Marketing Granted Orders

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 39 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 2025, 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 regarding ZYN products, click here.

• On July 17, 2025, the U.S. Food and Drug Administration (FDA) authorized the marketing of five JUUL e-cigarette products through the premarket tobacco product application (PMTA) pathway. The JUUL products now authorized for sale in the United States include the JUUL electronic device, Virginia Tobacco flavor JUULpods (3% and 5% nicotine concentration) and Menthol flavor JUULpods (3% and 5% nicotine concentration).
  
  Following an extensive scientific review, the FDA determined that evidence provided by JUUL Labs – including new information the company submitted in response to a deficiency letter from the FDA – demonstrated that these specific products meet the legal standard set by the 2009 Family Smoking Prevention and Tobacco Control Act to market new tobacco products in the United States.
  
  Also, to read the complete FDA announcement regarding the authorization of the JUUL electronic cigarette products, click here.

• On December 19, 2025, the U.S. Food and Drug Administration (FDA) authorized the marketing of six on! Plus nicotine pouch products through the premarket tobacco product application (PMTA) pathway. The on! Plus products now authorized for sale in the United States include the following:
  
                      Helix Innovations LLC - on! PLUS nicotine pouches 6 mg Mint
                      Helix Innovations LLC - on! PLUS nicotine pouches 9 mg Mint
                      Helix Innovations LLC - on! PLUS nicotine pouches 6 mg Tobacco
                      Helix Innovations LLC - on! PLUS nicotine pouches 9 mg Tobacco
                      Helix Innovations LLC - on! PLUS nicotine pouches 6 mg Wintergreen
                      Helix Innovations LLC - on! PLUS nicotine pouches 9 mg Wintergreen
  
  Also, to read the complete FDA announcement regarding the authorization of the on! Plus nicotine pouch products, click here.

• On March 12, 2026, the U.S. Food and Drug Administration (FDA) authorized the marketing of Glas Inc. e-cigarette products through the premarket tobacco product application (PMTA) pathway. The Glas Inc. products now authorized for sale in the United States include the following:
  
                      Glas Inc. - Glas G2 Device
                      Glas Inc. - Blonde Tobacco 59 MG/ML Pod
  
  Also, to search for the FDA’s inclusion of the Glas Inc. authorized e-cigarette products in the agency’s searchable tobacco product database, click here.

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).