The US Vape Industry Grows Discouraged as The FDA Rejects Thousands of PMTAs

The Vaping Post cites CEI on the vapor industry:

A recent blog on Competitive Enterprise Institute’s website highlighted that the amount of applications received by the agency was way over the 25 applications a year the FDA initially expected. “Perhaps that explains why the FDA now seems intent on coming up with excuses to issue sweeping denials and whittle that number down to a size it can handle,” reads the blog.

However, it added, these rejections came as a shock to say the least, as over the last six years, the FDA has approved new tobacco products from three companies, for which it was happy to accept more general evidence about the product category’s appeal to adults and youth, as well as their general risks to public health. These approvals included eight varieties of Swedish Match North America’s snus, the heated tobacco product, IQOS, made by Philip Morris, and combustible cigarettes with reduced nicotine made by 22nd Century Group.

“All of this came as a surprise to the vapor industry, which, after years of requests for clearer guidance from the FDA, was never told that the agency was uninterested in more general evidence about the safety of e-cigarette ingredients, products, or their efficacy in reducing risk to adult smokers. One reason they couldn’t have known this is because it isn’t the standard to which the FDA has held other tobacco products that have successfully completed its preapproval process,” read the blog about the applicants who got rejected.

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