As the September 9, 2020 PMTA deadline draws near, many ENDS companies are either already working or starting to work through the testing and application process. We’ve been in communication with a large number of companies over the last few weeks, and it’s becoming clearer the stresses of navigating the overall process combined with the impending time and cost pressures are weighing heavily.
Join Avomeen’s Consortium Program and Save on PMTA Testing Costs
To help minimize the overall cost burden for analytical testing, we have formed a consortium program of companies looking to begin or expand the PMTA process. By grouping companies to test their respective products at the same time, we are able to achieve economies of scale due to the overall volume as well as reduced setup time (as opposed to testing individually). As a result, we pass the cost savings on to you. Our goal is to apply our expertise to help bring safe and high quality ENDS products to the consumer, and we’re ready to partner with you!
How the PMTA Consortium Program Works
Request More Information
- Fill out our online form to get more information – just write “PMTA Consortium” in the “message” field
- A member of Avomeen’s Business Development (BD) team will provide FAQs and preliminary information
- After reviewing preliminary information, if you’re interested in pursuing the opportunity further, connect with your BD contact
- Provide your BD contact with the number of SKUs/flavors you’re looking to have tested, and they’ll email you a quote
Confirm Intent & Partner Up
- Confirm your intent to partner with Avomeen by providing a signed quote and/or Letter of Intent (LOI)
- Refer others to Avomeen for testing (you may be eligible for a referral bonus)
Enjoy Volume-Based Pricing
- You’ll be grouped with others that sign-on within a 15-day timeframe from your signing date
- Cost savings will reflect the number of companies in the consortium; a revised quote with volume-based pricing will be provided
Looking for more information about the program?Learn more in our 'How-it-works' guide
Q: What types of nicotine products does Avomeen have experience testing?
Avomeen has experience testing ENDS devices, e-liquids, and nicotine alternative products, including nicotine salts, pouches, chewing bags, lozenges, and gums. We can test both aerosolized and liquid vape formulations.
Q: Does it really make a difference if the lab I work with is FDA registered?
As an FDA-registered lab, Avomeen has nearly a decade of experience of working with FDA regulatory submissions, including PMTA submissions. We understand how regulatory agencies and regulatory submissions work.
Q: Why test now? The PMTA deadline has been pushed back before.
FDA is cracking down and prioritizing enforcement of PMTA regulations. If you wait until the deadline passes, you’ll be considered non-compliant and will be facing potential penalties including product seizure and fines. The PMTA filing deadline is quickly approaching, and if you start generating data now, you’ll be in better standing with FDA when the September 9, 2020 filing deadline is reached.
Q: What is HPHC testing, and how is it performed?
HPHCs, or Harmful or Potentially Harmful Constituents, is a list of chemicals or components of the product the FDA has determined are harmful for consumers if there are certain levels of exposure. Per the FDA guidance, Avomeen will test each SKU/flavor for HPHCs in both liquid and aerosol form.
Q: If a stability study takes several months, how can I submit my PMTA by the deadline?
The FDA will allow your initial PMTA submission (which includes the majority of the required analytical data) prior to the completion of a stability study as long as a commitment is made to provide additional data throughout the stability study until completion.
Q: What is Extractables and Leachables (E&L) testing, and why is it required in the PMTA?
E&L testing is a thorough analysis of the product container or any other item that comes into direct contact with the end product to determine if any there are any harmful ingredients that can affect the quality and safety of the product when used by the consumer.
Q: Is there a way to minimize the testing required if I have multiple nicotine strengths and/or sizes of container for each e-liquid?
In the June 2019 final guidance for PMTA submissions, the FDA specifically calls out bridging studies as being allowed and also provides more clear definition and direction for the use of bridging studies in a PMTA. Bridging studies may now be included in a PMTA submission for toxicology and clinical data. Additionally, bridging studies may be completed to support the analytical testing section of the PMTA for e-liquids at different nicotine strengths. To learn more about bridging studies, check out our blog.
Do you have questions about FDA requirements and your PMTA?Get In Touch With Us and Talk To Our Experts