Is the FDA’s Interpretation of Provision 301 a Threat to Supplements?

December 16, 2008
Category: Uncategorized

The FDA invited comment about how to interpret Section 912, Provision 301 of the FDA Amendments Act of 2007. In particular, the question was whether substances studied for clinical purposes and published could then be used in supplements or whether such substances could only be used in drugs.
Was this request for comment an immediate threat to supplements? Our answer was no. But we did feel that it was important to respond to the FDA and we therefore asked both scientists and consumers to send in comments.
We also noted that, in our opinion, an interpretation of Provision 301 that restricted supplements was not only incorrect; it was illegal because it would violate DSHEA. In short, we saw no immediate threat to supplements, but thought that the FDA should hear from us and that we should closely monitor what happens hereafter.
Other health freedom organizations also wrote about this matter. Organization A sounded a full scale alarm. Organization B responded that Organization A was “crying wolf”, that Organization A often “cried wolf” or distorted or exaggerated the facts, and that this wasn’t good for the health freedom community.
We agreed with Organization B. We were therefore surprised to see an article from Organization C, a leading natural health news service, stating that Organization B’s negative comments were aimed at AAHF. This was clearly not the case.
Organization B made it very clear that it was writing about Organization A, not AAHF. We at AAHF are great fans of Organization C, the news service, but they didn’t get this right. AAHF, like Organizations B and C, is committed to complete accuracy in its reporting on what are often technical matters involving the FDA. We are also committed to a completely science based approach to natural health (as opposed to an anecdotal one), and agree that everyone in the natural health community needs to check his or her facts and present them carefully.
Although Organization C (the news service) was mistaken about AAHF being the target of Organization B’s statement, Organization B’s article accurately highlighted an unfortunate reality: there are indeed some alarmists in the health freedom community. AAHF is not one of them. We work to ensure that our perspective is an honest one, grounded in science and fact.
So how concerned should people be about the potential implications of the FDA request for comment about Provision 301? At this stage, there is no threat. The FDA is simply collecting comment. Once the FDA decides how they want to move forward, there may be a more formal rule-making process, and that could impact dietary supplements, depending on what the FDA proposes. On the other hand, after reviewing the comments AAHF submitted from doctors and scientists in the community as well as concerned consumers, it is possible the FDA may not pursue this matter further.

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