The U.S. Food & Drug Administration (FDA) has announced plans to more aggressively regulate e-cigarettes and vaping products, specifically flavored pods or cartridges. At the same time, the agency has said that premium cigars are amongst the agency’s lowest tobacco priority.
None of what is announced today is in effect; it’s draft guidance, meaning that FDA is sharing its current thinking with the public and industry. In the document—largely focused on e-cigarettes—FDA also updated where it stands on premium cigars and flavored cigars.
For premium cigars, manufacturers will still be subject to all planned regulations, but the agency stated that it plans on directing its resources to aggressively go after e-cigarettes, meaning that some categories might receive less attention.
“FDA’s lowest priority among these products will include relatively expensive, large hand-rolled cigars that do not have flavors (e.g., fruit, candy, or mint), given what FDA understands to be their comparatively lower youth usage rates,” said the agency.
It explained that manufacturers will have to submit substantial equivalence by May 12, 2020, but the agency indicated that it would be selective about enforcement:
We have decided not to prioritize enforcement of the tobacco products covered by this section before May 12, 2020. Manufacturers of flavored cigars, however, just like manufacturers of all other deemed new tobacco products, will be required to submit marketing applications for those products by May 12, 2020, consistent with the U.S. District Court for the District of Maryland’s order directing FDA to require that applications be submitted to the Agency by May 12, 2020, for deemed new tobacco products on the market as of August 8, 2016, or be subject to FDA enforcement actions, in FDA’s discretion. As part of the premarket review process, FDA may evaluate, among other things, the product’s constituents, ingredients, additives, and properties; manufacturing practices; and any studies or investigations into the health risks of the tobacco product. FDA also has stated its intention to issue a regulation that would ban the use of characterizing flavors in cigars, and FDA is actively working towards that proposed rule.
That likely means the agency will not apply the same sort of scrutiny to premium cigar substantial equivalence and potentially less monitoring of the market to determine if there are non-compliant cigars on the market.
FDA also stated that it is not prioritizing flavored cigars, though indicated it is still working on a flavored tobacco ban:
However, such data do not appear to raise comparably urgent public health concerns, as the lower prevalence of youth use of these products suggests that (flavor cigars) do not appear to be as appealing to youth at this time.
Accordingly, at this time, FDA has decided to prioritize use of its limited enforcement resources to address the sudden and dramatic increase in youth use of ENDS products, as well as to focus on health and safety concerns connected to ENDS products such as vaping-associated lung injuries.
For e-cigarettes, FDA plans on targeting flavored pods or cartridges other than nicotine or menthol flavoring. The agency will require manufacturers of these products to prove a public health benefit, likely making the products illegal.
Not all flavored e-cigarettes will be banned. Shops that make their own vaping juice and non-cartridge based flavored liquids will still be allowed.
FDA will need to issue Final Guidance before it makes these changes.