It’s been 10 years since the Tobacco Control Act (TCA) granted FDA the authority to regulate tobacco products.
FDA has used this authority to take actions and craft regulations that aim to keep tobacco out of the hands of teens and ensure that consumers aren’t misled or sold illegally marketed products. One of FDA’s crucial public health roles is to make sure that regulated industry is complying with the law. For CTP, this means taking action in response to violations by tobacco product retailers, manufacturers, and distributors. Violations include, but are not limited to:
- Selling or advertising tobacco products to children;
- Selling or distributing adulterated, misbranded, or mislabeled tobacco products;
- Illegally marketing tobacco products with misleading or unsubstantiated claims; and
- Selling or distributing new tobacco products without FDA authorization.
When a retailer, manufacturer, or distributor fails to comply with the law, a number of actions may be taken. With a store or company’s first violation, CTP typically sends a warning letter that lets an establishment know that a violation has occurred. If the violation continues or is repeated, the establishment may receive civil money penalties of increasing values. Finally, for repeated illegal sales to minors by retailers, CTP can issue a no-tobacco-sale order to bar an establishment from selling tobacco at all – first for a limited time, and then permanently if the violations continue.
CTP’s tobacco compliance and enforcement program began almost immediately after the signing of the TCA, with the first warning letters sent in 2009 to 14 online retailers for the sale of flavored cigarettes. Soon after, CTP contracted with the first 15 states under its tobacco retailer inspection program, which has grown to include all U.S. states and territories. Today, FDA-commissioned inspectors across the country conduct tobacco retailer inspections so that CTP can ensure compliance with federal laws implemented by FDA.
In total, CTP has conducted more than a million tobacco retail inspections over the last decade and has issued more than 80,000 warning letters to retailers for selling tobacco products to minors (including more than 7,000 warning letters to retailers for illegal sales of e-cigarette products to kids). CTP has also initiated more than 20,000 civil money penalties and more than 140 no-tobacco-sale orders against retailers.
CTP doesn’t just ensure retailers are complying with the law; it also inspects manufacturing establishments and pursues enforcement action against manufacturers who violate the law. CTP has conducted more than 400 routine inspections of domestic tobacco manufacturers. During these inspections, investigators review, amongst other things, manufacturing procedures (e.g. product testing, process validation, certificates of analysis), supply chain, product marketing status, and packaging, advertising, labeling, and promotional activities. In addition, more than 1,200 vape shop were inspected, whereby inspectors determine the type of activities that are performed at the establishment and compliance with applicable requirements.
Youth use of e-cigarettes increased sharply between 2017 and 2018. As a result, FDA has used its tobacco compliance and enforcement program to take specific actions to address the illegal sale and marketing of e-cigarette products to youth. Most notably, in 2018 FDA initiated the largest coordinated enforcement action in FDA history to crack down on the sale of e-cigarettes to minors at both brick-and-mortar and online retailers, resulting in more than 1,100 warning letters and 130 civil money penalties for the sale of e-cigarette products to minors. FDA also sent more than 40 letters to companies marketing e-liquids with misleading labeling that mimicked food products particularly appealing to children, including juice boxes, candy, cookies, and kid-friendly cereal. Some of these letters were sent as part of a joint action with the Federal Trade Commission (FTC). In addition, FDA and FTC also recently issued warning letters to four firms that make or sell flavored e-liquids for violations related to online posts made by social media influencers on their behalf, including failure to include the required nicotine warning statement.
CTP works hard to make sure retailers and manufacturers understand their responsibility to comply with the law. For example, we educate retailers and manufacturers through regular webinars. These compliance training webinars help industry understand and comply with the law. CTP has developed and posted more than 70 compliance training webinars, many with topics relevant to e-cigarette industry, including small businesses. Further, to help retailers better comply with regulations, CTP launched “This is Our Watch” in 2017, a voluntary retailer education program that provides free tools and resources for owners, managers, and clerks of tobacco retail establishments.
CTP also has an Office of Small Business Assistance that answers questions from regulated industry, consumers, and the general public. To learn more, read the web feature that discusses helping businesses with limited resources comply with the tobacco law. And, visit our Small Business Assistance webpage for additional up-to-date information for vape shops and other small businesses.
CTP’s tobacco compliance and enforcement program plays a vital role in ensuring retailers and manufacturers comply with the law. Learn more at the CTP website.
FDA – July 23, 2019.