FDA Starts Issuing Marketing Denial Orders

Roughly one year after the PMTA deadline, the FDA has finished reviewing many of the PMTAs submitted. A current press release from the FDA highlights their progress, which has resulted in MDOs (Marketing Denial Orders) for over 946,000 products.

The reason for their rejections 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.”

Another quote from the FDA’s press release states “Importantly, we know that flavored tobacco products are very appealing to young people. Therefore, assessing the impact of potential or actual youth use is a critical factor in our determination as to whether the statutory standard for marketing is met.“

It appears like the FDA is against approving flavored products in general.

At the time this article was written, 104 PMTAs have been finished and have ended without permission to sell their products. The FDA can issue case-by-case extensions for products. However, no extensions have been publicly announced.

There was little said about the status of companies who are waiting on the decision of their own PMTA applications. At best, the press statement mentions that products with no PMTA applications and products with MDOs will be a higher enforcement priority than products with PMTA applications in review.

Some companies, most noticeably Puff Bar, have tried to avoid the PMTA restrictions by manufacturing e liquid using synthetic nicotine. Traditionally, synthetic nicotine was not used because it was more expensive and is basically the same thing as naturally extracted nicotine.

The FDA that regulates tobacco products defines tobacco products as “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product.” Because no tobacco plants were involved, they technically are not under PMTA rules (for now).

References:

FDA Makes Significant Progress in Science-Based Public Health Application Review, Taking Action on Over 90% of More Than 6.5 Million 'Deemed' New Tobacco Products Submitted | FDA

Puff Bar Defies FDA Crackdown on Fruity E-Cigarettes by Ditching the Tobacco

CTP Glossary | FDA

Tobacco Products Marketing Orders | FDA