On April 24, 2014, the Food and Drug Administration (“FDA”) issued a Proposed Rule specifically deeming electronic cigarettes, but not related accessories, tobacco products that are subject to the Tobacco Control Act.
Publication of the Proposed Rule opens a 75-day public comment period, after which a Final Rule could be issued with an effective date for implementation of regulations. If this deeming regulation is adopted in its current form, e-cigarettes will be subject to the following regulations, originally created and tailored to regulate traditional combustible tobacco products:
- enforcement action against products determined to be adulterated and misbranded;
- required submission of ingredient listing and reporting of harmful and potentially harmful constituents (HPHCs) for all tobacco products;
- required registration and product listing for all tobacco products;
- prohibition against use of modified risk descriptors (e.g., "light," "low," and "mild" descriptors) and claims unless FDA issues an order permitting their use;
- prohibition on the distribution of free samples;
- premarket review of products or proof of substantial equivalency to a “predicate product” commercially marketed before February 15, 2007;
- requirement for a minimum age of purchase;
- health warnings for product packages and advertisements, namely an addiction warning, which FDA is also proposing to apply to cigarette tobacco and roll-your-own tobacco; and
- prohibition of vending machine sales, unless the vending machine is located in a facility where the retailer ensures that individuals under 18 years of age are prohibited from entering at any time.
After the announcement of the Proposed Rule, FDA held a telebriefing to discuss the deeming regulation. During the briefing, a few interesting points were addressed.
- Director Mitch Zeller of the FDA’s Center for Tobacco Products said, “e-cigarettes need to be derived from tobacco” to fall under the purview of the deeming regulation. In short, nicotine derived from vegetables would not be subject to the proposed regulations.
- Establishment and registration and product listing for tobacco products is a priority for the agency and currently listed on the Unified Agenda. On the call, the agency stated that companies should be on the lookout for publication of a proposed regulation in the near future.
- Director Zeller stated that it is the agency’s interpretation that Congress’ intent was for the 2007 grandfathered date to apply to tobacco products. However, he emphasized that the agency welcomes comments on a different interpretation (e.g., one in which the grandfathered date would be the date of the finalized deeming regulation’s publication).
- FDA Senior Regulatory Counsel Gerie Voss discussed the compliance timeline for Premarket Tobacco Applications (“PMTA”) and the agency’s awareness of the implications of the February 15, 2007 grandfathered date. Due to these implications, Ms. Voss explained that FDA will not take enforcement action against companies that have filed a PMTA within 24 months of the final rule’s enactment while the application is pending.
- Director Zeller made it clear that the Proposed Rule was merely the foundation for the future of tobacco product regulation. Thus, the fact that the proposed deeming regulation does not discuss flavors is of no consequence and does not mean that the agency has no intention of regulating flavors as applied to e-cigarettes in the future.
If you have any questions regarding how the proposed deeming regulations may affect you or would like our assistance in preparing comments, please contact the authors of this alert.