Newly deemed “Tobacco Products” products must comply with Tobacco Control Act.
On May 10, 2016, the US Food and Drug Administration (FDA or Agency) will publish a final rule (the Final Deeming Rule) extending its authority to all tobacco products. Its authority will not extend to accessories (e.g., hookah tongs, cigar clips, ashtrays) of the new tobacco products. The Final Deeming Rule implements the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), and issues after 135,000 comments were submitted to the April 25, 2014 Proposed Deeming Rule.
The FDA also issued three accompanying guidance documents intended to help regulated entities understand and comply with the Final Deeming Rule:
- Small Entity Compliance Guide: FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements;
- Guidance: Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS); and
- Guidance: Tobacco Product Master Files.
The Tobacco Control Act provides the FDA with the authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. Section 901 of the FD&C Act, as amended by the Tobacco Control Act, permits the FDA to issue regulations deeming other tobacco products not named in the tobacco control statute (e.g., e-cigarettes) to be subject to the FD&C Act. Once a product is “deemed” to be subject to the FDA’s tobacco product authorities, FD&C Act § 906(d) provides the FDA with the authority to propose restrictions on the sale and distribution of tobacco products, including restrictions on access to and advertising of tobacco products, if the FDA determines that such regulation would protect public health.
PROPOSED DEEMING RULE
The 2014 Proposed Deeming Rule offered two alternatives for the scope of the deeming provisions:
Option 1: The first option would extend the Agency’s authority to all tobacco products not previously regulated by the FDA that meet the statutory definition of “tobacco product,” except accessories of such products.
Option 2: The alternative option would extend the Agency’s authority to all tobacco products not previously regulated by the FDA that meet the statutory definition of “tobacco product,” except premium cigars and the accessories of products not previously regulated by the FDA.
The principal difference between the two options is the scope of cigar regulation. Under Option 1, all cigars would be covered by the rule and regulated by the FDA. Under Option 2, only a subset of cigars (i.e. “everything but ‘premium’” cigars) would be covered by the rule.
Under both options in the Proposed Deeming Rule, accessories of the proposed deemed tobacco products would fall outside the scope of the proposed rule. The FDA defined accessories of the proposed deemed products to be those items that were not included as part of a finished tobacco product, or items that were intended or expected to be used by consumers in the consumption of a tobacco product. For example, hookah tongs, bags, cases, charcoal burners and holders, cigar foil cutters, humidors, carriers, and lighters would all be considered accessories. However, e-cigarettes (and the components thereof) and hookah pipes would be covered by the Proposed Rule.
FINAL DEEMING RULE
All Tobacco Products, Including Cigars and Tobacco Derivatives Are Regulated
The FDA adopted Option 1 of the Proposed Deeming Rule to effectively protect public health. Thus, all cigars are covered under the Final Deeming Rule. Unlike cigarettes, cigars may continue to be sold individually; however, retailers must display required warning statements on a sign at the point of sale. Cigars may bear one of seven different warnings, including the addictive nicotine warning required for all tobacco products. The FDA intends to issue a proposed product standard that would eliminate flavors in all cigars, including cigarillos and little cigars. Finally, the FDA slightly modified the definition of “covered tobacco products” to clarify that components or parts include those that contain any tobacco derivative.
The FDA states that while there are many types of e-cigarettes and other electronic nicotine delivery systems (ENDS)—including e- cigarettes, e-cigars, e-hookah, vape pens, personal vaporizers, and electronic pipes—all are subject to the Final Deeming Rule regardless of the name or heating source. Thus, all ENDS products must comply with the Final Deeming Rule requirements as listed below.
Many provisions of the FD&C Act call for a population-level public health analysis that takes into account the population as a whole, including users and nonusers of tobacco products. The FDA remains concerned about the rise in use of ENDS by youth and young adults and consumer misperceptions that ENDS products are “safe” tobacco products. The FDA continues to have concerns regarding the toxicants in e-liquid and the exhaled aerosol and the nicotine delivery from e-cigarettes, specifically e-liquids have been found to contain propylene glycol, glycerin, tobacco specific nitrosamines, tobacco alkaloids, carbonyls, ethylene glycol, diacetyl, and acetyl propionyl. While the FDA recognizes that the aerosol exhaled by ENDS is potentially less harmful than secondhand smoke from cigarettes, e-cigarette aerosols have been found to contain nicotine, carbonyls, tobacco specific nitrosamines, heavy metals, and volatile organic compounds and is not simply “water vapor.”
The FDA recognizes that specific product design parameters, such as voltage, can affect toxicant deliveries and understands that switching from cigarettes to ENDS may reduce the risk of tobacco related-disease for current cigarette smokers; however, further research is needed. The FDA is concerned about the risk of nicotine poisoning in both users and non-users of ENDS, stating that children under the age of 5 represent the largest proportion of e-liquid ingestion. The FDA reiterated its concerns from the Proposed Deeming Rule regarding quality control for the mixing of e-liquids, and also remains concerned about adverse events associated with ENDS use, including overheating and exploding batteries. The FDA addresses these concerns in its draft guidance addressing the premarket authorization of newly deemed ENDS products.
The FDA notes that ENDS products that are marketed as a cessation product must file an application with the FDA’s Center for Drug Evaluation and Research (CDER). No ENDS have been approved as effective as cessation aids.
If a vape shop establishment mixes or prepares e-liquids or creates or modifies aerosolizing apparatus for direct sale to consumers for use in ENDS, the establishment fits within the definition of "tobacco product manufacturer" and the combinations it mixes and/or prepares are new tobacco products. New tobacco products must receive premarket authorization, as noted below. The statute authorizes the FDA to regulate the manufacture of all new products, including those manufactured at the retail level. The FDA recognizes that vape shops may choose to cease manufacturing rather than comply with the statutory requirements, but believes that this will encourage innovation for products that present a lower risk of user and population harm.
PREMARKET AUTHORIZATION FOR “DEEMED” PRODUCTS
Manufacturers of newly deemed products that were not commercially marketed in the United States as of February 15, 2007 will be required to obtain premarket authorization of their products through one of three pathways:
- substantial equivalence (SE),
- exemption from SE, or
- premarket tobacco product applications.
A showing of SE requires the applicant to identify a valid pre-February 15, 2007 predicate and provide scientific data of SE to that predicate. The burden of demonstrating SE rests with the manufacturer submitting the application.
The FDA understands that many new tobacco products may not be able to identify a predicate product marketed before February 15, 2007 to support an SE claim. Additionally, the FDA states that these new alternatives may help adults to transition away from cigarettes. Thus, the FDA put forth two “continued compliance” periods for newly deemed tobacco products that were on the market as of the Final Deeming Rule, but that were not on the market as of February 15, 2007:
- Continued compliance for submission and FDA receipt of applications (12-24 months after publication); and
- Continued compliance obtaining premarket authorization (24-36 months after publication).
These timeframes vary based on the type of premarket authorization. Once the continued compliance period ends, new tobacco products on the market without authorization will be subject to enforcement.
KEY TAKEAWAYS FROM THE FINAL DEEMING RULE
- Deems all current and future products meeting the statutory definition of “tobacco product,” to be subject to the FDA’s tobacco product authorities. These products now include currently marketed products such as:
- Waterpipe tobacco;
- Electronic nicotine delivery systems (ENDS) (e.g., e-cigarettes, e-hookah, e-cigars, vape pens, advanced refillable personal vaporizers, and electronic pipes);
- Components or parts of tobacco products:
- As used in ENDS, e.g., atomizers; batteries (with or without variable voltage); cartomizers (atomizer plus replaceable fluid-filled cartridge); digital display/lights to adjust settings; clearomisers, tank systems, flavors, vials that contain e-liquids, and programmable software; and
- As used in waterpipe tobacco, e.g., flavor enhancers and the vials in which they are contained; hose cooling attachments; water filtration base additives (including those which are flavored); flavored waterpipe tobacco charcoals and the wrappers or boxes that contain the charcoals; and bowls, valves, hoses, and heads.
- The FDA notes that at this time, it plans to limit enforcement discretion to finished tobacco products and does not plan to enforce requirements for components of newly deemed products.
- Cigars (all types); and
- Pipe tobacco.
- Does not deem “accessories” of the newly deemed products to meet the statutory definition of “tobacco product.”
- For example, ashtrays, spittoons, hookah tongs, cigar clips and stands, and pipe pouches are considered accessories because they do not contain tobacco, are not derived from tobacco, and do not affect or alter the performance, composition, constituents, or characteristics of a tobacco product.
- Accessories of cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco remain subject to the FDA’s tobacco product authorities.
- Requires all newly deemed tobacco products to conform with the FD&C Act and regulations that apply to tobacco. These requirements are effective 90 days after publication of the Final Deeming Rule (i.e. around August 8, 2016) and include:
- Compliance with adulteration and misbranding provisions.
- Required registration of manufacturing establishments of tobacco products.
- Submission of ingredient listing and reporting of harmful and potentially harmful constituents (HPHCs).
- Prohibits the use of modified risk tobacco product (MRTP) claims (e.g., "light," "low," and "mild" descriptors), unless authorized by the FDA.
- Requires premarket review and prevents new tobacco products from entering the market that are not appropriate for the protection of the public health, are not substantially equivalent to a valid predicate product, or are not exempt from SE.
- Prohibits the distribution of free samples.
- Places restrictions on the sale and distribution of tobacco products to minors. These requirements include:
- Prohibit sales to persons under the age of 18 (in person and online).
- Require age verification by a photo ID.
- Prohibit the sale of newly deemed tobacco products in vending machines, except under adult-only establishments.
- Requires health warning on product packages and advertisements. These requirements include:
- All packages and advertisements of all covered tobacco products must bear a nicotine addictiveness warning label statement: “WARNING: This product contains nicotine. Nicotine is an addictive chemical.”
- Cigar packaging and advertising are also required to include warning label statements that vary based on how the cigars are presented for sale.
- Tobacco products that do not contain nicotine may display an alternative warning label.
The deeming provisions, the minimum age and identification requirements, and the vending machine restrictions are all effective 90 days from the date of publication of the Final Deeming Rule, August 8, 2016.
The health warning requirements are effective 24 months from the date of publication of the Final Deeming Rule (May 10, 2018), with an additional 30-day period in which a manufacturer may continue to introduce into interstate commerce existing inventory manufactured before the effective date that does not contain the required warning statements on packaging (June 9, 2018).
“Continued compliance” period applications and premarket authorization for newly deemed tobacco products that were on the market as of the effective date of the Final Deeming Rule, but that were not on the market as of February 15, 2007, vary based on the type of premarket authorization. Compliance with the requirement for the FDA’s receipt of applications ranges between 12-24 months. Compliance with obtaining premarket authorization ranges between 24-36 months.
Given that newly deemed products will be subject to the same FD&C Act provisions and relevant regulatory requirements that currently apply to cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco, and are also subject to new requirements specific to newly deemed products, entities involved in selling, manufacturing, and distributing newly deemed products should:
- Update product labels by removing modified risk descriptors (e.g., “light,” “low,” and “mild” descriptors), unless there is an FDA order authorizing their marketing;
- Review the FD&C Act provisions concerning adulterated and misbranded products;
- Identify potential HPHC ingredients;
- Develop best practices for preventing the sale of newly deemed products to minors, obtaining age verification, and limiting minor access to vending machines;
- Review premarket review requirements and identify potential predicates marketed before February 15, 2017;
- Develop new labels, product packaging, and signs to display required warning statements by May 10, 2018;
- Cease the distribution of free samples; and
- Review the FDA Guidance documents regarding compliance dates for specific products.