FDA: New Risk-Based Approach to Regulate Homeopathic Products

FDA is proposing a new, risk-based enforcement approach to homeopathic drug products that have the greatest potential to cause risk to patients.

The Food and Drug Administration (FDA) announced a new enforcement strategy to regulate drug products labeled as homeopathic. The new risk-based approach is a proposed update to the existing policy to better manage situations where homeopathic products are being marketed for serious diseases and/or conditions but where the products have not demonstrated clinical benefit. 

The FDA also reported that the proposed policy will address situations where products labeled as homeopathic contain potentially dangerous ingredients or do not meet current good manufacturing practices. 

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Homeopathic drugs are derived from different sources, including plants, minerals, chemicals, and human and animal excretions or secretions. They are commonly sold in pharmacies, retail stores, or on the internet. As their popularity has increased over the last 10 years, the FDA has observed a related increase in unsubstantiated health claims, serious adverse events, and poor manufacturing practices. 

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. “Our approach to regulating homeopathic drugs must evolve to reflect the current complexity of the market, by taking a more risk-based approach to enforcement. 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,” stated FDA commissioner Scott Gottlieb MD.

The new draft guidance emphasizes enforcement and regulatory actions towards unapproved drugs labeled as homeopathic that carry the highest potential to cause risk to patients. For example, infant and children’s products labeled to contain ingredients linked to potentially significant safety risks (eg, belladonna, nux vomica) and products marketed to treat serious conditions (eg, cancer, heart disease) may be subject to enforcement. In general, the Agency plans to focus its authorities on the following types of products:

  • products with reported safety concerns;
  • products that contain or claim 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-threatening diseases and conditions;
  • products for vulnerable populations; and
  • products that do not meet standards of quality, strength or purity as required under the law

Previously, the FDA issued warnings against homeopathic teething tablets and gels containing belladonna, zinc-containing intranasal products, homeopathic asthma products, and others labeled to contain nux vomica (contains strychnine). 

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 dangerous products.”

For more information visit FDA.gov.