Potentially affecting consumer access to dietary supplements, FDA released its much-anticipated draft guidance for New Dietary Ingredient (NDI) notifications in July.

The Natural Products Association (NPA), Washington, D.C., voiced concern that FDA might be overstepping Congress’s intent as expressed in the Dietary Supplement Health and Education Act (DSHEA), ultimately limiting the number of products in the marketplace.

“The draft guidance answers a lot of questions for the industry, but it also raises concerns about its overall impact,” said Cara Welch, PhD, vice president of scientific and regulatory affairs with NPA. “It could profoundly affect the ability of Americans to get the supplements they want and need.”

In terms of proving that an ingredient was on the market before 1994, FDA is asking for much more from the industry than most companies can probably produce, she added. “These requirements will reduce ingredients meeting the established grandfathered status to a regrettably small number.”

NDI notifications are required for: components of food marketed after 1994; a change in solvent when processing an ingredient; a change in manufacturing that produces nanoscale particles; and each manufacturer of each supplement containing an NDI. The agency further clarified that synthetic versions of dietary ingredients require an NDI notification, with the exception of synthetic botanical constituents, FDA has declared are not considered dietary ingredients. These situations, experts contend, have the potential to impact dietary supplement manufacturers far and wide.

“Today, half of all Americans trust dietary supplements and use them as part of a healthy lifestyle,” noted Dr. Welch. “For them and for our industry, it’s vital that we make sure consumers continue to have access to popular, safe dietary supplements.”

In a joint statement, NPA, the American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN) and the United Natural Products Alliance (UNPA) requested an extension for submitting comments on the document.

“Members of our respective organizations believe additional time is needed to adequately prepare meaningful feedback for the agency’s consideration. Therefore, on behalf of AHPA, CHPA, CRN, NPA and UNPA members, we are requesting that FDA extend the submission deadline by an additional 45 days (i.e., November 17, 2011).”

Steve Mister, president and CEO of CRN, said the draft guidance is simply that; it is not a new regulation and does not create new rights or responsibilities for the industry. “Nevertheless, this draft guidance does represent an important step for the dietary supplement industry—and for the agency—as it demonstrates further implementation of the requirements of DSHEA and will give companies clearer understanding of FDA’s expectations under the law.”

He added, “This guidance has potential for short- and long-term implications for our industry and for our consumers’ ability to have access to in-demand products and we want to be sure the guidance is appropriate, reasonable and practical for industry and the more than 150 million consumers who use dietary supplements year after year.”