The U.S. Food and Drug Administration (FDA) has issued draft guidance, “Drug Products Labeled as Homeopathic,” that would prioritize enforcement and regulatory actions to homeopathic products in several categories: (i) products with reported safety concerns; (ii) products that may contain ingredients associated with potentially significant safety concerns, such as pathogens, controlled substances or those with known toxicity; (iii) products administrated in a way other than oral or topical; (iv) products for prevention or treatment of serious or life-threatening diseases; (v) products for vulnerable populations, such as the elderly or immunocompromised; and (vi) products deemed adulterated under the federal Food, Drug, and Cosmetic Act. Public comments will be accepted until March 20, 2018.
“In many cases, people may be placing their trust and money in therapies that may bring little to no benefit to 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. “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 may want to use alternative treatments, but the FDA has a responsibility to protect the public from products that may not deliver any benefits and have the potential to cause harm.”