Lawsuit Challenges FDA’s Homeopathic Regulatory Policy
By Alvin J. Lorman, AAHP Counsel
A health freedom group and a homeopathic manufacturer have asked a U.S. district court to prohibit FDA from regulating homeopathic products as unapproved new drugs. The lawsuit, filed in Washington, D.C., claims that a provision in the 2020 allopathic OTC monograph reform legislation exempts homeopathic drugs from the new drugs provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The monograph reform legislation was part of the Coronavirus Aid, Relief, and Economic Security (CARES) Act.
The lawsuit was filed on Oct. 21, 2024 by the Alliance for Natural Health and New Mexico’s Meditrend, Inc. The plaintiffs argue that a provision of the monograph reform legislation which exempts homeopathic drugs from the new administrative order authority given to FDA means that homeopathic drugs cannot be subject to the new drug provisions of the statute. The lawsuit names the U.S. government, FDA, and FDA Commissioner Robert M. Califf as defendants.
The lawsuit asserts that until the revocation of Compliance Policy Guide 400.400 and the issuance of the current enforcement policy, FDA never treated homeopathic drugs as unapproved new drugs. The lawsuit seeks a declaration that homeopathic drugs marketed pursuant to an HPUS monograph prior to the passage of the FD&C Act in 1938 are not new drugs; that OTC homeopathic drugs are exempt from the premarket approval requirements of the Act; and that the new FDA guidance violates the Due Process Clause of the Fifth Amendment. The plaintiffs also asked the court to enjoin FDA from taking enforcement action against OTC homeopathic drugs on the ground that they are unapproved new drugs.
The government has 60 days to respond to a complaint, so it will likely be late December before FDA responds. At this point, it is impossible to predict whether—or to what extent—a new administration might take a different position on this litigation than the current administration. In the new post-Chevron world, if the court finds that the statutory provision is ambiguous, it is free to interpret it as it finds appropriate without deferring to FDA’s interpretation.
The statutory provision at issue is section 3853 of the CARES Act, which provides as follows:
“Drugs Excluded from the Over-the-Counter Review:
“(a) IN GENERAL.—Nothing in this Act (or the amendments made by this Act) shall apply to any non-prescription drug (as defined in section 505G(q) of the Federal Food, Drug, and Cosmetic Act, as added by section 3851 of this subtitle) which was excluded by the Food and Drug Administration from the Over-the-Counter Drug Review in accordance with the paragraph numbered 25 on page 9466 of volume 37 of the Federal Register, published on May 11, 1972 [i.e., homeopathic drugs].”
“(b) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to preclude or limit the applicability of any other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).”
A respected FDA blog recently noted that “the Agency reads the CARES Act exclusion to mean that to be on the market, homeopathic drug makers continue to need to have either an approved drug application (NDA or ANDA) or operate at their own peril under FDA’s risk-based enforcement framework.”
In 2020, the AAHP said that the inclusion of this language in the CARES Act was critical because it “confirms the exclusion of homeopathic products from OTC monograph reform/user fee amendment. This is important because the monograph reform provisions give FDA the authority to regulate by administrative orders, which might have enabled the agency to regulate homeopathic drugs as a group, something it cannot do now.”