The FDA has proposed using a risk-based enforcement approach to products labels as homeopathic. The draft guidance would update the agency’s existing policy toward situations where homeopathic treatments are being sold for serious diseases or conditions but have not been shown to offer clinical benefits. Homeopathic treatments that contain potentially harmful ingredients or that don’t meet current good manufacturing practices would also be affected.
The draft guidance would prioritize enforcement and regulatory actions involving unapproved homeopathic drug products that have the greatest potential to cause risk to patients, according to an FDA statement. This would include products with reported safety concerns, those that contain or claim to contain ingredients with significant safety concerns, and products intended to treat or prevent serious or life-threatening diseases or conditions.
In a statement provided to Drug Topics, the American Association of Homeopathic Pharmacists (AAHP) said that it applauded the FDA’s plan for illegal or unsafe homeopathic products. “In fact, the Association encouraged FDA to do just that in its comments at the regulatory body’s April 2015 workshop on the topic,” according to the statement. AAHP represents the interests of manufacturers, distributors and marketers of homeopathic drug products as well as individual pharmacists.
The draft guidance will not “materially affect” the majority of homeopathic products in the United States, according to the association.
Sales of homeopathic products have surged to nearly $3 billion in the last 10 years, according to the FDA. There has been an increase in serious adverse reactions from products labeled as homeopathic and in those that have been found to be poorly made or that contain dangerous amounts of the active ingredient. One example noted in the statement were homeopathic teething tablets and gels found to contain belladonna that were linked to serious adverse reactions in babies.
Homeopathy is an alternative medical practice that is based on two principles: that a substance that causes symptoms in healthy people can be diluted and used to treat illness (“like-cures-like”), and that the more diluted the substance, the more potent it is. Homeopathic drug products are prepared from many sources, including plants, minerals, chemicals and human and animal excretions or secretions. Lines of homeopathic products are often sold in pharmacies and online and are made by repeatedly diluting the substance that is the active ingredient in alcohol or distilled water.
Health organizations such as the National Health Service of Great Britain and the American Medical Association have issued statements of their conclusion that there is no good evidence that homeopathic treatment is effective for any health condition. At its website, the AAHP states that homeopathy is “a safe, gentle, and natural system of healing that works with your body to relieve symptoms, restore itself, and improve your overall health.”
There will be a 90-day period for public comments on the draft guidance.