FDA Seeks Penalties of Up to $11,000 Per Violation from E-Cigarette Companies
On February 25, 2023, the Food and Drug Administration (FDA) announced that it had filed civil money penalty complaints against four e-cigarette product manufacturers for violations related to the marketing and sale of their products. The companies named in the complaints include Juul Labs, Inc., Altria Group, Inc., Fontem US, LLC, and Reynolds American, Inc.
According to FDA, the companies' marketing practices were found to be in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which prohibits the marketing of tobacco products to minors and requires pre-market authorization for new tobacco products. FDA's complaints allege that the companies engaged in marketing practices that targeted minors, including the use of social media influencers and flavored products, and that they failed to obtain the required pre-market authorization for their products.
If the companies are found to be in violation of the FD&C Act, they could be subject to civil monetary penalties of up to $11,000 per violation, as well as other enforcement actions.
FDA's actions against these four e-cigarette manufacturers highlight the agency's commitment to enforcing regulations on the marketing and distribution of ENDS products. As the regulatory landscape continues to evolve, it is important for businesses in the vapor industry to stay up-to-date with the latest developments and seek legal guidance to ensure compliance and protect their interests.
For businesses in the vapor industry who may find themselves in a similar situation, these penalties could have significant financial and legal implications. Businesses may face regulatory action, litigation, and damage to their reputation and brand. In addition, businesses that have received warning letters from FDA may be at risk of further enforcement action.
Have you received a warning letter from FDA? Are you concerned about the threat of one or other enforcement action? We can help you understand your legal obligations and options, as well as develop compliance strategies to ensure that your products comply with FDA regulations. Have additional questions? Give our office a call today.
Ready to Learn More About CBP, OFAC,
BIS, FWS, and FDA?
We have dozens (literally!) of videos in our educational library on our YouTube channel related to importing, exporting, US Customs, BIS, OFAC, FWS, FDA, NFTs, and so much more. Subscribe to our channel now to stay up to date on the latest on these topics!
Our law firm helps growing companies who import and export comply with government regulations. We love what we do and we take our oath of confidentiality over your matters very seriously. How much? Watch this video to learn about it. CLICK HERE
Wondering "why should you have an attorney on your side?" Click here to watch one of our attorneys, Susan Steinman, break down the critical benefits as to why you want to have one on your side - whether you hire us to help you or another law firm.
Have questions? We are determined to help you.
We listen carefully to clients to ensure our understanding of the legal issues at hand, their factual context, and any limitations that might impact a chosen strategy. Feel free to connect with us using the contact form at the bottom of the Home page or send us an email at firstname.lastname@example.org.