Free Speech About Science is admirable, but could it re-open DSHEA to amendments?

By Elaine Watson

- Last updated on GMT

Related tags United states congress Dietary supplement

Gay: Regulation is sufficient, it just needs to be enforced
Gay: Regulation is sufficient, it just needs to be enforced
The Natural Products Association (NPA) sympathizes with the motivations behind the Free Speech About Science Act 2011 just introduced into Congress, but fears it could be a double-edged sword.

The Act (HR1364​), which was introduced to Congress by Jason Chaffetz (R-UT) and Jared Polis on April 5, says producers of healthy foods and supplements should be allowed to cite ‘legitimate scientific studies’ on the health benefits of their products on product labels and websites.

Commenting on the Act, which proposes an amendment ​to Food, Drug, and Cosmetic Act to enable supplement makers to cite scientific studies on their labels and websites, NPA chief executive John Gay said: “While we are sympathetic to the goal of more accurate information being allowed to be disseminated, it could end up opening up DSHEA (the Dietary Supplements Health and Education Act) to amendments and once you start this process you don’t know what is going to come out of it.


“There are a lot of people that still believe that this industry needs more regulation and we have to be vigilant. The regulation is sufficient, it just needs to be enforced. We have supported additional resources to the policing of DSHEA and we’re very happy that the Food and Drug Administration (FDA) has now phased in GMP (good manufacturing practice) regulations for all manufacturers.”

However, the American Herbal Products Association (AHPA), which does "not currently have a position on the Free Speech/Science bill",​ said it did not expect the industry's Congressional critics to introduce legislation imposing further restrictions on the trade in the 112th Congress given that its focus was so heavily on the economy and spending issues.

"While we will always remain vigilant against legislation that would reduce consumer access to supplements",​ said AHPA president Michael McGuffin, "Wedo not believe that any of our Congressional critics are planning to introduce any such legislation, at least in the near future."

As to whether members of Congress were well-informed about the issues affecting the sector, "the very public partnership between FDA and the supplement trade associations to confront the issue of drug-spiked products masquerading as supplements went a long way toward educating many Congressional offices that the majority of the dietary supplements industry is engaged in responsible commerce",​ he added.

Battle to tackle misconception that industry is unregulated still not won

However, there were still some politicians laboring under the misconception that the natural products industry was unregulated, claimed the NPA's Gay, who was speaking to after NPA’s annual Natural Products Day in Washington, in which industry representatives met with members of Congress and their staff to discuss issues affecting the natural products sector.

The day began with an issue briefing and advocacy training session, while retailers, manufacturers and suppliers from the natural products sector then spent the afternoon meeting lawmakers and key staff members from their districts and states.

“The day went very well,” ​said Gay. “Our primary aim was to educate and engage with the 100+ new members of Congress that joined in November that may not have any experience of the industry or how it is regulated.

“There is a wide variety of experience and interest, but even those with a personal interest in supplements do not necessarily know how the industry is regulated and there are still many people that believe that it is un- or certainly under-regulated, which is just not the case.”

The Council for Responsible Nutrition (CRN) said it did not have a position on the free speech Bill and was primarily focused on the full implementation of DSHEA. Mike Greene, vice president, government relations, said: "We're focused on enforcement issues in relation to DSHEA, in particular around drug-spiked products, plus the release of guidance on new dietary ingredients notifications, which we understand is coming out in early July."

Click here​ to read more editorial coverage about the Free Speech About Science Act 2011.

Click here​ to see the text of the Act.


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Reply to Pierce

Posted by Robert Fuller,

Your argument simply stated is that because your firm may have sponsored some studies on your product, that the entire industry should be banned from publishing all studies done by authoritative institutions which in no way infringe upon your limited proprietary data. Certainly the small number of studies your company may have sponsored, not actually conducted I suspect, represent a negligible percentage of the total evidence pertaining to the unidentified botanical referred to in your quite vague post compared to that data in the public domain. Furthermore, given that the present prohibitions on free speech being enforced by the FDA also prevent you from publishing your own studies on your own products how can you logically support their continuation? Either you do not understand how the law is being interpreted now or you would prefer that no data be alluded by any supplement manufacturer then risk the possibility that the data you may have sponsored be made available to the public by other firms. Unless your firm is a major research institution, which is clearly not the case according to your post, it is highly unlikely that your data is of much significance vis-a-vis the entire body of independent study and trial data relative to whatever ingredients or formulations you refer to.

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Free Speech About Science not that simple

Posted by Pierce Sioussat,

As a company that sells herbal supplements supported by product specific, published research, we are wary of the free speech act. It is common for companies to cite our research when supporting claims for their own products when it is clear that their products do not deliver the same proven safety or efficacy. To allow companies to cite research that has not been conducted on the product in their bottle is unfair to those of us who have invested in that research. We already have to operate within a regulatory framework that does not allow us to differentiate our products on the basis proven claims so all we have is our research. To begin to allow others to openly use that research because they happen to have the same plant species in their product would be both misleading to the public and unconscionable.

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A simple issue that should be supported

Posted by Robert Fuller,

The position of the NPA is disappointing to say the least. The issue is a simple one and the excuse for failing to support the industry in this instance is inexcusable.

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