Dear Mr. Guster,
Thank you for contacting the U.S. Food and Drug Administration (FDA) regarding its recently finalized rule, “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” (Deeming rule).
FDA anticipates that newly regulated businesses may have many questions and compiled this e-mail as a resource to help you better understand the Deeming rule and the potential impact to your business. We encourage you to review this information and keep checking our website for new information such as compliance training webinars and updates based on questions FDA receives.
The law defines a manufacturer as anyone who manufactures, fabricates, assembles, labels, or processes a tobacco product. Establishments, such as vape shops, that mix and/or prepare combinations of liquid nicotine, flavors, and/or other liquids, or an establishment that creates or modifies an aerosolizing apparatus for sale to consumers would be considered a tobacco product manufacturer.
These requirements include:
- Register domestic manufacturing establishment(s) and submit product listings to FDA by December 31, 2016;
- Reporting ingredients, and harmful and potentially harmful constituents;
- Requiring premarket review and authorization of new tobacco products by the FDA;
- Placing health warnings on product packages and advertisements; and
- Not selling modified risk tobacco products (including those described as “light,” “low,” or “mild”) unless authorized by the FDA.
Manufacturers of newly-regulated products must show that the products meet the applicable public health standard set forth in the law and receive authorization from the FDA, unless the product was on the market as of Feb. 15, 2007. For products that were not on the market as of the effective date, a premarket authorization is required prior to marketing those products. For products on the market as of the effective date, under staggered timelines, the FDA does not intend to enforce the premarket review requirements for up to three years while manufacturers submit – and the FDA reviews – a new tobacco product application. The FDA will issue an order granting marketing authorization where appropriate; otherwise the product will be subject to enforcement.
Under the new Deeming Rule, FDA now regulates any product that meets the definition of a tobacco product, except accessories (e.g., ashtrays, humidors, carrying cases). This includes any component of a tobacco product that is intended to alter the tobacco product’s performance, composition, constituents or characteristics or intended to be used with or for the consumption of a tobacco product. Some examples of components include cigar wrappers, cigar tobacco filler, coils, flavor cartridges, and liquid nicotine cartridges that are used in e-cigarettes.
All manufacturers of components of tobacco products that are sealed in final packaging intended for consumer use have to comply with certain provisions of the law. Some examples of these requirements include: establishment registration and product listing, premarket review, reporting of Harmful or Potentially Harmful Constituents (HPHCs), submission of tobacco health documents and ingredient listing, and compliance with the free sample ban.
Only those manufacturers of components of tobacco products that are sealed in final packaging intended for consumer use
and are made or derived from tobacco must comply with the nicotine warning statements required on package labels and advertisements. And
only those manufacturers of components of
cigars that are sealed in final packaging intended for consumer use
and are made or derived from tobacco must comply with the health warning statements required on the package labels and advertisements and submission of a rotational warning plan to FDA.
The following are a few examples for illustration:
Company A manufactures many liquid nicotine cartridges in different strengths that are packaged and intended to be sold to consumers to be used in an e-cigarette. Company A is required to comply with establishment registration and product listing, premarket review, reporting of HPHCs, submission of tobacco health documents and ingredient listing, and compliance with the free sample ban. Also, because the liquid nicotine is made or derived from tobacco, it also must bear the required nicotine statement on its packaging and advertisements.
Company B manufactures liquid flavor cartridges intended for use in flavored e-cigarettes. Company B sells their product to Company C who assembles a flavored e-cigarette closed system device. Company C sells their flavored e-cigarettes to Company D who packages and labels the flavored e-cigarette for sale to consumers. FDA will not require Company B or C to comply with any of the regulatory requirements listed above. Company D, however, is required to comply with the establishment registration and product listing, premarket review, reporting of Harmful or Potentially Harmful Constituents (HPHCs), submission of tobacco health documents and ingredient listing, and compliance with the free sample ban.
Company E manufactures many different flavors in different cartridges that are packaged and intended to be sold to consumers to be used in e-cigarettes. Company E is required to comply with establishment registration and product listing, premarket review, reporting of HPHCs, submission of tobacco health documents and ingredient listing, and compliance with the free sample ban. However, Company E does not have to comply with the nicotine warning on its packaging and advertisement because the component is not made or derived from tobacco.
Please see Deeming Rule and Small Entity Compliance Guide for further information.
FDA does not assess fees associated with the requirements identified above. The costs associated with compliance with these requirements may vary based on the type and complexity of the product, and, as a result, FDA is not able to provide an individualized estimate of costs that you may incur. However, FDA has included in the preamble to the Deeming rule its estimates of the quantified costs associated with the Rule over 20 years, as well as estimated hourly burdens on impacted entities (such as tobacco product manufacturers) for the requirements described above. Please see the link provided below for more information.
Final Rule and Accompanying Documents
Resources for Additional Information
FDA continues to update its
Deeming webpage to provide information designed to help industry understand the Deeming rule. We plan to soon add a chart that may help you determine which provisions apply to you and the timeframes for complying. In addition, FDA plans to post Tobacco Compliance Webinars.
We also encourage you to
subscribe to FDA’s “This Week in CTP.” By subscribing, you’ll receive updates about regulatory activities, retailer notices, upcoming events, and public education campaigns.
Should you have further questions after reviewing this information, you may contact CTP using the following communication methods:
Email:
SmallBiz.Tobacco@fda.hhs.gov
Phone:
1-877-287-1373
Mail:
Food and Drug Administration
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993
IM0978383
