Homeopathic Drug Makers Get Updated FDA Enforcement Guidance

Unapproved plant-based drug products won’t get over-the-counter safety determinations by FDA and must continue to go through standard approval requirements, the agency said in final guidance issued Wednesday.

Homeopathic products, including certain plant or mineral-based cold medicines, fall under a separate category from products that go through the agency’s over-the-counter drug review process, the Food and Drug Administration said in its recommendations. The final guidance updates 2019 draft recommendations to include provisions from the March 2020 Coronavirus Aid, Relief, and Economic Security, or CARES, Act. The law replaced the FDA’s rulemaking process for particular OTC drugs to allow the agency ...