FDA Deeming Regulations: What’s Next
Lawsuits, additional regulations and a grandfather-date battle all lie ahead
MINNEAPOLIS -- Now that the U.S. Food and Drug Administration (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, the logical question is, “What lies ahead?”
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.
In fact, when the proposed deeming regulations were issued for public comment last year, the FDA noted that, once other tobacco products were deemed to be regulated by the agency, the agency could issue additional regulations applicable to newly deemed products. In public comments filed in response to the deeming regulations, the FDA received many suggestions for new regulations that could apply to the deemed tobacco products. The FDA has stated that it is taking these comments under advisement and considering whether to issue proposed regulations for these suggested provisions.
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.
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 regulation 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.
The FDA states that the new deeming regulations are intended to be severable, which means that if the courts strike down one regulation, the other regulations remain in force. This severability interpretation was likely included in the deeming regulations because of the very real possibility that industry members would file lawsuits to overturn the deeming regulations. In the event any court or other lawful authority were to temporarily or permanently invalidate, restrain, enjoin or suspend any provision of this final rule, the FDA believes that the remaining regulations would continue to be valid.
Predicate Date (Grandfather Date)
In the deeming regulations, the FDA concluded that the agency lacks the authority to change the predicate date, or grandfather date, for the newly deemed tobacco products. The original predicate date is Feb. 15, 2007. Based on this predicate date, any tobacco product that was on the market as of Feb. 15, 2007, is “grandfathered” and not required to have a substantial equivalency (SE) application or premarket tobacco application (PMTA) filed with the FDA to remain on the market.
A manufacturer can submit a 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 that date. 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.
However, the FDA indicates that a significant number of deemed tobacco products would need to have SE or PMTA applications submitted in order for the products to remain on the market in the future. In the deeming regulations, the FDA estimates that compiling a single PMTA application will take more than 1,700 hours at an estimated cost of $330,000. Other estimates, by the industry and the Wall Street Journal, put the time and cost estimates much higher.
This is why 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 by Congress, 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 still would 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 a SE or PMTA application.