Guidance on keeping electronic cigarettes available comes a month after medical organizations and public health advocacy groups asked agency to investigate alleged smoking cessation claims by leading e-cigarette firm. Guidance maintains explanation FDA stated in 2016 draft guidance that approval of a Premarket Tobacco Product Application depends on showing a tobacco or nicotine product has some smoking cessation-like utility.
The US Food and Drug Administration's final guidance on keeping electronic cigarettes available comes a month after medical organizations and public health advocacy groups asked the agency to investigate alleged smoking cessation claims by a leading e-cigarette firm.
The guidance published June 11 includes an explanation on potentially applying for approval as a smoking cessation product, a designation...
Green Pharmaceuticals’ SnoreStop Nasal Spray, previously marketed as “NasoSpray,” still is available even though agency officials on multiple occasions for a month recommended a recall after an April inspection found “gross microbial contamination” in one lot.
Following Energy and Commerce Health Subcommittee hearing about FDA’s human food and tobacco programs on 10 September, gap between what the trade groups, committee leadership and the FDA each want more of doesn’t appear to be shrinking.
Children with ADHD often struggle with bedtime due to restless minds, difficulty winding down, and heightened sensitivity to nighttime distractions. This article explores the reasons behind these sleep challenges and offers practical solutions.
At one year, TikTok Shop conjures the early days of Amazon, representing the ‘Wild West’ of beauty ecommerce, said co-founders of private label and contract manufacturing company KO-Pack at the IBA Cosmetics Convergence Fall 2024 Virtual Symposium, “The Promise and Pitfalls of TikTok Shop.”
At one year, TikTok Shop conjures the early days of Amazon, representing the ‘Wild West’ of beauty ecommerce, said co-founders of private label and contract manufacturing company KO-Pack at the IBA Cosmetics Convergence Fall 2024 Virtual Symposium, “The Promise and Pitfalls of TikTok Shop.”
Court order dismisses claims against Perrigo and Joseph Papa, its former CEO, with prejudice. Settlement also bars any claim against plaintiffs and class members, “whether arising under state, federal, common or foreign law,” alleging liability for losses.
Semi-annual regulatory agenda of non-binding target dates also sets December goal for an NPRM to recognize N-acetyl-L-cysteine as a lawful dietary ingredient. Like IND exemptions rule, item on NAC included for first time in FDA’s list.
