The FDA has to respond to the lawsuit brought by the African American Tobacco Control Leadership Council and Action on Smoking and Health demanding a ban on menthol in cigarettes by April 29, 2021, the day after tomorrow. What the FDA is allowed to do will give a strong indication about how serious the Biden Administration is about dealing with tobacco, including the industry’s targeting of African Americans with menthol cigarettes.
The FDA had initiated a rule making process to deal with menthol in cigarettes under the Trump Administration, but the process disappeared.
Because the menthol exemption for cigarettes is written into the 2009 Family Smoking Prevention and Tobacco Control Act that gave the FDA jurisdiction over tobacco products, eliminating menthol in cigarettes will require a formal rule making, which is a slow ponderous process that will almost certainly trigger litigation by the tobacco companies.
So, even if the Administration allows the FDA to move forward, it will be a long time before menthol disappears from cigarettes.
The situation for new tobacco products, however, is quite different: The FDA could act to eliminate menthol in these products now.
The FDA already tried to substantially raise the bar for including menthol (and all flavors) in new tobacco products when it issued its “deeming” rule taking jurisdiction over e-cigarettes and other new products in 2016, but the Obama Administration dropped 17 pages from the proposed deeming rule that required specific justification to include menthol and other flavors in new products.
The Biden Administration could simply direct the FDA to use the process outlined in the dropped 17 pages as they assess new products, a process that is going on now. Indeed, the evidence that prohibiting menthol is stronger today than it was in 2016 when FDA tried to take action before.
The FDA could also expand its “enforcement discretion” banning most flavors in some kinds of e-cigarettes to include menthol and expand this ban to all e-cigarettes and newly deemed products.
Unlike getting rid of menthol in cigarettes, this is something that the FDA could do now.
One important technicality that people should pay particular attention to is whether any menthol restrictions ban menthol as an ingredient or as a “characterizing flavor.” Most people do not understand that the 2009 law (and subsequent FDA implementing regulations) only banned “characterizing flavors” — advertising the presence of a flavor — not the flavor itself. This loophole allows tobacco companies to continue using flavors (such as licorice and chocolate) in their products as long as they don’t promote the products as licorice or chocolate flavored.
If FDA acts against menthol as a “characterizing flavor,” companies could keep using menthol and simply dropping the word menthol and color code the packages green or blue and providing after-market ways to add menthol to tobacco products.
To head off these industry tricks, FDA needs to prohibit the use of menthol and its analogs as an ingredient.
So, here are the questions to ask about what the Biden Administration allows FDA to do on menthol:
Is the restriction on menthol as an ingredient or just as a characterizing flavor?
Is the menthol ban extended to all tobacco products, including newly deemed products, which can be restricted right away?
Reducing the level of nicotine in cigarettes
The Wall Street Journal has reported that the Biden Administration is also considering reviving a proposal the FDA was considering to reduce nicotine levels in cigarettes to non-addictive levels.
This is a good idea if done properly, but it should extend to all tobacco products. FDA’s original logic (described in the WSJ article) is that “The nicotine-reduction policy under consideration would lower the chemical in cigarettes to nonaddictive or minimally addictive levels, aiming to push millions of smokers to either quit or switch to less harmful alternatives such as nicotine gums, lozenges or e-cigarettes.”
The problem with this approach is that in the years since the limited nicotine reduction policy was first proposed the evidence of harm of e-cigarettes has been piling up. That is why the nicotine restriction policy should apply broadly.
In addition, as with flavors, a nicotine reduction policy could be implemented immediately as part of the premarket reviews and enforcement discretion for new tobacco products.
This idea is gaining currency outside the US. According to Physicians for a Smokefree Canada:
Sweden: Moving beyond tobacco and aiming to reduce all forms of nicotine use
In March, the Swedish Minister of Social Affairs, Lena Hallengren, presented her legislature with a new strategy to address alcohol, drugs, gambling, tobacco and nicotine. One of the key developments in the new strategy is “extending tobacco to also include nicotine products” [free translation].
Sweden’s decision to reduce nicotine use is significant given that it is often held up by outsiders (and the tobacco industry) as a model for a harm reduction approach which discourages smoking but which does not discourage nicotine use. Although rates of all tobacco use in Sweden are high, much of the tobacco used is in the form of snus and cigarette smoking rates are lower than in other European countries.
The Swedish decision to target the use of nicotine was not taken lightly. Last year an expert report was commissioned to review the evidence and make recommendations to government. The 500 pages report, Hårdare regler för nya nikotinprodukter (Stricter rules for new nicotine products) was made public last month. The experts involved in the review considered the expanding range of novel nicotine products, the way these p;roducts attracted young users and the gaps in Sweden’s current laws. They recommended that Sweden should aim to limit all use of nicotine, should ban all flavourings other than tobacco flavour in vaping liquids and should put all tobacco-free nicotine products under a similar regulatory frame as tobacco. [emphasis added]
Sweden’s legislature is now reviewing these proposals and is expected to vote on them at the end of the spring.
The Biden Administration should direct the FDA to do the same thing.