What proposed FDA regulations mean for e-cigarettes and cigars

I had a relaxing morning planned until the FDA announced its proposed regulations extending its authority to more tobacco products, including e-cigarettes and cigars. Predictably most of the press is focusing on the former, but the proposals over cigars are also very interesting. The long PDF detailing the proposal is here. Since you probably don’t want to read that, read this post instead.

First, a little background on how the existing law works with regard to cigarettes. The most important power that the Tobacco Control Act gave the FDA was pre-market review. Before releasing a new cigarette, producers must now get explicit approval from the FDA. This created three classes of products:

1. Products that were already on the market as of February 2007 are grandfathered in and allowed to be sold without review, although the FDA could hypothetically order them off the market.

2. Products introduced between February 2007 and March 2011 are allowed on the market while under provisional review. Producers have had to submit applications, but they are allowed to continue selling while the FDA reviews them.

3. Since March 2011, all new products must receive FDA approval before being sold.

This has resulted in a freeze of the cigarette market since 2011. In the three years since then, only two new cigarettes have been approved for sale. The anti-competitive effect this has had on the cigarette market has been my primary criticism of the FDA’s handling of tobacco. It has been reviewing applications for four years, currently has more than 150 employees working on reviews, has received approximately 4,000 applications, and has managed to rule on only 34 of them. For more detailed information on this, see my coverage in The Atlantic and Reason. (Keep in mind, too, that the Tobacco Control Act was fully backed and negotiated by Philip Morris. They knew what they were doing.)

It’s also helpful to know what the FDA is looking for in new product applications. The law establishes two routes to approval. One is for completely new products (premarket tobacco applications) and requires extremely burdensome amounts of data; this is basically uncharted territory at this point. The other is “substantial equivalence.” To get approval by this route, a new product must demonstrate that it is substantially equivalent to a predicate product that was already on the market as of February 2007 or has since been approved by the FDA. “Substantially equivalent” is defined to mean having the same characteristics (materials, ingredients, design, composition, heating source, or other features) or raising no new questions of health. (To see why this is a huge obstacle to new producers, see my articles above.)

It’s been known for a long time that the FDA planned to extend its authority beyond cigarettes. The biggest concern is how the agency’s sluggish review process will affect these new products, especially e-cigarettes and cigars. These are both dynamic sectors of the market and applying the same standards that the agency uses for relatively commodified cigarettes is extremely problematic.

Impact on e-cigarettes: As mentioned above, substantial equivalence applications must specify a predicate product by which to compare the new product. That predicate product must have been on the market by February 2007. You can see the problem here. The market for e-cigarettes barely existed then. Thus the review process as it exists now is essentially a death sentence for e-cigarettes. As the agency notes in its proposal today, its hands are tied: “Because this date is written into the statute, we do not believe that we have the authority to amend it with respect to e-cigarettes or other products.”

Because of this, the FDA’s proposal gives e-cigarette companies two years after the date the rule goes into effect to submit a premarket tobacco application (PMTA). What happens after that is anybody’s guess. But unless the law changes, it looks like the substantial equivalence option is off the table for e-cigarettes and the variety of products that remain for sale will be extremely restricted. If any products successfully navigate the PMTA process, they will likely be those with lots of financial backing and perhaps the right connections.

Impact on cigars: The FDA’s proposals regarding cigars are intriguing. The agency offered two options. Option 1 is to treat cigars just like other tobacco products, subjecting them to all the same burdens of review. Option 2 is to carve out an exemption for premium cigars.

The first option, as I’ve been warning for a long time, would be disastrous. Hundreds of new cigars come out every year in distinct blends, shapes, and ages. Forcing them into a review process that has managed to approve only two cigarettes in four years would destroy the market as we know it. It would also require all cigars to be substantially equivalent to those already on the market in 2007, making the sector considerably more boring.

The fact that Option 2 is even being considered shows that the FDA is aware of this. Under this option, exemptions would be made for premium cigars. A cigar would be exempt if it:

(1) Is wrapped in whole tobacco leaf

(2) contains a 100 percent leaf tobacco binder

(3) contains primarily long filler tobacco

(4) is made by combining manually the wrapper, filler, and binder

(5) has no filter, tip, or non-tobacco mouthpiece and is capped by
hand

(6) has a retail price (after any discounts or coupons) of no less than $10 per cigar

(7) does not have a characterizing flavor other than tobacco**

(8) weighs more than 6 pounds per 1000 units.

This is not a perfect definition, but it’s a start. The biggest drawback is that it would create a price floor of $10 per stick and this price would be adjusted (i.e. increased) every two years. It’s still possible to get pretty nice cigars for under $10, especially if one buys them a box at a time, so this would be a substantial imposition on cigar smokers. At this point, however, I’m just glad that the option to exempt premium cigars from the FDA’s pre-market approval process exists at all.

Impact on pipes: Pipe smokers, now few and far between, did not put a substantial lobbying effort into influencing the FDA’s new regulations. As a result, pipes get very little discussion in the proposal. However pipe tobacco will be subject to the full authority of the FDA and, if I am reading it correctly, pipes themselves would be subject to pre-market review as well. That seems potentially problematic for unique, handmade briar and meerschaum pipes. Pipe smokers, stock up now or prepare to order from overseas!

What’s next: There are seventy-five days to comment on the proposed regulations. The biggest fight will be over e-cigarettes, which are the hottest topic in the press. In my view it’s a mistake for the FDA to wade into this until it gets its review process under control or can provide a workable alternative to the substantial equivalence path. The upside is that it will take at least two years before it takes enforcement action, which will allow more studies on e-cigarette’s effectiveness as a harm reduction tool to be conducted.

(Note also that the law requires the FDA to examine health impacts on the population level, not on the individual user, so it could order e-cigarettes off the market even though they are unambiguously safer than cigarettes. Remember too that the head of the FDA’s Center for Tobacco Products, Mitch Zeller, came directly to the job from consulting for GlaxoSmithKline, which makes nicotine replacement therapies that compete directly with e-cigs. Might pharmaceutical companies use the new restrictive review process to develop nicotine vapor devices of their own? I would not be at all surprised.)

Cigars have been almost completely off the radar of press and anti-smoking groups, but expect that to change as the debate over exempting them unfolds. Cigar smokers will have to continue keeping the pressure on lawmakers and the FDA to not destroy the industry. It will be important to show that premium cigars are primarily enjoyed by adults and have different health effects than cigarettes for the typical user. (For a summary of the latter, see here.)

Regardless of which option the FDA takes, I expect black market sales of cigars to increase. If it takes Option 1, the variety of cigars available in the United States will suffer greatly. If it takes Option 2, the price will rise to $10 a stogie.* Cuban cigars are pretty alluring already! If you enjoy the company of your local tobacconist, savor the next few years you have together. Their store may not be around much longer.

* Update to add that cigars could escape the price floor by winning FDA approval, but given the agency’s record so far I would not expect many to achieve that. Cigars that were on the market before 2007 could remain available at a lower price too.

** Additional note: I’ve asked the FDA several times whether ageing tobacco in cedar wood, a traditional practice for many cigars, would run afoul of the rule against characterizing flavors. They have not been willing to clarify this.

Comments

  1. Regulation should be there to control the sale of e-cigarette even though it has some benefits over conventional tobacco cigarette as it is also a kind of addiction and almost has an equal impact on person’s health as imposed by real tobacco, so it must be passed through the test of its content before being sold into the market.
    Thanks for the post

    • Jayce says:

      If this had anything to do with people’s health, your point would be valid and well taken, but unfortunately, this has nothing to do with health at all. This is entirely about protecting the tax revenue from cigarettes and the profits for the tobacco companies.

      Numerous sources have shown that nicotine, in and of itself, poses very little health risk. It is the other things in tobacco smoke that cause nearly all the harm. The fact that the FDA, nearly every state legislature, AND (oh boy is this bit important!) the tobacco companies are drooling to ban vaping is rather telling.

      If you look closely, every major group attempting to restrict/ban/legislate vaping has a major financial interest in doing so.

    • Fergus Mason says:

      “almost has an equal impact on person’s health as imposed by real tobacco”

      A few months ago I’d have been charitable and assumed you just didn’t know what you’re talking about. With the research that’s now been done, however – including a recent review of NINE HUNDRED medical research papers – it’s obvious you’re lying. Nobody has identified any major health risks from e-cigs at all, so to say they’re nearly as harmful as tobacco is just dishonest, malicious rubbish. You should be ashamed of yourself.

    • levi says:

      The idea that the reason we need to regulate nicotine is because of its addictive properties is rubbish. Caffeine is extremely addictive and is sold in mass to all ages. Furthermore, liquids should be considered a food product more than a tobacco product due to the fact that 3 of the 4 ingredients are USP certified food grade ingredients. They should be manufactured in an Fda certified kitchen with strict guidelines on labeling. These are not tobacco products. They contain nicotine which is also found in foods and could be considered a food extract.

    • Patrick says:

      Your statement that E-Cigarettes have an “equal impact” on the health of a user is not based on any science or truth. Every study that has been conducted shows that e-cigs are clearly less hazardous that smoking a real cigarette. One study showed that e-cig use is as much as 900% less dangerous. These regs are designed for only one pupose. To destroy small businesses that have been controlling quality and restricting age already. The application fee is $2500 just to start, Then they also have to pay an additional $1500 per ingredient. Now some nicotine juice only contains as few as 4 or 5 ingredients, which means that the combined cost for the PMTA would be about $10,000 dollars. Many of the small vape shops have clean rooms and use ingredients already certified by the FDA as safe. But if they offer only 10 flavors that is still $100,000. And that does not take into consideration that the FDA is requiring a different application for each nicotine level sold. Vendors sell different levels so that an e-cig user can reduce their nicotine level over time to ween themselves off the habit. if a vendor sells 4 different nicotine levels of one single juice he still has to submit a different application for each nic level also, so we are now at $400,000. Very few small business owners can afford close to half a million dollars. These regs do nothing more than give an entire industry to big tobacco. There is no threat to public health. Clean air studies prove that no chemicals in the exhaled vapor is released in amounts that re above background. Simply put the amounts of any chemicals were below the levels of chemicals already existent in the air around the test area. The FDA is not relying on any science for these regs. They are relying on the “$”.

  2. Becky says:

    I disagree with Lionel above. I am married to a former smoker. He smoked for 36 years and tried all
    the approved products to quit. He has not smoked for the last two years, and has used e-cigarettes. There is no second hand smoke (which I don’t believe is a threat anyway), he has quit coughing, has not been ill the last two winters, etc. Whatever harms e cigarettes impose, I think it is the smoke and not the nicotine that is the culprit. In my state, Michigan, a few years back, legislators where going to limit the amount of nicotine in cigarettes, and doctors became upset because smokers would need more to get the same effect and the smoke is what causes damage. Is it 100% safe. Probably not. It has been an excellent alternative.
    I assuem the nicoret and tobacco companies don’t like e cigarettes, and for good reason. They should develop their own.

  3. Lynzi vanhouten says:

    So I own a vapor store. Opened 2013. What does this mean for my small business? I have to submit an application? If it is denied then what? I have to close my door?

    Lynzi

    • castello2 says:

      Join CASAA Lynzi! http://www.casaa.org

    • Sean says:

      Well that depends. How do you get your products? Do you directly import them from China? Then you will need to file PMTA applications for each and every product. Which will end up closing you down because big tobacco made it way to expensive to do. Now if you buy from a wholesaler, well, if the importer or distributor does the filings then you will continue to buy from them.

      But chances are it will be too expensive for them as well. So this will essentially consolidate the industry to a few players with deep pockets, which in turn will raise the prices of everything. And the worse part is they have not even started to tax the industry yet!

  4. Michael O'Hara says:

    I understand that nicotine inhalers are regulated by the FDA and are available by prescription only. Why aren’t e-cigarettes considered inhalers? Many of them contain the same substances that inhalers do. In other words, doesn’t the FDA already have adequate regulatory authority?

    Where can I comment on the proposed regulations?

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