Support Growing for NDI Draft Guidance Retraction

You have surely read about the deluge of comments submitted to FDA and calling on the agency to rescind its draft guidance for new dietary ingredient notifications (NDINs)—here's an excellent overview of comments submitted from industry by INSIDER's Sandy Almendarez. Not only did this call for retraction get some powerful voices from the US Senate, but these voices happen to be figures who were central to the development and passage of DSHEA in 1994. Senators Orrin Hatch (R-Utah) and Tom Harking (D-Iowa) wrote a letter to FDA director Margaret Hamburg, urging her to issue a new draft that will "provide needed clarification on what constitutes an NDI, but does not undermine the balance Congress struck in DSHEA to provide consumers with access to safe, affordable dietary supplement products." The dynamic duo argued the original intent of DSHEA was for NDI to apply to ingredients, not finished products, and took issue with the agency's definition of chemically altered ingredients. They also criticized FDA's assertion that synthetic botanical ingredients are not dietary supplements, stating this assertion is without statutory basis and contradicts long-standing FDA policy.

Naturally, the Natural Products Association (NPA) came out in support of this action by Hatch and Harkin: “The Natural Products Association appreciates the letter by Senators Tom Harkin and Orrin Hatch that calls on the Food and Drug Administration to rewrite the New Dietary Ingredients draft guidance," said Jeff Wright, president of NPA. "We agree with them that the FDA should start work on a new draft that is consistent with the Dietary Supplement Health and Education Act, or DSHEA.”

Wright said NPA is happy to see the Senators echo the draft guidance concerns and call for a re-write already voiced by NPA and other trade associations. "Of course, we expect this strong voice from leaders in the U.S. Senate to make a difference," he said.

The call for retraction of the NDI guidance might come as a surprise to Dan Fabricant and his FDA dietary supplement division, but having two primary authors of the legislation that mandated NDIs join the call for a redo is surely something FDA should take to heart.