Homeopathy is based on an 18th-century idea that substances that cause disease symptoms can, in very small doses, cure the same symptoms. As discussed in the guidance, FDA has neither approved nor found any homeopathic drug generally recognized as safe and effective (GRASE). Thus, all homeopathic drug products are unapproved new drugs under the FDC Act. However, FDA has routinely followed the 1988 CPG to exercise “enforcement discretion” to allow most homeopathic drugs to be marketed without FDA approval. The 1988 CPG delineated the conditions under which FDA would allow the marketing of homeopathic drug products: the product must the standards for strength, quality, and purity set forth in the Homeopathic Pharmacopeia of the United States (HPUS); product labeling must comply with the labeling provisions of Sections 502 and 503 of the FDC Act and 21 C.F.R. part 201; homeopathic products may be marketed as non-prescription products only when offered for use in self-limiting conditions recognizable by consumers; and homeopathic products must be manufactured in accordance with current good manufacturing practice, FDC Act § 501(a)(2)(B) and FDA’s implementing regulations.
As discussed in the draft guidance, in light of the growth of the industry since the 1988 CPG was issued, FDA determined in 2015 that it was time to reevaluate its regulatory framework for homeopathic products. The Agency held a public hearing in April 2015 to obtain input from stakeholders and the public on the use of homeopathic drugs and the Agency’s regulatory policy. The new draft guidance is FDA’s 2½-year later follow-up.
So what is new? As a result of the Agency’s evaluation and review of information obtained during the hearing and more than 9000 comments, FDA has determined that it would be prudent and in the best interest of public health to apply a “risk-based” enforcement approach, “consistent with FDA’s risk-based regulatory approaches generally.” Apparently, FDA felt that the 1988 CPG limited FDA’s ability to take enforcement actions against products that were unsafe but arguably complied with the CPG. Under the new guidance, FDA explains that it could take action based on risk even if the product meets the requirements for homeopathic products. FDA identifies six categories of homeopathic drug products with higher risk and therefore higher priority for enforcement and regulatory actions:
- products with reported safety concerns;
- products that contain or claim to contain ingredients associated with potentially significant safety concerns, e.g., belladonna or strychnine;
- products for routes of administration other than oral and topical, e.g., injectable and ophthalmic products;
- products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions, e.g., cancer, heart disease and opioid addition;
- products for vulnerable populations, e.g., children; and
- products that are deemed adulterated under FDC Act § 501, e.g., do not meet standards of quality, strength or purity as required under the law.
FDA recognizes that many homeopathic drug products fall outside these six categories and the Agency does not intend to take action against those products.
To be considered, comments to the draft guidance should be submitted by March 20, 2018.