This is Part II of the Post that began here in which we discuss the three important suits filed this summer by supplement lawyer Jonathan Emord challenging FDA administrative action on first amendment grounds.
The cGMP Challenge – FDA Overreaching?
The FDA supplement cGMP regulations were anticipated from the time that DSHEA was passed in 1994 since the statute delegated authority to the Secretary of Health and Human Services to prescribe good manufacturing practices for dietary supplements. ((See 21 U.S.C. § 342(g)) The FDA’s dietary supplement GMPs were to “be modeled after current good manufacturing practice regulations for food and may not impose standards for which there is no current and generally available analytical methodology.” ((Id.))
Of course, any regulation the FDA would promulgate under DSHEA would need to be consistent with the statute. DSHEA created a system of regulation where dietary supplements are deemed safe unless the FDA proves that a particular supplement presents a significant or unreasonable risk of illness or injury. As the cGMP Challenge Complaint correctly notes, “the express purpose of DSHEA was to ensure that ‘the Federal Government erects no regulatory barriers that impede the ability of consumers to improve their nutrition through the free choice of dietary supplements.'” ((See 140 Cong. Rec. S11705-06, at S11706 (Aug. 13, 1994)). Therefore, Congress placed “the burden of proof . . . on the Food and Drug Administration to prove that a product is unsafe before it can be removed from the marketplace.” ((Id.))
FDA dragged its feet on the cGMP regulations until finally in 2003 the FDA published its Proposed Rule for dietary supplement GMPs. ((See Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements; Proposed Rule, 68 Fed. Reg. 12158 (Mar. 13, 2003)) FDA published the Final Rule on June 22, 2007. ((See Final Rule, 72 Fed. Reg. 34752 (June 25, 2007))
The cGMP Challenge takes on the Final cGMP Rules on three separate fronts. First it argues that the cGMP Rules are contrary to DSHEA because under the regulations no longer is the burden on the FDA to prove a supplement is dangerous before it can be yanked from the market. Second it argues that the cGMP Rules create excessive burdens on small business and society. Third it argues that the cGMP Rules are unconstitutionally vague.
All these arguments appear sound. Emord argues convincingly that FDA has granted itself wide discretion to declare a dietary supplement adulterated for any violation of the Final Rule, without proof that a dietary supplement was prepared, packed, or held under conditions that violate the GMPs.
FDA concludes that it has no duty to prove a finished product to present a risk of illness or injury before deeming it adulterated and pulling it from the market for cGMP Rule violations. This is because under the GMPs, FDA can declare inadequate any record required to be kept and to deem on that basis alone a dietary supplement adulterated without meeting the statutory requirements of DSHEA.
The decisions that emerge from these cases could determine whether the courts will stand by the principles in DSHEA and protect the public’s access to supplement products in the future.