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

The FDA’s CTP has proposed two new regulations. These proposed regulations are known as product standards, which require the reduction or prohibition of an ingredient in a tobacco product.

• 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.

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.

Future Planned Tobacco Regulations

The FDA has announced that the agency plans to issue new tobacco regulations in the future. The two new regulations being planned are explained below.

• Nicotine Levels: Maximum level of nicotine in cigarettes and possibly other certain combustible tobacco products. The FDA plans to propose a product standard that would establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain other combusted tobacco products.
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  The Unified Agenda published by the Office of Information and Regulatory Affairs/Office of Management and Budget reports that a Notice of Proposed Rulemaking announcing this new regulation is scheduled to be issued in April of 2024.
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• Detention of Products: Administrative detention of tobacco products. The FDA is proposing a regulation to establish requirements for the administrative detention of tobacco products. This proposed rule, if and when finalized, would allow the FDA to administratively detain tobacco products encountered during inspections of manufacturers or other establishments that manufacture, process, pack or hold tobacco products that an authorized FDA representative conducting the inspection has reason to believe are adulterated or misbranded. The Unified Agenda published by the Office of Information and Regulatory Affairs/Office of Management and Budget reports that a Notice of Proposed Rulemaking announcing this new regulation is scheduled to be issued in October of 2024.
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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 27 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 June 2024, these are the only e-cigarettes authorized to be sold in the U.S." Click here to view the FDA flyer.

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).