FDA

FDA Regulation of Tobacco Products

BACKGROUND: In 2009, a new federal law titled the “Family Smoking Prevention and Tobacco Control Act” (Tobacco Control Act) was passed by Congress and signed into law by the President. This law authorized the U.S. Food and Drug Administration (FDA) to regulate the manufacture, marketing, distribution and sale of cigarettes and tobacco products in the United States. In order to administer this law, the FDA created the Center for Tobacco Products (CTP) to oversee the implementation of the Family Smoking Prevention and Tobacco Control Act.

The CTP’s responsibilities under this law include developing new regulations for cigarettes and tobacco products, issuing guidance documents which inform the tobacco industry about regulatory issues and explain the FDA’s current thinking on tobacco regulations, setting performance standards and solicit comments from the industry and the public on tobacco regulations as a part of the rulemaking process.

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Current News

Recent news reports and announcements from the FDA regarding regulations, enforcement actions, webinars, and other breaking news can be found on the FDA Center for Tobacco Products Newsroom at https://www.fda.gov/tobacco-products/ctp-newsroom.

Proposed Tobacco Regulations and Guidance Documents

The FDA has the authority to propose new tobacco-related regulations and issue Guidance documents. A Guidance document is an explanation of the FDA’s current thinking on how a regulation will be administered and enforced. Below are summaries of pending FDA proposed regulations and Guidance documents.

• Menthol: Prohibiting the use of menthol in cigarettes, heated tobacco products and roll-your-own cigarette tobacco. This product standard regulation is awaiting final action by the White House Office of Management and Budget. The most recent Federal Regulatory Information Notice included a statement that final action on the proposed menthol regulation should be concluded by March of 2024. However, on April 26, 2024, U.S. Department of Health and Human Services Secretary Xavier Becerra issued the following press release statement regarding the status of the FDA’s proposed menthol cigarette prohibition regulation:
  
  “This rule has garnered historic attention and the public comment period has yielded an immense amount of feedback, including from various elements of the civil rights and criminal justice movement. It’s clear that there are still more conversations to have, and that will take significantly more time.” 
  
  Read HHS Secretary Becerra’s press release statement here.
  
  » Click for more information on the Proposed Menthol Cigarette Prohibition.
   
• Flavored Cigars: Prohibiting characterizing flavors in cigars. This product standard regulation is also awaiting final action by the White House Office of Management and Budget. According to FDA Director Dr. Brian King, the timing of final action on the proposed regulation banning characterizing flavors in cigars will parallel final action on the proposed regulation banning the use of menthol in cigarettes.
  
  » Click for more information on the Proposed Flavored Cigar Prohibition.
   
• Nicotine Levels in Cigarettes and Other Combustible Tobacco Products: On January 16, 2025, the U.S. Food and Drug Administration published a proposed federal regulation that would set a maximum level of nicotine in cigarettes and other combustible tobacco products. The publication of the proposed regulation is Step 5 in the nine-step process that federal agencies must follow to adopt a new regulation.
  
  Based on published proposed regulation, the regulation would cap the nicotine level at 0.7 milligrams per gram of tobacco in cigarettes, cigarette tobacco, roll-your-own tobacco, most cigars (including little cigars, cigarillos, and most large cigars), and pipe tobacco. The proposed nicotine cap regulation would not apply to electronic cigarettes, nicotine pouches, non-combustible cigarettes (such as heat-not-burn tobacco products), waterpipe hookah tobacco, smokeless tobacco products, or premium cigars.
  
  The proposed nicotine cap of 0.7 milligrams per gram of tobacco is significantly less than the level of nicotine per gram of tobacco currently found in the vast majority of cigarettes and other combustible tobacco products.
  
  The FDA will accept public comments on the proposed regulation through September 15, 2025. This requirement to accept public comments is Step 6 in the regulation adoption process. The remaining Steps 7, 8 and 9 of the regulatory approval process include the FDA reviewing all the public comments and making any changes to the regulation, sending a final version of the regulation to the White House Office of Management and Budget (OMB) for approval, and then publishing the regulation with a specific effective date.
  
  As a part of the comment process, the FDA has specifically asked for feedback from industry members about whether manufacturers will be able to comply with the lower total nicotine content levels if the regulation were to go into effect two years after the regulation is finalized.
  
  To read more, click here. To read the published version of the proposed regulation, click here.
   
• Submission Tracking Numbers: Requiring an importer to submit an FDA-issued Submission Tracking Number (STN) into the Automated Commercial Environment (ACE) data interchange system operated by Customs and Border Protection for electronic cigarette products being imported into the United States. The submission of the STN would occur at the time the electronic cigarette products are entering a U.S. port. Currently, the submission of a STN for electronic cigarette products being imported is optional. This proposed regulation only applies to electronic cigarettes.
  
  » Click for more information on the Proposed Submission Tracking Number Regulation.
   
• Guidance Document on Enforcement of Cigarette Graphic Health Warnings: The FDA’s Center for Tobacco Products issued a Guidance document on September 12, 2024, explaining how the agency plans to enforce a regulation requiring graphic picture health warnings to be printed on cigarette packages and cigarette advertisements.
  
  The Guidance states that FDA intends to exercise enforcement discretion and not enforce requirements in the graphic health warnings regulation until December 12, 2025, plus refrain from enforcement activities for an additional 30 days until January 12, 2026 regarding cigarettes manufactured before December 12, 2025. However, the Guidance does not contain any language allowing an unlimited sell-through period for distributors and retailers to sell cigarette inventory that was manufactured up to December 12, 2025 without graphic health warnings printed on the cigarette packages.
  
  CDA has submitted a comment letter to the FDA asking the agency to clarify that the Guidance document should allow an unlimited sell-through period for cigarettes manufactured without graphic picture health warnings so that distributors and retailers do not lose their financial investment in the products.
  
  » Click for more information on the proposed Guidance Document.
  
  Litigation Updates: On November 25, 2024, the U.S. Supreme Court declined to hear an appeal filed by R.J. Reynolds Tobacco Company and other companies of a decision issued by the Fifth Circuit Court of Appeals in the case titled R.J. Reynolds Tobacco v. FDA, 24-189. The decision by the Fifth Circuit Court of Appeals upheld the FDA's regulation requiring new graphic and text cigarette health warnings on cigarette packages and cigarette advertisements. The Supreme Court justices did not issue any explanation with their decision to decline the appeal filed by R.J. Reynolds.
  
  Subsequent to the U.S. Supreme Court’s decision on November 25, 2024 to decline to hear an appeal in the R.J. Reynolds Tobacco Company lawsuit referenced above, a new lawsuit was filed on December 13, 2024, in the United States Federal District Court for the Southern District of Georgia naming the U.S. Food and Drug Administration (FDA) as the primary defendant and seeking to overturn the agency’s graphic cigarette health warning regulation, which is scheduled to go into effect in December 2025. The lawsuit was filed by four plaintiffs, including Philip Morris USA Inc., Dhaliwal & Associates, Inc. (which operates three convenience stores in Georgia), Stewart Candy Company d/b/a Stewart Distribution (headquartered in Blackshear, Georgia), and the Georgia Association of Convenience Stores, Inc.
  
  The lawsuit includes two key claims against the FDA’s graphic cigarette health warnings. First, the plaintiffs allege that the FDA violated the Administrative Procedures Act (APA), which is a federal law that governs the process by which federal agencies develop and issue new regulations.
  
  The second important claim made by the plaintiffs is that the graphic cigarette health warnings violate the First Amendment to the U.S. Constitution. The First Amendment protects free speech, and the U.S. Supreme Court has ruled that free speech includes “commercial speech,” which is advertising. With the graphic cigarette health warning regulation requiring the new warnings to cover the top 50% of the front and back of each cigarette package and the top 20% of all cigarette advertisements, the plaintiffs argue that the size of the warnings “drown[s] out the manufacturers’, distributors’, and retailers’ ability to speak their own message.”
  
  The new lawsuit requests that the U.S. District Court issue an order for the following relief:
  
  1. Vacate the graphic cigarette health warning regulation and send the issue back to the FDA for further review.
  
  2. Declare that the graphic cigarette health warning regulation violates the First Amendment and is, therefore, unconstitutional.
  
  3. Postpone the effective date of the regulation until 15 months after the U.S. District Court issues a final decision on the lawsuit’s claims.
  
  To read the full complaint in the new graphic cigarette health warnings lawsuit, click here.
  
  A federal judge in Texas has blocked the U.S. Food and Drug Administration from enforcing a looming requirement that cigarette packages and advertisements contain graphic warnings illustrating the health risks of smoking. On January 113, 2025, U.S. District Judge J. Campbell Barker in Tyler, Texas ruled in favor of R.J. Reynolds and other tobacco companies in finding the FDA went beyond its authority by requiring packaging and advertising to contain 11 specific warnings because the FDA regulation requiring 11 warnings goes above and beyond the nine warnings that Congress specified when in 2009 it passed the Tobacco Control Act, which gave the FDA the authority to regulate tobacco products and mandated adoption of the graphic warnings. Moreover, Judge Barker found that the FDA only used the exact text Congress required for two of the original nine warnings.
  
  The judge delayed the rule’s effective date by issuing a preliminary injunction until the court issues a final judgment in the case. The FDA had intended to begin enforcing the graphic cigarette health warnings in December 2025. The court also found that a preliminary injunction is necessary due to the FDA’s rewriting of some of the health warnings. 
  
  Read more here. View the January 13, 2025 Court Decision here.    

Flavored E-Cigarette/Vapor Product Restrictions

BACKGROUND: In September 2019, the Trump Administration announced a ban on flavored vape products. In early January 2020, Health and Human Services Secretary Alex Azar released FDA industry guidance which outlines the agency’s enforcement priorities to focus on flavored pod-based electronic nicotine delivery systems (ENDS), other than tobacco and menthol flavored ENDS. While not an outright ban, the action was a de facto ban on some types of vape products, as the agency prioritized enforcement against pod-based flavored ENDS products that have not been through premarket authorization. The policy does not apply to “open tank” type vaping systems or disposables.

STATUS: The new enforcement standards for certain flavors of pod-based vape products are in effect. Many states and localities have enacted bans on flavored tobacco products, including ENDS.

Pre-Market Tobacco Application Process (PMTA)

The 2009 Tobacco Control Act authorized the FDA to regulate not only cigarettes and other tobacco products, but to also “deem” other products containing “nicotine made or derived from tobacco” to be a tobacco product. On May 5, 2016, the FDA announced the final Deeming Rule, which deemed certain products to be “tobacco products” and subject to the Tobacco Control Act. Electronic cigarettes, or electronic nicotine delivery systems (ENDS), were deemed to be a tobacco product under the Deeming Rule.

The agency also issued guidance for the tobacco industry to instruct manufacturers in the Pre-Market Tobacco Application (PMTA) process. This PMTA process requires a manufacturer of a new tobacco product introduced in the market after February 15, 2007 to submit an application to the FDA for review and action. The FDA can refuse to accept an application if the documentation is insufficient, refuse to file an application if all of the requirements of a PMTA are not met, issue a Marketing Granted Order if the FDA finds the product “appropriate for the protection of the public health,” or issue a Marketing Denial Order if the agency finds that a product does not meet this health standard.

Click here to view the FDA’s PMTA Metrics webpage which provides data on the number of PTMAs submitted and the status of these PMTAs.

In addition, the FDA has placed on its website a set of lists of PTMAs submitted to the agency by September 9, 2020. These lists are voluminous and arranged alphabetically by the name of the manufacturer that submitted the application. Please note that these lists are not comprehensive, and the agency has not at this time included in these lists PTMAs submitted after September 9, 2020. Click here to view the FDA webpage with these PMTA lists.

Pre-Market Tobacco Application Metrics

The FDA provides an on-going update of the number of Pre-Market Tobacco Applications (PMTAs) by tobacco product category on the agency’s website. This PMTA update information can be accessed by clicking here.

In addition, the FDA also publishes on a regular basis charts with updates on the number of PMTAs accepted, filed, under review, and final action by tobacco product category. These PMTA charts can be accessed by clicking here.

Marketing Granted Orders

In order for a new tobacco product that was introduced in the market after February 15, 2007 and has continued to be marketed and sold in the United States, or for a product that has not yet been placed on the market, the Tobacco Control Act requires that a manufacturer compile and submit a Pre-Market Tobacco Application (PMTA) to the FDA and the agency must review the PMTA and then issue a Marketing Granted Order (MGO) authorizing the marketing and selling of the product. Click here to view a list of these authorized products on the FDA’s website.

In addition, the FDA has a printable flyer listing the 34 tobacco-flavored and menthol-flavored electronic cigarette products and devices for which the agency has issued Marketing Granted Orders authorizing the sale of these products. As indicated in the FDA's flyer, "As of July 2024, these are the only e-cigarettes authorized to be sold in the U.S." Click here to view the FDA flyer.

• On January 16, 2025, the U.S. Food and Drug Administration authorized the marketing of 20 ZYN nicotine pouch products through the premarket tobacco product application (PMTA) pathway following an extensive scientific review. This is the first time the agency has authorized products commonly referred to as nicotine pouches, which are small synthetic fiber pouches containing nicotine designed to be placed between a person’s gum and lip.
  
  The FDA determined that the specific products receiving marketing authorization met the public health standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act. This standard considers the risks and benefits of products to the population as a whole.
  
  According to the FDA’s Decision Summary document (see Page 4 of the linked document below), the agency has authorized the marketing of the following 20 Zyn products and will be issuing Marketing Granted Orders to Swedish Match USA Inc.:

To read the FDA Decision Summary, click here.

FDA Searchable Tobacco Products Database

The FDA has created a searchable tobacco products database on the agency’s website that contains a list of tobacco products, including electronic cigarette products, that may be legally marketed in the United States. The database is designed to provide key information in a single location, with search capabilities. The database, which can be accessed at www.fda.gov/searchtobacco, will be updated monthly by the FDA.

Within the database, the FDA provides information on three categories of products including: 1) new tobacco products that received marketing authorization from the FDA; 2) pre-existing tobacco products that were on the market as of February 15, 2007; and 3) provisional tobacco products that were removed from FDA agency review (see provisional tobacco products definition).

The FDA database contains a searchable list of nearly 17,000 tobacco products, with over 12,000 being pre-existing tobacco products. For each entry, the FDA provides available information on the tobacco product, including the product name, company, category, sub-category, the authority permitting its sale in the U.S. and the date of FDA action. Additionally, the database also includes links to regulatory and scientific documents, such as the Order Letter and Decision Summary, as well as the Environmental Assessment (EA) and related documents associated with a tobacco product application.

To help explain some of the terminology and context about the content of the database, the FDA has also developed the Searchable Tobacco Products Database – Additional Information webpage. The webpage also includes answers to potential questions about the database, including a question related to unauthorized products with pending applications. In general, the FDA is unable to provide information on pending applications in order to protect confidential commercial information. Moreover, for new products that require authorization, a pending application does not create a safe harbor to sell that product.

Marketing Denial Orders

If the FDA issues a Marketing Denial Order (MDO) after reviewing a Pre-Market Tobacco Application (PMTA), then the tobacco product covered under an MDO cannot be legally marketed, sold, or introduced into interstate commerce in the U.S. without risking FDA enforcement. The FDA website includes a list of companies whose products have been the subject of a MDO. However, the list only includes those products which were already on the market and for which a PTMA was submitted to the agency and then subsequently denied. The FDA does not include in this list those new tobacco products which were the subject of a PMTA, were not yet on the market, and which received an MDO. These products are not included in the list to prevent the disclosure of potential confidential commercial information. Click here to view this list.

Reporting Potential Violations

The FDA has set up an online portal and an email address for the public to report suspected violations of federal tobacco regulations. Information about a potential violation can be provided to the FDA’s Center for Tobacco Products through the online portal.

Also, a potential violation can be reported to the FDA via email using the email address: CTPCompliance@FDA.hhs.gov.

Reporting the Importation of Unlawful Products

The U.S. Customs and Border Protection (CBP) offers an e-Allegations portal, which provides a website page for the trade community and the public to report suspected trade violations to the CBP, including the importing of unlawful electronic cigarette products. The e-Allegations process enables CBP, in collaboration with its governmental partners, to protect the U.S. economy from the effects of unfair trade practices and guard against the entry of products that could pose a threat to health and safety.

The following link can be used to file an e-Allegation on the CBP website portal:
https://www.cbp.gov/trade/e-allegations

Filing a Trade Violation Allegation: to file a trade violation allegation using the e-Allegation webpage portal, click the link above and follow these instructions:

1. CBP E-Allegation Main Page: Click on the blue button titled “Report Trade Violation.”
    
2. Trade Violations Reporting Page: Click on the red button titled “Report Trade Violations.”
    
3. Contact Details Page: Under the “Who Are You” heading, choose the drop-down option that best describes you and fill in your address, phone number and email address. Or you can select “Anonymous” under the “Who Are You” heading.
    
4. Violation Type Page: Select either “Classification of Merchandise” if the products were not described properly (e.g., electronic cigarettes are described as toys) or “Prohibited Items” if the products are unlawful to sell in the United States.
    
5. Allegations Detail Page: Select “Yes” or “No” to the question, “Is this an immediate threat to loss of life or damage to property?" Under “Violation Type,” select either “Classification of Merchandise” (for misdescribed products), “Prohibited Items” (for unlawful products) or another appropriate classification. In the “Violation Description” box, type in specific information about the merchandise at issue and reference any evidence of the violation. In the “Product Category” box, select “24: Tobacco.” Under the “Violator Product” box, list the specific brand name of the product and any other identifying information about the merchandise. In the “Country of Origin” box, select the country from which the products were originally shipped.
    
6. Violator Details Page: On this page, type in the name, country and address information of the company that is allegedly violating the law.
    
7. Upload Files Page: Upload any documentation that supports the e-allegation report.
    
8. Review Page: Review all the information to ensure it is correct and then submit the information.

Industry Responsibility

We Card: The We Card Program, Inc. is a national non-profit organization serving the nation's retailers of tobacco, alcohol, e-cigarettes, vapor products and other age-restricted products. Individual retail establishments, as well as large retail chains, utilize We Card's educational and training services for their compliance efforts with federal, state and local laws on preventing age-restricted product sales to minors.

National and state retail trade associations, government officials, community groups and others also support We Card's ongoing efforts to raise awareness of responsible retailing and age verification requirements and to educate and train retail employees to identify and prevent underage attempts to purchase age-restricted products.

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FDA “This is Our Watch” Program: The FDA’s Center for Tobacco Products has developed an education program called “This is Our Watch.” This program helps tobacco retailers better understand FDA tobacco regulations and the importance of compliance. A full toolkit of “This is Our Watch” resources is available to retailers—including posters, stickers, age verification tools, and more—to help retailers better comply with federal tobacco regulations.

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Questions? Contact Tom Briant (tomb@cdaweb.net; (703) 208-1641),
Kathee Facchiano (kfacchiano@capitoldecisions.com; (202) 638-1950)
or Sarah Herbert (sherbert@capitoldecisions.com; (202) 638-0326).