The U.S. Food & Drug Administration (FDA) intends on re-evaluating how it goes about regulating premium cigars, specifically, researching the potential health effects of smoking premium cigars and delaying substantial equivalence until its research is complete.
All of this was said in a four-page document submitted yesterday to Judge Paul W. Grimm of The U.S. District Court for the District of Maryland.
This is the latest in American Academy of Pediatrics et al. v. United States Food and Drug Administration et al., a lawsuit filed in a federal court in Maryland by anti-tobacco groups and a group of pediatricians.
In March 2018, the lawsuit was filed against FDA arguing that the agency was not enacting certain parts of the regulations quickly enough and that FDA didn’t have the authority to delay parts of the regulations. This case was argued almost entirely about e-cigarettes and vaping products, but because cigars and e-cigarettes are included in the same set of 2016 regulations, the case would end up impacting the cigar industry.
Last year, Grimm ruled against FDA and threw out the agency’s planned August 2021 deadline for substantial equivalence, moving that deadline up to May 12, 2020. Due to the coronavirus COVID-19 pandemic, that deadline was pushed back until Sept. 9, 2020, though the cigar industry and others are once again trying to get the deadline delayed.
Yesterday’s filing was done under the guise that the Department of Justice wanted clarification that this action would be an acceptable modification to the substantial equivalence process as laid out in 2019. It seems plausible that Grimm could instruct FDA not to go through with this plan—and to be clear, it is just a plan as of now—which would likely send it to a higher court for further evaluation.
The plaintiffs—health groups and doctors—have until Aug. 17 to respond to this, giving Grimm just a few weeks to rule on the matter before the Sept. 9 deadline.
WHAT IS SUBSTANTIAL EQUIVALENCE?
Substantial equivalence is expected to be the main approval process for cigars once FDA’s regulations are fully in effect. In short, a manufacturer would argue that its product is substantially equivalent to an already approved or grandfathered product, and as such poses no additional health risks and does not market towards children.
Cigar manufacturers are required to either file for substantial equivalence or grandfather status by the deadline—currently Sept. 9, 2020—in order for their cigars to stay on the market. If they fail to do so, that product must be removed from sale in the U.S. and will not be able to be sold until FDA approves the report.
Deferring Substantial Equivalence for Premium Cigar Manufacturers/Importers*
FDA’s plan is to allow for premium cigar companies to apply for a deferral of the substantial equivalence process on a case-by-case basis.
The FDA intends to exercise its retained discretion by deferring enforcement of the premarket authorization requirement for premium cigar manufacturers and importers on a case-by- case basis. The deferrals are intended to help prioritize the use of the FDA’s limited enforcement resources while the agency undertakes a new research effort to evaluate the public health impact of premium cigars. The FDA intends to describe how manufacturers and importers can submit deferral requests in a guidance document that would take effect immediately upon issuance.
FDA is using the case-by-case standard because it was outlined in Grimm’s 2019 order: FDA could not delay the substantial equivalence deadlines as a whole but it could allow for modifications on a case-by-case basis.
FDA has said that companies will need to provide basic information like where the company is located, where the products are made, a list of the products, SKUs, a certification stating that the products meet the definition of “premium cigar” and a certification that the companies won’t market the products to children. FDA will then review the information and issue a ruling.
What’s not entirely clear is whether FDA will allow companies with a pending deferral to continue to sell those products without penalty, though that seems likely given the short period of time between now and Sept. 19.
HOW LONG WILL THE DEFERRALS LAST?
FDA says that it wants to study premium cigars and the potential health risks in a much more thorough manner. It describes a process that sounds like it would take multiple years at a minimum:
The FDA thus intends to undertake a research effort specific to premium cigars and their health effects, patterns of use (such as frequency of use and usage patterns among underage persons), and other factors. The FDA plans to seek broad public comment on the research plan and anticipates that the research will not only comprehensively assess the existing scientific evidence on these topics, but also generate new, high-quality scientific evidenc
WHAT IS A PREMIUM CIGAR?
FDA will consider most cigars you see sold in a humidor to be premium except for flavored or infused large cigars.
It defines “premium cigars” as those that meet all of the following criteria:
- is wrapped in whole tobacco leaf;
- contains a 100 percent leaf tobacco binder;
- contains at least 50 percent (of the filler by weight) long filler tobacco (i.e., whole tobacco leaves that run the length of the cigar);
- is handmade or hand rolled (i.e., no machinery was used apart from simple tools, such as scissors to cut the tobacco prior to rolling);
- has no filter, nontobacco tip, or nontobacco mouthpiece;
- does not have a characterizing flavor other than tobacco;
- contains only tobacco, water, and vegetable gum with no other ingredients or additives;
- and weighs more than 6 pounds per 1,000 units.
It should be noted that while this is an official court document, it’s not yet an official FDA rule.
There is a chance that multiple courts will have their say about this letter and its impacts, that there could be injunctions and an even larger legal fight. But it should be noted that all of this is quite fragile and none of it is official yet.