FDA’s Deeming Regs and What You Should Know

NATO_Thomas BriantRecently, the U.S. Food and Drug Administration authorized final deeming rules that pertain to other tobacco products—most which are important contributors to convenience store sales. Thomas Briant, executive director of the National Association of Tobacco Outlets (NATO), answered questions about specifics that c-stores should be aware of.

By Dave Bennett, Senior Editor

Convenience Store Decisions recently sat down with Thomas Briant, executive director of the National Association of Tobacco Outlets (NATO) regarding the most pressing regulatory issues the tobacco industry faces now. With the U.S. Food and Drug Administration (FDA) publishing its final deeming regulations May 10, he gave his take on how the deeming rules will likely impact convenience retailers and the industry.

CSD: What kinds of products are now “deemed” to be under FDA regulations?

TB: In the deeming regulations, the FDA has expanded its regulatory authority to include premium cigars, domestic cigars, pipe tobacco, e-cigarettes, e-hookah, e-cigars, vape pens, advanced refillable personal vaporizers, electronic pipes, hookah tobacco, dissolvable tobacco products and nicotine gels.

CSD: When do the deeming regulations go into effect?

TB: Generally, the deeming regulations go into effect on Aug. 8, 2016, but the FDA has various compliance periods for different regulations.

CSD: Did the FDA extend the minimum age to buy requirement to the deemed products?

TB: The FDA prohibits retailers from selling the deemed tobacco products (including over the Internet) to individuals under 18 years of age. It is important to note that state and local lawmakers have the authority to adopt a higher minimum age to purchase tobacco products.  Also, the FDA does not have the authority to raise the federal legal age; that authority rests with Congress.

CSD: What major regulations will now apply to manufacturers of cigars, pipe tobacco and e-cigarettes?

TB: The manufacturers of the deemed tobacco products must comply with several FDA regulations including: (1) submission of ingredient lists for each deemed tobacco product and reporting of harmful or potentially harmful constituents (HPHCs); (2) registration of tobacco product manufacturing facilities and a list of all tobacco products manufactured; (3) removal of modified risk descriptors (e.g., “light,” “low,” and “mild” descriptors) from products, and (4) filing substantial equivalency (SE) or pre-market tobacco applications (PMTA) for products introduced in the marketplace after Feb. 15, 2007, which is known as the predicate or grandfather date.

CSD: What is the difference between a substantial equivalence (SE) and a premarket tobacco application (PMTA) and why are these applications important to retailers?

TB: A manufacturer can submit an SE application if a product introduced to the market after Feb. 15, 2007 is substantially similar to a product that was already on the market on or before Feb. 15, 2007. A substantially-similar product is known by the FDA as a “predicate product.”  If there were no substantially-similar predicate products for a manufacturer to rely on, then the manufacturer would need to file a PMTA with the FDA.

Based on the fact that the predicate date/grandfather date has not been changed in the deeming regulations, and that a significant majority of cigars and pipe tobacco and virtually all e-cigarettes were introduced in the market after Feb. 15, 2007, manufacturers will be required to file SE or PMTA applications for a substantial number of cigars, pipe tobacco and e-cigarettes.

The number of SE and PMTA applications will be so high because the FDA believes that a separate SE or PMTA application will likely be necessary for just about each product SKU. The FDA has estimated that on average it will take 1,713 hours to compile just one of these PMTA applications and cost upwards of $330,000 for each application.

This is important for retailers because the time involved in preparing SE and PMTA applications plus the cost of doing so may be too expensive for some manufacturers, possibly resulting in various deemed tobacco products no longer being manufactured and being removed from the marketplace.

CSD: Is there an opportunity to change the predicate date so that manufacturers are not required to file all of these SE and PMTA applications?

TB: Members of the industry are supporting efforts in Congress to change the predicate date to the date that the deeming regulations take effect, which is Aug. 8, 2016. If the predicate date were to be changed, then all of the newly-deemed tobacco products would be grandfathered and not be required to have a SE or PMTA application submitted.

Changing the predicate date would not result in cigars, pipe tobacco or electronic cigarettes being exempt from other current or future FDA tobacco regulations. All of these products would still need to comply with the agency’s regulations, the only difference is that manufacturers would not be required to demonstrate why these products should continue to be sold in the marketplace through an SE or PMTA application.

CSD: Did the FDA give any indication about what other regulations may be proposed in the future?

TB: According to the FDA, the final deeming regulations differ from most public health regulations in that they are enabling regulations. In addition to directly regulating the newly-deemed tobacco products, the deeming regulations enable the FDA to issue further regulations related to tobacco products that are appropriate to meet the agency’s standard of protecting the public health.

Specifically, the FDA has the authority under Section 907 of the Food, Drug & Cosmetic Act to establish product standards for deemed tobacco products, which allow the agency to restrict, limit or ban ingredients in the deemed tobacco products or constituents in tobacco smoke. Also, the FDA has the power to ban self-service displays of the deemed tobacco products, which it did not do in the deeming regulations.

Moreover, to address concerns with the growing flavored cigar market and its impact on youth and young adult initiation with tobacco products, the FDA states in the deeming regulations that it intends to issue a proposed product standard that, if finalized and adopted, would eliminate characterizing flavors in all cigars, including cigarillos and little cigars.

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Comments

  1. Jackie Machala says:

    Does anyone in the FDA smoke? Can’t say for sure but I’d bet they do. Will these regulations affect any of the companies that sell the cigarettes, cigars, and the tobbaco for their pipes? Possible. You are messing with people’s businesses, who will possible shut down because of these regulations. Not only that, these so called this is good for you regulations will be extremely harmful.
    1. People that vape will try to make there own juices not knowing what they are doing. Putting wrong ingredients together resulting in possible injuries.
    2. People that vape will be forced to maintain their modes by doing their builds and the other services that the vape shops have that is at their disposal. Results extremely harmful due to the fact that these people have no idea what they are doing.
    These regulations that you are about to impose on the vape community will have no good results. Grandfather these companies that were started in 2014. This is about the time that it was realized that Vaping was an excellent way to stop smoking, which we all know is 10 times more deadly than cigarettes. These shops that were established during this year are the ones that are frequented by patrons that trust them to do the work for them because they learned and perfected the many products that are important to vapers.

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