FDA Regulation of Tobacco and Tobacco Products
The Family Smoking Prevention and Tobacco Control Act (also known simply as the Tobacco Control Act (TCA)) was signed into law by President Barack Obama on June 22, 2009. The TCA gives the U.S. Food and Drug Administration (FDA) comprehensive authority to regulate the manufacture, distribution, and marketing of tobacco products in the United States. The TCA imposed requirements on those who manufacture and import tobacco products, as well as those who sell or distribute them. When the TCA was enacted in 2009, only cigarettes, smokeless tobacco and roll-your-own (RYO) tobacco were covered, and included the following:
- Prohibits illegal sales of tobacco products to minor and implements advertising and promotion restrictions at the manufacturer and retailer levels.
- Requires tobacco companies to register with FDA and list their tobacco products, as well as submit to FDA a list of ingredients for any product sold or imported in the United States.
- Bans all flavored cigarettes, except for menthol.
- Require tobacco companies to report the nicotine content of their products.
- Requires enlarged, more visible and more informative warning statements on tobacco packaging.
- Prohibits the use of terms such as "mild" and "light" by requiring that tobacco products conform to certain standards regarding these terms.
- Add premarket review requirements for “new” tobacco products that were brought to market after February 15, 2007 (this date is also known as the “predicate date”).
Significantly, the TCA defines a “tobacco product” as anything made or derived from tobacco and intended for human consumption. If the FDA were to assert jurisdiction over products that meet the definition of a tobacco product (other than cigarettes, smokeless tobacco and roll-your-own tobacco), the TCA requires the FDA to “deem” these products through a rulemaking process. The FDA’s deeming regulation was proposed on April 25, 2014, and became effective on August 8, 2016, extending the Agency's “tobacco product” authorities to all other categories of products including cigars, pipe tobacco, e-cigarettes and other tobacco products which include nicotine derived from tobacco. CDA’s white paper highlighting the major provisions of this new rule may be found here.
CDA has been working to support efforts in Congress to clarify the FDA deeming authority specifically urging a change in the “predicate date.” As explained above, tobacco products that entered the market after this predicate date (February 15, 2007), including premium cigars and e-cigarettes, must comply with one of the premarket review pathways: Premarket Tobacco Applications (PMTA) or Substantial Equivalence (SE). Since there were virtually no e-cigarettes on the market on February 15, 2007, the SE pathway is not an option for e-vapor products.
However, on July 28, 2017 the FDA announced a comprehensive new regulatory plan regarding lowering nicotine in combustible cigarettes, and extended timelines for applications for newly-regulated combustible tobacco products (cigars, pipe tobacco and hookah) and newly-regulated non-combustible products (ENDS and e-cigarettes).
FDA will extend timelines to submit tobacco product premarket review applications for newly regulated tobacco products that were on the market as of August 8, 2016, as follows:
- Applications for cigars, pipe tobacco and hookah tobacco will be due by August 8, 2021.
- Applications for non-combustible products such as ENDS or e-cigarettes will be due by August 8, 2022.
- The sunset provision for marketing during FDA’s review of premarket applications will be lifted and manufacturers will be able to continue to market products while the agency reviews product applications.
- FDA intends to issue Advanced Notice of Proposed Rulemakings (ANPRMs) to:
- Seek public comment on the role that flavors (including menthol) in tobacco products play in attracting youth and may play in helping some smokers switch to potentially less harmful forms of nicotine delivery.
- Solicit additional comments and scientific data related to the patterns of use and resulting public health impacts from premium cigars.
- Seek public comment on how to make combustible products less addictive or non-addictive.
- FDA plans to examine actions to increase access and use of FDA-approved medicinal nicotine products, and work with sponsors to consider what steps can be taken under the safety and efficacy standard for products intended to help smokers quit.
- FDA plans to issue regulations outlining what information the agency expects to be included in:
- Premarket Tobacco Applications (PMTAs),
- Modified Risk Tobacco Product (MRTP) applications, and;
- Substantial Equivalence (SE) reports.
- FDA plans to finalize guidance on how it intends to review PMTAs for ENDS.
- FDA may reconsider whether to continue to use its resources to review certain pending provisional Substantial Equivalence (SE) reports.
This announcement contains some encouraging news for CDA members, as the timelines for applications for newly regulated tobacco products are extended significantly, and FDA explicitly states that products can be marketed during the application process. This means that all newly deemed products on the market as of August 8, 2016, including cigars (premium and little cigars), pipe tobacco, hookah, and e-cigarettes, can be sold without any marketing authorization from FDA until 2021 or 2022. As for currently regulated products such as cigarettes and smokeless tobacco, many of these products remain subject to pending provisional SE applications and may remain on the market unless FDA issues a Not Substantially Equivalent (NSE) Order, which requires the manufacture to cease manufacturing the tobacco product (FDA exercises enforcement discretion at the retail level for an additional 30 days to account for existing inventory of NSE products).
FDA has issued three Advance Notices of Purposed Rulemaking (ANPRMs), one setting a maximum level of nicotine in cigarettes and possibly other tobacco products, one on the role of flavors in tobacco products and one on the premium cigar category. This will be a very lengthy regulatory process. CDA has added our comments to FDA’s official docket on nicotine and flavors. We will continue to monitor and report on FDA activity on regulation of tobacco and nicotine products, and will advocate for thorough, science-based regulations that are beneficial to the convenience distribution industry and our industry partners.
Even with the July 28, 2017 announcement, legislation to address the predicate date is still relevant and necessary. The Cole-Bishop bill, H.R. 1136, goes further than FDA’s final rule for newly-regulated vapor products to fill gaps around consumer safety and marketing, addressing youth access related concerns expressed during last year’s debate on this issue. The bill ensures FDA regulates e-vapor products in a manner that makes sense in light of the public health opportunities that those products offers and also closes the regulatory gap with respect to consumer protection measures needed for this new product category. Without a change to the current structure of the TCA regarding the predicate date for newly deemed products, FDA would be forced to regulate e-cigarettes in a more onerous manner than traditional cigarettes.