The Consumer Healthcare Products Association submitted a citizen petition on 14 November urging the US Food and Drug Administration to exercise its existing statutory authority to swiftly issue a regulation establishing a clear pathway for manufacturers to lawfully market cannabidiol in dietary supplements. The FDA should require manufacturers of CBD-containing products to submit new dietary ingredient notifications for CBD and comply with other agency regulations, including using appropriate labeling and claims, adhering to good manufacturing practices and reporting serious adverse events, CHPA says. “NDI notifications would provide FDA with much-needed data on CBD since they must include evidence establishing a reasonable expectation of safety when used under the conditions recommended or suggested in the product’s labeling,” the association says. CHPA also asks the agency to work quickly by either issuing an interim final rule that takes effect right away or by issuing guidance on enforcement discretion for reputable manufacturers that take certain steps to ensure product quality while potentially lengthy notice-and-comment rulemaking is underway.
HBW Market News: CHPA Petitions For CBD Reg, PEW Urges Stronger Supplement Oversight
AHPA releases guidance for tea and infusion products on regulatory and liability implications as a result of increasing Prop 65 lawsuits; CHPA files citizen petition urging FDA to act on a CBD pathway; PEW pushes for stronger supplement oversight; and more.
More from Legislation
“If this doesn’t get reauthorized, look at the number of the ingredients out there, the number of products, what would happen all those products out there for the consumer, on that shelf, in the drugstore or someplace?” says Rep. Bob Latta during House hearing.
Energy and Commerce Health Subcommittee Democrats focus on criticizing HHS Secretary Kennedy’s RIF announcement, including 3,500 FDA jobs among cuts across HHS agencies. “If we reauthorize it, will it continue?” Texas representative Lizzie Fletcher asks of OMUFA.
HBW Insight speaks to AESGP director general Jurate Švarcaite about what's on the agenda for the upcoming 61st AESGP Annual Meeting, which will take place in Warsaw, Poland, between 2-4 June. Highlights include the role of prevention in self-care, discussions about how regulators will ensure the competitiveness of European industry on the world stage and incoming changes to sustainability legislation.
“Protecting the environment is a shared responsibility. It is unfair to expect only two sectors to fund wastewater treatment modernization and operation,” argues AESGP director general Jurate Švarcaite.
More from Policy & Regulation
Reclassifying ethanol as a carcinogenic, mutagenic, or reprotoxic substance - something the European Chemicals Agency seems likely to do in the near future - would be “tantamount to a de facto ban” with “fatal consequences” for medical care in Germany, says Pharma Deutschland in a joint paper with 13 other German healthcare industry associations.
Two AESGP papers reviewing the evidence for AMR risk associated with a range of OTC antifungals and antivirals conclude there is litte to no risk associated with the responsible self-care use of such medicines.
HBW Insight speaks to AESGP director general Jurate Švarcaite about what's on the agenda for the upcoming 61st AESGP Annual Meeting, which will take place in Warsaw, Poland, between 2-4 June. Highlights include the role of prevention in self-care, discussions about how regulators will ensure the competitiveness of European industry on the world stage and incoming changes to sustainability legislation.