SALT LAKE CITY—FDA has more than 146,000 pages of New Dietary Ingredient (NDI) Draft Guidance comments from around 7,000 unique entries to review, according to Daniel Fabricant, Ph.D., Director, Division of Dietary Supplement Programs, FDA, during a post comment webinar hosted by the United Natural Products Alliance (UNPA).
"We've got a large stack of paper," Fabricant said." And as much as I try, I'm not getting folks to come in on weekends." Fabricant said he could not give a timeline or comment on when a final version of the guidance may be released. The agency has receives requests for meetings with trade associations, and Fabricant said it is happy to hold those discussions.
Concerning to Fabricant, he said, even despite FDA releasing its current thinking on NDI notifications (NDINs), he expects to receive only about 50 NDINs for 2011, which is similar to the amount the agency has received every year since the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA). According to the Draft Guidance, FDA believes the number of NDINs should be much higher given the number of products on the market. Fabricant said NDINs are a requirement set forth in DSHEA, and is still an obligation firms must meet, regardless of the release of a final—or even draft—guidance.
"People have confused the guidance with the statutory obligation," he said. Several times during the webinar, he brought up the point that a guidance is not law. " Whether people like the guidance or not, there's a statutory requirement," he said. "It's fine to be upset with FDA over the guidance, but we didn't write the law."
He added, "The key thing is that it is a Draft Guidance. Guidance or a draft guidance represents the agency's current thinking. It does not create or confer any rights for or on any person and it does not operate to bind FDA or the public."
Furthering this point, he said if a company doesn't like the Draft Guidance, it can choose to use a different approach to NDINs; however, he said, that alternative approach must comply with the relevant statues and legislation. "The agency is more than willing to discuss an alternative approach as long as it complies with statues and regulations," he said.
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