FDA deeming rule: A step forward, especially if the FDA acts quickly on the advertising rules and educational campaign

The FDA issued its “deeming rule” extending jurisdiction to e-cigarettes, all cigars, hookah, and other products (including products that have not been created).  The rule itself is 499 pages long, not counting related “guidance” documents that detail implementation.
 
The best evidence that this rule represents a step (albeit small) forward is the fact that Mike Siegel has described it as “a disaster for public health.”
 
Based on my very fast (and likely incomplete) reading of the rule, I think Siegel’s summary of the provisions (but not the public health impact) is accurate as far as it goes.  Here is what he wrote  (less his commentary).

1. Pre-Market Tobacco Applications

SUMMARY
 
As expected, the regulations require virtually every manufacturer of a vaping device and/or e-liquid to submit a burdensome and costly pre-market tobacco application (PMTA) for each of its devices and products. The FDA established a grandfather date of February 15, 2007, meaning that unless your product was already on the market in 2007, you must submit a PMTA. Although the FDA allows a pathway for products that are "substantially equivalent" (SE) to predicate products that were on the market in 2007, virtually none (if any) existing products are substantially equivalent to products on the market in 2007.
 
To demonstrate substantial equivalence, the FDA will require the manufacturer to show that the product is not only similar to the predicate product, but that any differences between the products raise no "questions of public health." Since virtually every aspect of the design of e-cigarettes and e-liquids affects its public health implications, unless a product was actually on the market in 2007, it will not be able to demonstrate substantial equivalence. This means that, as expected, the PMTA pathway will be the only available pathway for virtually every vaping product whose manufacturer wishes to stay on the market.
 
The effective date of the regulations will be approximately August 10, 2016. Manufacturers will have two years from that date to submit PMTA's for every product (meaning every vaping device and every e-liquid) they wish to stay on the market. If the manufacturer submits a PMTA within this two-year period, it will be allowed to stay on the market for one additional year unless the FDA makes a decision on its application prior to that additional 12 months. If the application is not approved, the product must be taken off the market.
 
In addition, no new vaping products or e-liquids will be allowed on the market from August 2016 forward unless the manufacturer submits and obtains approval of a PMTA.
 
What constitutes a vaping product or e-liquid? Every different vaping device is considered a separate product, and a PMTA must be submitted for each. Similarly, every different e-liquid is considered a separate product and a PMTA must be submitted for each. E-liquids with different nicotine strengths are different products. So are e-liquids with different flavors or any differences in ingredients. Thus, if you are a manufacturer that makes 20 different e-liquid flavors and each comes in three nicotine strengths, you will have to submit 60 different PMTA applications, each one demonstrating that the particular e-liquid in question, when used in a variety of different vaping devices, will be beneficial for the public's health.
 
To demonstrate that a product is beneficial for the public's health, the manufacturer will have to consider not only the risks and benefits to smokers, but the risks and benefits to nonsmokers (including youth) and former smokers. Manufacturers will have to demonstrate not only that the product is safer than cigarettes, but that it is effective for smoking cessation and its cessation benefits will not be outweighed by uptake of the product by nonsmokers, including youth.

 
2. Modified Risk Claims

 
SUMMARY
 
As of the effective date of the regulations (approximately August 10, 2016), manufacturers will not be allowed to make modified risk claims. This means two things: (1) they will not be able to truthfully inform consumers that vaping is much safer than smoking; and (2) they will not be able to truthfully inform consumers that vaping does not produce smoke, that e-cigarettes do not contain tobacco, or that the levels of constituents in the e-cigarette aerosol are much lower than in tobacco smoke, or absent altogether. The FDA has specifically stated that companies cannot even describe their products as a "smoke-free" alternative to smoking.
 
While a company could apply to be allowed to make a modified risk claim, the regulations make it extremely unlikely that a successful application could be developed. To make a claim that e-cigarettes are safer than real cigarettes, one would most likely have to conduct or cite relevant human studies demonstrating long-term benefits of the product. This would be a time-consuming and cost-prohibitive process that could only be conducted by the very largest of the manufacturers.
 
To make a reduced exposure claims, such as that e-cigarettes contain lower levels of a particular carcinogen or that they are smoke-free, one would have to show that consumers will not interpret this to mean that the product is safer than cigarettes. I believe this is an impossible showing.

 
3. Listing of Potentially Harmful Aerosol Constituents

 
SUMMARY
 
Within three years of the effective date of the regulations, every company will have to submit - for every one of its products - a list of all of the potentially hazardous constituents present in the aerosol. This is itself very costly, as it requires contracting with a testing laboratory, the testing is expensive, and every single flavor or variation must be tested separately.
 

 
All these actions are a step forward, particularly the prohibition on making claims that e-cigarettes are good for smoking cessation or reduce risk without first presenting data to support these claims.
 
Some other good things:
 

  • FDA prohibits vending machine sales except in adult-only places like bars; not as good and an outright ban, but better than nothing.

 

  • FDA allows states to add their own warnings in addition to the FDA warning, protecting California’s Proposition 65 warning.

 

  • The rule covers all cigars.

 

  • The rule adds warning labels to all products, including a reproductive toxicity warning on cigars.

 

  • The rule prohibits free samples

 

  • As best as I can tell, there is no mention of consumer surplus ("lost pleasure") due to regulation

 

  • While not  stated explicitly, the fact that e-cigs, cigars, hookah, and other products are “deemed,” FDA can include them in its educational campaigns, which is probably the best thing FDA has done so far

 
Some bad things:
 

  • The compliance period is 24 months to submit pre-market tobacco application (plus 12 months for FDA review, on a case-by-case basis will extend review period), which will allow lots of dangerous products to stay on the market for years.  (Small tobacco manufacturers will get extra time to file information with FDA)

 

  • No ban on internet sale; an 18 year old requirement is included, but as we and others commented, this is hard to enforce in practice

 

  • No restrictions on flavors, although the FDA says it is working on a flavor rule (which, based on the time it took to get the deeming rule out, will likely take many years)

 
THE BOTTOM LINE:  A substantial step forward, especially if the FDA acts quickly on the advertising rules and educational campaign.
 
It is important to note that responsibility for regulating where e-cigarettes are used and how they are taxed remains with state and local government.  FDA has no authority in these areas.

Comments

Comment: 

Hi Stan,
I think you give me too much credit for being a “litmus test” for proposed tobacco control policies.
I think a better litmus test is the reaction of the cigarette company financial analysts to the announcement. They unanimously viewed the regulations as being very positive for the cigarette industry, predicting that as a result of these regulations, future cigarette consumption will be far higher than it would otherwise have been. This is the reason that I think FDA could have done better.
Also – you should know that it’s not that I am opposed to FDA regulation. It’s just that I think they could have done a lot better than this. They did not regulate marketing to kids. They did not regulate where e-cigarette companies can place their ads (such as youth-friendly venues or media with high youth audiences). They did not ban the exploding batteries. They did not ban the use of diacetyl in e-liquids. They did not ban devices which heat e-liquids to a high temperature to prevent formaldehyde and other carbonyl compounds from forming and getting into the aerosol. These are all things I would have done if I were in Mitch’s shoes. Ironically, while you may view me as unconcerned about the health risks, I actually believe that my proposed approach would do a far better job of regulating the health risks, and doing it immediately, than the FDA’s ridiculous scheme of these crazy pre-market applications.
Also, keep in mind that if you are going to <strong;really</strong; use me as a litmus test for tobacco control policies, you will have to tell your blog readers that they should oppose:
<ul;
<li;Complete bans on smoking in all workplaces, including bars and casinos;</li;
<li;Increased cigarette taxes with all the money going to comprehensive tobacco control programs with hard-hitting media campaigns that directly attack the tobacco industry;</li;
<li;More funding for state tobacco control programs;</li;
<li;Penalties on cigarette manufacturers based on rates of youth smoking of their brands, with the money going to an aggressive national anti-smoking campaign;</li;
<li;Requiring the MPAA to explicitly consider depiction of smoking in its ratings;</li;
<li;Raising the age of all tobacco sales to 21;</li;
<li;Banning the use of menthol in cigarettes (and not just as a characterizing flavor); and</li;
<li;Gradual elimination of nicotine in cigarettes using a phase-out approach.</li;
</ul;
I will submit this as a comment to your blog in case you wish to share with your readers what my positions <strong;really</strong; are on these issues.
Best regards,
Mike

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