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
CRN petition argues against general preclusion while NPA petition addressed specifically FDA’s wielding of the provision to prohibit the use of NMN supplements available in US. “FDA has acknowledged that they really can't answer one without answering. The two are inextricably linked,” says CRN CEO Steve Mister.
A week after announcing 2024 full-year and fourth-quarter results, the firm says its corporate name will be Niagen Bioscience Inc. starting 19 March. It stated in its latest results that during 2024 it launched Niagen Plus line of pharmaceutical-grade Niagen.
Veteran pharma executive leads Vitamin Angels; CEO change to lead unifying Dr. Scholl's brand worldwide; and first CEO change for Prinova in 42 years.
It wasn’t a quick decision for Xlear to accept DoJ attorneys’ offer to dismiss the case. “I want the I want the FTC to change its policy and its behaviors,” says Xlear president Nathan Jones.
Direct seller has deals to fully acquire and 51% ownership of Link BioSciences, which formulates personalized supplements. It also announced a deal to acquire Pruvit Ventures, ketone supplements direct seller.
Eliminating self-affirmation process would require companies to publicly notify FDA of their intended use of ingredients and provide safety data before they’re introduced. Kennedy says the process is “a loophole” for introducing ingredients and chemicals “with unknown safety data.”