Malcolm Spicer, Managing Editor – US
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Latest From Malcolm Spicer
FDA and CDC Analysis of the 20,791 adverse event reports for vitamins, minerals and supplements from 2006 through 2015 found that 3,962, 19.1%, indicated swallowing problems and the 10 products most commonly identified in the reports all exceeded 17 mm, or 0.67 inch, in length.
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.
FDA provides "step-by-step instructions on how to convert" units of measure for folate, niacin and vitamins A, D and E to units required in the agency's 2016 final rule for Supplement and Nutrition Facts labels. Compliance date for firms with sales of $10m and up.