SUBSCRIBE BY RSS rss feed | EMAIL
Natural Solutions Radio header image

Regulation: Claim making and claim taking

By Shane Starling, 22-Jan-2010

In a world with a chronic ‘globesity’ problem spreading beyond western shores to places like India and China, products that promise to help individuals manage their weight via calorie control, fat burning, satiety, or some other mechanism, enjoy rampant demand.

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.”

"The enforcement must reach a level where it serves as a deterrent to illegal behavior rather than simply notifying the public about adulterated products."

Shao suggested better enforcement of New Dietary Ingredient rules as a means to improve quality, while noting economically motivated adulteration (EMA) was difficult to police because it often occurred in otherwise high-quality, GMP produced conditions.

"This is one of the clearest pathways FDA has at its disposal to either prevent the marketing of products that are not dietary supplements or to remove from the market products containing ingredients that may either be NDIs, but for which no NDIN has been filed, or are not legal dietary ingredients in the first place."

Reactionary

According to Paris-based food lawyer, Nicole Coutrelis, widespread claims abuse has created a highly cautious regulatory environment for weight management products – at least in Europe.

This situation is being compounded by the fact potential claims are facing newly formalised scientific criteria copping a lot of criticism for being inappropriate for weight management and other kinds of claims. EFSA is in the process of assessing 1000s of health claim dossiers, some of which seek to make weight management claims, but is yet to approve a single one, rejecting some major players along the way.

“It is one of the greyest areas,” she said, “more so than other areas. It’s a difficult situation.”

The 2006 EU nutrition and health claims regulation names and shames weight management claims in article 12(b) which prohibits “claims which make reference to the rate or amount of weight loss” .

Patrick Coppens, the secretary general of the European Responsible Nutrition Alliance (ERNA) highlighted difficulties industry faces in making weight management claims in the EU.

“We understand that EFSA has problems with this kind of claim and it is of course very difficult, if not impossible to do double blind placebo controlled trials to show such an effect,” he said.

“Where the mechanism underlying the effect would be satiety, the same problem arises and EFSA has highlighted this when it sent back over 2000 claims to the EC for further clarification.”

Useless

There is no approved claim under the FDA’s qualified health claims system, nor is there likely to be any time soon, according to Ullman, noting a category plagued by a history of, “dicey products and claims”.

“I believe [a permitted FDA-approved weight management claim] is highly unlikely unless it is an incredibly qualified claim that is basically useless from a marketing standpoint.”

Prochnow warned that no amount of regulation could completely lift the responsibility of individuals to be vigilant.

“Those who purchase weight loss products must assume more individual responsibility to assess the credibility of the testimonials, endorsements and test data results that are presented to them daily by promoters of all food and drug products,” he said.