The agency has proposed a risk-based enforcement approach to protecting patients against unproven homeopathic drugs.
18, 2017 that the agency is cracking down on homeopathic products that claim to treat serious health conditions.
Although homeopathic drugs must meet the same approval, adulteration, and misbranding legal requirements as any other drug product, many (prescription and non-prescription) have been developed and distributed without the FDA's approval enforcement policies since 1988. FDA will focus its enforcement activities on products and ingredients with reported safety concerns, products that are not administered orally or topically; products promoted to treat serious conditions; products marketed to vulnerable populations; and products that don't meet quality, strength, or purity standards. It's grown into a $3 billion industry, and the agency has seen a corresponding uptick in safety concerns around the products, which are easily found at retail stories, pharmacies and online.
FDA commissioner Scott Gottlieb laid out the rationale in stark terms.
The Food and Drug Administration said Monday it wants to crack down on alternative remedies that are sold as "homeopathic" products but contain potentially harmful ingredients or show no clinical benefit.
The new draft guidance emphasizes enforcement and regulatory actions towards unapproved drugs labeled as homeopathic that carry the highest potential to cause risk to patients.
Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, added, "The draft guidance is an important step forward in the agency's work to protect patients from unproven and potentially unsafe products". "The draft guidance is an important step forward in the agency's work to protect patients from unproven and potentially unsafe products". But he also noted the FDA's public safety obligation when it comes to homeopathy.