Legal Expert Discusses Vape and the Law
Bidi Vapor Webcast: FDA authorization process defines rules around tobacco-derived nicotine
MELBOURNE, Florida — While the deadlines for filing Premarket Tobacco Product Application (PMTA) for vape products has come and gone, confusion remains over what’s legal and what’s not. Azim Chowdhury, a regulatory specialist from the law firm Keller Heckman based in Washington, D.C., recently participated in a Bidi Vapor webcast, informing the audience on some pertinent legal matters concerning the industry. To watch the webcast, click here.
Chowdhury mentioned that according to the Tobacco Control Act and U.S. Food and Drug Administration’s (FDA) deeming rule, the agency has been regulating companies marketing traditional, tobacco-derived nicotine products since 2016. These products should have been part of PMTAs submitted in a timely manner by September 2020. “If the company could do that and get their application accepted and filed, the court indicated that companies could continue marketing those products without the threat of enforcement for up to a year, ending in September 2021,” Chowdhury said.
After that, it’s now up to the FDA’s enforcement discretion to decide whether a product could remain on the market that was still subject to a pending application. Most companies marketing non-tobacco flavored products who submitted PMTAs had those applications denied because the FDA changed their standard of review for flavored products. So, companies with tobacco-derived nicotine cannot market products if those products are subject to a Marketing Denial Order (MDO).
In August 2022, the 11th U.S. Circuit Court of Appeals set aside the MDO against Bidi Vapor’s non-tobacco flavored electronic nicotine delivery systems (ENDS). The decision allowed Bidi Vapor to legitimately sell those products, subject to FDA enforcement discretion, while the FDA reviewed the related PMTAs.
Regarding where the market stands–retailers, wholesalers, and distributors need to be aware that they are subject to breaking the law and penalties from FDA and state authorities for marketing and distributing adulterated products. “It’s critical for those businesses to be aware and to obtain confirmation from their suppliers about the legality of the products and to understand that having a PMTA acceptance letter does not necessarily mean the product is legal to market,” Chowdhury said.
A PMTA submitted and accepted just means the FDA is reviewing the application. It’s not authorization to sell the product, he said.
There are penalties involved for wholesalers and retailers caught selling non-compliant products. Anyone selling, marketing, or distributing an adulterated tobacco product not tied to a properly filed PMTA is subject to penalties. Many dubious companies enter the market every day with
what appear to be new products, new technology, and new types of disposables. Still, marketing products like those are declared prohibited under the Federal Food, Drug, and Cosmetic Act (FDCA), with penalties ranging from initially getting warning letters from the FDA to eventually increased enforcement. Such actions include seizures of products and court-ordered injunctions to stop selling products or being forced out of the business. The FDA can also seek criminal prosecution against companies violating the law, ranging from a misdemeanor to felonies in cases where the potential for public harm exists.
Chowdhury adds, “We haven’t seen the FDA bring down the hammer to that extent in this industry, but we are witnessing FDA and the Department of Justice or the DOJ get involved more in issuing initial warning letters and some product seizures.”
Chowdhury also commented on synthetic nicotine, emphasizing that those products are currently not allowed on the market.
For more information, watch the latest Bidi Vapor webcast, “Vape Update: What’s Legal, What’s Not?” here.
