WASHINGTON -- For many tobacco retailers, the significance of Aug. 8, 2016, will soon fade into memory, but the reality of the FDA’s so-called “deeming" rules and its mandate of a “complex” approval process for new products in the OTP category will reverberate for years.
The so-called “freeze date” of Aug. 8 means that new products, especially with regards to the e-cig and vapor categories, can't enter the market without approval from the U.S. Food and Drug Administration. The application process for FDA approval, according to Bonnie Herzog, senior analyst for Wells Fargo, New York, is “complex,” and favors the bigger manufacturers with the resources to provide the expensive components (think clinical trials) needed to properly apply.
Essentially, two types of approvals exist, one for what are basically existing products, called a substantial equivalence (SE) application; and the other for new products, called a premarket tobacco application (PMTA), which is more complex than an SE, said Thomas Briant, executive director of the National Association of Tobacco Outlets (NATO), Minneapolis. Speaking at the recent CSP Total Nicotine Conference held in Chicago, Briant said the PMTA application could cost $330,000 and take more than 1,700 hours to complete. Time-wise, that’s someone working full time for 10.5 months.
The deeming rules extend FDA authority over other elements as well:
- Components and parts such as e-cig batteries, microchips and atomizers.
- Purchasing age, with the minimum age for these products set at 18.
- Free samples, which are banned.
With approval times and grace periods in flux for SE and PMTA applications and existing products, Briant said he expected product availability to remain “status quo” for another 30 to 36 months.
Retailers attending the CSP forum expressed concern over knowing which products to carry going forward, because not all suppliers would have the resources to apply for FDA approval. “I don’t want to get stuck with product that I’ll have to take off the shelves, or carry brands that will eventually go away,” said one Midwest retailer, who spoke on condition of anonymity.
Most panelists speaking at the conference agreed with Briant that grace periods for existing products will have little effect on retailers in the short term, but many suggested retailers keep in close contact with their suppliers.
“Choose your partnerships carefully,” said Kevin Roberts, director of regulatory affairs and communications for Logic, Pompano Beach, Fla. Most manufacturers should be able to discuss the status of their applications or if they have intentions on doing so, he said. “There’s going to be a consolidation of the category.”