CHICAGO—With its recent NDI guidance, FDA has not only reversed it earlier indication that a new dietary ingredient (NDI) notification would be required for only ingredients, not supplement, but the agency also is going against the intent of Congress, according to comments submitted by Amin Talati LLC, a Chicago-based law firm active in the natural products industry.
"In the draft guidance, FDA reverses its longstanding, publicly accepted policy and practice of requiring NDI notification for new dietary ingredients and not necessarily for the supplements that may contain the new dietary ingredients," the firm wrote. "In contrast, the draft guidance now mandates NDI notification by manufacturers or distributors of each and every dietary supplement that contains an NDI with other dietary ingredients. FDA has made a complete about-face in re-interpreting the statute." The firm further argued FDA's latest interpretation contradicts the plain language of the Dietary Supplement Health and Education Act of 1994 (DSHEA) and, therefore, violates the Administrative Procedures Act (APA).
Since 1994, FDA has acknowledged, with letters of non-objection, many NDI notifications submitted by ingredient suppliers for new ingredients. The firm said it could find no instance in which FDA, when objecting to a notification, cited a concern about lack of information about the other ingredients in formulation/finished product that would contain the new dietary ingredient.
"This clearly demonstrates FDA‟s interpretation to be ingredient specific and not supplement specific," the comments stated, accompanied by graphical examples of real cases. "We have not been able to locate any Agency document prior to the draft guidance that even suggests that NDI notifications are supplement specific. To the contrary, FDA‟s own documents show that the Agency itself has always considered notification to be ingredient specific."
Referencing the precedent statues (Chevron, U.S.A., Inc. v. Natural Resource Defense Counsel) of agency interpretation of authorizing, the firm noted the court will look for a clear intent from Congress; if there is ambiguity, the court will determine if the agency's interpretation is a permissible construction of the statute. In its NDI comments, the firm argued the regulation (Section 413(a)(2)) is not ambiguous in requiring NDI notifications for ingredients, not necessarily finished dietary supplements—the title of the section is even simply "New Dietary Ingredients."
Admin Talati made another key point in its comments to FDA. In its preamble to the 21 CFR 190.6 Final Rule, FDA estimated the total number of businesses that would be affected by the rule to be “no more than the number of new ingredients (estimated to be 0 to 12 per year).” More recently, the agency said it expected to receive an estimated 55 notifications per year, which would nnot be the estimated number, obviously, if it had expected or thought notifications were required of ingredients and complete supplements.
Requiring a notification for each supplement containing an ingredient for which a notification is required would place an undue burden on both the agency and the industry, according to the firm's submitted comments., which further note the agency has not detailed how this extra burden would enhance consumer health and safety. Rather, Congress provided FDA other authority to sufficiently regulate post-market safety issues, including any adulteration issues involving a dietary supplement containing an NDI.
The firm divided section 413(a)(2) into three parts. First, a plain reading of section clearly indicates the evidence of safety is to establish that the new dietary ingredient will reasonably be expected to be safe. The second part includes both the "manufacturer or distributor of the dietary ingredient or the dietary supplement" but only to inform that a finished product manufacturer/distributor can also file the NDI notification. Lastly, it appears FDA interprets “has concluded that a dietary supplement” to mean a notification for the dietary supplement is required, but the firm argue this interpretation is not supported by the plain reading. Instead, the firm contends the statement requires a supplement to "reasonably be expected to be safe" but does not require an NDI notification.
"Indeed, Congress could have, but chose not to apply the notification requirement to each and every dietary supplement containing the NDI," the firm wrote. "In the draft guidance, FDA inexplicably goes further, grafting on a requirement that Congress did not direct nor leave open to FDA the option to adopt."
In addition these two major concerns, Admin Talati, in its comments, noted the new guidance and burdensome requirements on finished dietary supplements would raise significant intellectual property issues, as ingredient suppliers and finished manufacturers would have to share confidential information and protected trade secrets.
