Malcolm has expertly covered the OTC drug and nutritional supplement industries and markets since 2006. He provides authoritative and highly analytical insight into how and why the US Food and Drug Administration regulates OTC drugs, including homeopathics, and nutritional supplement manufacturing and marketing and also how companies competing in these industries can most efficiently and effectively comply with FDA regulations, the cornerstone for their success.
Latest from Malcolm Spicer
MediNatura expands recall to include all lots of both ReBoost and ClearLife nasal sprays after microbial contamination and yeast or mold were found. Firm in 2021 challenged homeopathic drug oversight change from policy in place since 1988.
Third-Party Audit Results ‘Definitely The Direction’ For FDA Supplement Facility Inspection Planning
“There's a lot of third-party audit information out there. Could we take that and apply it into our inspectional planning process?” says Office of Dietary Supplement Programs Director Cara Welch.
“We have rarely, if ever, enforced this requirement” FDA says announcing enforcement discretion regarding requirement for disclaimer about supplement structure/function and other label claims to be printed on every panel of a product’s package.
Urban Retreat didn’t cooperate with Direct Selling Self-Regulatory Council’s review or “indicate any intent to comply with” recommendations to discontinue claims for its Balance Capsules. LoveBiome responded sufficiently to merit a DSSRC recommendation to pull three health claims.
CDER Office of Generic Drugs publishes MaPP for prescription-to-nonprescription switches and ANDAs to explain regulatory responsibilities for makers of generic copies of reference listed drugs approved for OTC switch.
Sunscreen products industry and public health advocacy groups have been critical that FDA has not approved a new filter since 1999 even as countries in Europe and other regions allow using numerous additional ingredients in sunscreens.