In 2016, the Food and Drug Administration (FDA) finalized a rule extending its authority to all tobacco products, including vaporizers, vape pens, hookah pens, electronic cigarettes, e-pipes, and other types of electronic nicotine delivery systems (ENDS).
According to the FDA, it now regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of ENDS. This includes components and parts of ENDS but excludes accessories. Some examples of components and parts include e-liquids, a glass or plastic vial container of e-liquid, cartridges, atomizers, batteries, cartomizers and clearomizers, digital display, tank systems, drip tips, flavorings, and programmable software.
If a product is marketed for therapeutic purposes (e.g. to help people quit smoking), then it’s regulated by the FDA through the Center for Drug Evaluation and Research (CDER). To help avoid customer confusion, the FDA proposed a rule clarifying the jurisdiction over tobacco products, drugs, and devices.
FDA Bans Sale of E-cigarettes to People Under 18
The term “tobacco product” now officially includes electronic cigarettes, vape pens, e-pipes and other types of electronic nicotine delivery systems. This means that the FDA is also prohibiting the sale and distribution of these newly regulated tobacco products to anyone under 18 years old, and buyers will have to show photo identification as proof of age before purchasing cigarettes. Furthermore, the FDA has announced its intention to conduct youth access checks on online retailers to ensure that they can only sell their products online if they have an adequate age verification platform.
Requirements for Manufacturers
- Stop distributing products with modified risk claims (other than “light,” “low,” or “mild”) by August 8, 2016
- Report user fee information for cigars and pipe tobacco by August 20, 2016, and monthly thereafter
- Pay user fees for cigars and pipe tobacco by December 31, 2016, and quarterly thereafter
- Submit tobacco health documents by February 8,2017 or by November 8, 2017 for small scale tobacco product manufacturers
- Submit cigar warning plans by August 10, 2017
- Register your establishment and submit a list of products (including labeling and advertisements) by September 30, 2017
- Submit ingredient listing by November 8, 2017 or by May 8, 2018 for small scale tobacco product manufacturers
- Submit a premarket application for “new” tobacco products to stay on the market via Exemption from Substantial Equivalence by November 8, 2017
- Stop distributing products with modified risk claims (i.e., “light,” “low,” or “mild,” or similar descriptors) unless you have a Modified Risk Tobaco Product order in place by November 8, 2017
- Submit ingredient listing by May 8, 2018 for small scale tobacco product manufacturers
- Submit a premarket application for “new” tobacco products to stay on the market via:
- Substantial Equivalence (SE) by May 8, 2018
- Premarket Tobacco Applications (PMTA) by November 8, 2018
- Include Required Warning Statements on Packages and Advertisements on regulated tobacco products by August 10, 2018
- Submit quantities of Harmful and Potentially Harmful Constituents by November 8, 2019
Requirements for Retailers
Beginning August 8, 2016
- Only sell tobacco products to customers age 18 and older
- Check for photo ID of anyone under age 27 who wants to purchase tobacco products
- Do not give away free samples, including any components or parts
- Do not sell in a vending machine unless you’re in an adult-only facility
Beginning August 10, 2018
- Do not sell, distribute, or display advertisements for any tobacco product without a health warning statement on the package.