WASHINGTON — For retailers unsure of what the premarket tobacco application (PMTA) process means for their businesses or what will be required of them, here’s some basic facts:
- After Sept. 9, 2020, retailers will need to know what tobacco, vape and other tobacco products (OTP) they can continue to sell per U.S. Food and Drug Administration (FDA) guidance and rules.
- Retailers will have to communicate with manufacturers about which product SKUs they submitted as PMTAs. That’s because the FDA will not produce a list of who submitted applications or for which products.
Here’s how it works.
The FDA requires any tobacco or nicotine product put on the market or modified after Feb. 15, 2007, to go through review to stay on store shelves.
The FDA’s process covers two types of applications: the more widely publicized PMTAs and substantial equivalence (SE) applications. PMTAs are for new products and likely involve categories such as electronic cigarettes, e-vapor, hookah, nicotine gels or oral alternative nicotine tobacco products, according to tobacco retailing association NATO, Lakeville, Minn.
SEs cover products that are substantively similar versions of products that were on the market before Feb. 15, 2007, so they will most likely involve combustible or moist smokeless tobacco products.
The FDA recently coordinated a shift in the final deadline to submit SEs or PMTAs from May 12 to Sept. 9, 2020.
If a manufacturer submits an SE or PMTA to the FDA, its product can stay on the market until the FDA decides whether it should stay on store shelves. Because federal law prohibits the FDA from disclosing information about pending market authorization applications, the agency has said it will not publish a list of SEs or PMTAs that have been accepted for review or share their status.
This means retailers and wholesalers need to rely on manufacturers to inform them about the status of their SE or PMTA applications. With this in mind, the PMTA deadline delay also grants retailers a reprieve, said Chris Howard, vice president, general counsel and chief compliance officer for E-Alternative Solutions, Jacksonville, Fla.
“C-store retailers would have more time to assess which manufacturers are planning to submit PMTAs for their products,” he said. “They should be seeking for manufacturers to provide evidence of submission prior to Sept. 9.”
In addition, Howard said retailers can request letters of filing or acceptance from the FDA, which manufacturers should expect to receive in later stages of the FDA review process.
With the deadline reset to Sept. 9, manufacturers have weighed their options. Some have kept to their original timetables. In April, Winston-Salem, N.C.-based R.J. Reynolds Tobacco Co. said it would keep to the May 12 deadline. Likewise, Fontem U.S. announced April 28 that it had submitted several PMTAs for its family of myblu e-cigarettes to the FDA.
“We agree that the electronic vaping industry should be held to the highest product and marketing standards while providing adult smokers with alternative products that could serve the interest of the public health,” said Antoine Blonde, president of Fontem U.S., Greensboro, N.C. “Fontem U.S. looks forward to working with the FDA as the agency develops and enforces an evidence-based regulatory policy.”
Other manufacturers will likely take advantage of the extension. In its court request to delay the FDA deadline, officials with Richmond, Va.-based Altria Group said that while it was set to meet the original May deadline, many of its third-party contractors, such as analytical labs, were requesting more time due to stay-at-home orders and other government-imposed prevention measures.
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