On April 24, 2014, the U.S. Food and Drug Administration(FDA) announced that it was officially “deeming” e-cigs, e-hookah, vape pens, and other tobacco products subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act). This article covered the proposed regulation at the time. On May 10, 2016 the FDA published the final rule on the new deeming law.
What Are Tobacco Products and What’s Being Regulated?
New Tobacco Products Regulated include: All cigars (premium and domestic), pipe tobacco, e-cigarettes, e-hookah, e-cigars, vape pens, advanced refillable personal vaporizers, electronic pipes, hookah tobacco, dissolvable tobacco products, and nicotine gels. As well as any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product. All of the above have been deemed tobacco products and are now subject to FDA regulation.
How Does FDA Regulations Affect Manufacturer, Distributor, Importer, and Retailer?
Under §1140.10; Each manufacturer, distributor, importer, and retailer is responsible for ensuring that the cigarettes, smokeless tobacco, or covered tobacco products it manufactures, labels, advertises, packages, distributes, imports, sells, or otherwise holds for sale comply with all applicable requirements under this part.
Hookah/Vape Shops Become Manufacturers.
An additional effect of the new deemed tobacco products by the FDA will consider, and regulate some retailers as manufacturer. Under §1140.3 manufacturer means any person, including any rapacker and/or relabeler, who manufactures, fabricates, assembles, processes, or labels a finished tobacco product. This means that retailers that mix e-liquids for e-cigarettes or vapor devices, that prepare, compounds or process tobacco products will meet the definition of tobacco product manufacturer.
Rules, Regulations, and Requirements for Tobacco Products
Methods of Sale
In Person Sales
Under the FDA regulation retailers may only sell cigarettes or smokeless tobacco to:
- persons over the age of 18,
- whose age is verified by means of photographic identification containing the bearer’s date of birth,
- in a direct, face-to-face exchange without the assistance of any electronic or mechanical device.
Tobacco products regulation is slightly different. Retailers may only sell tobacco products to:
- persons over the age of 18,
- whose age is verified by means of photographic identification containing the bearer’s date of birth.
Retailers may, however, sell tobacco products (not including cigarettes or smokeless tobacco) with the assistance of electronic or mechanical devises, if the retailer can ensure that no person younger than 18 years of age has access to it. This leaves the internet as a possible method of sale, as long as the retailer can ensure that no person under the age of 18 is allowed access. The FDA added a comment to this specific issue saying that it did not intended to prevent the sale of tobacco products over the internet, as long as it was to persons over the age of 18 only.
Vending Machine Sales
This also means, that a retailer may sell tobacco products with the use of a vending machine, if the retailer can ensure that no person under 18 is allowed in the area where the vending machine is located.
Warnings, Advertisement, And Packaging.
All tobacco product’s, other than cigars, packages must bear a required warning statement on the package label. “WARNING: This product contains nicotine. Nicotine is an addictive chemical.” Advertisements must display this warning in the ad as well, in order to be lawful. Both warnings (package and advertisements) are subject to FDA regulation and standards.
Cigars are subject to additional warnings, besides the nicotine warning. These warnings include warnings about cancers of the mouth and throat, warnings about lung cancer and heart disease, and warnings about smoking while pregnant. Advertisements of cigars must display this warning as well. Both Warnings are subject to FDA regulation and standards.
Warning Plan Required – Rotating: Cigars manufacturers, retailers, importers, and distributors must have a warning plan on how warnings will be randomly displayed, distributed on packages, and rotated on advertisements, this plan must be submitted to and approved by the FDA.
Additional Regulation for manufacturers
Pre-Market Review and Pathways
Just like manufacturers and importers of cigarettes, smokeless tobacco and roll your own tobacco, manufacturers and importers of the newly deemed tobacco products will need to comply with premarket review requirements.
There are three pathways to enter into the US newly deemed “tobacco” products, and its extremely important to keep in mind that pre-market review requirements will consistently include the predicate date (grandfather date) of February 15, 2007, which means, because your product was commercially marketed in the United States, without any modifications, as of February 15, 2007 you are therefore “grandfathered in” and are not a “new” product and therefore, don’t have to comply with one of the 3 pathways below:
- Premarket tobacco product applications (PMTA – 24 months to submit your application),
- Substantial Equivalence (SE – 18 months to submit your application) – Provide data to demonstrate that the characteristics of your new product are the same as the predicate that’s been on the market by or before February 15, 2007 (or differences don’t raise new questions of public health), or
- Exemption from Substantial Equivalence (SE Exemption – 12 months to submit your application) – The importers and manufacturers of tobacco products that were on the market between the grandfathered date and August 8, 2016, will have to submit a substantial equivalence (SE exemption) request to keep their products on the market.
Compliance with the FDA can be complicated and exacting, especially if you have products already on the market and aren’t sure which pathway will apply to you and you want to make sure you meet your deadline to continue marketing your product. You’ll need to ensure you have an expert by your side to assist you through the process. Diaz Trade Law specializes in compliance with the FDA and other regulatory government agencies – Call 305-456-3830 or email email@example.com today for a consultation! Visit www.diaztradelaw.com for more information.