October 29, 2012
Supplements not on an FDA “approved” list could disappear.
The NDI guidance interprets the rules for new supplements. After your protests got the first draft scrubbed, work on a second draft continues at FDA. A second meeting between FDA and “stakeholders”—mostly trade groups, with ANH-USA once again the only grassroots consumer group present—took place on October 16.
As we reported after the first meeting, the New Dietary Ingredients guidelines still pose a major threat. This is because FDA is trying to reaffirm the policies of the original guidance, particularly the elements that could remove huge numbers of supplements from the market.
Much of the meeting was dedicated to a discussion about how to create a list of “grandfathered” dietary ingredients (supplements). These supplements would have been sold prior to 1994, the year the underlying law, DSHEA, was passed and therefore would not require jumping through further regulatory hoops before being sold. The question was: what evidence would be required to show that a supplement was sold prior to 1994?
FDA says such a list won’t necessarily be final, and won’t be the only supplements allowed to be sold. But we could easily conceive of that being the outcome if left to the agency. We are also concerned that FDA wants to set the evidentiary bar so high that many supplements which were definitely sold prior to 1994 still won’t pass.
According to FDA, any of the following is sufficient to prove that a supplement was marketed before DSHEA was passed: an invoice, a bill of lading, a product label, or a catalog, provided it clearly indicates a date. But many companies don’t have this kind of documentation from eighteen years ago! For example, pyridoxamine (a B6 vitamin) was marketed before DSHEA, but no one in the industry has been able to provide the documentation required by FDA. Even signed affidavits from industry members have been inadequate in FDA’s eyes.