Alliance for Natural Health Sues FDA to Invalidate Dietary Supplement CGMPs

August 16, 2009

By Ricardo Carvajal & JP Ellison

It’s been a busy month at the Alliance for Natural Health.  In addition to suing FDA over its handling of health claims, the Alliance (in conjunction with other plaintiffs) has sued FDA to invalidate certain provisions of the agency’s Current Good Manufacturing Practice (“CGMP”) regulation for dietary supplements.  In part, the complaint maintains that FDA cannot lawfully issue a regulation under FDCA section 402(g) that deems a dietary supplement adulterated unless that supplement violates FDCA section 402(f) (under section 402(f)(1)(A), a dietary supplement is adulterated if it presents a significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in labeling, or in the absence of those conditions, under ordinary conditions of use).  The complaint takes aim at the many recordkeeping requirements imposed under the regulation, and the fact that a dietary supplement can be deemed adulterated if any of those requirements is not met.

FDA has issued other regulations that deem certain foods adulterated if specified recordkeeping requirements are not met.  Generally, those regulations are partially grounded in FDCA section 402(a)(4), which deems a food adulterated if it has been processed, packed, or held "under conditions whereby it may have been rendered injurious to health.”  FDA’s reasoning has been that appropriate recordkeeping is essential to ensure that those foods are not produced under conditions that might render them injurious to health.  By comparison, section 402(g) deems a supplement adulterated if it has been prepared, packed, or held "under conditions that do not meet current good manufacturing practice regulations.”  Section 402(g) authorizes FDA to issue CGMP regulations for dietary supplements that are “modeled after current good manufacturing practices for food.”  Thus, there is no explicit reference in section 402(g) to the potential for injury to health.  FDA can therefore be expected to argue that is has considerable discretion in fashioning GMP requirements for dietary supplements, and that those requirements need not be contingent on the potential for injury to health.

An issue likely to be central to resolution of the case is whether the CGMP requirements imposed by FDA under the authority of section 402(g) derive from the text of the statute, in which case they would pass muster under step one of Chevron USA, Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984), or are grounded in a reasonable interpretation of that text, in which case they would pass muster under Chevron step two.  The complaint appears to take the position that the CGMP regulation fails under Chevron step one.  FDA will argue that the regulatory analysis should be conducted under Chevron step two, in which case FDA's interpretation of section 402(g) would be entitled to substantial deference.

The case is Alliance for Natural Health US et al. v. Sebelius et al., No. 1:09-cv-01523-CKK (D.D.C. filed August 12, 2009)