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The agency has proposed a risk-based enforcement approach to protecting patients against unproven homeopathic drugs.
FDA announced on Dec. 18, 2017 that the agency is cracking down on homeopathic products that claim to treat serious health conditions. New risk-based enforcement priorities taken by the agency will protect consumers from products that may do more harm than good. 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.
The agency has seen an increase in products labeled homeopathic and marketed for a variety of diseases and conditions in recent years. According to FDA, homeopathic treatments have become a $3-billion industry. While prescription and nonprescription drugs labeled homeopathic have been manufactured without FDA approval since 1988, the agency has also seen an increase in safety concerns related to these products. FDA Commissioner Scott Gottlieb stated in a press release that the agency’s approach to these products must evolve. “We respect that some individuals want to use alternative treatments, but the FDA has a responsibility to protect the public from products that may not deliver any benefit and have the potential to cause harm.”
FDA has published draft guidance describing the agency’s plan to enforce regulations on homeopathic treatments. “Homeopathic products have not been approved by the FDA for any use and may not meet modern standards for safety, effectiveness and quality,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research in the press release. “The draft guidance is an important step forward in the agency's work to protect patients from unproven and potentially dangerous products."
FDA joins the Federal Trade Commission (FTC) in efforts to ensure the safety of the public when it comes to use of these products. In 2016, the FTC enacted a new enforcement policy that explained it would hold efficacy and safety claims of homeopathic treatments to the same standard as other products.