FDA Might Pick At Nicotine Toothpick Firm's Drug, Supplement Products
FDA warns Smart Toothpicks about selling nicotine-infused toothpicks to a minor and its online claim, "nicotine satisfaction without smoke damage to your lungs.” Escaping FDA attention so far are a dry mouth claim and a B12 formulation.
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GSK’s Proposal For Mouth Spray Nicorette Delayed By FDA Questions On Label
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.
ACT Dry Mouth 'Immediate,' 'Moisturizing,' 'Lubricating' Claims OK In Review Appeal
Council of Better Business Bureaus' advertising review appeals panel says Sanofi didn't support claiming ACT Dry Mouth Lozenges "are uniquely formulated to stimulate saliva flow” because no evidence supported uniqueness. On review of initial findings from August 2018 on GSK challenge, which markets Biotene dry mouth products, panel considered appeals by both firms.
Biotene OTC Dry Mouth Competitor Remains On Market As GSK Litigates
Former Biotene owner Laclede ordered by federal judge to stop using brand, now owned by GSK, to promote its competing line of Salivea dry mouth products. But judge rejected GSK’s request that the Salivea dry mouth product marketers are subject to a lifetime non-compete agreement.