Faced with fast-changing compliance issues for e-cigarette manufacturing...

...a major e-liquid manufacturer needed to carry out extensive studies to support their regulatory objectives and submissions for the PMTA approval process. How did they succeed?

They needed to test for all relevant HPHCs in every flavor of e-liquid they had on the market to date.

The Problem

A major e-liquid manufacturer needed to carry out extensive studies to support their regulatory objectives and submissions for the PMTA approval process.

The Assignment

Recommended as a consultative problem solver with deep experience in e-liquids, Quantum Analytics Group was asked to meet with the manufacturers stakeholders to spearhead the project.

In a phased approach, Quantum agreed to provide methods, validation and findings for the FDA submission. Phase 2 would include assistance with the final documents and additional regulatory advice.

What would the price of re-formulation cost?

The Challenge

The client had real concerns about outcomes. Would the same e-liquid they produced now pass the more stringent FDA tests? Would other, more dangerous chemicals be found in the liquid?

The Issues

Even though staff and equipment were readily available, the client team was unclear on the best approach to this kind of testing.

The in-house lab team was unfamiliar with the typical processes, timelines and expenses associated with an analytical project of this size.

How long would it take to test every product they produced? And how long would method validation take before being included in the regulatory file? Do we even have a chance to make the May, 2020 deadline?

The Timing

The elephant in the room was the looming deadline for FDA submission.

The Approach

“In this kind of high-pitched analysis, it’s best to keep things as simple as possible…and keep the regulatory objectives in mind – always”.

“The dunning requirements were quite clear…our experience has taught us to first and foremost control what’s there and don’t stray from the real goal”.

“The fact that these compounds can be analyzed by compound-specific methods which DON’T require complex sample manipulation, such as derivation, was a breakthrough for the time/cost concerns of this client”.

The Solution

For the tests, Quantum analyzed samples of each e-liquid by several compound-specific methods including gas chromatography-mass spectrometry and HPLC with UV detection.

The Work

“During the actual testing, our equipment scanned at a ppb level so that any new compounds, outside the 33 that we knew, could easily be identified - the accuracy of this tool makes it a great identifier”.

“We used 2 mass-spec procedures that can ID any compound which we normally wouldn’t look for. With this, anything outside the ordinary gets picked up”.

“This is an invaluable in-house resource that provides solid assurance that other compounds were not present in any of the findings”.

More Work

“We use the most current NIST spectral library to analyze any peaks that stood out from the GCMS analysis”.

The Insight

“We knew exactly which 33 compounds we were dealing with out of the 93 that the FDA had identified as HPHCs…and we knew which methodologies would work right off the bat. That’s just pure experience”.

Each method was designed fit for purpose...so validation was streamlined and gave the FDA exactly what they were looking for.

The Result

All testing has been completed and the data has been filed with the FDA with 6 months lead time before the deadline.

No additional compounds were identified from any of the tests.

The Value

The appropriate and timely submission of the forms – especially in this high-profile scenario – was important to this company in lieu of media volatility and their need to be aligned with new, and changing regulations.

A highly experienced and consultative analytical laboratory can save a manufacturing company millions.

Call (800) 448-2968 for more information on our Consulting and Testing Services