FDA proposes risk-based enforcement for homeopathic products – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889
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consumers who choose to use homeopathic products, FDA recently proposed a new, risk-based enforcement approach in the draft guidance Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry.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