FDA Proposes New Guidance For Regulating Homeopathic Drugs

Federal drug regulators are calling for new rules designed to increase oversight of homeopathic products, as part of a continuing effort to better protect consumers. 

The FDA proposed new enforcement guidelines for homeopathic products on December 18, updating the agency’s existing policy. The draft guidance is designed to protect consumers who use homeopathic products from potentially harmful ingredients, according to the agency.

The guidelines are aimed to focus on homeopathic treatments which are being marketed for serious diseases and or conditions, like heart disease or cancer. However, in the case of these homeopathic products, they have not been show to offer any benefits to patients.

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The draft guidance follows a two-day conference held in 2015, which focused on evaluating the safety of homeopathic products on the market, which are not subject to regulatory review for safety before being sold.

The FDA warns that some homeopathic products may potentially harm consumers because they contain questionable ingredients or don’t meet good manufacturing practices. Under the new guidance, the FDA will focus on enforcing certain products which may pose a higher risk, including:

  • Products with reported safety concerns
  • Products that contain ingredients with safety concerns
  • Products taken in other ways, besides oral and topical
  • Products intended to prevent or treat serious or life threatening diseases or conditions
  • Products for vulnerable populations
  • Products that don’t meet safety standards of quality, strength or purity

Some products which may have safety concerns are those intended for infants and children with ingredients that may be potentially harmful, like belladonna and nux vomica.

Homeopathic Safety Concerns

Homeopathy as a medical practice developed in the 1700s. It is based on the idea that a substance that may cause symptoms in a healthy person can be used to treat an illness in diluted amounts. Manufacturing and distribution began without FDA approval in the mid 1980s.

Homeopathic products are prepared from different sources, including plants, minerals, chemicals, and human and animal excretions and secretions. They are sold in pharmacies, in stores, and online.

It was a small market, until recently. Over the last decade the market has grown significantly to create a $3 billion industry.

However, as the industry has grown, the FDA has seen an increase in problems with safety and side effects.

One homeopathic product that has been recalled repeatedly are Hyland’s Baby Teething Tablets. In April, the FDA finally issued a complete, nationwide Hyland’s teething tablet recall following at least 10 child fatalities caused by belladonna toxicity. In 2015, the FDA warned consumers against using homeopathic asthma treatments because it would prompt users to forgo tested medical treatment for unproven homeopathic “cures” which may not work.

“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,” wrote FDA Commissioner Scott Gottlieb, M.D. “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.”


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