Don’t destroy hard-won health claim freedom, says ANH

By Shane Starling

- Last updated on GMT

Related tags: Health claims, Dietary supplement

The Alliance for Natural Health says a recent missive sent to the FDA by the Center for Science in the Public Interest (CSPI) calling for the abolishment of structure-function and qualified health claims, would favor large companies and decimate the natural products industry.

In a statement published today ANH executive and scientific director, Dr Robert Verkerk, responded to the 158-page CSPI document which highlighted examples of claims abuse, by highlighting the devastating effect revoking the claims would have on smaller players in the industry.

“It is the hundreds of much smaller companies that will feel the pinch if CSPI gets its way,”​ Verkerk wrote.

“The US health food industry has for many years enjoyed one of the least restrictive claims environments in the world. This regulatory environment hasn’t come by accident. It’s been hard won,”​ he said, noting the passage of the 1994 Dietary Supplement Health and Education Act (DSHEA).

Without it, small and medium-sized companies would have been decimated by drug laws, “leaving only a sprinkling of very large corporations as players in the market.”

“Contrary to what CSPI alleges,”​ Verkerk continued, “health claims in the US are far from out of control. As with all industries, there will be some irresponsible players, but there are already ample mechanisms in place to deal with false and misleading claims.”

While enforcement measures could be tweaked, wholesale changes were regressive, he said.

“This would create the kind of exclusive health claims club that is benefiting the likes of transnational corporations like Unilever in Europe under the Article 14 procedure of the nutrition and health claims regulation.”

“In the case of product advertising, the Federal Trade Commission has enormous power to penalise companies unable to substantiate claims, and highly publicised prosecutions have had the expected effect in making the vast majority of companies responsible in their use of claims.”

“Regardless of what CSPI or others wanting to eliminate the structure/function claims environment might say, these claims are not unregulated.”

He observed the FDA must be notified within 30 days of a structure/function claim being employed on-product.

Qualified health claims

Verkerk commented that the qualified health claims system was already being compromised by excessive disclaimers that rendered them almost commercially unusable. Selenium and antioxidant claims, which the ANH and others are challenging in the courts, were cited as examples.

“It is becoming increasingly clear that this process is controlled by pharmaceutical interests or their sympathisers conducting studies that are intended to yield negative results. These data are then used by the pharma industry’s accomplices at the FDA to give the supplement industry yet another knocking.”

Verkerk said the main drivers for claims restriction were coming from the European Union and Codex Alimentarius – the World Health Organization/Food and Agriculture Organization arm that concerns itself with global food regulations.

He said a lack of clarity in what constitutes ‘generally accepted scientific data’ was allowing a bias toward drug-style criteria.

Claims were drawing negative opinions under the EU nutrition and health claims regulation because they were supported, “largely by animal studies, biochemical evidence or emerging science.”

Verkerk said regulatory harmonization initiatives such as Codex were inevitably influenced by “horsetrading”​ between governments and large corporations.

“We see it in virtually all areas in which big business is dominant, or has a lot to lose—or gain. The push to harmonise laws on carbon dioxide emissions is a recent and key example.”

He said the ANH was raising funds if legal action was required on either side of the Atlantic.

Related topics: Regulation, Product claims

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