Tobacco and E-Cigarette
Successfully navigate the complex regulations around tobacco and related products — so you can take your business to the top
FDA tobacco product regulation is confusing to say the least. Regardless of whether you’re selling a new tobacco product, vape, e-cigarette, or hookah, there are a number of guidelines you need to abide by.
The Tobacco Control Act regulates disclosure, labeling, manufacturing, distribution, advertising, modified risk, and safety data requirements. Ensure you have detailed knowledge of FDA regulation so you can successfully market and sell your products.
Did you know that the deadline for the Premarket Tobacco Product Applications (PMTA) is coming up in May 2020? Anyone who does not have their PMTA by this date may be taken off the market by the FDA. We provide analysis to help clients understand whether they need a PMTA, and take them through the process of filing their application to get one.
At FDA Atty, our goal is to empower our clients with our expertise. We help tobacco companies gain compliance in a number of areas regulated by the FDA:
- Ingredient, additive, and harmful and potentially harmful constituent disclosure requirements
- Health document submissions
- Good Manufacturing Practice guidance
- Substantial equivalency determinations and exemptions
- Modified Risk Tobacco Product Applications
- Labeling requirements
- Retailer compliance issues
- Tobacco product testing requirements
Get rid of the anxiety around ensuring compliance. We focus on the FDA regulations for you, making sure your business meets the necessary requirements.
How We Help
Are you in trouble with the FDA?
Don’t panic — you’ve got backup. Download 5 Tips to Help You Navigate FDA Enforcement and learn how to resolve the situation now.
Expert knowledge of FDA regulations that helps you strategically grow your business
We retained Marc to answer some extremely time-sensitive and complex questions regarding COVID-19 and FDA regulations. Despite being overloaded with clients, Marc was very responsive and was able to provide us with the comprehensive answers we needed within 24 hours. This enabled us to respond quickly and effectively to the changing regulatory landscape. I strongly recommend using Marc and look forward to working together again in the future.
Marc Sanchez has provided our company with expert advice and letters that have saved us time and money in dealing with the FDA. We have worked with many FDA attorneys and consultants in the past and they can't hold a candle to the knowledge and expertise that we have found with Marc.
Jeff Maier (VP Sales & Marketing)
I am truly impressed… Marc understands the workings of the regulatory agencies and this allows him to very effectively achieve the results that his customers want without creating an environment of confrontation. Beyond that, he has insight into the laws governing foods, supplements, and medicine that goes beyond that of the federal officials involved in these regulatory areas. This allows him to open avenues of compromise and agreement that would not have existed before he was brought to bear on the difficulty. Even as he produces compromise and agreement, it is clear that he holds his customer's interest at heart.
I have never found a more powerful and effective counsel.
Steven Frank CEO
Nature's Rite Remedies
Marc is incredibly intelligent, poised and able to make reasonable, timely recommendations about risk. Additionally, he is extremely organized, has a calm demeanor and has provided insightful counsel to me on many regulatory issues. I strongly recommend him.