Now that the September 9th deadline for PMTA submission has been and gone, what does it mean for the small bricks and mortar vape stores which have been doing business across the US over the past 5 or so years?

Core to many vape stores is their ‘self-mixing’ offering, essentially making them tobacco product manufacturers under the PMTA, and so the question of compliance of such stores is raised; how can a vape store comply with the PMTA in a way which allows it to continue its business?

In our assessment of guidance from the FDA published in June 2019 , there appears to be a life-line thrown by the FDA for such businesses. In order to understand how your store can meet the stringent requirements of the PMTA, it is often helpful to consider the objectives of the regulators in passing such rules. One perspective is that the intention and responsibility of the FDA, as the industry regulator, is to ensure that products which are on the market are safe for public use, and so the question then arises as to how vape stores can sufficiently demonstrate that their products are safe for public use. 

There are two specific tasks vape stores should consider that are crucial in being able to demonstrate PMTA compliance:

In order to demonstrate that products manufactured on a day to day basis in a vape store are consistent with the product submitted to support the PMTA, control over the manufacturing process is essential as required under section 910(b)(1)(C) of the FD&C Act. 

The purpose of implementing a QMS is to ensure product consistency and, at this point, it has been generally accepted that ISO9001 would be the appropriate model to adopt for vape stores wishing to comply with the PMTA. The QMS should consist of a series of inter-related processes detailing how the store goes about its business from how new staff are trained to how the suppliers of ingredients are selected.

The FDA has provided guidance as to the summary of procedures it would expect to have been implemented in order to demonstrate product controls. This does not mean the installation of expensive machinery, but rather a logical approach to what the risks and variables in manufacturing may come from, and how to ensure that any variability or risks are reduced as far as practical. A simple standard operating procedure (SOP) on how to mix an e-liquid would allow all staff to follow the same process and ensure a consistent product is produced, representative of the product submitted as part of the PMTA. 

The purpose of process validation is to see what potential variables in manufacture do to the final e-liquid. An example of this is to consider the difference between 7.1g vs 7.9g of propylene glycol in small-batch manufacturing, would the 0.9g difference result in any difference to the e-liquid viscosity or boiling point? Without process validation, it would not be possible to answer this question with confidence.

There are multiple approaches to process validation, the simplest is to consider the two extremes of manufacture and demonstrate that under both sets of conditions an equivalent product is manufactured. Some areas to consider for process validation include; different personnel, different mixing times, speeds or inversions, significantly different temperatures (from winter to summer) particularly if manufacture is done by volume. 

Manufacturing validation should be conducted under the QMS and be recorded as evidence. This can be conducted in combination with other FDA requirements to reduce costs, such as to investigate the impact of different viscosities or boiling points on the toxicant formation from e-liquids. 

Although the PMTA process set down by the FDA presents challenges to vape stores, with a little pragmatism and hard work there is a pathway for this key part of the industry. It is foreseeable that vape stores who are committed to compliance can comply with the FDA’s intent under PMTA and will continue to play an important alternative for adult smokers. 

We understand the importance of vape stores and are committed to providing pragmatic solutions that will help enable compliance under the PMTA. If you would like further information on our approach please contact info@inter-scientific.com or click here to learn more about our PMTA services.

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