FDA claims to be working on a revised “Draft Guidance: Dietary Supplements: New Dietary Ingredients” (“Draft NDI Guidance”) in light of industry concerns expressed in comments to the agency. It is unknown when a revised draft will be issued by the agency and, if issued, whether it will include any significant changes. In the interim as the industry waits for FDA’s response, FDA on a case by case basis is enforcing positions reflected in its flawed Draft NDI Guidance. The fact of enforcement during the pendency of guidance consideration begs the question: Is FDA’s draft NDI Guidance comment procedure a subterfuge, inducing industry to believe its comments sufficient, without those comments having any effect on agency enforcement?
The Dietary Supplement Health and Education Act of 1994 (“DSHEA”) amended the Food, Drug, and Cosmetic Act (“FDCA”) by, among other things, defining the term “new dietary ingredient” (“NDI”). 21 U.S.C. § 350b(d) (defining a NDI as “a dietary ingredient that was not marketed in the United States before October 15, 1994”). Under DSHEA, the manufacturer or distributor of a dietary supplement containing a NDI must submit a notification to FDA at least 75 days prior to introducing or delivering for introduction the supplement into interstate commerce unless the supplement contains only dietary ingredients that have been present in the food supply as an article used for food in a form in which the food has not been chemically altered. Id. at § 350b(a)(1) & (2). When required, the NDI notification should contain history of use or other evidence showing that the NDI is reasonably expected to be safe under its conditions of use. Id. at § 350b(a)(2). A supplement containing a NDI “for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury” is adulterated regardless of whether a NDI notification was submitted. Id. at § 342(f)(1)(B).
In 1997, FDA published regulations implementing the NDI notification requirement at 21 C.F.R. § 190.6. Section 190.6 announced the general content requirements for the NDI notification, such as, but not limited to, the level of the NDI in the supplement, the supplement’s conditions of use as recommended in its labeling, and the history of use or other evidence of safety, including published articles, establishing that the NDI will reasonably be expected to be safe when used in accordance with the recommended conditions of use.
In 2011, the FDA Food Safety Modernization Act (“FSMA”) was signed into law. Under section 113(b) of FSMA, FDA was required to publish a guidance clarifying when a supplement ingredient is an NDI, when an NDI notification is required, the evidence needed to establish the NDI’s safety, and satisfactory methods for establishing the NDI’s identity. FDA published its Draft NDI Guidance in July 2011 to comply with that requirement. The response from the regulated class was overwhelmingly negative. Most concluded that FDA had deviated fundamentally from the plain and intended meaning of the NDI statute, causing most products then on the market, safely consumed, to be considered NDIs based on the agency’s proposed redefinition of that term.
After the draft NDI Guidance was published in the Federal Register, FDA received approximately 7,000 comments. In those comments, the NDI Draft Guidance was criticized as interpreting DSHEA’s NDI provision to mean the opposite of its plain and intended meaning. For example, it was criticized for creating a de facto pre-market approval process requiring the same type of scientific evidence that is necessary for a food additive petition against Congress’ wishes, and for prohibiting the use of synthetic copies of a constituent or extract of an herb or other botanical. It was also criticized for requiring a manufacturer or distributor to submit an NDI notification when another manufacturer or distributor had already submitted an NDI notification for the same ingredient, indicating that FDA’s position is that the NDI notification is for supplements, not ingredients. Critics claim that FDA’s requirement would result in redundant filings that Congress never intended. According to the Council for Responsible Nutrition, the Draft NDI Guidance “can be viewed as a variety of maneuvers by FDA to recharacterize as many dietary ingredients as possible as NDIs, and then to impose a standard of proof for their safety that few manufacturers would be able to meet; one that Congress and the courts clearly did not intend to be applied to dietary supplements.”
In response to the harsh criticism of the Draft NDI Guidance, FDA said it would release a revised version that took into account industry’s concerns. Unfortunately, however, FDA has not said when it will release the new draft and has not hinted at what, if any, changes are in the offing. Although it has been nearly a year and a half since the Draft NDI Guidance was published, a revised version has yet to be released.
Despite FDA’s acknowledgement of the weaknesses in its Draft NDI Guidance, it continues to oppose the majority of NDI filings. In Fiscal Year 2012 Quarter 1 alone, FDA’s Office of Nutrition, Labeling and Dietary Supplements objected to 85% of NDI notifications. Additionally, in an April 24, 2012 Warning Letter to manufacturers and distributors of dietary supplements containing 1,3-dimethylamylamine (“DMAA”), FDA said that a NDI notification was required for DMAA, and, consistent with the Draft NDI Guidance, FDA said that synthetically-produced DMAA is not, a “dietary ingredient.” It was therefore not eligible to be used as an active ingredient in a supplement.
This suggests that FDA is enforcing the basic positions it took in the Draft NDI Guidance when, case by case, it evaluates product ingredients, and that its statements about revising the Draft NDI Guidance are more of a diversion than a substantive change in actual enforcement.
Because of the uncertainties surrounding the Draft NDI Guidance, FDA needs to either quickly withdraw the draft Guidance and halt enforcement consistent with its provisions until such time as FDA adopts a new standard for enforcement or explain plainly to the regulated class which portions of the draft NDI Guidance it is currently enforcing.
