FDA to Increase Regulation of Homeopathic Drugs

Homeopathic products may be subject to risk-based policies under proposed FDA rule.

The FDA recently issued a statement about implementing a risk-based enforcement strategy to combat the potential harms of homeopathic drugs.

To protect Americans, the FDA plans to update their existing policy to address instances where alternative medicine products are advertised to treat a serious condition but have not shown clinical benefits, according to a press release.

The new approach also includes circumstances where homeopathic treatments include harmful ingredients or violate good manufacturing practices.

The law subjects homeopathic products to the same requirements needed for approval, adulteration, and misbranding of other drugs, according to the release. The FDA notes that alternative medicine products have been sold without approval since 1988.

“In recent years, we’ve seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer. In many cases, people may be placing their trust and money in therapies that may bring little to no benefit in combating serious ailments, or worse — that may cause significant and even irreparable harm because the products are poorly manufactured, or contain active ingredients that aren’t adequately tested or disclosed to patients,” said FDA Commissioner Scott Gottlieb, MD. “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.”

The novel approach emphasizes enforcement actions for products that have the largest potential to harm patients. The FDA expects that many homeopathic products will not meet the risk-based categories outlined by the guidance.

The FDA plans to focus on homeopathic products:

  • With reported safety issues
  • That include ingredients that may cause safety concerns
  • That are not administered orally or topically
  • That claim to prevent or treat serious conditions
  • Marketed to vulnerable patients
  • That do not meet quality, strength, or purity standards as dictated by the law

For example, the FDA highlighted the potential dangers of children’s products that include ingredients such as belladonna and nux vomica, which may be linked to safety concerns, according to the release. The agency will also be targeting products that are said to treat cancer, heart disease, and other serious conditions.

Due to growing concerns about the prevalence of potentially ineffective and harmful homeopathic products, the agency may consider taking additional actions, according to the release.

The FDA reported that over the last decade the homeopathic drug market has become a $3 billion industry that may be increasing patient exposure to unapproved and untested products. As the market for homeopathic treatments has grown, so has the occurrence of serious adverse events and other safety concerns, according to the release.

The agency has previously issued warnings about several homeopathic products that may cause harm.

“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 Center for Drug Evaluation and Research. “The draft guidance is an important step forward in the agency's work to protect patients from unproven and potentially dangerous products."