Malcolm Spicer
US Consumer Health Managing Editor
Latest From Malcolm Spicer
Demi Moore’s Wonderbelly Antacids Investment Lands Supporting Role In Her Promotional Posts
Wonderbelly Antacids “free from” ad claims work but failing to disclose Demi Moore is an investor in her promotions doesn’t, NAD says. Dakota Nutrition fails again on NAD’s test of its testing for elderberry in its supplements.
Valisure Will Continue As 'Inconvenient' Reminder For Change To US Drug Quality ‘Status Quo’
“I think the symptoms of the core disease of quality is not having an independent layer or just not being able to invest more in quality or whatever the other root causes of addressing these quality issues,” says analytical lab president David Light.
Preemption, Constitution Counter New York Law Age-Restricting Some Supplement Sales – CRN
Trade group’s lawsuit filed 13 March in New York alleges NY General Business Law 391-oo, which the state legislature enacted in October 2023 with 22 April effective date, violates US Constitution’s First and 14th amendments plus corresponding articles of the state’s constitution.
US FDA Wants ‘Minor’ Labeling Changes For OTCs Available Through NDAs/ANDAs In Annual Reports
Fewer labeling changes submitted for OTC NDAs/ANDAs makes more time available for CDER reviews of other applications for OTC switches as well as non-minor labeling changes to nonprescription drugs plus far larger number of submissions for Rx drug approvals and labeling.
Tylenol Label Warning Complaint Dismissed With Judge's Federal Preemption Question Unanswered
Marketers of other drugs available under FDA OTC monograph should note dismissal of complaint against Kenvue didn’t resolve the judge’s questions about whether federal preemption precludes challenges to safety and labeling.
Biden Administration's $7.13Bn FDA Budget Request For FY2025 Includes $3.3Bn In User Fees
White House’s 1,298-page budget request published on 11 March includes around $2m more than the agency’s total FY2024 spending Congress approved on 8 March and the president signed the next day. Of FDA’s total FY2025 spending $3.286bn would come from user fees.