The FDA is proposing a new, risk-based enforcement approach to homeopathic drug products that may be harmful. FDA is going to update its existing policy to address situations where these treatments are marketed for serious diseases and conditions, but have not shown any clinical benefits. The policy will also cover situations where these products contain potentially harmful ingredients or don’t meet current good manufacturing practices.
FDA Commissioner Dr. Scott Gottlieb said in a statement, “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. 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.”
This authority is going to be focused on 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, and products that are intended to be used for the prevention of or treatment of serious diseases and conditions. The policy will also target products for vulnerable populations, and products that don’t meet standards of quality, strength, or purity under the law.
Products that may be subject to this policy include infant and children’s products that contain products that are of concern to safety, including nux vomica, which contains strychnine that can build up in the body, and belladonna, which can block functions of the body’s nervous system. The government is also concerned about products that are marketed for conditions such as cancer and heart disease.
Homeopathy is based on the belief that a substance that causes symptoms in a healthy person can be used in a diluted form to treat illness, and that the more diluted the substance, the more potent it is. These products are sold over the county in pharmacies, online, and in retail stores. In the last 10 years, this market has grown exponentially.
During the last ten years, the FDA has seen a corresponding increase in safety concerns, including serious adverse events associated with homeopathic drug products. And the FDA has found an increasing number of poorly manufactured products that contain potentially dangerous amounts of active ingredients.
For instance, last year the FDA warned agains that use of homeopathic teething tablets and gels that contain belladonna. those products were associated with serious issues, including seizures and deaths, in infants and children. FDA lab analysis found that some of these products contained elevated and inconsistent levels of belladonna.
Other homeopathic products that have been warned against include zinc-containing intranasal products that can cause the loss of the sense of smell; homeopathic asthma products that don’t treat asthma; and products with nux vomica.
Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research said, “Homeopathic products have not been approved by the FDA for any use and may not meet modern standards for safety, effectiveness and quality. The draft guidance is an important step forward in the agency’s work to protect patients from unproven and potentially dangerous products.”
You can comment on the draft guidance during the 90 day comment period. And if you have experienced an adverse event while taking a homeopathic product, you can report that to the FDA’s MedWatch Program.
