Senior Editor, Consumer Health
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Latest From Malcolm Spicer
In its comment on draft guidance, OTC industry trade group urges US FDA to issue final guidance on "Innovative Approaches For Nonprescription Drug Products" in addition to a rule the agency has indicated would soon follow. CHPA expects that identifying information away not within a Drug Facts label that will be considered in an FDA evaluation would be determined on a case-by-case basis, with a switch NDA sponsor and the agency agreeing to terms of approval during a proposal development and review.
The surprising support of Senate majority leader Mitch McConnell is integral to the success of a provision in legislation to reauthorize USDA programs that would clarify hemp's removal from the federal list of controlled substances and ease limits on its production in the US. Meanwhile, Charlotte's Web Holdings' recent $100m IPO is a strong sign of investors' confidence in the future market for hemp products.
Excedrin Extra Strength US sales for the 12 months ending Aug. 12 were up 4.07% to $77.2m, but those figures don't include the 12,000 free packages of Excedrin gel tablets consumers ordered during GSK's the Limited Edition promotion. The firm offered Excedrin in packages marked with causes consumers commonly link with headaches: commuting, bad dating and "adulting."
Marketers' websites and product labels stated other noncompliant claims that render their products unapproved new drugs, but references to opioid withdrawal treatment got FDA Commissioner Scott Gottlieb's attention. "Despite our warnings and previous regulatory and enforcement actions, we continue to find marketers actively selling kratom with unsubstantiated claims," Gottlieb says.
US FDA proposes to repeal regulation that, since 1955, has required an NDA or ANDA for any drug product sterilized by irradiation, including drugs that otherwise would be marketed under an OTC monograph. It notes the Trump administration's order that federal agencies identify and potentially eliminate any unnecessary rules and regulations.
Until CFSAN decides whether to engage in a rulemaking to amend FDA's supplement labeling regulation, it intends "to exercise enforcement discretion for those firms that choose to declare the quantitative amount of live microbial ingredients in the Supplement Facts label by CFUs in addition to weight," according to draft guidance.