By expecting finished product manufacturers to submit NDI notifications for every product that contains an NDI or whenever a formula is changed if an NDI is present (as outlined in the FDA’s new draft guidance on NDIs) the FDA had contravened “both the spirit and the letter” of the 1994 Dietary Supplement Health and Education Act (DSHEA), claimed the group.
“Neither American consumers nor the dietary supplement industry are going to take this unconscionable attempt by the FDA - via various NDI-related side doors – to effectively re-write DSHEA… sitting down.”
Should NDI notifications be for finished products or ingredients?
While the industry’s key trade bodies have yet to submit formal comments, most regard the FDA’s insistence that NDI notifications should relate to finished products rather than ingredients as a major sticking point.
Speaking to NutraIngredients-USA last month, United Natural Products Alliance (UNPA) executive director Loren Israelsen said: “The critical issue is the dietary supplement vs dietary ingredient issue.
“Somewhere in the last few years the FDA appears to have changed its mind and switched from focusing on ingredients to supplements.”
American Herbal Products Association (AHPA) president Michael McGuffin added. “What they have told us for 16.9 years is that the NDI notification is for the ingredient, and then on July 5, 2011 [when the draft guidance was published], they say, what we really mean is that it’s for supplements. Well that’s not what the law says.
“You can twist the meaning of the word ‘it’ in the middle of one paragraph [of the Dietary Supplements Health and Education Act (DSHEA) of 1994], but the industry won’t tolerate a misreading of the law.”
Is guidance already exerting a coercive effect on the industry?
While the guidance was not legally binding, FDA’s apparent expansion of the definition of what constitutes an NDI had immediately rendered a large number of supplements already on the market technically unlawful, putting supplement makers in a very difficult position, added Israelsen.
“Whether it is already exerting a coercive effect on industry [by making firms believe they must remove products from the market to avoid the risk of being charged with adulteration] I’m not sure, but in a few months’ time, the fear of imminent action from the FDA will only rise.”
Click here to read the FDA draft guidance document.
Click here to submit comments to the FDA, which recently extended deadline for submitting comments to December 2.