likes of the US Federal Trade Commission (FTC) launching a dedicated campaign against spurious weight management claims in 2004 called Big Fat Lie.

New York-based food attorney, Marc Ullman, observed. “The FTC has consistently said that it does not believe that any supplement can cause weight loss without lifestyle changes. Companies are on notice that if they make this type of claim the Commission is going to react with great skepticism.”

A company first targeted in this campaign was recently ordered to pay $2m by a US court – a decision that shows just how serious breaches of this kind can be.

Colorado-based food industry attorney, James Prochnow, added the decision would impact the claims-making culture.

”We expect that a significant impact of these developments will first be noticed in the marketplace in the second one-half of 2010,” he suggested.

“By then, distributors of such products will have had a fair opportunity and time to modify the way in which traditional consumer testimonials are used and will have had the opportunity to carry out clinical trials to determine what expected weight loss should be for the typical consumer.”

Contaminants

Contamination with the likes of steroids has also been a problem in the weight management area, and the FDA has issued many warning letters to companies making products with banned ‘added extras’, an encouraging sign according to Andrew Shao, senior vice president, scientific and regulatory affairs, at the US Council for Responsible Nutrition (CRN).

“The industry and regulators must be particularly vigilant regarding ‘lifestyle’ products – a category of products conveyed to and/or perceived by the consumer as providing a quick fix or immediate relief,” he said.

“Weight management and sexual enhancement products fall into this category. Some consumers often are less concerned about the legality of these products, or what they contain, as long as they deliver the desired effect. Unscrupulous manufacturers cater to this desire by providing products adulterated with pharmaceuticals, masquerading as dietary supplements when they are really unapproved drugs.”