FDA offers a new, risk-based strategy to protect customers from homeopathic drugs with safety concerns
Recently the U.S. Food and Drug Administration (FDA) offered new risk-based enforcement priorities to protect consumers from taking potentially harmful homeopathic drugs. In order to do that the FDA will update the current regulations which cover the situations when serious diseases and/or conditions are stated as indications for taking these drugs. Moreover, the update will better address the situations when homeopathic drugs contain potentially harmful agents which do not meet GMP standards.
According to law, all homeopathic drugs should also be approved, and they have the same requirements regarding adulteration and misbranding issues as all allopathic drugs. Though, prescription and nonprescription homeopathic drugs have been produced and distributed without getting the FDA 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,” stated FDA Commissioner Scott Gottlieb, M.D.
The FDA is planning to put efforts into improving the regulations for manufacturing of homeopathic drug products which safety reports are concerning; include potentially harmful ingredients; routes of administration are not oral or topical; are indicated for treating serious or life-threatening illnesses; are indicated for vulnerable populations (for example, children); do not meet the requirements of quality, efficacy or purity.
For example, homeopathic drug products for children which contain potentially dangerous ingredients such as belladonna may be subjected to this enforcement approach.