SILVER SPRING, Md., June 7, 2019 /PRNewswire/ -- The U.S. Food and Drug Administration and the Federal Trade Commission today issued warning letters to four firms that manufacture, advertise and offer for sale or distribution several flavored e-liquid products for violations related to online posts by social media influencers on each company's behalf, including failure to include the required nicotine warning statement. The warning letters are just one aspect of the FDA's Youth Tobacco Prevention Plan designed to limit youth access to all tobacco products, with a particular focus on youth e-cigarette use.
"Years of progress to combat youth use of tobacco is now threatened by an epidemic of e-cigarette use by kids, and unfortunately research shows many youth are mistaken or unaware of the risks and the presence of nicotine in e-cigarettes. That's why it's critical we ensure manufacturers, retailers and others are including the required health warning about nicotine's addictive properties on packages and advertisements – especially on social media platforms popular with kids," said Acting FDA Commissioner Ned Sharpless, M.D. "Under my leadership, the FDA will continue to tackle the troubling epidemic of e-cigarette use among kids. This includes limiting youth access to, and appeal of, flavored tobacco products like e-cigarettes and cigars, taking action against manufacturers and retailers who illegally market these products or sell them to minors, and educating youth about the dangers of e-cigarettes and other tobacco products. We cannot and will not risk a generation of youth to a lifetime of nicotine addiction. We appreciate the FTC joining us on these and other actions to protect youth from the dangers of nicotine and tobacco products."
Social media influencers are individuals with a large number of online followers that often help to promote products on behalf of certain brands or companies. Through social media sites such as Facebook, Instagram and Twitter, influencers on behalf of Solace Technologies LLC (doing business as Solace Vapor), Hype City Vapors LLC, Humble Juice Co. LLC and Artist Liquids Laboratories LLC (doing business as Artist Liquid Labs) posted content touting the flavored e-liquid products or recommending their social media followers try the products without including the required nicotine warning statement.
The FDA has determined that the e-liquid products labeled and/or advertised on behalf of the companies in these social media posts, or in two cases, on the companies' own social media accounts are misbranded because they fail to include the statement, "WARNING: This product contains nicotine. Nicotine is an addictive chemical," a requirement that the FDA has enforced since Aug. 10, 2018. The FTC joined the FDA on the warning letters under Section 5 of the Federal Trade Commission Act, which prohibits unfair or deceptive advertising.
"These letters are a reminder that companies who use social media influencers to promote their products must comply with all applicable advertising requirements," said Andrew Smith, director of the FTC's Bureau of Consumer Protection. "Moreover, ads must disclose material health or safety risks – in this case, the fact that nicotine is highly addictive."
The products that are subject to the warning letters include: Solace Black Sea Salt Blueberry, Solace Black Tropical Freeze, Solace Salts Peach, Solace Salts Strawberry, and Solace Salts Dragon Fruit Menthol; Hype City Vapors Mango Candy and Hype City Vapors Berry Lemonade; HMBL SALT Mango Pineapple, HMBL SALT Blue Blood High, HMBL SALT Strawberry Kiwi, HMBL SALT Apple Jay Jay, HMBL SALT 99 Pink Balloons, and HMBL SALT Watermelon Patch; and Artist Liquids Peanut Butter Rocket Nicotine Salt, Artist Liquids Nice Melons Nicotine Salt, Artist Liquids Cotton Cookies Nicotine Salt, Artist Liquids Strawberry Clouds Nicotine Salt, and Artist Liquids Blue Label Nicotine Salt.
The FDA and the FTC have requested responses from each of the companies within 15 working days. The companies are directed to inform each agency of the specific actions taken to address each agency's concerns. The warning letters also state that failure to correct violations may result in further action such as seizure or injunction.
More than 3.6 million middle and high school students across the country were current (within the past 30 days) e-cigarette users in 2018, according to the National Youth Tobacco Survey conducted by the FDA and the U.S. Centers for Disease Control and Prevention. This is a dramatic increase of 1.5 million students from the previous year. The data also showed that youth who used e-cigarettes also were using them more frequently, and they were using flavored e-cigarette products more often, than in 2017.
The increased popularity of e-cigarettes among youth raises a number of other health concerns: risk of addiction to nicotine early on in life; potential harm from nicotine exposure to the developing adolescent brain; and exposure to chemicals associated with adverse health effects. In addition, research shows that, compared with non-users, youth who use e-cigarettes are more likely to transition to conventional cigarettes ‒ risking a lifetime of addiction to smoking and resulting smoking-attributable disease.
To address this growing use among kids, over the past year the FDA has taken enforcement actions to combat the illegal sales of e-cigarettes to youth, and other actions to target kid-friendly marketing that increases the appeal of these products to youth.
From April 2018 through April 2019, the FDA issued more than 3,950 warning letters and more than 665 civil money penalties (fines) to brick-and-mortar and online retailers for illegal sales of electronic nicotine delivery system (ENDS) and e-liquid products to minors. The FDA also took actions – many in conjunction with FTC – against more than 15 firms for selling e-liquids that resemble kid-friendly foods, such as juice boxes, cereal and candy; and the FDA continues to investigate whether companies are introducing new e-cigarettes in violation of premarket authorization requirements.
Last year, the FDA also launched "The Real Cost" Youth E-Cigarette Prevention Campaign – a comprehensive effort targeting nearly 10.7 million youth, aged 12-17, who have used e-cigarettes or are open to trying them. The campaign features hard-hitting advertising on digital and social media sites popular among teens, as well as posters with e-cigarette prevention messages in high schools across the nation. The FDA also joined forces with Scholastic to expand distribution of youth e-cigarette prevention posters to every public and private high school in the U.S. and released new resources for doctors, youth groups, churches, state and local public health agencies, and others on the dangers of youth e-cigarette use.
The FDA has also undertaken efforts to further the discussion and understanding around how we can help aid those kids who are already addicted to the nicotine in e-cigarettes quit. This includes holding a public hearing and a separate scientific workshop to discuss efforts to eliminate youth e-cigarette use as well as other tobacco product use, with a focus on the potential role of drug therapies to support cessation and the issues impacting the development of such therapies for youth.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
SOURCE U.S. Food and Drug Administration