The news media is flooded with stories about FDA proposing to regulate electronic cigarettes (e-cigs) for the first time, according to the proposed rule published on April 24. Despite the news stories and FDA’s talking points, the proposed rule talks very little about electronic cigarettes and does a lot more that will dramatically alter how all of tobacco is regulated.
The proposal:
- Extends regulatory authority over all “tobacco products,” which includes cigars, pipe tobacco, hookah tobacco, nicotine gels, electronic cigarettes, and anything else that meets the legal definition of “tobacco product.” However, FDA will exclude accessories and possibly premium cigars (which would be very narrowly defined, needing to satisfy 8 criteria).
- Prohibits the sale of tobacco products to anyone under 18.
- Requires health warnings about nicotine on all tobacco products, and unique warnings for cigars (which adopts four of those required by the consent decree between the Federal Trade Commission (FTC) and the seven largest marketers of cigars, and adds one more).
What does extending regulatory authority mean?
Most of the key parts of the Family Smoking Prevention and Tobacco Control Act (FSPTCA) are self-executing; this means that FDA does not have to pass regulations before industry must comply with the requirements. Once FDA completes extending regulatory authority over all of the tobacco products, industry will have to:
- For non-grandfathered products, obtain premarket clearance from FDA either by submitting a 905(j) Report or New Tobacco Product Submission
- Test for and submit any harmful or potentially harmful constituents (HPHCs) to FDA
- Register their facilities and list each product’s ingredients with FDA
- Submit any health documents developed by the company
- Label the products appropriately
What did the proposed rule say?
The proposed rule is primarily about cigars and clarifying how FDA will regulate them. All other tobacco products (including electronic cigarettes) play a secondary role in the text. However, due to the recent explosion of youths using electronic cigarettes, and Congressional pressure, FDA has focused on a secondary part of the proposed rule to satisfy those concerns.
This, however, does not mean that FDA will not focus more heavily on electronic cigarettes in future proposed rules. First, the Agency is seeking to claim regulatory authority over the products. After obtaining authority and being able to analyze the product, FDA will craft rules tailored to electronic cigarettes. This process will take the Agency years.
Additionally, FDA will have to wrestle with a regulatory gap for electronic cigarettes. The law only allows FDA to regulate products that contain tobacco or have a tobacco derivative (like nicotine). Electronic cigarettes without nicotine are outside of FDA’s regulations. This creates an awkward situation where some electronic cigarettes are FDA-regulated and others are not. It will take a literal act of Congress to fix this gap.
