Congressmen launch fresh bid to change rules on science on labels, websites

By Elaine Watson

- Last updated on GMT

Related tags: Dietary supplement, Food and drug administration

Polis: Common sense act
Polis: Common sense act
The congressmen behind last year’s abortive attempt to enable supplement makers to cite scientific studies on their labels and websites have launched a fresh bid to change the rules, but legal experts predict they face an uphill struggle.

The Free Speech About Science Act (HR 1364) was introduced by congressmen Jason Chaffetz (R-UT) and Congressman Jared Polis (D-CO - pictured) in the House of Representatives yesterday.

The bill mirrors a bill they introduced last March – which died at committee stage - in calling for an amendment to the Food, Drug, and Cosmetic Act to allow producers of healthy foods and supplements to cite ‘legitimate scientific studies’ on the health benefits of their products on product labels and websites.

Death in committee – second time around?

But Virginia-based food law attorney Jonathan Emord said the chances that it would progress beyond committee stage second time round were slim.

“I think there is little likelihood that it will be voted out of the Energy and Commerce Committee​ [to which it has just been passed] because the Committee is dominated by apologists for FDA ​[the Food and Drug Administration].

“I also think the bill, even were it to pass, would be unlikely to result in any increase in the quantity of peer-reviewed science available in the marketplace. The FDA Modernization Act included a similar measure intended to cause FDA to permit ‘authoritative’ government statements associating nutrients with disease.

“Through creative construction of ambiguous language in that law, FDA defeated the intent of Congress, negating the worth of the provision.”

Meanwhile, the language of the Free Speech About Science Act – which requires firms to provide ‘an accurate balanced summary’ of peer-reviewed research supporting any claims - was “similarly situated and invites mischief by FDA, despite the good intentions of its sponsors”,​ added Emord.

‘Uphill climb’?

The bill, which has been referred to the Committee on Energy and Commerce, “just has the ​[support of the] leads right now​ [Chaffetz and Polis], but last year it had Dan Burton (R-IN] Lincoln Diaz-Balart (R-FL), Sue Wilkins Myrick (R-NC)​ [as co-sponsors], said a spokesman from Polis’ office. “The text is the same as last Congress.”

While a large number of co-sponsors would help the cause, there was no guarantee that the Committee would take it further, he said. “For some bills the number of co-sponsors doesn’t necessarily mean anything. We have put a lot of effort into this and have a lot of support, so hopefully we’ll get a good sense of where it’s heading soon.”

The Alliance for Natural Health USA (ANH-USA) admitted it faced an “uphill climb​”, but said it was lobbying hard to attract co-sponsors, adding: “This year we have a new committee chairman and prospects are much better.”

The proposed bill would allow manufacturers of dietary supplements and healthy foods to:

  • Cite legitimate scientific research.
  • Provide a clear definition of the types of research that may be referenced.
  • Ensure that referencing such research does not convert a food or dietary supplement into an unapproved (and therefore illegal) new drug.
  • Retain the authority of FDA and FTC to pursue any fraudulent and misleading statements.

Dietary supplements and healthy foods or unapproved drugs?

Current rules prohibit any reference to a scientific study by manufacturers of a dietary supplement or producers of healthy foods if the information documents any health benefits, explained ANH-USA communications chief Darrell Rogers.

“Breaching these can result in FDA declaring common dietary supplements and foods to be unapproved drugs.”

Introducing the bill to the House of Representatives, Chaffetz said: “The Free Speech About Science Act helps insure their access to legitimate scientific research to make the necessary decisions to improve their personal health and the health of their families.”

Polis added:​ “As we begin to reform our nation’s healthcare system, supplements are an innovative way to help reduce costs.

“This is a common sense act that will make it easier for doctors and consumers to learn about the cheaper, healthier alternatives to costly medicines that food and nutritional supplements provide.”

The ANH-USA added: “It is perverse to allow pharmaceutical companies to spend so many billions on consumer advertising but not to allow food producers to tell the public about legitimate and revolutionary food research.

Executive and legal director Gretchen DuBeau added: “This is what we call the great Catch 22 of contemporary American medicine, the FDA, which is supposed to guard and promote our health, is hostile to the kind of natural medicine—based on diet, supplements, and exercise—that represents the real future of healthcare.”

Related topics: Regulation, Product claims

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2 comments

Support this bill

Posted by Al Stone,

I'm in favor of this bill. There are many studies that I could cite in support of the benefits of my Chinese herbal medicines. While B. Sardi believes that there are sufficient regulations, they also get in the way of my stating true and not misleading research data. I wouldn't paint the entire industry with the same brush of profits over service to humanity. There are those in every industry who exploit for profits, but there's no benefit to silence the legitimate voices in the Chinese medicine profession.

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Scientific substantiation of supplements

Posted by Bill Sardi,

There are sufficient regulations now against unsubstantiated claims on dietary supplement labels and advertrising, but the FDA and FTC aren't enforcing them, turning the industry over to outlaw companies, largely on the internet. The model for successful supplement marketing today is to ignore regulations and hire attorneys after making loads of money. I support licensure of supplement companies whose executives must sign a document they have read FTC advertising guidelines and Title 21 FDA regulations before entering business.

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