Tag: warning letter

  • FDA Warns 6 Companies for Trade Show Sales

    FDA Warns 6 Companies for Trade Show Sales

    Credit: Mr. Fog

    The U.S. Food and Drug Administration has issued six warning letters to manufacturers and retailers for selling or distributing unauthorized e-cigarette products promoted at an industry trade show.

    After observations made by Center for Tobacco Products (CTP) staff attending the trade show, the FDA conducted investigations and issued warning letters to six retailers and manufacturers for selling or distributing unauthorized e-cigarette products.

    Regulated entities must comply with all applicable requirements under the Federal Food, Drug, and Cosmetic Act. Under these requirements, the sale and distribution of unauthorized tobacco products is illegal, including at industry events such as trade shows or expos, according to the FDA.

    “Regulated industry should be aware that CTP obtains leads that inform investigations from many sources, including trade shows,” said John Verbeten, director of CTP’s Office of Compliance and Enforcement. “We remain committed to identifying and taking action against those breaking the law, including at these events.”

    FDA also announced the issuance of warning letters to five online retailers for selling unauthorized e-cigarette products popular with youth, including products marketed under the brand names Breeze, Mr. Fog, and Raz.

    “Results from the recently released 2024 National Youth Tobacco Survey found that Breeze and Mr. Fog were among the top five most commonly used brands among youth who use e-cigarettes,” an FDA release states. “Additionally, Raz was identified as a popular brand through routine surveillance, with youth-appealing flavors such as sour mango pineapple and razzle-dazzle.”

    The companies receiving these warning letters sold or distributed e-cigarette products without marketing authorization from the FDA. Warning letter recipients are given 15 working days to respond with the steps they will take to address the violations cited in the warning letter and to prevent future violations.

    Failure to promptly address the violations can result in additional FDA actions such as an injunction, seizure, and/or civil money penalties.

    The trade show was not named in the FDA release.

  • Warning Letters for 5 Online Illegal Vape Retailers

    Warning Letters for 5 Online Illegal Vape Retailers

    Credit: Marcus Krauss

    The U.S. Food and Drug Administration has again  issued warning letters to five online retailers for selling unauthorized disposable e-cigarette products marketed under the brand names Geek Bar, Lost Mary, and Bang. It’s the second wave of warning letters issued in July.

    The retailers included Smoke and Vape Company, LLC d/b/a Smoke and Vape Co.; Smoking Vibes LLC d/b/a Smoking Vibes; Cavalry Industries d/b/a Select Vape; HTXW LLC d/b/a FOMO Culture; and Global Supply Allies Inc. d/b/a Vapor Grab.

    These warning letters were a result of FDA’s ongoing monitoring of multiple surveillance systems, including a review of various data, to identify emerging products of particular concern that are popular among youth or have youth appeal, according to an agency press release. For example, emerging data showed that Geek Bar – a Chinese-owned and manufactured brand – has recently seen an uptick in sales and can appeal to youth.  

    Warning letter recipients are given 15 working days to respond with the steps they will take to address the violation(s) cited in the warning letter and to prevent future violations. Failure to promptly address the violations can result in additional FDA actions such as an injunction, seizure, and/or civil money penalties. 

    FDA holds retailers accountable for selling unauthorized tobacco products, particularly those popular with youth. To date, FDA has issued over 680 warning letters to firms for manufacturing, selling, and/or distributing unauthorized new tobacco products, issued more than 690 warning letters to retailers for the sale of unauthorized tobacco products, and filed civil money penalty complaints against 64 manufacturers and more than 140 retailers for distribution and/or sale of unauthorized tobacco products. 

    As of August 1, 2024, the FDA has authorized 34 e-cigarette products and devices. The agency maintains a printable one-page flyer of all authorized e-cigarette products that retailers can easily consult to determine which products can be lawfully marketed and sold in the U.S. Entities manufacturing, importing, selling, or distributing e-cigarettes without the required premarket authorization risk enforcement.

  • More Warnings for Sellers of Elf Bar, Lost Mary Vapes

    More Warnings for Sellers of Elf Bar, Lost Mary Vapes

    Credit: Chris Titze Imaging

    The U.S. Food and Drug Administration announced on July 25 that it had issued warning letters to 80 brick-and-mortar retailers in 15 states for selling unauthorized e-cigarette products, including Elf Bar and Lost Mary. 

    The regulatory agency also filed complaints for civil money penalties (CMPs) against eight other retailers who failed to take action after being previously warned about selling unauthorized e-cigarettes.

    “These warning letters and CMPs are a result of FDA’s ongoing monitoring of multiple surveillance systems to identify products that are popular among youth or have youth appeal. The 2023 National Youth Tobacco Survey, according to an FDA release, found that more than 50 percent of youth who use e-cigarettes reported using the brand Elf Bar.

    Additionally, the brand Lost Mary—manufactured by the same firm as Elf Bar—was identified as popular or youth-appealing following an agency review of retail sales data and emerging internal data from a youth-use survey. 

    The FDA generally sends warning letters the first time an investigation or inspection reveals a violation. Warning letter recipients have 15 working days to respond with the steps they will take to correct current violations and prevent future violations. However, failure to promptly correct the violations may result in additional FDA action, including CMPs.

    For the retailers receiving the eight CMPs, the FDA previously issued warning letters for to them for selling unauthorized tobacco products. Follow-up inspections revealed that the retailers had failed to correct the violations, and the agency is now seeking $20,678 from each retailer.

    These actions are the latest in the FDA’s ongoing efforts to address the marketing and sale of unauthorized e-cigarettes that appeal to youth. Throughout the last year, the agency has conducted inspections of retailers to identify those selling unauthorized e-cigarettes, including in May, March, and February. As a result of these actions, the FDA has issued more than 690 warning letters and more than 140 civil money penalty actions to retailers for the sale of unauthorized e-cigarettes.

    To date, the FDA has authorized 34 e-cigarette products and devices. These are the only e-cigarette products that currently may be lawfully marketed and sold in the United States. Further information on tobacco products that may be legally marketed in the United States is available in the FDA’s Searchable Tobacco Products Database.

  • FDA: 14 More Warning Letters for Flavored Vape Sales

    FDA: 14 More Warning Letters for Flavored Vape Sales

    The U.S. Food and Drug Administration announced on May 1 that it had sent warning letters to 14 online retailers. The reason for the warning letters was that these retailers were selling unauthorized e-cigarette products.

    The warning letters specifically mentioned the sale of disposable e-cigarette products marketed under various brand names such as Elf Bar/EB Design, Esco Bars, Funky Republic, Hyde, Kang, Cali Bars, and Lost Mary, according to press release.

    The retailers receiving these warning letters sold or distributed e-cigarette products in the United States that lack authorization from FDA, in violation of the Federal Food, Drug, and Cosmetic Act.

    Warning letter recipients are given 15 working days to respond with the steps they will take to address the violation(s) cited in the warning letter and to prevent future violations. Failure to promptly address the violations can result in additional FDA actions such as an injunction, seizure, and/or civil money penalties.

    The agency announced on April 30 that the U.S. Marshals Service seized more than 45,000 unauthorized e-cigarette products valued at more than $700,000 in California.

    The seized products were mostly flavored, disposable e-cigarette products, including brands such as Puff Bar/Puff, Elf Bar/EB Design, Esco Bar, Kuz, Smok and Pixi.

  • Warning Letters for Vapes Resembling Alcohol Products

    Warning Letters for Vapes Resembling Alcohol Products

    Image: FDA

    On Dec. 20, 2023, the U.S. Food and Drug Administration issued warning letters to three online retailers for selling and/or distributing unauthorized e-cigarettes that imitate packaging for bottles of alcohol. These retailers sold Luckee Vape Daniels brands, which are flavored disposable e-cigarette products that come in a variety of common alcoholic drink flavors that may be appealing to young people, including icy pina colada, frozen strawberry daiquiri, frozen mangorita and watermelon martini.

    Data from the 2023 National Youth Tobacco Survey indicate that disposable products are the most commonly used type of e-cigarettes among U.S. middle and high school students. Among current youth e-cigarette users, approximately nine in 10 reported using flavors, with fruit flavors being the most popular (63.4 percent) and about one in 14 (7.2 percent) reporting use of products with alcoholic drink flavors.

    “FDA is committed to taking action across the supply chain, including among retailers, to remove unauthorized tobacco products from the marketplace,” said Brian King, director of the FDA’s Center for Tobacco Products, in a statement. “This includes continued monitoring of the online marketplace to identify and combat against emerging products of concern.”

  • FDA Continues Crackdown on Youth Appealing Vapes

    FDA Continues Crackdown on Youth Appealing Vapes

    Credit: iCheer

    Today, the U.S. Food and Drug Administration issued warning letters to seven online retailers for selling and/or distributing unauthorized e-cigarettes.

    The unauthorized e-cigarettes are packaged to look like youth-appealing toys and drink containers, including milk cartons, soft drink bottles, and slushies. The products’ design may also help youth conceal the e-cigarettes from adults or be confused with an everyday object and the contents accidentally ingested by young children, according to the agency.

    “As we continue into the school year, it’s critical that parents, teachers, and other adults are aware of illegal e-cigarettes deceptively packaged to look like everyday items,” said Brian King, director of FDA’s Center for Tobacco Products (CTP). “These types of products can be easily concealed and contain nicotine, which is highly addictive and can harm the developing adolescent brain.”

    The unauthorized products described in the warning letters issued today include e-cigarettes that:

    • Imitate drink containers for youth-appealing drinks such as milk, soft drinks, and slushies.
    • Are designed to look like youth-appealing toys such as dice, phones, and action figures.

    “FDA uses a variety of surveillance tools to monitor the rapidly evolving e-cigarette landscape and to identify emerging threats to public health,” said Ann Simoneau, director of the Office of Compliance and Enforcement within the CTP. “We use data from these tools to help prioritize investigations of youth-appealing products across the supply chain to ensure illegal products stay off the shelves.”

    The retailers receiving these warning letters sell and/or distribute e-cigarettes in the United States that lack authorization from the FDA, which is a requirement under the Federal Food, Drug, and Cosmetic (FD&C) Act to legally market a new tobacco product.

    In addition to the specified products mentioned in the warning letters, the retailers were warned to address any violations that are the same as or similar to those stated in the warning letter, and promptly take any necessary actions to bring the tobacco products that they offer for sale in the United States into compliance with the FD&C Act.

    The seven retailers issued warning letters were given 15 working days to respond with the steps they will take to correct any violations and to prevent future violations. Failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure, and/or civil money penalties.

    Today’s warning letters are the latest in a series of FDA’s efforts across the supply chain to address illegal e-cigarettes that appeal to youth.

    As of November 2023, FDA has issued approximately 630 warning letters to firms for manufacturing and/or distributing illegal e-cigarette products and devices, issued more than 400 warning letters to retailers for the sale of unauthorized e-cigarettes, filed civil money penalty complaints against 35 e-cigarette manufacturers and 42 retailers for manufacture or sale of unauthorized products, and worked with the Department of Justice to seek injunctions against 6 manufacturers of unauthorized e-cigarettes.

  • FDA Warns Nic Nac Naturals for Illegal Flavored ‘Nicotine Mints’

    FDA Warns Nic Nac Naturals for Illegal Flavored ‘Nicotine Mints’

    The U.S. Food and Drug Administration issued a warning letter to Nic Nac Naturals for the marketing of their unauthorized dissolvable nicotine products, which the company describes as “nicotine mints” and which resemble a pack of mints. These products are of particular concern because of their resemblance to popular candies and the potential to cause severe nicotine toxicity or even death if accidentally ingested by young children, according to the FDA.

    “FDA remains steadfast in our commitment to actively monitor the marketplace and to crack down on companies selling unlawful products, particularly those that can appeal to youth,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “Our goal is to identify and prevent these emerging threats to our nation’s youth before they become mainstream.”

    The manufacturer markets these tobacco products in a variety of mint and fruit flavors, all of which come in two nicotine strengths (3 mg or 6 mg). The packaging states the products contain nontobacco nicotine. The FDA regulates tobacco products containing nicotine from any source, including nontobacco nicotine. Nic Nac Naturals does not have a marketing authorization order from the agency to sell or distribute these products in the U.S.

    One container of 15 of these mints can have as much as 90 mg of nicotine total. According to research, the FDA stated, ingesting 1 mg to 4 mg of nicotine could be toxic or severely toxic to a child under 6 years old, depending on body weight. This means ingesting one mint could be severely toxic to a child under 6 years old. Nicotine toxicity among youth of any age can lead to nausea, vomiting, abdominal pain, increased blood pressure and heart rate, seizures, respiratory failure, coma and even death. The FDA also stated that nicotine is highly addictive and exposure during adolescence can harm the developing brain.  

    “Today’s action is another example of our ongoing efforts against illegal nontobacco nicotine products,” said Ann Simoneau, director of the CTP’s Office of Compliance and Enforcement. “We remain unwavering in our use of compliance and enforcement resources to curb unlawful marketing of tobacco products, particularly those that youth could easily confuse with something that they consume regularly—like candy.”

    The company has 15 working days to respond to the FDA with steps they will take to correct and prevent future violations. Failure to respond and correct violations may result in addition FDA action, such as an injunction, seizure and/or civil money penalties.