e-cigarettes – FDA Compliance Made Easy https://giannamore-law.com Mon, 09 Sep 2019 17:29:33 +0000 en-US hourly 1 https://giannamore-law.com/wp-content/uploads/2018/01/Untitled.jpg e-cigarettes – FDA Compliance Made Easy https://giannamore-law.com 32 32 FDA Warns JUUL, Alleging Marketing Violations https://giannamore-law.com/fda-warns-juul-alleging-marketing-violations/?utm_source=rss&utm_medium=rss&utm_campaign=fda-warns-juul-alleging-marketing-violations Mon, 09 Sep 2019 17:29:27 +0000 https://giannamore-law.com/?p=1924 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 to Regulate New Tobacco Products, E-Cigarettes https://giannamore-law.com/fda-to-regulate-new-tobacco-products-including-e-cigarettes/?utm_source=rss&utm_medium=rss&utm_campaign=fda-to-regulate-new-tobacco-products-including-e-cigarettes Tue, 06 May 2014 15:09:27 +0000 http://giannamore-law.com/?p=1130 On April 24, 2014, the U.S Food and Drug Administration (FDA) announced its publication of newly proposed regulations pertaining to new tobacco products, as permitted by the Family Smoking Prevention and Tobacco Control Act of 2009. The products covered under the newly-proposed regulations are any tobacco related products that fall under the statutory definition of tobacco products, including presently uncontrolled, advertised products like pipe tobacco, electronic cigarettes (e-cigarettes), nicotine gels, water pipe tobacco, cigars and other related products. While some products, like electronic cigarettes, don’t directly consist of tobacco, these products fall under FDA’s tobacco authority, as promulgated by Congress, in that they are derived from tobacco and/or contain nicotine, i.e., e-cigarettes contain nicotine derived from tobacco and therefore meet the definition of tobacco product under federal law. Currently, the FDA’s final regulations only cover smokeless tobacco, cigarettes, rolling tobacco and cigarette tobacco. More information about the FDA’s announcement may be found here.

Similar to tobacco products previously regulated by the FDA, the new regulations would require product manufacturers and marketers, including marketers of e-cigarettes, to follow certain guidelines, such as the following:

  • FDA registration and reporting of product information
  • Certain new tobacco products can only be marketed after a full FDA review
  • Free samples cannot be distributed
  • Only scientifically proven, direct claims of a decreased health risk, i.e., “smoking e-cigarettes is safer than traditional cigarettes”,  can be made where the FDA is able to verify that the evidence meets a certain level of scientific support

Additionally, the new proposed rules will include certain restrictions on newly-regulated tobacco related products, including e-cigarettes, that apply to marketing and sale of previously-regulated tobacco products, such as the following:

  • Product packaging must list health warnings
  • Identification and minimum age requirements in order to prevent underage purchases
  • Products cannot be sold in vending machines unless the machine is located in a facility does not allow underage youths

The full text of the proposed regulations may be accessed here.

Although new tobacco products like e-cigarettes are not subject to current, final regulations pertaining to other tobacco products, the agency is working hard to gain control over these items, as illustrated through the proposed rule. If and when the regulations pertaining to e-cigarettes and other new tobacco products are finalized, importers and marketers of these products will be required to comply with the various requirements in order to ensure that their products may be marketed in a manner consistent with federal law. Accordingly, product registration and changes in marketing, including revisions to current labeling for e-cigarettes and the like, may be necessary in order to continue doing business in the United States.

If you have any questions about the FDA’s proposed tobacco product regulations or how you can maintain compliance with FDA regulations, please contact us at contact@sglawfl.com.

FDA Lawyer

]]>