FDA Regulation of Tobacco Products: Then
The road to tobacco regulation has been a long one for FDA. Although the public health consequences of tobacco usage had been observed for several decades, FDA was not very involved in the regulation of tobacco products until 1996. In 1996 FDA issued the “FDA Rule,” a set of regulations that aimed to reduce children’s exposure to tobacco. However, tobacco companies sued, claiming that Congress had not given FDA regulatory authority over tobacco products. It was 2009 when Congress passed the Family Smoking Prevention and Tobacco Control Act, which gave FDA the authority to regulate the manufacturing, distribution, and marketing of tobacco. This Act, among other provisions, required that tobacco companies include warning labels on advertisements and disclose detailed ingredient information to FDA.
On May 10, 2016, FDA published its tobacco deeming regulations, which extended its authority over tobacco products. In the regulations, FDA stated that its authority extends to all products derived from tobacco and their components and parts, including e-cigarettes, cigars, hookah tobacco, pipe tobacco, and e-liquid products containing nicotine extracted from tobacco leaves.
FDA Regulation of Tobacco Products: Now
FDA recently announced its intention to shift resources to focus on combating the harmful effects of tobacco use through the development of regulations to reduce nicotine levels in combustible tobacco products. The new comprehensive plan for the development of tobacco and nicotine was announced by the commissioner and in a press release on July 28, 2017. In the press release, FDA stated that it aims to protect public health by reducing risks from nicotine products like cigarettes and encouraging the development of safer nicotine delivery systems. As part of its multi-year plan, FDA intends to seek input on a variety of topics in the hopes of making tobacco and nicotine products less addictive, toxic, and appealing to children.
The agency also acknowledged that nicotine delivery products come with varying levels of risk. It will be issuing requests to the public for information on various nicotine-related topics, including how to limit children’s exposure to liquid nicotine, the role of flavors in attracting youth and in aiding smokers to switch to less harmful products, the patterns of use and health impacts from premium cigars, and the benefits and adverse effects of reducing nicotine in combustible cigarettes. FDA will also work on increasing the performance and use of approved medicinal nicotine products intended to assist smokers in quitting.
In alignment with its declared intention to focus more on nicotine reduction, FDA has extended certain compliance deadlines for newly regulated tobacco products on the market as of August 8, 2016*. The revised deadlines are August 8, 2021 for combustible product applications and August 8, 2022 for ENDS or e-cigarettes. FDA expects that manufacturers will continue to market their products while they review product applications. The release also states that FDA will issue regulations enumerating required information for Premarket Tobacco Applications (PMTAs), Modified Risk Tobacco Product (MRTP) applications and Substantial Equivalence reports, as well as rationales and procedures for reviewing PMTAs for ENDS.
With increased focus on nicotine addiction, FDA is addressing a substantial public health issue and further defining its regulatory regime. FDAImports.com has regulatory specialists and attorneys that can assist clients in navigating the regulatory landscape of tobacco and nicotine products. For information on how we can help you and your business, contact us at contact@fdaimports.com.
*The new enforcement policy will not affect compliance deadlines for cigarettes and smokeless tobacco, only the requirements for the newly-regulated tobacco products like cigars and e-cigarettes.
