Advisory and Enforcement Actions Against Industry for Unauthorized Tobacco Products
On this page:
- Which Products Are Subject to FDA Enforcement Action?
- Warning Letters
- Civil Money Penalty (CMP) Complaints
To protect the health of future generations, FDA closely monitors industry compliance with tobacco laws and regulations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and takes action when violations occur. FDA regulates tobacco products containing nicotine from any source, including non-tobacco nicotine (NTN), such as synthetic nicotine.
Which Products Are Subject to FDA Enforcement Action?
Before introducing a new tobacco product to the U.S. market, a company must submit a marketing application, such as a premarket tobacco product application (PMTA), to FDA and receive authorization.
New tobacco products on the market without the required premarket authorization are adulterated and misbranded under the FD&C Act and are subject to FDA enforcement action.
To date, FDA has authorized 23 tobacco-flavored e-cigarette products and devices. These are the only e-cigarette products that currently may be lawfully sold in the U.S.
Currently, no NTN product has received marketing authorization.
Generally, when companies are manufacturing, selling, and/or distributing unauthorized tobacco products in the United States, FDA will typically first issue a warning letter in an attempt to achieve voluntary compliance with the law.
If you have received a warning letter, you should follow the instructions provided to respond to the warning letter within 15 working days. Additional compliance education and information, including information about responding to warning letters issued to tobacco manufacturers for violations, are available on FDA’s Tobacco Compliance Webinars page. If you have questions, contact the Center for Tobacco Products at CTPCompliance@fda.hhs.gov.
How Do I Find Warning Letters Issued to Manufacturers of Unauthorized Tobacco Products?
From January 2021 through May 2023, FDA issued more than 560 warning letters to firms for manufacturing, selling, and/or distributing new tobacco products without marketing authorization from FDA.
On FDA’s warning letters page, you can find all of these warning letters by entering “Center for Tobacco Products” in the “Issuing Office” box in the “Filter by” section of the search tool.
How Do I Find Warning Letters Issued to Retailers for Selling Unauthorized Tobacco Products?
On May 31, 2023, FDA announced that it had issued warning letters to 30 retailers, including one distributor, for illegally selling unauthorized tobacco products, specifically various types of Puff and Hyde disposable e-cigarettes, two of the most commonly reported brands used by youth e-cigarette users in 2022. To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices. These are the only e-cigarette products that currently may be lawfully sold in the U.S. The distribution or sale of unlawfully marketed products is subject to enforcement action.
If you have any questions about warning letters issued to retailers, contact the Center for Tobacco Products (CTP) at 1-877-CTP-1373 or via email to the address listed in your warning letter: CTP-WL@fda.hhs.gov or CTPCompliance@fda.hhs.gov.
A * in the list below denotes a brick-and-mortar tobacco product retailer. See sample warning letter issued to brick-and-mortar retailers
|5/31/2023||E-Juice Vapor, Inc.||1610 E. Orangethorpe Avenue, Unit A||Fullerton||CA||92831||Puff Bar 300 Disposable – Cucumber and Puff Bar 300 Disposable– Grape|
|5/31/2023||Empire Imports, LLC d/b/a Vapor Empire, LLC||4250 E Lowell St||Ontario||CA||91741||Puff Plus TFN Disposable 800 Puffs 3.5mL – Guava Ice; Puff Plus TFN Disposable 800 Puffs 3.5mL – Lemon Ice|
|5/31/2023||Huff and Puffers, LLC||12105 Brookhurst St., Ste E||Garden Grove||CA||92840||Puff Xtra Limited Disposable Vape – Gummy Bear and Puff Xtra Limited Disposable Vape – Peach Gummy|
|5/31/2023||JTBC Holdings LLC d/b/a Disposable305||19532 Diplomat Dr||Miami||FL||33179||Puff Plus – Orange Soda and Puff Plus – Aloe Grape|
|5/31/2023||MDM Group Inc. d/b/a Eliquidstop.com||2005 Orange St, Unit I||Alhambra||CA||91803||Puff Flow Kiwi Strawberry and Puff Plus Straw Watermelon|
|5/31/2023||Mr. Smokey Tobacco Corp d/b/a Smoke Shop/The Boss Tobacco||8580 Stirling Rd #102||Hollywood||CA||33024||Puff Plus Vape 800 Puffs Mixed Berries and Puff Plus Vape 800 Puffs Peach Ice|
|5/31/2023||Mr. Smokey Tobacco Corp. d/b/a Hqdpods.com||70 West 49th St||Hialeah||FL||33012||Puff Plus - Mixed Berries and Puff Plus - Lychee Ice|
|5/31/2023||NAKV Enterprises, Inc. d/b/a Fat Puff Wholesale||500 N. Harbor City Boulevard, Suite A||Melbourne||FL||32935||Puff Plus Disposable – Fruit Fusion and Puff Plus Disposable – Grape|
|5/31/2023||Sooner Distributor & Wholesalers International Inc||6835 E 44th Street||Tulsa||OK||74145||PUFF XXL Disposable Vape Stick Pina Colada and PUFF XXL Disposable Vape Stick Energy Drink|
|5/31/2023||Superpuff Inc. d/b/a MyVapor||3045 Edinger Ave||Tustin||CA||92780||Hyde Retro|
|5/31/2023||The Drip Ship (N.I.) LTD d/b/a buycbdcigarettes||Puff Bar Disposable Pod Device – 5% Mango and Puff Bar Disposable Pod Device – 5% Watermelon|
|5/31/2023||TheSY, LLC d/b/a Element Vape||10620 Hickson St||El Monte||CA||91731||Hyde Rebel, Hyde Retro, and Hyde Edge|
|5/31/2023||Vape4Style, Inc||1762 Gerritsen Ave||Brooklyn||NY||11229||Puff Bar Disposables – Lush Ice and Puff Bar Disposables – Lychee Ice|
|5/31/2023||Vaperistas, LLC||591 N Edgewood Ave||Wood Dale||IL||60191||Hyde Edge and Hyde Rebel|
|5/25/2023||*Bath General Store and Market||502 Carteret Street||Bath||NC||27808||Puff Plus Watermelon Kiwifruit Ice; Puff Plus Cherry Honeydew ENDS|
|5/25/2023||*Clark's Food Mart||26605 US Highway 264 East||Pantego||NC||27860||Puff Plus Lemon Agave ENDS; Puff Plus Tangerine Ice ENDS|
|5/25/2023||*Mini Market / Tobacco and Vape||732 Beechurst Avenue||Morgantown||WV||26505||Puff Plus Strawberries and Cream ENDS|
|5/25/2023||*Texaco / Short Stop||560 5th Street North||Toledo||WA||98591||Puff Bar Pomegranate ENDS|
|5/25/2023||*Tobacco Shop||492 Jimmy Deloach Parkway, Suite 101||Savannah||GA||31407||Puff XXL Apple Ice ENDS|
|5/25/2023||*660 Vape and Smoke||660 East Blue Ridge Boulevard||Kansas City||MO||64145||Puff Plus Loquat Aloe ENDS; Puff Plus Pumpkin Ice ENDS|
|5/25/2023||*Fast Way Service Station||52A Hannah’s Rest||Frederiksted||VI||00840||Puff Plus Banana Papaya ENDS|
|5/25/2023||*D and H Candy and Tobacco||127 East 23rd Street||New York||NY||10010||Puff Plus Grape ENDS|
|5/25/2023||*United Food Mart Dollarway Road||5320 Dollarway Road||Pine Bluff||AR||71602||Puff Plus Whisky ENDS|
|5/25/2023||*Payless Smokes||901 Southwest Fairlawn Road, Suite 161||Topeka||KS||66606||Puff Bar Blue Razz ENDS; Puff XXL Banana Ice ENDS|
|5/25/2023||*Neo Tobacco and Vape||9330 Center Lake Drive, Suite 140||Charlotte||NC||28216||Puff Bar Tangerine Ice ENDS; Puff Bar Cucumber ENDS|
|5/25/2023||*E-Cig City Hawaii||1810 North King Street, Suite A||Honolulu||HI||96819||Puff Bar Watermelon ENDS; Puff Plus Watermelon ENDS|
|5/25/2023||*T.H.C. Smokes||3230 East Union Hills Drive, Suite 115||Phoenix||AZ||85050||Puff Bar Pomegranate ENDS; Puff Plus Guava Ice ENDS|
|5/25/2023||*Hurricane Tobacco and Vape||270 Progress Way, Suite 209||Hurricane||WV||25526||Puff Plus Long Island Ice Tea ENDS|
|5/25/2023||*Speedy Mart Food Stores||915 Country Road 517||Hackettstown||NJ||07840||Puff Bar Banana Ice ENDS|
|5/25/2023||*7-Eleven / Conoco||1499 South Federal Boulevard||Denver||CO||80219||Puff XXL Lush Ice ENDS; Puff XXL Banana Ice ENDS|
Civil Money Penalty Complaints
FDA has authority to assess CMPs for violations of the FD&C Act relating to tobacco products. This includes failing to obtain the required marketing authorization for new tobacco products.
In general, penalties for violating requirements of the FD&C Act may not exceed the statutory maximum set by law. Currently, the maximum penalty amount for violating a requirement of the FD&C Act relating to tobacco products is $19,192 for a single violation. However, the FD&C Act also allows for an enhanced penalty amount for certain intentional violations relating to tobacco products. FDA intends to seek the maximum allowed by law in CMP cases relating to unauthorized tobacco products.
Which Manufacturers Has CTP Filed CMP Complaints Against for Violations Relating to Unauthorized Tobacco Products?
On February 21, 2023, CTP filed CMP complaints against four manufacturers for manufacturing and selling tobacco products that lacked the required marketing authorization. This was the first time CTP filed CMP complaints against tobacco product manufacturers for their failure to comply with the premarket review requirements.
CTP continues to file CMP actions when appropriate against manufacturers that have failed to comply with the FD&C Act and applicable regulations.
- Lynda’s Legacy LLC doing business as Chaney’s Tobacco Station
- RTP Vapors LLC doing business as RTP Vapor
- Cloud 9 Systems LLC doing business as Cloud 9 Vapor
- Singing Hawk LLC doing business as Sin City III
- Sabor Vapors LLC doing business as Sabor Vapors
- Hothead Vapor LLC doing business as Hothead Vapor
- BAM Group LLC doing business as VapEscape
- Great American Vapes LLC doing business as Great American Vapes
- The Vapor Corner Inc. doing business as Vapor Corner Inc., The Vapor Corner, and Vapor Corner
- 13 Vapor Co. LLC doing business as 13 Vapor
An injunction is a civil judicial process initiated to stop current violations of the law and prevent them going forward, halt the flow of violative products in interstate commerce, and correct the conditions that caused the violation to occur.
Which Manufacturers Has CTP Initiated Permanent Injunction Actions Against Relating to Their Continued Manufacture of Unauthorized Tobacco Products?
On Oct. 18, 2022, the U.S. Department of Justice (DOJ), on behalf of the U.S. Food and Drug Administration, filed complaints for permanent injunction in federal district courts against six e-cigarette manufacturers for continued violations relating to their manufacture, sale, and/or distribution of unauthorized new tobacco products. These cases represent the first time FDA has initiated injunction proceedings to enforce the premarket review requirements for new tobacco products. FDA will continue to pursue injunction actions when appropriate.
- Morin Enterprises Inc. doing business as E-Cig Crib in the District of Minnesota
- Soul Vapor LLC in the Southern District of West Virginia
- Super Vape’z LLC in the Western District of Washington
- Vapor Craft LLC in the Middle District of Georgia
- Lucky’s Convenience & Tobacco LLC doing business as Lucky’s Vape & Smoke Shop in the District of Kansas
- Seditious Vapours LLC doing business as Butt Out in the District of Arizona