As we have discussed in previous blog posts, the Food and Drug Administration (FDA) released its long-awaited proposed e-cig regulations earlier this year. Last week, 29 state attorneys general submitted a letter to the FDA urging the agency to adopt additional regulations that would better protect minors from the harms associated with use of tobacco products.
New E-Cig Regulations
Under the FDA’s proposed regulations, the definition of “tobacco products” has been expanded to include “dissolvables, gels, hookah tobacco, electronic cigarettes, cigars, and pipe tobacco.” Learning from its past mistakes, the FDA has also included a provision that would allow it to regulate future tobacco products that have yet to be invented.
By far the most important aspect of the proposed regulations involves the registration and approval process for e-cigs. As we predicted, the FDA will require that each e-cig manufacturer provide the agency with a detailed description of its manufacturing processes and ingredient lists, substantiated with verifiable scientific data. E-cig manufacturing facilities will also be subject to FDA inspections.
There was initially a fear that the FDA would require all e-cig companies that began operating after 2007 to have their products submit to a substantive equivalence determination, which would require e-cig companies to remove their products from the market until it was demonstrated that their products were in compliance with FDA regulations and substantially equivalent to other approved products that contain nicotine. Instead, the FDA has decided to allow existing e-cig products to remain on the shelves, provided that e-cig manufacturers apply for FDA approval within two (2) years of enactment of the final regulations.
The draft regulations also propose to establish a nationwide minimum age requirement in order to purchase and use e-cigs. If the draft regulations are passed, no one under the age of 18 will be able to legally purchase e-cigs.
Attorneys General E-Cig Marketing Concerns
While the draft regulations address a number of important aspects of the e-cig industry, they fail to address marketing limitations or restrictions on the availability of flavored e-cigs. In direct response to this omission, 29 state attorneys general sent a letter to the FDA on August 8, 2014, urging the agency to, among other things, adopt additional measures to protect minors by prohibiting flavors in all new tobacco products and by restricting advertising and marketing for e-cigs in the same manner as for cigarettes.
More specifically, the attorneys general letter requests that the FDA:
- Prohibit flavors other than tobacco and menthol in e-cigs and other tobacco-based products;
- Restrict the advertising, marketing, and promotion of e-cigs consistent with how it has restricted the advertising, marketing and promotion of cigarettes and smokeless tobacco;
- Restrict the advertising, promotion, and sale of all tobacco products over the Internet;
- Strengthen the health warnings for all tobacco products; and
- Define e-cig parts and accessories and apply the proposed restrictions on age verification, vending machine sales, and health warnings to those parts and accessories, regardless of whether such components and parts contain nicotine.
Notwithstanding the foregoing, it is important to remember that if e-cigs are marketed as therapeutic or tobacco alternative products, they must abide by the current marketing regulations enforced by the FDA Center for Drug Evaluation and Research, which govern the marketing of nicotine patches and gums.
In light of the FDA e-cig regulations and the state attorneys general letter relating thereto, it is a best practice to plan a course of action early and retain experienced counsel to help navigate the murky regulatory climate.
The development of the FDA’s new e-cigarette regulations should be of interest to anyone involved in the e-cigarette industry.