On August 8, 2019, FDA issued warning letters for 44 flavored e-liquid and hookah tobacco products, notifying 4 companies that the cited products can’t be legally sold in the U.S. because they don’t have the required marketing authorization. In a recent press release about the enforcement of Electronic Nicotine Delivery System (ENDS) and hookah tobacco products, FDA cited their ongoing, aggressive efforts to investigate and take action against illegally marketed tobacco products in the midst of the youth e-cigarette use epidemic.
FDA Issuing Warning Letters for E-Juice and Hookah Tobacco Products without Market Authorization
All of the e-juice and hookah tobacco products cited in the FDA warning letters were released to the market or modified after August 8, 2016, the date that FDA’s authority was extended to all tobacco products.
How E-Liquid and Hookah Tobacco Companies Respond to FDA Warning Letters
In this case, the four companies who received warning letters must respond to FDA within 15 working days, and the response must include:
- How they plan to address FDA’s concerns
- The dates they stopped selling/distributing the E-liquid and tobacco products in question
- Their plans for staying in compliance with the Federal Food, Drug, and Cosmetic Act’s (FD&C Act) premarket requirements
What Happens to ENDS Companies if FDA Violations Aren’t Corrected
A failure to correct violations may result in further action from the agency, including fines for the ENDS companies or judicial actions being taken against the e-cigarette manufacturers/distributors, including seizures or injunctions. Additionally, any adulterated or misbranded products that are imported into the U.S. can be refused entry, and can also be detained.
FDA Has Taken Action Before on E-Juice, E-Liquids, E-Cigarettes, and Vape Flavors
FDA sent letters to nearly 90 companies previously, specifically looking for information about more than 130 ENDS products, requesting evidence the products in question were legally marketed. As a result of this FDA inquiry, a number of companies have withdrawn products from the market.
How to Avoid an FDA Warning Letter for Vape Products
The only way to avoid an FDA warning letter for selling or distributing E-liquid, E-cigarette, ENDS, and vape juice products for the same reason – not having required marketing authorization – is to comply with regulatory requirements by obtaining Premarket Tobacco Application (PMTA) approval. A comprehensive PMTA must be submitted to FDA for review before any approval or authorization can be granted. With filing deadlines quickly approaching and FDA actively enforcing the guidance, now is the time to find the right partner to complete a successful PMTA.
How Avomeen Can Help
Avomeen is an independent testing lab proudly serving E-cigarette, vape juice, E-liquid, E-juice, and ENDS manufacturers, distributors, consultants, other laboratories, entrepreneurs, and companies of all sizes. We are experienced with new testing standards pertaining to the e-liquids/e-cigarettes and the FDA’s PMTA requirements.
We customize our approach for every customer we serve and offer full support for your projects. Our regulatory consultants can aid your team in their efforts to gain FDA approval, both during and after a project is completed. Get in touch with us to discuss your project.
To help you understand some of the important methods and relevant equipment required for e-liquids testing, we’ve put together some Cliff Notes to help you navigate this complicated environment.
Want to know more about the new PMTA guidelines? Check out our blog, What You Need to Know About the FDA’s New PMTA Guidance.
We’ve outlined the major similarities and differences between the 2016 and 2019 PMTA guidance in our blog, Overview of Premarket Tobacco Application (PMTA) FDA Guidance for ENDS.
The 9 most commonly asked questions about PMTA requirements are answered in our blog, 2019 FDA PMTA Guidance FAQs.
Is finding the right lab to partner with stressing you out? Our blog, Choosing the Right Lab for PMTA Compliance, offers some guidance.
Extractables & Leachables (E&L) testing is required in the new PMTA guidance. Our blog, E-Liquids Extractables and Leachables Testing for the PMTA, outlines what you need to know about this integral part of the submission.
Want to know more about bridging studies and how they’re utilized in the PMTA? Check out our blog, The Use of Bridging Studies in the PMTA.
With the court ruling on July 11, 2019, the deadline for submissions has been moved up significantly. For more information, check out our blog, ENDS Industry Faces Tighter PMTA Deadlines with May 2020 Fast Approaching.
We’ve outlined some common regulatory strategies that have emerged amongst leading ENDS manufacturers in our blog, Will my E-Liquid Product Receive PMTA Authorization?
Concerned about state-led e-liquid bans? Check out our blog, Proposed E-Liquid Bans and the PMTA, for insight into how state-led policies are impacting submission strategies.
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