FDA’s Proposed E-Cigarette Regulations: The 75-Day Response Clock Starts Now
By Kerry Roche and Emily Krulewitz,
FDA’s widely anticipated “deeming regulation” was released today, bringing e-cigarettes, cigars, pipe tobacco, dissolvable tobacco products, water pipe tobacco, and nicotine gels under the umbrella of the Food and Drug Administration’s regulatory control. While the following information applies to all of these products, this post will discuss the regulations as they relate to e-cigarettes, given their large market-share compared to the other products. Electronic cigarette use has exploded in popularity over the past few years, and the regulation of e-cigarettes has been a hotly debated issue. Canada has chosen to regulate them as drug-delivery devices, the EU has decided they can be sold as consumer products, and the MHRA (UK’s regulatory body) has determined they will be controlled as medicines. The proposed rule released today confirms what most suspected; in the US, e-cigarettes will be regulated as tobacco products.
Interested parties have 75 days to comment on the proposed regulations, and given the polarizing nature of the e-cigarette debate thus far, we can expect FDA to receive arguments from both sides. Some of the main points from the proposed rule include:
- Limits on the sale and marketing, including:
- Bans on the sale of e-cigarettes to those under age 18
- Bans on the distribution of free samples
- Prevention of claims that e-cigarettes are less harmful than cigarettes (without submitting scientific information and getting FDA approval)
- Regulatory requirements, including:
- Premarket review requirements through a marketing application
- Registration and listing of products with FDA
- Following manufacturing requirements (not yet determined) and submission to FDA inspections
- Specifies labeling requirements, including:
- List of ingredients
- Warnings that nicotine is addictive in advertisements and on packages
FDA repeatedly remarks that “certain new tobacco products that are non-combustible (such as e-cigarettes) may be less hazardous than combustible products, given the carcinogens in smoke and the dangers of secondhand smoke.” This sentiment may explain why the Agency is not recommending all the same rules that currently exist for tobacco cigarettes. FDA did not propose to limit the use of flavors in e-liquids, ban the sale of e-cigarettes over the internet, or limit television advertising, as is done for conventional cigarettes. Also absent from the proposed rule is any limit on indoor use of e-cigarettes, indicating that FDA is unlikely to ban use of e-cigarette indoors but instead will leave this to local lawmakers.
It appears that FDA is taking a reasonable, science-based approach to e-cigarette regulation, demonstrated by their requests for information on many issues in order to determine how e-cigarettes should be regulated based on the continuum of nicotine-delivering products. The Agency specifically requests data on the potential benefits of e-cigarettes for smoking cessation, as well as health and behavioral data both for dual use and use as a gateway drug. Parties with a stake in these regulations should carefully prepare comments on the docket addressing FDA’s requests. Even though FDA is open to comments and the details of the regulations are not yet final, sponsors can bet that submitting a marketing application for these products will become law. While some products can reach the market by the substantial equivalence route, those that were not on the market in 2007 (including e-cigarettes) will have to submit a premarket tobacco application. Sponsors should not underestimate this task; the Agency’s own estimation is that companies will spend approximately 5,000 hours in order to gain FDA approval to market a product. Clients with questions on the effects of the proposed rule, submitting a premarket tobacco application, or the proper course of action should call us to assist.
As for immediate impact, it will likely take several months to years to finalize the proposed rule. Even then, companies will have two years after the rule is finalized until they are required to start abiding by these regulations and submit marketing applications. Though this means that regulations won’t hit the industry until Summer 2016 at the earliest, there is plenty sponsors can do in the meantime to prepare.
Written by: Kerry Roche, Senior Consultant, and Emily Krulewitz, Researcher, at The Weinberg Group, the world’s leading food and drug regulatory consulting firm and a leading expert on tobacco regulation. If you have any questions or thoughts on this blog post or others, please contact us.