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The FDA is Accused of Keeping The Public In The Dark About Vapes

During the annual E-Cigarette Summit in Washington, DC, the theme for a big part of the day was the fact that the Food and Drug Administration (FDA) has continued to communicate the “continuum of risk” of nicotine products very poorly.

Diane Caruana

December 16, 2022

The Summit which this year was held on May 17th, has been described by Filter as “perhaps the most eclectic conference in tobacco control”, and it is attended by consumer advocates, vape business owners, tobacco harm reduction researchers, regulators and industry executives.

For many it presented a rare opportunity to pose questions to policymakers. This year, the director of the Office of Science at the FDA’s Center for Tobacco Products (CTP), Matthew Holman, and Kathleen Crosby, the director of CTP’s Office of Health Communication and Education, were bombarded with questions as to why even though the FDA is finally authorizing some vape products through its premarket tobacco production application (PMTA) process, the public has been left in the dark about the relative benefits of the products.

Two of the most prominent speaker, David Ashley, a former director of the Office of Science at CTP himself, and Vaughan Rees, the director of the Center for Tobacco Control at Harvard, both highlighted that vaping has played a major role in decreasing smoking rates. “What’s the ethics of doing that—misleading people to get behavior change?,” they questioned.

Synthetic nicotine regulations

Meanwhile, following a new legislation enacted on March 15th, the US Food and Drug Administration (FDA) can now regulate tobacco products containing nicotine from any source.

The new law took effect on April 14th, and requires that “manufacturers, distributors, importers and retailers of tobacco products containing non-tobacco nicotine (NTN)—that is, nicotine not made or derived from tobacco, such as synthetic nicotine—must ensure compliance with applicable requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act) resulting from this law, such as:

Not selling these products to persons under 21 years of age (both in-person and online);
Not marketing these products as modified risk tobacco products without FDA’s authorization; and
Not distributing free samples of these products.”