FDA proposes risk-based enforcement for homeopathic products
Agency issues draft guidance for drug products labeled as homeopathic
To protect consumers who choose to use homeopathic products, FDA recently proposed a new, risk-based enforcement approach in the draft guidance Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry. This proposed new approach would update FDA’s existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet good manufacturing practices.
Under this approach, many homeopathic products will likely fall outside the risk-based categories described in the guidance and will remain available to consumers. FDA intends to prioritize enforcement and regulatory actions involving drug products labeled as homeopathic and marketed without FDA approval in the following categories (in no particular order):
- 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 for vulnerable populations such as those with compromised immune systems, infants and children, older patients, and pregnant women
- Products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions
- Products deemed adulterated under section 501 of the Federal Food, Drug, and Cosmetic Act
Proponents of products labeled as homeopathic tout their safety in part because they believe them to be “natural,” while skeptics assert that the ingredients are generally diluted to such an extent as to be unable to cause a pharmacological reaction. However, as with all drug products, the safety of these products depends upon many factors, including the identity and amount of the “active” ingredient and manufacturing quality.
FDA encourages public comments on the draft guidance during the 90-day comment period. The agency also encourages health professionals and patients to report adverse events or quality problems experienced with homeopathic or any drug products to FDA’s MedWatch program.