FDA to Revise NDI Draft Guidance

June 20, 2012

In terms of timeline, CRN said that FDA has not stated when it expects to issue the new draft guidance.

* Updated June 25, 2012

FDA says it will in fact revise its draft guidance for new dietary ingredients (NDIs)-news welcomed by dietary supplement industry organizations. The dietary supplements industry largely criticized the draft guidance’s initial version, which FDA released almost a year ago, last July.

FDA will revisit a number of what the supplements industry has deemed “problem points,” including, according to industry association the Council for Responsible Nutrition (CRN; Washington, DC):

  • The guidance’s treatment of synthetic versions of botanical ingredients

  • The guidance’s requirement for NDI submissions for all finished products containing an NDI, instead of just for NDI ingredients

  • The definition of what FDA considers “chemically altered” ingredients

  • The level of data FDA considers necessary to demonstrate the safety of NDIs

  • Putting the onus on industry to prove that an ingredient is grandfathered. (Industry says that in fact the onus is on FDA to prove that an ingredient is not grandfathered and as a result an NDI.)

Read a more comprehensive Nutritional Outlook article on the various “problem points” here.

CRN said FDA made its announcement to revise after a meeting with top agency officials, including FDA Commissioner Margaret Hamburg, FDA Deputy Commissioner Mike Taylor, and Senators Orrin Hatch (R-UT) and Tom Harkin (D-IA).

In terms of timeline, CRN said that FDA has not stated when it expects to issue the new draft guidance. But, said CRN in its press release, “the agency has indicated its desire to move quickly.”

CRN’s president and CEO Steve Mister further said he hopes the agency and industry members will continue to maintain an open dialogue through the process. “We are grateful to FDA for its willingness to have an open and ongoing dialogue with our industry,” he said. “We understand the complexities involved for FDA in developing practical and workable regulation, and we remain willing to work cooperatively to help ensure the guidance will be manageable for industry and enforceable for FDA, and will ultimately benefit consumers.”

CRN and Mister also credited industry members for urging FDA to revise guidance, praising their persistence in expressing concerns to FDA and petitioning members of Congress.

 

Additional Industry Response

At the Natural Products Association (NPA; Washington, DC), NPA executive director and CEO John Shaw said in a press release, “NPA is pleased that the FDA will rewrite the NDI draft guidance to provide greater clarity and address concerns that the document is not in line with the intent of DSHEA. This action by the FDA shows that they are committed to an open dialogue with industry on these issues. We appreciate their desire to get it right, and we all need to work together to find a solution acceptable to both sides-the industry and the FDA.”

“I’d like express my heartfelt gratitude to our members for their input and support and to our Congressional champions for their tireless efforts on behalf of the industry,” he added.

Loren Israelsen, executive director of the United Natural Products Alliance (Salt Lake City), also praised Senators Hatch and Harkin for their help in encouraging the revision. “More specific details will follow from us in short order [regarding developments with the draft guidance revision], but for now, the main story is that Senators Hatch and Harkin continue to provide the leadership for implementation of DSHEA, as only they can do.”

Israelsen said he is hopeful about further development between FDA and industry, but with some reservations. “Yes, this [FDA’s agreement to revise the guidance] is encouraging, but having been around for about 32 years in this business, you can imagine that I will really be impressed if and when we all come to a common agreement on how to manage NDIs.”

“But,” he said, “I take FDA at their word that they are willing and ready to revisit the draft guidance and offer further views that reflect-we hope-our concerns.” 

In the meantime, NPA’s vice president of scientific and regulatory affairs, Cara Welch, PhD, reminded industry members, “While the draft guidance is being rewritten, industry must still submit notifications for new dietary ingredients.”

In June, The International Probiotics Association (IPA; Zurich, Switzerland) said in a press release that it was glad FDA will take a second look at the NDI draft guidance, especially because the initial version “went so far as to impose significant burdens on manufacturers and especially on manufacturers of probiotic supplements.”

“The initially proposed guidance document went far beyond its intent as it imposed burdens all the way through the probiotic supply chain running from the original manufacturer to the company marketing the finished product,” IPA continued.

“This is a huge move forward for the supplement industry, yet there’s still a lot of work to be done,” said Ioannis Misopoulos, director general of the IPA.