Those homeopathic drug products for which no determination that the product is a new drug may be marketed under the Federal Food Drug and Cosmetic Act. However, given the current burgeoning homeopathic market, the FDA held a public hearing on March 27, 2015 to seek comments on its current regulatory framework for such products. “As a result of the Agency’s evaluation, including consideration of the information obtained as a result of the public hearing, FDA has determined that it is in the best interest of public health to issue a new guidance that applies a risk-based enforcement approach to drug products labeled as homeopathic and marketed without the required FDA approval, consistent with FDA’s risk-based regulatory approaches generally.”
The Agency’s risk-based enforcement approach will focus on:
- Products with reported safety concerns
- Products that contain or purport to contain ingredients associated with potentially significant safety concerns
- Products for routes of administration other than oral and topical
- Products intended to be used for the prevention or treatment of serious and/or life-162 threatening diseases and conditions
- Products for vulnerable populations
- Products deemed adulterated under section 501 of the FD&C Act
Of course , FDA does have limited resources, but these criteria appear to be clear (see guidance for further definitions of these criteria here) and it will be interesting to see if the FDA takes some serious actions based on this new enforcement approach. At the same time that the FDA finalizes this draft guidance, it will withdrawCompliance Policy 25 Guide (CPG) 400.400, Conditions Under Which Homeopathic Drugs May be Marketed, issued on May 31, 1988. Will FDA jump the gun and begin enforcement actions earlier? Will this be the beginning of a new paradigm for the marketing of Homeopathic drugs? Only time will tell, but this appears to be to be the first in a series of actions that may be designed to reign in this market.
