FDA to Issue Revised NDI Guidance – Nutraceuticals World Reports

Representatives of the Dietary Supplement Industry have indicated they are pleased that the FDA plans to issue a “revised draft guidance on new dietary ingredients (NDIs) used in dietary supplements,” reported Nutraceuticalsworld.com. The FDA’s new dietary ingredients draft issued in July 2011 has been widely criticized as “a flawed attempt by the agency to reinterpret the NDI section of the Dietary Supplement Health and Education Act of 1994 (DSHEA).”

The American Herbal Products Association (AHPA) called for the FDA to withdraw its guidance stating that it would “increase the burden on the supplement industry…”

Nutraceuticalsworld.com states that “NDIs are dietary ingredients that were not already marketed in the United States when DSHEA was passed. The manufacturer or distributor of an NDI or a supplement containing an NDI is generally required to submit a notification to FDA 75 days before market introduction, though there are exceptions to this rule.”

Steve Mister, President and CEO of The Council for Responsible Nutrition, was quoted commending the FDA, stating, “We are grateful to FDA for its willingness to have an open and ongoing dialogue with our industry.  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.”

The Council for Responsible Nutrition stated that it understood the FDA would reconsider five problematic areas associated with the draft:

“·       industry responsibility for proving grandfathered status of particular ingredients;
·         the permissibility of using synthetic versions of botanical components in supplements;
·         the definition of the term ‘chemically altered’;
·         NDI submissions for an ingredient versus finished products; and
·         the level of data necessary to demonstrate the safety of NDIs.”

At this time, the FDA has not offered a date in which to expect the revised NDI guidance. To read the full article, visit Nutraceuticalsworld.com.

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