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FDAs Deeming Rule on Vape & Tobacco Products – Who is It Applicable To?
As explained in another article of ours, the FDA’s “deeming rule” refers to the series of compliance requirements that went in to effect on August 8, 2016 which regulates what FDA refers to as “tobacco products,” and by definition includes not just traditional varieties of tobacco, e.g., cigarettes and smokeless tobacco, but also that of e-liquids, vape pens, and other electronic nicotine devices (“ENDS”) products, in addition to, components, parts, or accessories of tobacco products which includes atomizers and batteries.
FDA categorizes its legal obligations according to which entity type(s) you are considered, namely whether you are a
- Retailer
- Manufacturer
- Importer, and / or
- Distributor
of tobacco products. Therefore, the first step to understanding your obligations under this new rule is to define your role with respect to such products.
Retailer of Tobacco Products Defined: A retailer is defined as anyone who sells tobacco products to individuals for personal consumption, or who operates a facility where vending machines or self-service displays are permitted, including
- ENDS e-liquids
- ENDS devices or hardware
- ENDS replacement pieces
whether online or in brick and mortar locations
Distributor of Tobacco Products Defined: Anyone who furthers the distribution of tobacco products, whether domestic or imported
- at any point from the original place of manufacture
- to the person who sells or distributes the product
- to individuals for personal consumption
Manufacturer of Tobacco Products Defined: Defined as any person, including any repacker or relabeler, who
- Imports a finished tobacco product for sale or distribution in the US, or who
- Manufactures
- Fabricates
- Assembles
- Processes, or
- Labels a tobacco product
Importer of Tobacco Products Defined: Defined as any person who imports any tobacco product that is
- Intended for sale or distribution
- Specifically to consumers in the United States.
Whether with us, other attorneys, or the FDA itself, once you have identified in which capacity you deal with tobacco products, it’s important to make sense of the obligations and compliance dates your business is subject to.
Have questions about your compliance obligations? Feel free to connect with us via the Contact form above.
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