The New Dietary Ingredient (NDI) draft guidance represents ‘rulemaking by guidance’ and should immediately be ‘withdrawn and revised’, says New York-based law firm Ullman, Shapiro & Ullman, LLP.
Comments submitted to FDA and signed by Marc Ullman state that the NDI draft guidance is at odds with existing NDI regulation, based on language used in the Dietary Supplements Health & Education Act (DSHEA) Final Rule that FDA views the DSHEA NDI component as applying to ingredients rather than finished products.
Under DSHEA, firms are required to notify the FDA if they intend to market a dietary supplement in the US that contains a ‘new dietary ingredient’ (which has not been marketed in the US dietary supplements market before October 15, 1994) and demonstrate that it is safe.
The recently released NDI draft guidance, however, calls for submission to FDA of information relating to every new ingredient and every multi-ingredient dietary supplement that includes an NDI in its formula.
“This is a substantive change in scope to that which the agency has previously issued in their original NDI rulemaking,” said Ullman.
“This is ‘rulemaking by guidance’, which is frowned upon by Congress and the courts. It is well beyond that which the agency had previously made clear in 1996, which clearly applied only to ingredients rather than supplements containing ingredients. To implement this change they have to do it formally.”
A gaping hole
"I think this is a solid argument,” said Ullman in an interview with NutraIngredients-USA today. “The draft guidance should be withdrawn. I’m not expecting it to be, but it should be withdrawn.”
The “substantive change” to the original NDI rulemaking represented a “gaping hole in the agency’s position”, he added.
The law firm’s comments state that the new draft guidance “essentially creates a ‘new dietary supplement’ notification process”, and calls for the immediate withdrawal and revision of the draft guidance to make it “consistent with the existing NDI regulation”.
According to the “Benefit-Cost Analysis” FDA included as part of the DSHEA Final Rule (21 CFR 190.6; Sept. 23, 1997), “FDA estimated the number of new ingredients to be 0 to 12 per year and the cost per notification to be $410, for an annual cost range of $0 to $4,920 per year.
“In the most recent year , the industry introduced six new ingredients for an estimated cost of $2,460. FDA received no comments on these estimates and consequently concludes that the actual costs of this rule will not be significant.”
However, an apparent change to require NDI’s for every combination of ingredients in finished products would be “so burdensome on the industry with far-reaching implications that could ultimately severely limit consumer access to thousands of products”, said Ullman.