FDA Authority Over E-cigarettes Expanded

The Food and Drug Administration (FDA) today announced long-awaited final rules expanding the FDA’s authority over e-cigarettes and other tobacco products.  The rule broadens the definition of tobacco products to include e-cigarettes, hookahs, pipe tobacco, premium cigars, little cigars and other products.

Acting under its authority as established through the Tobacco Control Act of 2009, the FDA has set forth a number of new requirements that will affect manufacturers as well as retailers of e-cigarettes and other tobacco products.

The biggest change is a requirement that producers of e-cigarettes and other tobacco products register their manufacturing establishments and provide product listings to the FDA.  The registration and listing requirements will also apply to vape shops that mix their own e-cigarette liquids, as these are considered producers under the final rule.

E-cigarettes and other tobacco products will need to receive marketing authorization from the FDA for all new tobacco products, unless the product was on the market as of Feb. 15, 2007.  Producers will be required to submit a detailed accounting of their products’ ingredients, packaging and marketing; as well as disclose their manufacturing processes and scientific data, to obtain authorization.  E-cigarettes and other tobacco products must obtain an order granting marketing authorization where appropriate; otherwise, the product may face FDA enforcement.

Consistent with the FDA’s mission to improve public health, all e-cigarettes will be required to bear health warnings on product packages and advertisements; and modified risk tobacco products (including those described as “light,” “low,” or “mild”) must be specifically authorized by the FDA. Additionally, provisions aimed at restricting youth access, will include:

  • Not allowing products to be sold to persons under the age of 18 years (both in person and online);
  • Requiring age verification by photo ID;
  • Not allowing the selling of covered tobacco products in vending machines (unless in an adult-only facility); and
  • Not allowing the distribution of free samples.

The FDA has established a staggered timeline for implementing the new rules.  Once the final rule goes into effect in 90 days, companies with products on the market now, including vape shops that mix their own liquids, will have an additional two years to request marketing approval of their e-cigarette products. Tobacco products covered by the new rule will be permitted to stay on the market for another year while the FDA reviews their application.

Understanding that developing the data necessary to obtain market approval for e-cigarette products will be a timely and costly process, we urge producers of tobacco products affected by the new rules to act sooner rather than later.  If you are a producer of e-cigarettes or other tobacco products needing guidance on how these new regulatory requirements affect your company, we are here to help.  Our experienced FDA compliance attorneys will walk you through this complex regulatory scheme, and develop a unique compliance strategy for your company.  to get started today, contact Ann Marie Gaitan, Esq. via e-mail at amg@suarezgaitanlaw.com or by calling our office at 786.440.8115.