Filter: FDA Denies Additional 800 Products

The Food and Drug Administration on Aug. 31 denied the premarket tobacco product applications for 800 vaping products from three e-liquid manufacturers, according to Filter. The marketing denial orders have not been published on the agency’s website.

Earlier in August, the FDA announced its first outright denial of 55,000 flavored vaping products from three other companies. Prior to that, the FDA refused to file 4.5 million of the 6.5 million applications sent to the agency because the company that put them together did not include appropriate environmental assessments for each product.

All of the products rejected on Aug. 31 were flavored, and consumer advocates and manufacturers are worried that the FDA is moving toward an effective flavor ban.

According to industry consultant Dimitris Agrafiotis, the applications he helped the three companies file were unfinished. The companies had intended to send more data piecemeal to the agency as substantial product stability testing wrapped up. Just last week, his clients drafted a letter to the FDA, stating that they would be sending further information.

Agrafiotis said that each company he represents is now moving into the synthetic nicotine space, a legal gray area. The FDA defines a “tobacco product” as anything “made or derived from tobacco that is intended for human consumption, including any component, part or accessory of a tobacco product.”

The FDA has until Sept. 9 to determine the legality of other vaping products, though the agency has signaled it will rule on the major players but not complete the process for everybody else by then.