NDI draft guidance comments

AHPA to FDA: Tear up NDI draft guidance and start again

By Elaine Watson

- Last updated on GMT

Related tags Ahpa Dietary supplement Food and drug administration

AHPA to FDA: Tear up NDI draft guidance and start again
The Food and Drug Administration should tear up its “hugely flawed” draft guidance on new dietary ingredient (NDI) notifications and go back to the drawing board, according to the American Herbal Products Association (AHPA).

In a 75-page submission filed with the FDA on Friday, the AHPA says the industry asked for guidance on NDIs and welcomes the fact that the FDA has - after 17 years - finally provided it.

Wholly unnecessary and inappropriate

However, the version currently on the table is not consistent with the legislation it was designed to clarify and should be scrapped and rewritten, says the AHPA, which also plans to submit “extensive and specific comments​” on the section of the draft related to safety research at a later date.

AHPA president Michael McGuffin said: “AHPA’s view is that this section goes far beyond the intent of the law and is wholly unnecessary and inappropriate in many cases to establish a reasonable expectation of safety.

“AHPA also calls on the agency to issue new guidance, ensuring that it is consistent with the Dietary Supplement Health and Education Act (DSHEA) by incorporating revisions to conform to DSHEA and the intent of Congress with regard to NDIs.”

Duplicative and pointless notices

Along with other trade associations, the AHPA says the FDA should ditch its insistence on multiple end-product specific notifications, which it says would force firms to spend millions filing “duplicative and pointless notices”.

It also calls on the FDA to accept industry grandfathered lists of old dietary ingredients as a starting point for discussions rather than requiring each firm to prove its products contain only pre-DSHEA dietary ingredients and sending them on “unnecessary and costly hunts for information that may be unobtainable.

“AHPA agrees that there is not a single list that identifies every single ingredient that was marketed in the US before this date ​[October 1994].

“But AHPA also believes that better questions could be asked that would identify the relevance of AHPA’s Herbs of Commerce (both the 1992 and 2000 editions) and of the lists compiled by trade associations and submitted to FDA in the years immediately following the passage of DSHEA.”

Synthetic botanical constituents

Along with other commentators, the AHPA also takes issue with the FDA’s views on which processes constitute chemical alteration.

“AHPA believes it is sometimes but not always accurate that a change in a manufacturing process that alters the chemical composition or structure of a dietary ingredient necessarily results in production of a NDI.”

It also challenges the FDA’s view that synthetic botanical constituents - even if they are chemically identical to their ‘natural’ counterparts - are not dietary ingredients.

“There is no valid scientific or toxicological reason to suppose that a human-synthesized, bio-identical copy of a naturally-occurring constituent will exhibit any different biological function in vivo than the purified naturally-occurring constituent itself, barring the presence of any toxic impurities (the possibility of which can be suitably addressed by the company submitting a NDI notification).

“The fact that synthetic copies of natural substances are equivalent to the original substance in safety and in supplementing the diet is amply demonstrated through the fact that many such substances are already in the food supply, such as synthetic caffeine, vitamin E, lycopene and taurine.”

Read NutraIngredients-USA tomorrow to hear what the Alliance for Natural Health USA (ANH-USA) and the International Scientific Association for Probiotics and Prebiotics (ISAPP) think the FDA should do with its draft guidance.

Related topics Regulation NDI draft guidance

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