NPF: Many ignorant of disease/drug claim rules and where testimonials fit in

By Elaine Watson

- Last updated on GMT

Related tags Dietary supplements Food and drug administration Dietary supplement

Marc Ullman on unauthorized drug/disease claims about dietary supplements: 'Some firms don’t care, some are just ignorant, and let’s say some take a decision not to know.'
Marc Ullman on unauthorized drug/disease claims about dietary supplements: 'Some firms don’t care, some are just ignorant, and let’s say some take a decision not to know.'
A surprising numbers of companies contacted by the Natural Products Foundation (NPF) about unauthorized disease or drug claims on supplements are unaware that they are breaking the law, according to NPF executive director Deb Knowles.

The NPF, which sent out 85 warning letters over such claims in 2011 as part of its Truth in Advertising (TIA) initiative, said 50 firms had amended materials to comply with the law.

35 had ignored advice and had been referred to the Federal Trade Commission (FTC) and Food and Drug Administration (FDA).

‘The whole point of the initiative is to educate the market’

Many of those that did respond were simply “unaware of the nuances of the law”, ​said Knowles, particularly when it came to testimonials.

Some also believed they could make disease prevention claims as long as they cited supporting clinical evidence, when the law was clear that dietary supplements cannot claim to prevent, treat or cure disease, she said.

Many of the companies we contact are obviously not having claims – particularly on websites – carefully reviewed ​[by a lawyer or someone familiar with the law].”

But she added: “The fact that well over half the companies we contact do amend their advertising is great. The whole point of this initiative is to educate the market.”

Marc Ullman, a partner at legal firm Ullman, Shapiro & Ullman and chairman of the NPF legal advisory council, met the FTC last month to present documentation on the latest 22 firms ignoring NPF warnings (information on the other 13 was presented last summer).

He told NutraIngredients-USA: “Some firms don’t care, some are just ignorant, and let’s say some take a decision not to know. But the good thing is that more than half of the firms we contact make a sincere effort to amend their materials.”

The TIA initiative works to educate publishers, manufacturers, suppliers, and retailers to ensure that the information presented to consumers concerning dietary supplements adheres to the law.

Health claims and dietary supplements

Under the 1994 Dietary Supplement Health and Education Act, any claims to prevent, treat, or cure a specific disease are expressly prohibited unless they have been approved by the FDA (eg. ‘diets high in calcium may reduce the risk of osteoporosis’.)

However, manufacturers can make claims describing the supplement's effects on the structure and function or general well-being of the body (’calcium builds strong bones’), as long as they are truthful and bear the following statement, ‘This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.’

While the FDA is responsible for policing claims made on product labels, the FTC is responsible for policing claims made in advertising and other marketing materials.

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