Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                CTP Newsroom

CTP Newsroom

                        Feature Stories Home
          Tobacco Products
          CTP Newsroom
          FDA Issues Marketing Denial Orders for Approximately 6,500 Flavored E-cigarette ProductsCTP Newsroom FDA Issues Marketing Denial Orders for Approximately 6,500 Flavored E-cigarette Products
  
  					Products Cannot Be Sold or Risk Enforcement
	
    Share
    Post
    Linkedin

    Email
    Print*May 12, 2023*

On May 12, FDA issued marketing denial orders (MDOs) to 10 companies, which collectively manufacture and market approximately 6,500 flavored e-liquid and e-cigarette products. The companies may not market or distribute these products in the U.S., and retailers who sell these illegal products risk FDA enforcement action.

The premarket tobacco product applications (PMTAs), which were for a variety of flavored e-cigarette products, did not provide sufficient evidence to show that permitting the marketing of these products would be appropriate for the protection of the public health. Flavors of some of the products denied include Citrus, Strawberry Cheesecake, Cool Mint, and Menthol.

Today’s actions add to FDA’s continued progress on reviewing and issuing decisions on the applications for over 26 million new tobacco products that FDA has received since Spring 2020, the majority of which were for e-cigarette products. To date, FDA has completed review and taken action on over 99% of these applications.

**“Science is a cornerstone of FDA’s tobacco product review process,” said Matthew Farrelly, Ph.D., Director of the Office of Science within FDA’s Center for Tobacco Products. “Today’s decision to deny approximately 6,500 products was based on the lack of scientific evidence provided in the applications. We will continue to ensure all new tobacco products undergo robust, scientific premarket evaluation to determine whether they meet the appropriate public health standard to be legally marketed.”**

FDA evaluates PMTAs based on a public health standard that considers the risks and benefits of the product on the population as a whole. As part of reviewing these companies’ PMTAs, FDA considered whether the products in the applications showed an added benefit to adult smokers, as compared to tobacco-flavored e-liquid and e-cigarette products, that could outweigh the known and substantial risk of flavored e-liquid and e-cigarette products to youth. The evidence submitted by the applicants was not sufficient to demonstrate such a benefit, resulting in today’s denial orders.

**“It is the applicant’s responsibility to provide sufficient scientific evidence to demonstrate that marketing a new tobacco product is appropriate for the protection of the public health.” said Brian King, Director of the Center for Tobacco Products. “That bar of scientific sufficiency has not been met to date for any flavored e-cigarette product, including in this instance. But if an applicant were to meet that bar, FDA would authorize the product.”**

The companies that received MDOs include:

Imperial Vapors LLC
	Savage Enterprises
	Big Time Vapes
	SWT Global Supply Inc.
	Great Lakes Vapor
	DNA Enterprise LLC dba Mech Sauce
	Absolute Vapor Inc.
	ECBlend LLCFDA is not disclosing the names of the other two companies that received MDOs to protect potential confidential commercial information (CCI).

FDA remains committed to ensuring all members of the industry – manufacturers, importers, distributors, and retailers – are complying with the law. Tobacco products subject to a negative decision, including those subject to an MDO, may not be offered for sale, distributed or marketed in the United States. Such products may not be introduced or delivered for introduction into interstate commerce. If the product is already on the market, the product must be removed from the market or risk enforcement.

Today’s actions move FDA one step closer toward ensuring all deemed new tobacco products have undergone science-based review and received marketing authorization by FDA before they can be legally marketed.  To learn more about the tobacco products FDA has authorized for manufacture, sale and/or distribution in the U.S., visit the Tobacco Products Marketing Orders webpage.

                                                                                  Content current as of:
      05/12/2023
              
              
Regulated Product(s)
		 TobaccoCTP Newsroom

          
                        Feature Stories
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop