The U.S. Food and Drug Administration has announced it will issue draft guidance that makes major policy change in terms of enforcement of regulations on flavored tobacco products, including flavored cigars. This will involve modifying its compliance policy from August 2017 where it will begin enforcing the deeming regulations for non-grandfathered flavored cigars that were on the market as of August 8, 2016, thirty days after the issuing of a final guidance. The announcement was made as FDA Commissioner Dr. Scott Gottlieb steps down at the end of this month. These actions may be what he is remembered for best during his tenure.
As a part of the regulatory process, the draft guidance will go through a public comment period. The FDA will review the comments before issuing the final guidance.
When the FDA Deeming Regulations were issued in 2016, tobacco companies (including e-cigarette makers) were given a two-year window for products on the market as of August 8, 2016 to get approval to keep these products on the market. Exempt from this window, were “grandfathered” (predicate) products that were on the market as of February 15, 2017.
Following the appointment of Dr. Gottlieb as FDA Commissioner, he announced he was delaying enforcement of the regulations on cigars for products on the market as of August 8, 2016 until August 8, 2021, and ENDS (Electronic Nicotine Delivery System) devices/e-cigarettes/vapes until August 8, 2022. At the time this was tied to a bigger initiative involving reducing nicotine levels in tobacco products. The delay essentially allowed the FDA to reconsider how or if all premium cigars should be regulated.
Since then, the FDA has been zooming in on both flavored tobacco and flavored e-cigarettes. Last year an ANPRM was issued on Flavored Tobacco. Late last year, the FDA announced its plans to go after flavored cigars and e-cigarettes. At that time Dr. Gottlieb said flavored cigars should no longer be subject to the extended compliance date for pre-market authorization. The issuing of the draft guidance now takes a step in that direction.
Under the new changes, the FDA would prioritize enforcement of non-grandfathered flavored tobacco and flavored-cigarette products if they did not come off the market 30 days after the final guidance. Companies who produce these types of products would have to seek pre-market authorization in order to have them be re-introduced to the market. There will now be a deadline until August 8, 2021, to apply for the pre-market authorization for such products. This moves up the deadline for flavored e-cigarettes by one year. Non-flavored (traditional) cigars will still have until August 8, 2021, to apply for pre-market approval.
In terms of the change in direction, the FDA commented in the draft guidance:
The Agency’s July 2017 announcement also indicated that extended compliance periods would allow time for FDA to set out additional rules and guidances and for industry to develop higher quality applications. We are continuing to pursue such regulations and guidances; however, the recent surge in youth use of ENDS (Electronic Nicotine Delivery System) products has caused us to reevaluate our priorities and modify the compliance policy for certain products, as set forth in this guidance. With respect to flavored cigars affected by this revised compliance policy, we note that any tobacco product, including cigars, may utilize the appropriate pathway to market, including the SE (Substantial Equivalence) pathway or an exemption from SE.
Dr. Gottlieb also said, “we’re moving forward with a proposed rule to ban all characterizing flavors in cigars.” The FDA also said it expects many flavored cigars to come off the market. Dr. Gottlieb noted that the FDA’s plan had the “strong support” of President Donald Trump. This comment seems to indicate that while Dr. Gottlieb is leaving his post, the policies outlined in the draft guidance will go forward.
The comment period will begin once the draft guidance is published to the Federal Register.