In the recent course of my practice, it has come to my attention that there are small to midsized co-packers and online retailers of e-liquid vaping products in the U.S. that are still unaware that a co-packer/retailer could be treated as a “manufacturer” under the Family Smoking Prevention and Tobacco Control Act (the “Tobacco Control Act”).
Although, to some, the scope of the definition of a “manufacturer” may be overly broad, the Tobacco Control Act clearly provides that an entity that makes, modifies, mixes, manufactures, fabricates, assembles, processes, labels, repacks, relabels, or imports any “tobacco product,” is considered a tobacco product “manufacturer.” In this regard, be mindful of the following ground rules:
- Vape shops that mix, prepare, or combine liquid nicotine and other components of tobacco products meet the definition of a “tobacco product manufacturer” under the law, and are therefore subject to the same legal requirements as all other tobacco product manufacturers.
- If a vape store is not mixing, preparing, or combining any products, then that store may be considered a retailer, not a manufacturer. Certain requirements apply only to manufacturers, such as requirements relating to establishment registration, product listings, and premarket applications.
- Importers of “finished tobacco products,” are regulated as tobacco product manufacturers, distributors, or both.
Since January 2021, FDA has issued over eighty Warning Letters to online retailers of e-cigarettes and vaping products for marketing e-liquid and other tobacco products without the required marketing authorization.
- The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires “new tobacco products” to have a premarket authorization.
- A “new tobacco product” is any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007.
- In the U.S., there are three pathways available to bring a new tobacco product to market: Premarket Tobacco Product Application (PMTA), Substantial Equivalence, and Reports, Requests for Exemption from Substantial Equivalence.
- A new tobacco product sold without the required marketing authorization is adulterated and misbranded.
CHART A lists the Warning Letters issued by FDA since April 1st of this year to online retailers of adulterated and misbranded e-liquid products. Notably, all the recipients of the Warning Letters have previously listed hundreds of e-liquid vaping products. One recipient has listed over 257,000 e-liquid vaping products. Accordingly, the Warning Letters evidence that it is not just inexperienced companies that are running afoul of FDA regulations regarding adulterated and misbranded tobacco products. Over the past five months FDA has made a concerted effort to educate experienced online retailers of authorized tobacco products that they have a primary responsibility to ensure that all the tobacco products they sell comply with each applicable provision of the FD&C Act and FDA’s implementing regulations.
If you operate an online e-cigarette store and/or vape shop and are unsure whether you are selling and/or advertising adulterated and misbranded tobacco products, then contact me (786/420-7217) or another one of YK Law’s experienced FDA attorneys. Our team of experienced regulatory attorneys will advise on the steps necessary to mitigate your regulatory risk, including advising you on achieving premarket authorization for the e-liquid vaping products and other tobacco products that you sell and/or advertise.