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
Texas Democrat Lizzie Fletcher didn’t pose questions for witnesses at House Health Subcommittee hearing but used her floor time to question whether Congress will keep federal agencies afloat. “I have real concerns that even if we reauthorize these programs, we won't have the funding or the staff to
FDA’s fourth approval in past two months for color derived from natural sources to use in foods is Gardenia Blue Interest Group’s color additive petition for gardenia blue. Lycored launches StellarYellow and C Clear as alternatives for synthetic dyes yellow Nos. 5 and 6 and OrangeOvation C Clear for
Subcommittee members aren’t on same page about whether FDA staff cuts ordered by the Trump administration will prevent the agency from fulfilling its responsibilities for the OTC drug sector.
Recent warning letters to seven companies marketing products with kratom extract known as 7-OH are FDA’s first in three years referencing unlawful products containing kratom and the first of all its kratom-related warnings to reference extracts from the botanical.
Health Subcommittee will discuss reauthorizing OMUFA during a hearing on how to “maintain and improve” the public health workforce and rural health as well as access to OTC medicines.
First Insight report from survey conducted in April with 1,267 US consumers notes that the Private Label Manufacturers Association recorded private label sales increasing by nearly 4% in 2024 to a record $271bn.