Thursday, May 05, 2016

FDA E-Cigarette Deeming Regulations are a Disaster for Public Health

Ninety minutes ago, the FDA released its long-awaited electronic cigarette deeming regulations. Sadly, the "deeming regulations" would better be called "The Cigarette Smoking Promotion Regulations of 2016." They regulate tobacco-free and smoke-free electronic cigarettes much more stringently than real tobacco cigarettes, which the agency knows kills more than 400,000 Americans each year. And by essentially decimating the vaping industry, stifling innovation, and forcing dishonest marketing, the regulations prevent these much safer products from competing with cigarettes - the deadliest consumer product on the market.

I will have much to say about the regulations in the coming days, but for now, I want to outline the three major provisions of the regulations and discuss their impact on public health.

1. Pre-Market Tobacco Applications

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.


The FDA has conservatively estimated the cost of a PMTA to be $330,000. While I think this is a gross underestimate, even if we accept this as accurate, a manufacturer of 20 e-liquid flavors with three nicotine strengths each is looking at a capital cost of $19.8 million. Quite clearly, this is a cost that only a very small number of manufacturers (the tobacco companies and the very largest of the independent manufacturers) can afford. This is why the e-cigarette industry will be devastated and thousands of companies will be forced out of business.

Although vape shops will not themselves have to submit PMTA's unless they mix their own liquids, the companies that produce the products sold in vape shops are almost uniformly small manufacturers that will be forced out of business. Thus, there is no way vape shops will be able to survive. The only products remaining on the market will be those produced by the largest companies, and those are typically sold in convenience stores and drug stores rather than vape shops. Thus, these regulations are going to specifically decimate the more than 16,000 vape shop businesses, creating a significant negative economic impact and putting tens of thousands of people to the unemployment line.

More importantly, the severe contraction of the market will limit the growth of the overall market. I don't see the possibility for the continued growth of this market under these circumstances and believe that the level of e-cigarette use will plateau within five years. Thus, the prediction that vaping products could produce a public health miracle - decreasing tobacco cigarette consumption by 50% in the next decade - has been extinguished by the FDA.

Moreover, the regulations will stifle innovation. They not only take away any incentive for innovation because of the burdensome new product application process, but they also make it literally impossible for all but the largest manufacturers to commit the resources necessary to develop and test the new products extensively enough to submit a successful new product application. The public health impact of this requirement is that it will greatly impede the development of even safer and much more effective vaping products that can help a greater proportion of smokers to quit in a way that minimizes any long-term health risks.

2. Modified Risk Claims

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.

There are two major implications of the modified risk provisions of the regulations. First, it means that manufacturers will not be able to market their product based on the three most important benefits of the product: (1) that they can help people quit smoking; (2) that they are safer than cigarettes; and (3) that they contain no tobacco and produce no smoke. This severely hampers the ability of the companies to market their products and of course, this will reduce the potential demand for vaping products. This will also result in the protection of cigarette sales because it eliminates the most effective competitive market claims that could possibly be made to convince people to switch from tobacco cigarettes to tobacco-free vaping products.

Second, it will prevent companies from telling consumers the truth and will effectively force them to lie to the public. Remember that deception can occur not only from what a company says, but from what the company fails to say. By forcing companies not to tell consumers that the products are intended to help smokers get off cigarettes and to reduce the risks from smoking, the FDA is essentially forcing companies to deceive the public. For this reason, I believe this aspect of the regulations is unconstitutional as it violates the free speech rights of vaping manufacturers.

3. Listing of Potentially Harmful Aerosol Constituents

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.

This aspect of the regulations - although burdensome - will not actually increase the burden of the regulations because in order to submit a successful PMTA, a company would have to present the results of chemical testing of the aerosol produced by every one of its products anyway. So this requirement is superfluous because you can't submit a PMTA without providing this information anyway.

The Rest of the Story

Without question, the FDA has done a huge favor for the continued strength of cigarette consumption in the United States. It has blocked what would otherwise been a wonderful opportunity to develop a strong competitor to tobacco cigarettes that could have eventually eroded the cigarette market by nearly 50%, resulting in what could have been literally a public health miracle in terms of the number of lives saves and diseases and suffering averted.

Instead, the FDA basically preserves the status quo, with more than 400,000 Americans dying each year from a cause that is very much preventable.

This is a huge disaster for public health.

What Can Be Done
The only way out of this disaster would be for Congress to enact legislation that prevents the FDA from requiring PMTA's for vaping products and forces the FDA instead to develop actual safety standards for these products. While the Cole amendment is a step in the right direction, it is still problematic because PMTA's would still be required for new products. We need to encourage innovation, not stifle it. That is the only way to develop safer and more effective products that will maximize the benefits while minimizing the risks associated with this much safer alternative to cigarette smoking.

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