February 2005

AHPA addresses FDA’s premarket notification program

The American Herbal Products Association (AHPA) has filed comments with the Food and Drug Administration (FDA) to help shape the content and format requirements for new dietary ingredient (NDI) notifications as required by the Dietary Supplement Health and Education Act (DSHEA).

The NDI process requires dietary supplement manufacturers and marketers to submit information to FDA to show that a new ingredient will reasonably be expected to be safe.

Since the passage of DSHEA in 1994, FDA has posted online 260 NDI notification reports. According to AHPA, some of those NDI notifications were incomplete or for old ingredients that did not need review.

In October, 2004, FDA called a public meeting and requested comments on several specific NDI issues outlined in the Federal Register. In that notice FDA stated, “The problems with NDI notifications … suggest that it may be helpful for FDA to consider ways to assist submitters of NDI notifications to ensure that they contain the information the agency needs to evaluate the notification.”

“We welcome the opportunity to dialogue with the agency,” said Michael McGuffin, AHPA’s president, “and we have much to offer FDA to facilitate its gatekeeper role of reviewing safety substantiation prior to NDIs coming to market.”

AHPA’s input includes pragmatic suggestions to winnow out dietary ingredients that are not new; suggests that a botanical’s Latin binomial, author and part be identified; and opposes FDA’s contention that the “chemical composition” or “active components” need to be disclosed.

AHPA has urged FDA to reject filings for new dietary supplements, foods and old, or already known, ingredients and to allow a company to withdraw a notice. AHPA also outlined key factors to define the standard for “reasonably expected to be safe.”

“Bringing new products to market is important in every industry, including this one,” McGuffin said. “We are pleased that FDA is taking steps to implement DSHEA fully, including the NDI safety review process.”

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