FDA ENDS Regulations & Authorization
To create or modify a new tobacco product, including e-juice/e-cigarette brands and vape juice or vape flavor ingredients for Electronic Nicotine Delivery Systems (ENDS), you need to comply with newly released FDA tobacco regulations and undertake Premarket Tobacco Product Application (PMTA) testing.
Before marketing the product, manufacturers must first obtain authorization from the FDA, per the Federal Food, Drug, and Cosmetic Act (FD&C) section 910(a). The FDA guidance released in June 2019 provides clarification on a number of requirements, and to help you with your PMTA authorization, we’ve outlined some of the most critical information.
ENDS PMTA Deadlines
The FDA has extended deadlines for new tobacco products that were on the market as of August 8, 2016, several times. In a final ruling, as of May 10, 2016, two compliance deadlines for obtaining FDA authorization were outlined: One for submission and FDA receipt of applications and one for obtaining premarket authorization.
In June of 2019, the FDA released the long-awaited guidance on PMTA for ENDS. It is unlikely that the FDA will enforce regulations during the extended compliance period. The new compliance deadlines are:
- August 8, 2021 for newly regulated combustible tobacco products
- August 8, 2022 for newly regulated noncombustible products
With the release of the June 2019 FDA guidance on PMTA for ENDS, the time frame to submit to the FDA is now rapidly approaching.
Avomeen is a US-based, FDA-registered testing lab and our scientists are ready to assist e-liquid, e-cigarette, vape flavor, and ENDS manufacturers navigate the ever-changing regulatory landscape and prepare for timely compliance. Are you ready to start planning your PMTA strategy? Let’s talk.
Who and What Has to Comply with the June 2019 PMTA ENDS Guidance?
The final rule extends FDA’s tobacco product authorities to all products, other than accessories of deemed tobacco products, that meet the statutory definition of “tobacco” product” in section 201(rr). As ENDS products meet the definition of “tobacco products”, the PMTA authorities apply to the components and parts of ENDS delivery systems that supply aerosolized e liquid when inhaled.
An ENDS retail establishment (or a vape shop) that mixes or prepares combinations of liquid nicotine, flavors, or other e-liquids for direct consumer use in ENDS devices meets the definition of tobacco manufacturer and is also subject to PMTAs.
How PMTA Guidance Applies to ENDS Products-Related Accessories
The PMTA authorities do not apply to ENDS products-related accessories which are not included in finished ENDS products:
- Vape pens
- Personal vaporizers
- Digital displays/lights to adjust settings
- Tank systems
However, when these accessories are included in a finished ENDS device, they are governed by PMTA.
The FDA will enforce the requirements of section 910 to tobacco products, including components and parts of ENDS products sold or distributed separately for consumer use, which are different than the accessories listed above. They do not intend to enforce these requirements for components and parts that are deemed for further manufacture into finished ENDS products.
An e-liquid or vaping flavor that is sealed in final packing that is to be sold or distributed to consumer for use is considered a finished tobacco product.
Regulating ENDS Marketed for Therapeutic Purposes
If an ENDS product that is directly marketed for tobacco cessation or for any other therapeutic purpose, this product would be considered a drug or medical device and would be subject to the authority of CDER (Center for Drug Evaluation and Research) or CDRH (Center for Devices and Radiological Health). The product would require their approval as a drug or device.
How Can Avomeen Help?
Avomeen is an independent testing lab proudly serving entrepreneurs, manufacturers, distributors, lawyers, other laboratories, and companies of all sizes. We are experienced with new testing standards pertaining to the e-liquids/e-cigarettes and the FDA’s Premarket Tobacco Application (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.
FDA is actively enforcing PMTA guidance. Check out our blog, FDA Issues Warning Letters for E-Liquid Products without Marketing Authorization, for more details.
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.
In January of 2020, FDA banned flavored e-cigarette cartridge products. Learn more in our blog.
Unsure how you’re going to meet PMTA submission deadlines and comply with 2-year stability requirements? Look to our blog for more information.
Our expert blogger is Dr. Derek Beachamp, Avomeen’s Senior Technical Director of Analytical Sciences. His PMTA regulatory pathway expertise has been featured in industry publications including Vapor Voice and Smoke & Vape Business Solutions.
Learn more about Derek’s expertise and experience.