The United States Food and Drug Administration officially published today it’s 241-page long proposal for regulating the sale of e-cigarettes. The entire document is available on the Federal Register site for you to peruse as you please, but that’s a lot of information to take in, so we’ve put together this quick overview to give you the gist of the proposal and the impact it might have on e-cigarette users.
What the proposed rules would change
First and foremost, the rules would extend the statutory definition of “tobacco product” to include categories of products that are not currently regulated under the Federal Food, Drug, and Cosmetic Act and Tobacco Control Act. The new definition would be extended to include things like “dissolvables, gels, hookah tobacco, electronic cigarettes, cigars, and pipe tobacco.”
Components and parts of tobacco products (but not their related accessories) would also fall under the scope of this proposed rule. This means that the sale of things like filters, rolling papers, tubes, pouches, flavorings, flavored hookah charcoals, and e-cigarette cartridges would be more tightly regulated by the federal government, rather than simply being left up to individual states to regulate.
The proposed rules also include provisions that allow the FDA to regulate future tobacco products that haven’t even been invented yet. The agency envisions that there could be future tobacco products absorbed through the skin or mouth, for example.
Additionally, by extending the definition of what are deemed “tobacco products,” the FDA’s proposal would also extend federal minimum age and identification requirements to those products. In other words, if this proposed legislation is accepted, it would mean that in order to purchase any newly-deemed tobacco products — including things like e-cigarettes, pipe tobacco, or rolling papers — you would be required to provide identification that proves you are over the age of 18.
Under the new rules, companies would no longer be able to offer free samples, and e-cigarettes would be required to come with warning labels saying that they contain nicotine, which is addictive.
Perhaps the biggest proposed change would require producers of cigars and e-cigarettes to register with the FDA, provide the agency with a detailed accounting of their products’ ingredients, and disclose their manufacturing processes and scientific data. Producers would also be subject to FDA inspections.
What the proposed rules would not change
Despite the wide-reaching scope of the FDA’s proposal, the rules proposed rules do not seek to regulate how e-cigarettes are marketed or advertised. That being said, however, there are rules included that would prohibit companies from asserting that e-cigarettes are less harmful than real cigarettes — unless they gain approval from the FDA to do so by submitting scientific information.
Additionally, despite voicing concerns over their potential appeal to children, the FDA’s current proposal would not place any restrictions on the range of e-liquid flavors available to consumers. The agency is staying out of that issue for the time being, but FDA officials did say these new regulations are the first major step toward asserting the agency’s authority, and eventually being able to regulate flavors and marketing in the future. So you can hang on to your gummy bear- and churro-flavored liquids for now, but down the road they might be more difficult to get your hands on.
What you can do about it
Now that the proposal has been officially published, the public has 75 days (until July 9, 2014) to issue comments on the proposal. Interested persons may submit comments electronically at Regulations.gov. After this, the FDA will assess all comments and begin to draft a finalized version of the proposal, a process that will likely take multiple months to complete, and perhaps even as long as a year if affected organizations rally to contest the proposed rules.