The Premarket Tobacco Application (PMTA) was rolled out on August 8th, 2016. This means new responsibilities for the Food and Drug Administration (FDA). The organisation must deliver market authorisations for any product in the electronic cigarette sector. The FDA has stated this is an impossible task that will slow down the organisation and hinder its effectiveness.
Given the unknowns in terms of long-term effects of vaping, the FDA needs more time to study the issue. This is why the FDA asked for the PMTA roll-out to be delayed to the year 2021.
With these requests for more time, many American public health organisations are losing patience. The American Academy of Pediatrics and the Campaign for Tobacco-Free Kids have teamed up to sue the FDA, accusing the organisation of allowing vaping to take hold in teen populations. The FDA is accused of not taking its responsibilities seriously.
A victory for anti-vaping organisations?
On May 15th, judge Paul Grimm sided with the health organisations, convinced that the FDA’s “reaction was so slow it amounted to a total failure of responsibility”.
As a result, the FDA has been forced to submit a PMTA roll-out plan within a two week period. The anti-vaping health organisations must also submit similar plans. Once the documents have been received, the judge will decide on a deadline for PMTA application.
This decision caused a great outcry from the vaping community. Worried, e-cig manufacturers hope to get some guidance in these troubled times, to maintain production while staying in line with regulations. Testing protocols will most likely be too expensive for smaller companies. Professionals in the sector are hoping that the FDA will appeal the decision.