The FDA has once again delayed an essential deadline for vaping manufacturers hours before the deadline. The agency announced on Tuesday (November 7th, 2017) that the requirement for large-scale manufacturers to submit ingredient listings would be suspended six months, until May 8, 2018.
The deadline was yesterday, November 8th, 2017. The FDA announced the delay less than 10 hours before the listings were due.
Listings for small-scale manufacturers, those with fewer than 150 employees or sales under $5 million per year were anticipated next May 8th, 2018. Those smaller companies will now have a year to complete the required action until November 8th, 2018.
Since the considered regulations took effect on August 8, 2016, the FDA has postponed deadlines for several compliance actions and in some cases multiple times. The process of registering and submitting product listings revealed how poorly prepared the agency was to implement any useful regulation for vapor products.
Why did the FDA delay the deadline?
The current requirement is a listing of all product ingredients. For e-liquid manufacturers, that means listing each flavoring used in each product, as well as nicotine, PG, and VG. However, the system in place for manufacturers to submit ingredient listings called eSubmitter is an incredibly out of date program that has so much complexity that manufacturers find challenging to complete.
The FDA’s Center for Tobacco Products (CTP) official statement blames the problems on technical issues. With this additional delay and the complexities imposed we can only assume that the FDA is not taking the idea of vaping manufacturers complying with regulations thoughtfully.
It appears that the regulations were never designed to provide sensible rules and standards to enable manufacturers to deliver quality products to vaping consumers. They were intended to discourage, frustrate, and force out of business small the manufacturers that are the core of the independent vapor industry.
Following the July 28th announcement of FDA commissioner Scott Gottlieb that the agency would delay the deadline for submission of premarket tobacco applications (PMTA’s). His promise of producing actual standards with real benchmarks for filing successful applications, the CTP has been forced to face the fact that its compliance procedures are entirely inadequate for an industry composed up of tens of thousands of businesses and millions of products.
Why does the FDA despise the vaping industry?
The FDA claims to be working with vaping manufacturers to streamline the eSubmitter program and make it simpler for listings to be submitted. The fact is that a substantial majority of large-scale manufacturers have already spent the time and money getting the ingredient listings submitted on time.
What this means for the smaller companies, which make up the majority of the independent vaping industry are overwhelmed with red tape and have to jump through hoops while being branded tobacco product manufacturers which comes as a real insult to those who aim to help smokers avoid cigarettes.
Based on past performance, what is likely to happen is that the agency will change the entire process between now and next May when the deadline rolls around again. Then they will change it again and again and then delay some more ensuring that the smaller manufacturers will not be allowed to survive.