The FDA just posted a new Advance Notice of Proposed Rulemaking (ANPRM) asking for comments, feedback, and studies related to ‘premium cigars’ to determine if they should be regulated differently from non-premium cigars. As many cigar smokers are aware, the FDA has been in the business of regulating cigars since they were lumped in with other tobacco products in a 2016 rule. Before diving in to the new proposed regulation and what it means, let’s take a walk down I’d-rather-forget lane and recall what the 2016 regulations required of cigar manufacturers. It includes:
- Submission of ingredient lists to the FDA
- Prohibition on giving out free samples
- Testing to be submitted to the FDA for approval before going to market with cigars not sold before 2007
- Warning labels on boxes and advertisements
Remember that most cigar companies are small businesses, and you can see how there’s quite a bit of effort and financial burden needed to meet the requirements. The regulation’s impact is already being felt: Cigars For Warriors can’t get enough donations to fulfill requests by the troops now that cigar companies unable to donate, small companies like Edolara Cigars have begun to shut down, and many manufacturers are concerned by the potential price tag of go-to-market testing. We even have Rocky Patel going on Fox News to talk about how the cigar industry is being destroyed. It’s a tough time to be making cigars.
So what’s this new proposed regulation?
The new ANPRM is a request for “comments, data, research results, or other information that may inform regulatory actions FDA might take with respect to premium cigars.” It asks for information in 3 key areas:
- Definition of premium cigars
- Use patterns of premium cigars
- Public health considerations associated with premium cigars
There’s a comment period that lasts until June 25, 2018. After that, the FDA will review the submitted information and determine if they should regulate premium cigars differently. Anyone can leave comments, so make your voice heard if you feel strongly. You can submit a comment right on the regulation’s webpage.
This is a good thing, right?
It can’t be much of a bad thing – the worst that happens is that nothing changes. The cigars we love would be regulated the same way as the FDA has been planning to regulate them. It would, however, be nice if we could have Swisher Sweets regulated differently from Opus X.
They’re obviously different! This will be a walk in the park, right?
I don’t think so. While I’m glad to see this, and it has a non-zero chance of success, I’m not holding my breath for any sort of change. Let me put in the obligatory “I am not a lawyer or a politician” and explain why I think this is an uphill battle.
The many challenges
Challenge 1: Defining Premium Cigars
When it comes to knowing what a premium cigar is, many of us probably think “I know it when I see it.” Unfortunately, we need an actual definition. And that’s where it gets complicated. Do we include flavored cigars with premium cigars? If we do, we run right into another new ANPRM about regulating flavors in tobacco products. I have a feeling the cigar industry’s argument would be stronger if it excluded flavored cigars from its definition of ‘premium cigars’, but there are large companies who definitely don’t want flavored cigars excluded: Acid, Java, and other flavored cigars sell very well. It will be interesting to see how different parts of the industry define premium cigars.
Previous proposed regulation has included the possibility of a price point in the definition of a premium cigar. At the time, they said a premium cigar cost $10 or more. I assume there will be continued discussion of price points, and I also assume almost nobody will agree on a price where a cigar magically becomes ‘premium’ by virtue of its cost.
Let’s not forget the long-filler-vs-short-filler distinction, either. How much short filler can a cigar include and still be a premium cigar? This will be another point of disagreement.
We don’t have a clear definition that all members of the industry can agree upon. That makes the challenge of defining it very difficult. What we’ll see is various groups proposing various definitions. That will leave it to the FDA to figure out the definition, which can’t bode well for us.
Challenge 2: We Need New Information
I’ve read a number of studies about cigar smoking, most of them coming out around the year 2000. But check out this part of the ANPRM:
“FDA is seeking comments, evidence, information, data, and analysis that were not submitted in response to the proposed deeming rule, or that may have become available since then, that could further inform FDA’s thinking about the regulation of premium cigars.”
Did you catch it, that were not submitted?
I know of one new study since the 2016 rule came out: a study partially funded by the FDA concluded that about 2% of children aged 12-17 had ever taken puffs from a cigar. Do you know of other new studies that I don’t know about? If you do, please leave them in the comments below.
I’m concerned that they’re asking for new information, but most of the information we have was already submitted. If there’s something new, I hope it gets distributed to all cigar smokers so we can strengthen our arguments when we submit comments.
Challenge 3: Relevance of New Information
Even if there are new studies since 2016, or new information to share, is that information specific to whatever definition of premium cigars we end up with? I’ve never seen a study that really broke apart premium cigars from non-premium cigars in terms of their effects or use patterns.
It would be hard to fight back with information about all cigars when we’re trying to separate premium cigars from all the rest. I don’t think the studies have been done. Please leave a comment to let me know if I’m missing studies that separate premium cigars from non-premium cigars.
Challenge 4: The Burden Is On A Few
Cigar smokers are a small but mighty group. We’re relying on lobbyists, cigar company lawyers, Cigar Rights of America, and angry smokers to submit comments to help save the industry as we know it. We’d benefit from more organization. If any of those groups have studies or information that would be good for others to reiterate, it would be good if they shared it. I’d love to see a lot of information-sharing and an effort to get as many people as possible to post relevant, useful comments on the ANPRM.
There’s some hope
While I’m not optimistic about our chances, there are some reasons to think this could succeed.
The FDA has heard loud and clear that we feel that premium cigars are different. Lobbying efforts, pushed by Cigar Rights of America, information campaigns by IPCPR, and enough angry smokers have led the FDA to at least consider a change.
The FDA-funded study about children not smoking cigars is useful. It shows that few children have tried cigars at all, and that even fewer claim to use them with any frequency. They’re products enjoyed by adults.
This administration might be swayed by a business case. A lot of small businesses would fail if the current FDA regulations stand. Whether you agree or disagree with the current administration, they have a pro-business, anti-regulation slant.
What can you do?
Each of us can do something rather than nothing. If you’d like to see these difficult regulations destroyed for premium cigars, consider:
- Donating to Cigar Rights of America or becoming a member
- Signing CRA’s petition on their website (same link as above)
- Learning more about the FDA regulation so you can defend cigars knowledgeably
- Donating cigars or money to Cigars For Warriors to help make up for manufacturers not being able to donate
- Researching studies about the health effects or use patterns of premium cigars so those studies can be used in comments
- Leaving a comment on the ANPRM with information that will help the FDA make a wise decision