NDI draft guidance comments

ABC: Expert panel should clarify list of grandfathered dietary ingredients

05-Dec-2011 - Last updated on 05-Dec-2011 at 15:34 GMT

The Food and Drug Administration (FDA) should recognize the existing industry list of ‘grandfathered’ or ‘old’ dietary ingredients (ODIs) sold in the US pre-1994 – but work with an expert panel to clarify its contents, according to the American Botanical Council (ABC).

The FDA provoked a storm of controversy in July when it said it would not accept industry lists of ODIs as authoritative and said firms must prove that their ingredients were sold in the US in supplements before the 1994 Dietary Supplement Health and Education Act or submit costly new dietary ingredient (NDI) notifications.

But the ABC says the FDA should not force firms to waste time and money on trying to prove the ODI status of scores of ingredients that have been on the market for years and did not represent a safety risk.

Instead it should work with industry to clarify lists that are already available via an expert panel that could evaluate the consolidated ODI list and ensure it is “dynamic, not static, and subject to revision with added ingredients”.

A new process that would bring clarity on ODIs

In a seven-page submission to the FDA filed last Friday afternoon, ABC executive director Mark Blumenthal said:

"One of the biggest problems in the NDI notification process has been the ambiguity of what ingredients are in fact ODIs, so-called 'grandfathered' ingredients that are not required to go through the NDI notification procedure.

"What ABC is proposing is a process in which more clarity can be brought to this entire area. Eventually this would reduce or eliminate confusion and provide benefit to both industry and the FDA."

The panel would evaluate any entries that may be ambiguous and ascribe the correct plant part(s) known to have been sold in the market prior to DSHEA, he said.

The list of ODIs in question was published in 1999 by the then-named Utah Natural Products Alliance (now the United Natural Products Alliance or UNPA) and combines lists prepared by three other trade associations: the American Herbal Products Association (AHPA), the Council for Responsible Nutrition (CRN), and the then-named National Nutritional Foods Association (now the Natural Products Association or NPA).

Safety is what matters, not the extraction process per se

Along with the NPA and the CRN, the ABC also urges the FDA to ditch its call for supplement-specific NDI notifications and points out that the FDA’s definition of ‘chemically altered’ needs a rethink.

While changing a solvent and/or an extraction process could alter the chemical composition or structure of the ingredient and theoretically be the basis for potential safety problems, this was not automatically the case, said Blumenthal.

“The emphasis for the matter of determining whether an NDI notification should be made should focus on the safety (which implicates chemical profile) of the resulting extract, not the process by which it is made nor the solvent(s) that is/are used in the extraction process.”