CRN has set a letter to FDA Commission Margaret Hamburg saying that the agency’s current position which holds that synthetic constituents of botanicals, not having been extracted from the given plant materials, cannot qualify as dietary ingredients is contrary to the intent of the Dietary Supplement Health and Education Act of 1994 (DSHEA) and has no basis in science.
The agency’s current position on the matter was elucidated in the draft guidance on New Dietary Ingredients that was first released in early July 2011. Industry reacted negatively to many portions of the guidance, including on the synthetic botanical issue. Trade associations, including CRN, called for the guidance to be revised, something the agency agreed to do in June after a meeting that included Senators Orrin Hatch (R-UT) and Tom Harkin (D-IA) (the authors of DSHEA) and Commissioner Hamburg.
“What concerns me is that we understand when the commissioner met with Senators Hatch and Harkin back in the summer that there was an agreement that they would not enforce the controversial aspects of the guidance until there was a full vetting of the issues,” CRN’s chief executive Steve Mister told NutraIngredients-USA.
Cases of enforcement on issue
In the letter to Hamburg, CRN cites cases where FDA has used this position about synthetic botanicals to form part of the underpinning for enforcement actions. In footnotes in the letter, the trade organization cites the 10 warning letters on DMAA, and also references the decision on homotaurine. Another footnote references at least two cases in which shipments of vinpocetine have been detained at point of entry because of the ingredient's synthetic status.
“Our feeling is despite what FDA may have told Senators Hatch and Harkin, there does seem to be ongoing enforcement on this issue,” Mister said.
After that top level meeting in June, FDA has met with the major industry trade organizations to go through the controversial aspects of the first draft of the guidance. Those include the status of Old Dietary Ingredients and what (if any) industry-generated lists might be accepted to identify “grandfathered” ODIs, what kinds of chemical processes or manufacturing changes or improvements so alter an ODI that it then becomes an NDI, the issue of whether NDI notifications are required only on new ingredients or also on new products containing NDIs and the synthetic botanical issue.
Of the meetings, Mister said, “The issue of the synthetic botanicals has not been raised in our discussions at all. They asked that we start with a discussion about grandfathered ingredients.”
Position not grounded in law or science
In the 26-page letter to Hamburg, Mister said CRN makes clear that the synthetic botanical issue should never have been part of the NDI draft guidance in the first place. Among other arguments, CRN said in the letter that the Food Drug and Cosmetic act makes no distinction between synthetic and natural dietary ingredients and that a dietary ingredient is defined by its biological activity, not its chemical structure or origin.
Mister said CRN was calling on FDA to suspend enforcement activities on the synthetic botanical issue without waiting for the resolution of the other issues surrounding the NDI guidance.
“Because such enforcement actions are not grounded in the law, they exceed FDA’s statutory authority and must be ceased,” Mr. Mister wrote. “FDA’s actions and comments are having an immediate chilling effect on the industry and are irrevocably damaging commerce, innovation and investment.”