FDA Proposes Risk-Based Enforcement of Homeopathic Products

December 19th 2017

The FDA has proposed an updated approach to assessing homeopathic drug products, according to an FDA statement.

The FDA has proposed an updated approach to assessing homeopathic drug products, according to an FDA statement.

The policy will also apply to situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices.

Under this approach, the FDA intends to focus on the enforcement of:

The new approach is based on risk-based enforcement of homeopathic drug products to protect consumers from potential harm. An update to the agency's existing policy, the approach will better address products that are being marketed for serious conditions or diseases but do not demonstrate evidence of clinical benefit.

  • 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
  • Products that do not meet standards of quality, strength, or purity as required under the law

“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,” FDA Commissioner Scott Gottlieb, MD, said in the statement. “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.”

The FDA has previously taken action by issuing warnings on homeopathic products. According to the statement, the FDA has seen a corresponding increase in safety concerns associated with drug products labeled as homeopathic, as well as an increasing number of products that contain potentially dangerous amounts of active ingredients.

In January 2017, an FDA analysis confirmed the presence of elevated levels of belladonna

found in homeopathic teething tablets and gels, after the products were associated with serious adverse events in infants and children.

The FDA encourages public comments on the draft guidance during the 90-day comment period. Additionally, health care professionals and patients are encouraged to report adverse events or quality problems experienced with homeopathic or any drug products to the FDA’s MedWatch program.

Reference

FDA proposes new, risk-based enforcement priorities to protect consumers from potentially harmful, unproven homeopathic drugs [news release]. FDA’s website.

. Accessed December 18, 2017.

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm589243.htm

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