Abboud went on to say that no business should be expected to have conducted the tests required by the PMTA requirement without proper guidance. While the FDA did publish a guidance document for vapor manufacturers to follow for the PMTA process back in June 2019 [read more here], the earlier deadline leaves many companies scrambling to conduct all the necessary tests necessary to file the PMTA. Many questions about the process and its requirements, however, have gone left unanswered and to comply will require more resources than some companies have available to them. This is why Vapor Stockroom, a manufacturer based in Lexington, Kentucky, also joined in on the lawsuit.
“Our company complied with every regulation imposed by FDA and invested in our business while waiting for FDA to deliver on all of the promised PMTA rules, guidance and standards,” commented Tony Florence, President of Vapor Stockroom, LLC. “We never thought that FDA would wait so long to provide any direction and then immediately shrink the deadline so that we had no chance to stay in business. It’s a devastating one-two punch to small businesses all over the country.”
Abboud warns of the devastating impact the PMTA process could have on many businesses if the FDA isn’t challenged. The VTA an VSR are being represented by Thompson Hine LLP and the case is titled Vapor Technology Association, et al. vs. Food & Drug Administration. The filing can be viewed here.
For all the latest news from the Vapor Technology Association, visit vaportechnology.org.
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