On August 11, the U.S. Food and Drug Administration (FDA) AmarilloSnuffCoFCo Snuff, Inc. issued a warning letter due to the business’s manufacture, marketing, and distribution of unauthorized smokeless tar merchandise, including merchandise made from corn cobs instead of tobacco. Because these unauthorized merchandise contain non-cigarette tar, the FDA regulates tobacco merchandise including any source of smoking tar.
Dr. Brian King, director of the FDA’s Center for Tobacco Products, said, “Last year, Congress clarified FDA’s authority to regulate tobacco products, including any tobacco product, which eliminated the regulatory loophole that some companies were trying to avoid. He said, “We have clear jurisdiction over these products, and the FDA is committed to holding those responsible for illegal goods accountable for their behavior.”
A requirement of the Federal Food, Drug, and Cosmetic Act for the legal marketing of new cigarette merchandise is that the merchandise referred to in the warning letter lacks FDA marketing authorization. As of today, the FDA has not authorized any non-tobacco nicotine products. Therefore, all non-cigarette tar products on the market are illegally marketed.
Typically, FDA issues a warning letter when an investigation or inspection first reveals a violation. In order to achieve voluntary compliance, recipients of warning letters are required to respond within 15 business days with steps they will take to correct and prevent future violations. However, failure to promptly correct a violation may result in other actions by the FDA, such as injunctions, seizures, and/or civil money penalties.
“Most companies that receive a warning letter will correct their violations, but if they fail to do so, those products will be subject to enforcement action,” said AnnSimoneau, director of CTP’s Office of Compliance and Enforcement. “FDA will continue to pursue enforcement actions, including injunctions and civil monetary penalties.”
Today’s warning letter is the latest action in the FDA’s efforts to combat the marketing of illegal non-tobacco nicotine products in the tobacco product supply chain. As of July 28, 2023, FDA has issued nearly 600 warning letters to manufacturers of illicit tobacco products, with more than 100 of those letters targeting illicit non-tobacco nicotine products. On the retailer side, as of June 30, 2023, FDA had issued more than 2,800 warning letters and 825 civil penalties to underage retailers selling e-cigarette brands, including more than 1,000 warning letters and more than 140 civil penalties, as well as illegal sales of non-cigarette and tar products to minors.
【1】FDA Warns Firm Responsible for Illegal Smokeless Products Made With Non-Tobacco Nicotine