FDA “Interested” in Grandfathered List for NDIs, Did Not Intend Product-Specific NDI Rule

October 4, 2012

CFSAN director says FDA and industry associations will meet on October 16 to discuss revising NDI draft guidance.

FDA has “internal interest” in creating a grandfathered ingredients list related to new dietary ingredient (NDI) regulations, stated Michael Landa, director of FDA’s Center for Food Safety and Applied Nutrition (CFSAN) division, at today’s Council for Responsible Nutrition (CRN; Washington, DC) annual conference in Laguna Beach, CA.

Additionally, Landa confirmed, the agency will revise-but not withdraw-its NDI draft guidance document. Landa also reported that on October 16, FDA will again meet with dietary supplement associations to discuss the NDI draft guidance and issues such as grandfathered lists. This meeting follows the first draft guidance meeting that FDA had with associations back in July.

 

“Interest” in a Grandfathered List

Landa said FDA is interested in the notion of establishing a list of grandfathered ingredients.

Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, any dietary ingredient in the U.S. market prior to October 15, 1994, is considered grandfathered and does not require an NDI notification. After DSHEA’s passage, several dietary supplement industry associations compiled lists of ingredients believed to merit grandfathered status. But FDA has continued to state that the agency does not formally recognize any independent grandfathered lists compiled by industry groups.

At the CRN conference today, Landa said, “There is an interest, internally in CFSAN, in trying to find a way to have such a list, for it to be developed, for FDA to have the confidence it needs [in a list].”

Still, he said, the agency is unlikely to simply adopt, as an official FDA grandfathered list, any list independently compiled by associations. “FDA has been resistant to [the idea that] we would accept any lists that any outside organizations gave us; FDA never accepts that kind of list from anyone.”

He added, “It’s a tricky issue. It’s tricky because so much time has gone by [since 1994]. How do you establish what kind of evidence you need to support such a list…evidence or information that we’re prepared to rely on?...I think that the question [has] always been around what kind of information or evidence would FDA need to be comfortable with the inclusion of a particular ingredient on the list.”

Industry members have meanwhile encouraged FDA to consider association-compiled lists as a “starting off” point for creating an official grandfathered list.

 

Parts of Draft Guidance “Not Clear Enough”

Landa also admitted that industry’s high concern about the draft guidance is “a function of [FDA] not being clear enough about what it is we were trying to say.”

For instance, he said, FDA did not intend for the draft guidance to infer that every single finished product-even products containing nearly identical formulations-would require an NDI notification. Members of the dietary supplements industry are highly concerned about this point of the draft guidance.

But, Landa said, “I think there was a misperception of what we were saying for a new dietary ingredient, that you could not have one submission covering an ingredient that was in different strengths and in multiple formulations. We didn’t mean to say you couldn’t do that. That’s clearly how it was interpreted, at least by some folks.”

Finally, he said that FDA will not withdraw the guidance, but it will revise it. “We’ve also said that what we intend to do is not to withdraw the guidance, but to issue it in revised form for additional comment. We think that some of it was not confusing and was helpful; some of it, we may just have disagreements.”

He reassured stakeholders that FDA would again accept comments on a revised draft. “We think that the way to keep that moving forward is to issue the revised draft. There will still be ample opportunity for comment, and if there are remaining concerns there will be an opportunity to come and talk to us face to face as there was the last time around.”

Landa declined to comment on predicting any timeframe for when a revised draft guidance might be released.

Read more about industry’s concerns about the NDI draft guidance.