About a year after the PMTA deadline, the FDA concluded its review of a number of the PMTAs they received. A recent press release from the FDA provides an update on the progress they have made that has led to MDOs (Marketing Denials) for more than 946,000 items.
The reason for their denial was that the applications “lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products.”
A different quote in the press release of the FDA says, “Importantly We know that tobacco products with flavors are extremely appealing to youngsters. Thus, assessing the effect of young people’s use is an important element in determining to whether the legal standard for marketing is satisfied.”
It seems that the FDA is not in favor of approving flavored products generally.
When this article was published, at the time of writing, 104 PMTAs were completed and ended without a license to sell their products. The FDA may grant case-by-case extensions for certain products. However, there haven’t been any extensions publically announced.
There was no mention of the status of businesses that are awaiting the outcome regarding their individual PMTA applications. The press release states that products without PMTA applications and those with MDOs are given an upper priority for enforcement over products that have PMTA applications under review.
A few companies, notably Puff Bar, have been trying to get around the PMTA restrictions by producing E-liquids that contain synthetic nicotine. Traditionally, it was not utilized because it was expensive and was basically the same as the naturally extracted nicotine.
The FDA, which controls tobacco-related products, defines tobacco in the form of “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product.” Because there were no cigarettes were used, and therefore, they technically do not fall legally protected under PMTA guidelines (for the moment).).
