8 May 2014
CASAA’s Basic Background for Understanding FDA Regulation of E-Cigarettes
FDA’s release of the draft deeming regulations has caused an explosion of interest in the law and politics relating to e-cigarettes among those who have not followed the topic previously. Some are new to the entire world of vaping-related chatter, while others have been immersed in the social media but have never understood the governance side. Here are some very basic facts for getting up to speed and trying to take effective action.
- In 2010, a federal court ruled that FDA could not regulate e-cigarettes as medicines unless therapeutic claims were being made in marketing. It suggested that the FDA had the option of asserting authority over them as tobacco products. (Contrary to how it is sometimes interpreted, the ruling did not give FDA that authority directly, nor did it say they had to take it.) That assertion of authority is what is happening now.
- There is no serious doubt that, under the Family Smoking Prevention and Tobacco Control Act (TCA), that the FDA has the authority to regulate the nicotine liquids currently used in electronic cigarettes. There is no point in trying to argue that these products are not technically tobacco (they clearly meet the definition of “tobacco products” in the TCA), nor that FDA cannot do this (they can). There are, however, arguments to be made that FDA should not exercise its available authority (either in whole or in part).
- FDA has a great deal of flexibility about how they regulate tobacco products that are already under their purview, as well as the products that they are in the process of “deeming” to be tobacco products. However, the TCA imposes some limits on their flexibility. (The full details of how those break down are complicated, but it is useful to just know that this is the case.)
- Specifically, declaring various products to be tobacco does not mean that they will all be treated the same. Unfortunately, the low-risk products that FDA already regulates (smokeless tobacco) have basically been treated the same as cigarettes.
- One of the biggest concerns about the FDA process is that it is already broken. The main approval process that e-cigarettes and other new products would have to go through is already in place for cigarettes and smokeless tobacco, and it is failing miserably, with an enormous backlog of applications that they have failed to act on. Moreover, the separate approval process available for introducing a product because it is low risk, or allowing low-risk claims to be made, is so onerous that it has never been applied.
- Other major concerns have been identified in the CASAA blogs. Watch those for further information. (blog.casaa.org, antiTHRlies.com)
- There are different interests at play here. CASAA and a few other advocates represent consumers, while other organizations represent the industry.
- CASAA believes that consumers are best served by ensuring diversity in the marketplace, namely, many different devices as well as a variety of liquid flavors and strengths. Many of the loudest voices represent industry interests, which are often not the same as consumer interests.
- Within industry, there are also varying interests. Smaller manufacturers (boutique hardware and liquid manufacturers; specialty retailers) seem to have interests closely aligned with consumers, since the main harm to consumers from the proposed regulations would be putting them out of business (and destroying market diversity) as a result of the approval process.
- Large manufacturers, particularly NJOY and Johnson Creek, who might benefit from the lack of competition, have come out in favor of the proposed regulations. (Note that there is some disagreement about whether they really would benefit.)
- The deeming regulation process is slow-moving. There is a 75-day comment period (which we hope will be extended), followed by some time for FDA to issue the final regulations. If the final regulations are similar to the draft, there will be two years after that before the most harmful provisions take effect.
- However, other rules could be issued during that two year grace period. For example, the draft regulations overtly seek comments that would provide justification for banning flavors.
- It seems likely that the details will ultimately be decided by the courts. It is important that the messaging be done with that in mind.
There are several ways consumers can effectively respond to this proposal.
- CASAA will be issuing guidance for consumers about how to effectively comment on the FDA process directly. We will also issue suggestions about contacting members of Congress and others who might influence this process.
- Consumers should also join CASAA (numbers matter!), encourage others to do so, and encourage your vendors to encourage their customers to do so. Watch the CASAA main blog or our social media for updates.
- Except perhaps at the local level, petitions are generally pointless, accomplishing nothing even when they are sensible. They tend to give the illusion of having done something, dissipating energy that could be directed usefully. Even worse are inaccurate and otherwise flawed petitions that just send the message that vapers need to be regulated because they apparently do not understand matters well enough to look out for themselves.
- Submitting comments early and without an informed strategy is unlikely to be useful, and is potentially harmful. There is no advantage to submitting comments early rather than waiting for strategy and guidance. Lashing out in ways that do not speak the right language is as bad as or worse than signing a bad petition.