By Riëtte van Laack –
The FDC Act, as amended by the Dietary Supplement Health and Education Act (“DSHEA”) of 1994, excludes from the definition of dietary supplement any article that is approved as a new drug and any article “authorized for investigation as a new drug . . . for which substantial clinical investigations have been instituted and for which the existence of such investigations have been made public” unless the article was “before such approval, . . . or authorization marketed as a dietary supplement or as a food.” FDC Act § 201(ff)(3)(B).
A recent Warning Letter from FDA suggests that the Agency interprets the second part of this “exclusionary clause” to set the date the IND was made effective rather than the date the substantial clinical investigations under the IND were completed and made public as the critical date to determine who wins the race to market, the drug or the dietary supplement.
In a Warning Letter to Deseo Rebajar Inc. the Agency asserted, inter alia, that Burn 7, a dietary supplement containing sibutramine, cannot be a dietary supplement because it is excluded under section 201(ff)(3)(B)(ii) of the FDC Act.
FDA states the following in the Warning Letter:
The [IND] application for Meridia (sibutramine) was received by FDA on December 24, 1985, and sibutramine became authorized for investigation as a new drug under an IND on January 23, 1986. When Meridia was approved for marketing as a new drug [on November 22, 1997] in the United States, the existence of substantial completed clinical investigations of sibutramine became public. Given that sibutramine was not marketed as a dietary supplement or as a food before Meridia was authorized for investigation as a new drug, your product Burn 7 is excluded from the definition of a dietary supplement. [(Emphasis added)]
Thus, it appears that FDA took the date that the IND was granted rather than the date that the existence of the substantial investigations was made public (more than 10 years later) as the date for the exclusion. This, in our opinion, is an untenable, and unconstitutional, interpretation.
FDA does not disclose the existence of an IND. Consequently, unless the drug company makes the IND public, a dietary supplement company cannot determine whether an IND for its ingredient exists. Moreover, even if the dietary supplement company knows that an IND exists, the marketing of the ingredient as a dietary supplement is legal in the absence of publication of the existence of substantial clinical investigation. The statute does not simply exclude any article “authorized for investigation as a new drug.” In fact, such investigations may never be instituted or publicized.
As a result, a dietary supplement company could find itself in the situation where it for years lawfully markets a dietary supplement that suddenly, without advance notice, becomes illegal because a company publishes the existence of substantial clinical investigations. This interpretation of the exclusionary clause not only is at odds with the intent of this provision, the lack of fair notice also runs afoul of the Due Process Clause of the Fifth Amendment. FDA’s interpretation does not allow the dietary supplement industry to “steer between lawful and unlawful conduct” and does not give a manufacturer a reasonable opportunity to know what” constitutes a dietary supplement that may legally be marketed. See Grayned v. City of Rockford, 408 U.S. 104, 108-109 (1972); see also United States v. Farinella, 558 F.3d 695 (7th Cir. 2009)(It is a denial of due process of law to hold a person liable for violation of an agency’s “secret” understanding of the law).