Nicotine Gummies Sold For Smoking Cessation Doused Under US FDA Tobacco Regulations
FDA says warning to VPR Brands could be its first move to reign in sales of nicotine gummies. Statements on brand’s site could indicate sales of nicotine gummies for smoking cessation are on the rise even though the claim isn’t approved.
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Glaxo plans to make changes FDA requested in Complete Response letter sent on 18 October, the agency’s deadline for acting on NDA for an oral spray that delivers 1 mg per spray of aqueous buffered nicotine solution for oromucosal use.
GSK's proposed usage for mouth spray product – reducing withdrawal symptoms, including nicotine craving – differs little from the first NRT product approved in US in 1984. Additional suggested label instructions primarily focus on stating NRTs can be used to reduce smoking or gradually stop tobacco use as opposed to quitting within a specified amount of time.
Submitting other OTC monograph program communications through CDER's NextGen Portal, including proposals to add formulations or indications to a monograph, will have to wait.