Ullman says FDA draft guidance on NDIs oversteps legal boundaries

Ullman says FDA draft guidance on NDIs oversteps legal boundaries

The Ullman, Shapiro & Ullman, LLP law firm has submitted initial comments to FDA on the recent Draft Guidance for Industry that this guidance should be immediately withdrawn because it substantively alters the reporting requirements established by the existing NDI regulation.

 

The Ullman, Shapiro & Ullman, LLP law firm has submitted initial comments to FDA on the recent Draft Guidance for Industry entitled “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues” laying out a strong argument that this guidance should be immediately withdrawn because it substantively alters the reporting requirements established by the existing NDI regulation.

“This is a substantive change in scope to that which the agency has previously issued in their original NDI rulemaking,” said Marc Ullman, who has been practicing regulatory law in the dietary supplements industry for 15 years. “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.”

The comments, signed by Marc Ullman, make the argument that within the “Benefit-Cost Analysis” FDA included as part of the DSHEA Final Rule codified in the Code of Federal Regulations as 21 CFR 190.6 on September 23, 1997 is language that makes it clear that FDA views the DSHEA NDI component as applying to ingredients rather than finished products. The Draft Guidance issued in July 2011, however, calls for submission to FDA of information relating to every new ingredient and every multi-ingredient dietary supplement that includes a “New Dietary Ingredient” in its formula. Ullman points out that this constitutes impermissible “rulemaking by guidance” by amending the preexisting NDI Regulation. This action violates the procedures outlined by the Administrative Procedures Act, and is a prime example of “Rulemaking by Guidance,” a practice which has previously been rejected by the DC Circuit Court of Appeals.

The position taken by FDA in the Draft Guidance is that NDI’s are required for every combination of ingredients. Such a requirement would be so burdensome on the industry with far-reaching implications that could ultimately severely limit consumer access to thousands of products.

Ullman’s comments stated that “because the Guidance Document essentially creates a “new dietary supplement” notification process, it is fatally flawed, contrary to law, should immediately be withdrawn and revised so that it is consistent with the existing NDI regulation.”

New York based Ullman, Shapiro & Ullman, LLP, represents clients in legal matters relating to Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA) matters, regulatory issues, Federal Trade Commission (FTC) proceedings, IP and Trademark matters and litigation. http://www.usulaw.com

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