OTC
FDA Releases New Guidance on Oral Phenylephrine, Xlear Responds
On Nov. 7, the U.S. Food and Drug Administration (FDA) proposed removing oral phenylephrine from over the counter (OTC) medications due to “effectiveness concerns.” According to FDA, oral phenylephrine is widely used as an active ingredient in nasal decongestants. The agency conducted a comprehensive review of all available data on the safety and efficacy of ...
Industry Responds to RFK Jr.’s Nomination as HHS Director
On Nov. 14, President-elect Donald Trump nominated environmental attorney Robert F. Kennedy Jr. (RFK) as director of the Department of Health and Human Services (HHS). After ending his own presidential campaign, Kennedy endorsed Trump and has since launched “Make America Healthy Again,” a campaign that “prioritizes regenerative agriculture, protects natural resources and removes harmful toxins ...
FDA Warns Selling of Topical CBD Products Violates FD&C Act
On March 22, the U.S. Food and Drug Administration stated that it has issued warning letters to two companies for selling topical pain relief products labeled as containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the warning letters addressed the illegal marketing of unapproved drugs labeled ...
FTC Issues Statement on Homeopathic Drug Marketing Claims
The Federal Trade Commission (FTC) announced a new “Enforcement Policy Statement on Marketing Claims for Over-the-Counter (OTC) Homeopathic Drugs.” The policy statement was informed by an FTC workshop held last year to examine how such drugs are marketed to consumers. The FTC also released its staff report on the workshop, which summarizes the panel presentations ...
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