If you are a retailer, manufacturer, distributor, or importer of tobacco products, become familiar with the final rule by FDA Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act (also known as the “Deeming rule”). Here is a brief overview.
FDA Extends Its Authority over all “Tobacco Products”
The upshot is that FDA is extending its existing authority over tobacco products to new products that FDA “deems” to be tobacco products. Hence, the notion that FDA is “deeming tobacco products” of all kinds to be subject to the federal Food, Drug & Cosmetic Act (FDCA).
FDA published the rule on May 10, 2016; the final rule goes into effect August 8, 2016.
In a release to retailers, manufacturers, importers, and distributors entitled Notice to Industry: Additional Tobacco Products Now Regulated by the Food and Drug Administration, FDA explains that the Deeming rule extends FDA’s authority to additional products that meet the legal definition of “tobacco product.”
FDA already regulates:
- Cigarette tobacco
- Roll-your-own tobacco
- Smokeless tobacco products
However, the regulation now extends FDA rules to “newly deemed” tobacco products such as:
- Electronic cigarettes
- Hookah (water pipe)
- Pipe tobacco
- Components and parts (but not accessories) of the above
“Newly deemed” is simply a way of saying that FDA has caught up with the times.
The Deeming rule also includes additional restrictions for “covered tobacco product,” which means any newly deemed tobacco product (but not any component or part that is not made or derived from tobacco.
Obligations of Retailers and of Manufacturers, Importers, and Distributors
According to the Notice, obligations include the following.
Tobacco product retailer must comply with many provisions 90 days after publication of the Deeming rule, including:
- not selling newly deemed covered tobacco products to anyone under the age of 18;
- requiring age verification by photo ID for anyone under the age of 27 attempting to purchase covered tobacco products;
- not selling covered tobacco products in vending machines (unless in facilities that prohibit persons under the age of 18 from entering at all times); and
- not distributing free samples of newly deemed tobacco products.
Further, retailers must comply with provisions regarding “tobacco products” found in the FDCA and FDA regulations. Importantly, this includes the fact that all newly-deemed tobacco products require premarket authorization, unless grandfathered (i.e., were on the market as of 2/15/07 and have remained unchanged since then). FDA expects products currently on the market to remain available for up to three years, while manufacturers seek authorization under staggered compliance periods.
Some retailers may also be considered product manufacturers, if they “manufacture, fabricate, assemble, label, or process a tobacco product.”
- Manufacturers, Importers, and Distributors:
Manufacturers of tobacco products must comply with new requirements under the Deeming rule, including requirements related to warning statements; not placing modified risk tobacco products into interstate commerce without an FDA order; and complying with premarket review and authorization requirements. We’ll talk about premarket review in more detail in another blog post.
Manufacturers must also, among other things:
- Register their establishments
- List their products with FDA
- Submit to FDA lists of Harmful and Potential Harmful Constituents (HPHCs)
(FDA notes that it will initially limit enforcement to finished tobacco products—i.e., those sealed in final packaging intended for consumer use).
FDA also addresses regulatory requirements relevant to Manufacturers such as required industry submissions, tobacco product review and evaluation, tobacco product site tours, laboratory site tours, and rules governing cigarette packages and advertisements.
Distributors and importers continue to have previous responsibilities with respect to tobacco products, which are now extended to newly deemed products.
Importers of tobacco products must comply with applicable importing requirements under FDCA for importers of tobacco products, including submitting appropriate tobacco health documents such as, at least 90 days prior to introducing a tobacco product into interstate commerce, a listing of all ingredients of the tobacco product.
ENDS (Electronic Nicotine Delivery System)
As FDA explains in Extending Authorities to All Tobacco Products, Including E-Cigarettes, Cigars, and Hookah, one important type of newly tobacco products is the electronic nicotine delivery system (ENDS).
FDA devotes some time in Vaporizers, E-Cigarettes, and other Electronic Nicotine Delivery Systems (ENDS) to explaining that these products use liquid-containing nicotine as well as flavorings and other ingredients, which is heated into an aerosol and inhaled, but may look like conventional cigarettes, cigars, or pipes (or not).
According to FDA’s summary, components or parts include “an assembly of materials intended or reasonably expected alter or affect the tobacco product’s performance, composition, constituents, or characteristics; or to be used with or for the human consumption of a tobacco product,” including:
- A glass or plastic vial container of e-liquid
- Certain batteries
- Cartomizers and clearomizers
- Digital display or lights to adjust settings
- Tank systems
- Drip tips
- Flavorings for ENDS
- Programmable software
As with other FDA regulatory classifications, if a product is marketed for therapeutic purposes (such as to help people quit smoking), then it may be classified as a drug or device. FDA is proposing regulations to clarify when products made or derived from tobacco are regulated as drugs, devices, or combination products, depending on intended use.
Manufactures of ENDS and e-liquids must, among other things:
- Submit an application and obtain FDA authorization to market a new tobacco product (for timelines and more details please see Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act)
- Register establishment(s) and submit product listing to FDA by December 31, 2016 (this currently only applies to domestic manufacturers)
- Submit listing of ingredients
- Submit information on harmful and potentially harmful constituents (HPHCs)
- Submit tobacco health documents
- Do not introduce into interstate commerce modified risk tobacco products (e.g., products with label, labeling, or advertising representing that they reduce risk or are less harmful compared to other tobacco products on the market) without an FDA order
- Manufacture your tobacco product with the required warning statement on packaging and advertisements
- Market your tobacco product in compliance with other applicable statutory requirements, rules and regulations
The nicotine warning statement of deemed tobacco products is: “WARNING: This product contains nicotine. Nicotine is an addictive chemical.” If the manufacturer submits a self-certification to FDA that the product does not contain nicotine and that the manufacturer can support this certification with data, then the manufacturer may substitute: “This product is made from tobacco.”
Adverse Event Reporting
No surprise: All must report adverse experiences and product violations.
Our View of the Deemed rule
We view FDA’s regulation here as FDA responding to industry developments by keeping up with technological and market changes, and simply extending its previous rulemaking to new situations in a logical way.
FDA has done this kind of keeping up with technological and market before in areas such as its guidance on mobile medical apps, and its guidance on low-risk, general wellness devices and products.
FDA also uses the premarket authorization and substantial equivalence rules that are somewhat familiar from the medical device arena. As FDA explains:
Under section 910 of the FD&C Act, a premarket order for a new tobacco product is required prior to its introduction and distribution in the United States, unless
- the manufacturer submits a report under section 905(j) and FDA determines the tobacco product to be substantially equivalent to an appropriate predicate tobacco product;
- FDA determines that the product is exempt under 905(j)(3) from the requirements demonstrating substantial equivalence.
Overall, while the FDA website is in some respects a model of clarity, the rules are nested and FDA provides overlapping information in a variety of ways. This can create some confusion for those seeking to comply.
Again, we will cover more detail on the tobacco products Deeming rule in subsequent blog posts.