FDA delays ingredient listing deadline – with 10 hours to go

Will the FDA ever come up with real standards for vape manufacturers?

2
Delays signal

The FDA has once again delayed an important deadline for vaping manufacturers. The agency announced Tuesday that the requirement for large-scale manufacturers to submit ingredient listings would be delayed six months, until May 8, 2018.

The deadline was today, Nov. 8. 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 due next May 8. Those smaller companies will now have a year to complete this required action, until Nov. 8, 2018.

Since the deeming regulations took effect on August 8, 2016, the FDA has postponed deadlines for several compliance actions — some of them multiple times. The process of registering and submitting product listings exposed how badly prepared the agency was to implement any kind of workable regulation for vapor products.

Why was the deadline delayed?

snail

The current requirement is for a listing of all product ingredients. For e-liquid manufacturers, that means listing each flavoring used in each product, as well as nicotine, and PG and VG. But the system in place for manufacturers to submit ingredient listings — called eSubmitter — is a hopelessly out of date program that tied manufacturers in knots with slothful speed and unnecessary complexity.

The official statement from the FDA’s Center for Tobacco Products (CTP) blames the problems on technical issues. But the real issue if the FDA never taking seriously the idea of vaping manufacturers complying with regulations at all.

The deeming regulations were never designed to provide sensible rules and standards that would allow manufacturers to deliver quality products to vaping consumers. They were intended to demoralize, confuse, and drive out of business the small manufacturers that are the heart of the independent vapor industry.

With new FDA commissioner Scott Gottlieb’s July 28 announcement that the agency would delay the deadline for submission of premarket tobacco applications (PMTA’s), and his promise of actual standards with real benchmarks for filing successful applications, the CTP has been forced to confront the fact that its compliance procedures are wholly inadequate for an industry made up of tens of thousands of businesses and millions of products.

Why does the FDA hate us?

stressed man

The FDA has supposedly worked with vaping manufacturers to streamline the eSubmitter program, making it simpler for vendors to submit listings. That’s nice, but the vast majority of large-scale manufacturers have already spent the time and money to get the ingredient listings submitted on time.

What will probably happen is that the agency will change the whole process between now and next May, when the deadline rolls around again. And then it’ll get changed again, and postponed again. And then again.

The entire deeming process has been one long string of indignities for the small mom-and-pop companies that make up the bulk of the independent vaping industry. First they were “deemed” to be tobacco product manufacturers — a real insult to people who live to help smokers avoid cigarettes — then they were swamped with oceans of red tape and forced to jump through flaming hoops just to do what they were asked to do.

Now they get to wait and wait and wait some more for a herd of uncaring bureaucrats to decide if their small businesses will be allowed to survive. These small companies aren’t tobacco manufacturers at all, but they’ve been treated by the federal government with utter disrespect, in a dismissive way that the real tobacco manufacturers have never experienced.

Jim McDonald

I spend most of my time studying the regulatory, legislative and scientific challenges to vaping, advocating for our right to exist, and talking with others who do the same. Consider me a source for information, and feel free to agree or disagree with anything I say. I love good coffee and sweet Michigan cherries. My childhood hero was Gordie Howe.

  • Tara Caron Antonuccio

    Great article, Jim. I hadn’t even considered manufacturers who already got their ingredients submitted, only to potentially have it all change next year. And you are absolutely correct that vapor companies are being treated worse than tobacco companies ever were.

    • Jim McDonald

      Thanks, Tara!