Health And Wellness Industry News: Court Slams FDA E-cigarette Delay, Neopac Launches US Production
Executive Summary
A Maryland federal court says FDA acted illegally on e-cigarettes guidance; Deadline for FSMA Qualified Importer Program applications extended; FDA allows enforcement discretion for potassium chloride salt labeling; Swiss packaging firm Hoffmann Neopac opens US plant; and more news.
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Application Deadline Ordered To Stop Vaping Industry Evasion Of FDA Approval
"Balancing the need to address the existing public health crisis among today’s youth ... and the need to avoid creating an additional public health crisis if e-cigarette availability dropped so precipitously as to push users to combusted tobacco products," Judge Paul Grimm sets a May 2020 PMTA deadline for vaping products, noting the industry’s "lack of effort to obtain approval without an imminent deadline."
E-cigarettes' Future Generates Questions, Not Their Efficacy For Smoking Cessation
FDA has made clear since e-cigarette sales emerged that they're not approved for labeling as products to help consumers stop using combustible tobacco. Agency also has acted on concerns about products' safety and appeal of flavored nicotine to minors. But likelihood of sales in US ending, not whether products help smokers quit, was discussed at FDLI conference.
FDA Rule Stifles E-Cigarettes' Harm Reduction Role With Grandfather Date, Application Costs
Makers of e-cigarettes and other types of what FDA terms "electronic nicotine-delivery systems" look to Congress for help on allowing products already available when the agency published the rule to remain available without pre-market approval. However, litigation also has been filed against the rule.