On July 28th, the FDA issued a warning letter to Visible Vapors, based in Pennsylvania, advising them that continued sale of products that lack an FDA PMTA application is illegal. Visible Vapors has over 15 million e-juice products registered with the FDA but did not submit a PMTA by the September 9th, 2020 deadline.
Any vape products that lack an active PMTA are illegal to sell in the United States. However, many companies have continued to sell illegal products in defiance of the FDA--that is, until they get caught. The website of Visible Vapors had already gone dark by the time the FDA warning letter hit the news.
The FDA is monitoring and conducting surveillance of companies participating in this black market and had issued 131 warning letters as of June, covering 1,470,000 vape liquids. However, many vape companies who are playing by the FDA rules, and shouldering tremendous costs and regulatory burdens at a time when many businesses are already suffering, feel FDA is not doing enough.
The vape juice black market is still booming and illegal sales are diluting the sales of honest companies. The pain is real. Bringing products through the FDA PMTA process costs hundreds of thousands to millions of dollars with no guarantee of success. With so many vape companies struggling to afford these costs, the black market represents a real threat to the industry.
In a seeming nod to the industry, the FDA stated in a press release announcing the Visible Vapors warning letter:
"The FDA wants all tobacco product manufacturers and retailers to know that we continue to watch the marketplace very closely and will hold companies accountable for breaking the law."
Let's hope the FDA cleans up the black market quickly enough to enable the honest players to survive.