FDA Warns JUUL, Alleging Marketing Violations

Mon, 09 Sep 2019 17:29:27 +0000

On September 9, 2019, the U.S. Food & Drug Administration (FDA) issued a Warning Letter to JUUL Labs, Inc. (JUUL), in connection with the marketing of its exceedingly popular e-cigarette products. According to the FDA, JUUL is alleged to have marketed its products in violation of federal laws by marketing its products as modified risk tobacco products without prior authorization from the FDA.

Under federal law, a “modified risk tobacco product” is a product whose label or advertising represents that the product presents lower risk of tobacco-related disease or is less harmful than other commercially-available products. 21 USC 387k. In order to legally market a product as a modified risk tobacco product (MRTP), an order must first be issued by the FDA permitting the marketing as a MRTP. To date, FDA has not issued a single MRTP order.

According to the FDA’s Warning Letter, found here, JUUL representatives allegedly made statements suggesting its products were safe and were safer than cigarettes. If made, these statements would cause JUUL’s products to be marketed as MRTPs, in violation of federal laws and FDA requirements. As with all warning letters issued by the FDA, the Company has 15 business days to respond to the allegations.

The FDA regulates tobacco products under the Family Smoking Prevention and Tobacco Control Act (Act), which was signed into law by President Obama in 2009. The Act grants FDA the authority to regulate various tobacco products, including electronic delivery nicotine systems or “ENDS”, like JUUL products. ENDS and all covered tobacco products must meet FDA requirements, including labeling and marketing requirements and in many cases premarket notification or authorization requirements. If you have questions about marketing tobacco products, please contact us at contact@sglawfl.com.

FDA Warning Letters for Alzheimer’s Supplement Claims

Sun, 03 Mar 2019 20:44:43 +0000

On February 11, 2019, the U.S. Food & Drug Administration (“FDA”) published a warning to the public entitled “FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer’s disease” (“FDA Warning”). Found here, the FDA Warning notifies the public of recent FDA Warning Letters dietary supplement marketers for products claiming to prevent, treat, or cure Alzheimer’s disease. According to the Warning, FDA has recently issued 12 FDA warning letters and 5 online advisory letters to companies who are marketing over 58 products labeled as dietary supplements but promoted to treat Alzheimer’s disease.

Under the Federal Food, Drug and Cosmetic Act (“the Act”), products that are promoted for the prevention, treatment and/or cure of diseases are deemed drug products. 21 USC 321(g). This means that products that may otherwise be marketed as dietary supplements, including those that have “Supplement Facts” labeling and those containing only botanicals and vitamins, would be classified as drugs if they are marketed for disease treatment. Accordingly, it is important to ensure that dietary supplements are properly marketed in order to avoid classification as drug products and avoid FDA action.

When developing a product it is important to ensure that all claims made in labeling comply with federal law and regulations enforced by the FDA. If you have any questions about how you can market products in compliance with the laws and regulations enforced by the FDA, please contact us at contact@sglawfl.com.

fda warning letters – FDA Compliance Made Easy

FDA Warns JUUL, Alleging Marketing Violations

FDA Warning Letters for Alzheimer’s Supplement Claims