Tuesday, November 10, 2015

IN MY VIEW: In Reality, FDA Deeming Regulations are Thinly Veiled Prohibition

Yesterday, based on my analysis of the FDA draft guidance that will accompany the electronic cigarette deeming regulations, I explained that the requirements for a pre-market tobacco product application (PMTA) are so cumbersome and expensive that only a few of the largest e-cigarette manufacturers would be able to keep their products on the market.

Today, I add a few clarifications and expansions on my commentary, which I didn't have time to discuss yesterday because I wanted to present a general overview of the regulations and their likely impact.

There are two additional points that come out of my analysis that deserve some discussion:

1. In reality, the requirements for a PMTA appear to be technically impossible to satisfy.

While I argued that most small businesses (e.g., vape shops) and e-cigarette companies will not be able to complete successful PMTAs because of the cost, resources, and lack of scientific expertise, it might be the case that not even the largest manufacturers - such as the tobacco companies - could be able to technically complete a successful application under the FDA deeming regulations and guidance. The studies necessary to demonstrate that the public health benefits of e-cigarettes outweigh the risks will take years. Required will be not only clinical trials of e-cigarettes to determine rates of smoking cessation, but also population-based studies to determine the rate of progression to tobacco cigarette smoking among youth who are exposed to electronic cigarettes as well as studies of the rate at which former smokers relapse to nicotine use with e-cigarettes and to cigarette smoking. Moreover, longitudinal studies will need to compare the rates of initiation or relapse with e-cigarettes with the rates that would have occurred in the absence of e-cigarettes. It's not clear to me that this can be done at all, but it certainly cannot be done within a period of 2 years (which is what the proposed deeming regulations suggested as a grace period). Even if the deeming regulations extend that grace period to 5 years, it will still not be enough time to answer all the questions that need to be addressed.

A second factor that makes the PMTA requirements technically impossible to satisfy is that a company must demonstrate the effect that marketing its particular product will have on the public's health, not merely the impact that the marketing of e-cigarettes as a category will  have on the public's health. But it is technically impossible to identify the impact that marketing a particular product will have on the public's health unless the marketing of all other products was temporarily suspended. In other words, the impact of one particular product on the public's health depends not only on the marketing of that product, but on the marketing, nature, health risks, and price of all other e-cigarette or vaping products on the market.

For example, imagine that a new very-low nicotine cigarette wanted to demonstrate that it would result in a positive public health benefit. The only way such a product would likely benefit the public's health is if all cigarettes on the market were required to be very low in nicotine. If there were alternative products on the market with higher nicotine, the low-nicotine product would be a bust, and therefore, despite any evidence of success in clinical trials, it would not improve the public's health. You simply can't demonstrate the public health impact of a single, specific product in the absence of knowing what all the products on the market are, their safety profiles, their appeal, their prices, and their effects on youth. In other words, what the companies are being asked to do in the PMTAs is technically impossible.

2. The deeming regulations represent a de facto prohibition of electronic cigarettes, rather than a regulatory approach to these products.

I have argued for several years that the appropriate approach for the FDA to take would have been to simply promulgate a set of regulations that establish uniform manufacturing, safety, and quality control standards for electronic cigarettes. These standards could address issues such as battery safety, voltage or temperature regulation, use of known harmful flavors such as diacetyl, use of pharmaceutical grade propylene glycol, etc. That is a true regulatory approach.

But what the FDA is doing instead is essentially making a decision to prohibit these products, or at very least, to prohibit 99% of these products. This is not a valid regulatory approach, especially when compared to the FDA's regulatory approach for real cigarettes, which is to do nothing!

Carl Phillips provides a much more detailed and thoughtful explanation of why the FDA deeming regulations are not truly a "regulatory" approach. He writes: "Any normal use of the word [regulation] in the context of products refers to rules for product characteristics, performance standards, manufacturing standards, labeling, and the like, such that a product in the category must meet the rules to be allowed on the market. FDA’s tobacco “regulation” includes almost none of that. There are some packaging and labeling rules, a ban on characteristic flavoring for cigarettes, and a prohibition against selling to minors (which is redundant with state laws). There is constant chatter about some day imposing some real regulations, like limiting quantities of particular chemicals that some believe to be independent sources of health risks, but there is nothing like that now. And there may never be, because the real effect of FDA “regulation” is simply to make it nearly impossible for manufacturers to introduce a new product or even make changes to existing products."

1 comment:

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