FDA Regulation of Tobacco and Tobacco Products
The Family Smoking Prevention and Tobacco Control Act (also known simply as The Tobacco Control Act) was signed into law by President Barack Obama on June 22, 2009. The act gives the U.S. Food and Drug Administration (FDA) comprehensive control on tobacco products in the United States, as well as the power to regulate tobacco including the following:
- Require tobacco companies to submit an ingredients list of any product sold or imported in the United States.
- Require tobacco companies to make public the nicotine content of their products and to adopt standards of nicotine content and to reduce or eliminate other harmful substances present.
- Enlarge warnings on tobacco packaging so that they take up 50% of the front and back panel area.
- Regulate the use of terms such as "mild" and "light" by requiring that tobacco products conform to certain standards regarding these terms.
- Most importantly, the act grants FDA authority to “deem” other tobacco products subject to the authority of Title IX of the Food, Drug and Cosmetic Act, effective retroactively as of XXXX.
The FDA’s deeming regulations became effective on August 8, 2016, extending the Agency's “tobacco product” authorities to all other categories of products that meet the statutory definition of “tobacco product” in the FD&C Act. 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” by which new tobacco and tobacco-derived products such as premium cigars and e-cigarettes must Premarket Tobacco Applications (PMTA), an additional, expensive and burdensome regulatory hurdle imposed by the FDA.
On July 28, 2017 the FDA announced new regulations regarding nicotine and extended timeline for applications for newly regulated tobacco products.
FDA will extend timelines to submit tobacco product review applications for newly regulated tobacco products that were on the market as of Aug. 8, 2016, as follows:
- Applications for cigars, pipe tobacco and hookah tobacco will be due by Aug. 8, 2021.
- Applications for non-combustible products such as ENDS or e-cigarettes will be due by Aug. 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.
FDA will be issuing ANPRMs on a number of other issues, including "determining what role flavors play in attracting youth and may play in helping smokers switch to potentially less harmful forms of nicotine delivery, and making cigarettes less or non - addictive." This will be a very lengthy regulatory process. CDA will continue to monitor and report on FDA activity on regulation of tobacco and nicotine products, and will advocate on behalf of thorough, science based regulations beneficial to the convenience distribution industry and our industry partners.
Even with these changes, legislation to address the timelines and deeming authority is still relevant and necessary. The Cole-Bishop bill, HR 1136, goes further than FDA’s final rule for newly-regulated vapor products to fill gaps around consumer safety and marketing, addressing 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.
CDA continues to make changing the predicate date a top priority and urges our members to visit our Federal Advocacy Action Center to send a message to your legislators urging their support for efforts to accomplish this goal. It is important to continue to make your views known on this important issue. Thank you for your support!