By: John Long


In a letter to a member of Congress, FDA acknowledged it failed to clearly convey some of its views regarding five-year-old draft guidance governing notifications of new dietary ingredients (NDIs).

In reviewing comments related to the draft guidance and meeting with consumers and the dietary supplement industry, “it became clear that there was considerable misunderstanding about parts of the draft guidance and that, in some cases, our views were not stated clearly,” an FDA official, Dayle Cristinzio, wrote in a March 10, 2016 letter to Rep. Jason Chaffetz, a Republican from Utah.

Cristinzio advised the congressman that FDA was “in the later stages of preparing the revised draft NDI guidance” and hoped “to publish this document in the near future.”

The letter, which INSIDER obtained Thursday from FDA through a Freedom of Information Act request, makes clear that the new draft guidance will not be final.

“We want to stress that we are publishing a revised draft guidance, rather than a final guidance, to provide the public and interested stakeholders with a further opportunity to comment,” Cristinzio, FDA’s Acting Assistant Commissioner for Legislation, stated.

Industry sources have described release of the new document as “imminent” and said it could be unveiled in the coming weeks in response to criticisms that the July 2011 guidance poses undue burdens to companies and is contrary to the 1994 Dietary Supplement Health and Education Act (DSHEA).

“We’re happy to see that the agency is making this [guidance] a priority and hopeful that it will be out soon,” said Daniel Fabricant, Ph.D., executive director and CEO of the Natural Products Association (NPA).

Under DSHEA, an NDI is considered “adulterated” unless the “dietary supplement contains only dietary ingredients which have been present in the food supply as an article used for food in a form in which the food has not been chemically altered”; or FDA receives a notification at least 75 days before the new substance is introduced into the market, establishing that the product containing the new ingredient “will reasonably be expected to be safe.” As INSIDER has reported, three out of four NDI notifications have been met with some type of an objection by FDA, such as a finding there is inadequate safety data or the company failed to sufficiently describe the ingredient.

“The revised draft guidance will clarify matters that were not clear in the 2011 draft guidance or that were subject to misinterpretation,” Cristinzio wrote. “The purpose of issuing guidance on the topic of New Dietary Ingredient … notifications is to provide clear recommendations on when firms should file such notifications and what information should be included in a notification. In other words, the guidance is intended to provide information and tools to help companies meet their statutory obligation to ensure that dietary supplements containing NDIs are reasonably expected to be safe.”

Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), looked forward to FDA offering guidance on information that companies should include in an NDI notification. He referenced NDI submissions that are rejected by FDA for obvious reasons, such as failure to sufficiently characterize the nature of the ingredient or failure to disclose the manufacturing process to confirm the ingredient can be made consistently.

“Things like that are things that the industry absolutely needs in a guidance so that we don’t have these rejections for silly reasons, [and] the industry understands going into the NDI notification process what’s expected in that submission,” Mister said in a phone interview.

Chaffetz’s office did not immediately respond Thursday to a request for comment. Neither did the White House’s Office of Management and Budget, which must review the draft NDI guidance before it is published.

In writing to FDA earlier this year, Chaffetz reiterated his previous position that the 2011 guidance was inconsistent with the law.

Finally, Mister said the 2011 draft guidance reflects more than just a misunderstanding between FDA and the industry.

“It’s all in how you couch the gulf, the divide, between the industry and the agency,” he said. “We saw it as more than just a, ‘Oh you weren’t being clear.’ We saw it as, ‘No, you got it wrong in some cases and so this is your chance to re-evaluate the position and come back and get it right.’”