Regulating E-Cigarettes: The Federal Government Steps In
July 11, 2016
Category: Licensing and Regulation
After months of review, the U.S. Food and Drug Administration (FDA) has issued final regulations governing the manufacture, distribution, and sale of e-cigarettes, vapor liquids, and some tobacco products. The federal regulations come soon after the passage of a new Washington law (ESSB 6328) that, among other things, also regulates the sale of e-cigarettes and vapor products and prohibits their sale to persons under the age of 18. The federal regulations make additional requirements not covered by the state law, but, where both address the same subject, there does not appear to be any conflict.
The new federal regulations require that manufacturers submit e-cigarette and vaping liquid products to the FDA for testing and approval before they can be sold. Products that were on the market before February 15, 2007, however, will be “grandfathered in” and not be required to obtain FDA approval. Manufacturers will have up to two years to submit their products for federal approval, and the testing and approval process may take a year to complete. During the testing and approval process, products currently on the market may continue to be sold.
In addition to requiring government product approval, the new federal regulations also:
- require a listing of the product’s ingredients;
- prohibit the sale of e-cigarettes and vaping liquid to persons younger than 18;
- require proof of age by photo identification before a purchase can be made;
- prohibit the sale of products in vending machines (unless the machines are located in an adults-only establishment);
- require packaging to be child-resistant;
- require health warnings on the products and in advertisements;
- prohibit the sale of products labeled as “light,” “low,” or “mild” unless they obtain FDA approval; and
- prohibit the distribution of free samples.
Although some of the regulations relate solely to e-cigarettes, others place new market authorization requirements on some tobacco-related products, such as hookah tobacco, pipe tobacco, nicotine gels, cigars, water pipe tobacco, and dissolvable tobacco products. Testing and approval of these “new” products—those not on the market before February 15, 2007—will be required before they can be sold, except their sale can continue during the two-year period allowed for submitting the products for testing and during the expected one-year FDA testing period.
The new federal regulations are scheduled to go into effect on August 8, 2016. Whether or to what extent the new federal regulations will actually go into effect on August 8 is uncertain as legislation is pending in Congress which, if approved, might prevent the FDA from requiring retroactive safety reviews of e-cigarettes and vapor liquids already on the market and could exempt some premium or large cigars from the regulations. Lawsuits to block implementation are also possible.
For additional information on the new state law regulating e-cigarettes that went into effect on June 9, 2016, see my New Law Regulates E-Cigarettes and Vapor Products blog post.
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