Senior Editor, Consumer Health
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Latest From Malcolm Spicer
CEO Walmsley's familiarity with Glaxo's consumer health business was clear in her response to analysts' questions about the firm's future as a three-unit operation. The business marketing brands including Flonase and Excedrin is a more reliable revenue driver than the pharma business, she said.
Gottlieb is not the first FDA commissioner nominee to profess support for its regulatory framework established by DSHEA, but the focus of Hatch's question serves stronger notice than similar questions asked of previous candidates that the agency authority to enforce in the space does need adjustment.
FDA realizes more products labeled as supplements but making claims to treat cancer or other serious conditions are available online from firms that have not been identified in ongoing searches by "staff devoted to rooting out health fraud scams."
An April 18 alert update about a Chinese firm distributing HGH-containing supplements follows the launch of the alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient.
Like FDA's draft guidance on NDI notifications and its previous estimates for compliance with that regulation and the GMP final rule, the agency's latest estimate on manufacturers' annual burdens associated with GMP recordkeeping prompts industry questions.
FTC is implementing Trump administration directives on "eliminating wasteful, unnecessary regulations and processes," but attempting to reduce regulated industries' compliance burden is not the same as slowing FTC enforcement against false and misleading advertising, attorneys say.