On May 5, 2016, FDA finalized its tobacco deeming regulations, which will extend its authority to all tobacco products, including e-cigarettes, cigars, hookah tobacco, and pipe tobacco products. These deeming regulations are intended to help implement the Family Smoking Prevention and Tobacco Control Act (“TCA”) of 2009. While FDA’s goal is to protect consumers from tobacco-related diseases, the implementation of the deeming regulations brings about potential development hurdles for the tobacco product industry. There are two key issues that industry should monitor for new developments.
How will the deeming regulations affect e-liquid products containing synthetic nicotine?
The TCA defines a “tobacco product” as “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory . . . of a tobacco product.”
Typically, e-liquid products are considered tobacco products because the nicotine within them is extracted from tobacco leaves. However, those that contain synthetic nicotine are arguably not subject to FDA jurisdiction, since they are not made or derived from tobacco. Despite this, many predict that FDA will attempt to regulate e-liquids even if the statue does not necessarily permit it – FDA may try to regulate synthetic nicotine products as drugs, due to nicotine’s effect on the body, even without explicit therapeutic claims.
In fact, as of September 2016, 18 lawsuits have been filed against FDA over the deeming regulations. These lawsuits commonly argue that FDA has exceeded its statutory authority based on the definition of “tobacco product,” and the extension of the agency’s regulatory authority through the deeming regulations is not an accurate interpretation of the TCA. We will continue monitoring the progress of these lawsuits and provide updates as necessary.
How will FDA regulate zero nicotine e-liquids?
FDA’s definition of “tobacco products” seemingly prevents FDA from regulating zero-nicotine e-liquids, because most of them are not made or derived from tobacco. Despite this, FDA has indicated its intention to regulate them as tobacco products based on the definition of “component or part.”
For manufacturers of zero-nicotine e-liquids, this is especially important. For example, if a company develops a zero-nicotine product that is intended to be mixed with nicotine, FDA may deem the e-liquid as a component or part, and thus, a tobacco product.
Given FDA’s interpretation of “tobacco products” and litigation push-back by the tobacco industry, we don’t expect these issues to be resolved anytime soon. For additional discussion on the topic, please read this article, published in the Food and Drug Law Institute’s Update Magazine.
If you have any questions regarding the above, please do not hesitate to contact us.
