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
Both companies announced that during special meetings on Jan. 29, their shareholders voted nearly unanimous support for Kimberly-Clark’s $48.7bn acquisition proposed in November at $3.50 per share plus 0.14625 share for each Kenvue share.
Changing self-GRAS regulation, providing NDIN safety and identity guidance and modernizing supplement industry regulatory framework are on FDA’s “2026 priority deliverables,” but not requirement for public listing of all supplements available.
Wonderbelly reached market in 2022 and has notched nationwide footprint through major retailers over the years, Target stores starting in March 2023, CVS since June 2024 and Walmart since May 2025.
When FDA warned Agebox about selling iKids-Growth IGF-1 Support supplements as unapproved drugs, agency along with CDC had for around a month been investigating outbreak of infant botulism linked to ByHeart formula.
FDA Human Foods Program’s list notes Kennedy’s GRAS focus as first item in “Food Chemical Safety” category, saying the agency in 2026 “will publish a proposed regulation to require the submission to FDA of GRAS notices for all substances claimed to be GRAS.”
Lawsuit filed in District of Columba federal court alleges FDA violated the authoritative statement provisions of FD&C Act, Constitutional Avoidance Doctrine and First Amendment by rejecting ANH-USA’s petition to allow 114 science-based health claims sourced directly from federal agencies.