In May 2016 the Food and Drug Administration issued a final rule “deeming” that e-cigarettes as well as hookahs, and pipe tobacco, and nicotine gels, as well as other tobacco products that have yet to be invented, would be subject to FDA regulation, in the same way that cigarettes and cigars are. You may have heard this in the news, or on your favorite vape site – it’s often referred to as the vapocalypse. Part of the new regulation was that any e-cigarette products, including vape juice, that were not on the market prior to August 2016 would need to undergo FDA approval for sale to the public. The FDA understood that many of these products were new to the market and that the required approval process would require significant time and money, so they told the vaping industry that the products on the market as of August 8, 2016, would be required to obtain testing and approval no later than August 8, 2022.
According to the FDA website, the agency “regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of ENDS [electronic nicotine delivery systems], including components and parts of ENDS but excluding accessories.” These include everything from vape juice and pods to batteries, cartridges, and flavorings.
(However, this does not apply to vape products specifically marketing to help those quitting smoking – those products, including nicotine gum and the patch, are regulated by the FDA through the Center for Drug Evaluation and Research.)
One of the regulatory hurdles the vaping industry faced was the reporting deadline for FDA e-liquid compliance, and the fact that the FDA had not yet issued final guidelines or regulation for required reporting of Harmful and Potentially Harmful Constituents (HPHC).
The Vapor Technology Association (VTA), a national trade association representing vaping manufacturers, wholesalers, and small business owners, pressed the FDA to extend its deadline on HPHC reporting until clear guidelines or regulation had been released on what they were supposed to be testing for, and how those tests were to be conducted, among other things.
Last week, the FDA announced “This revision extends the Harmful and Potentially Harmful Constituents (HPHCs) reporting compliance date to a date that is six months after the publication date of a final guidance regarding HPHC reporting under section 904(a)(3) and nine months after that publication date for small tobacco product manufacturers.”
The Family Smoking Prevention and Tobacco Control act defines “small tobacco product manufacturers” as those manufacturers “that employ fewer than 350 employees” — which applies to much of the vaping industry.
A VTA spokesperson said in a statement, “while the extensions of time are shorter than we asked, (and beg the question of how it would be possible to complete the significant amount of testing that might be required within 6 or 9 months), FDA clearly heard the message that we need clear guidance or a final regulation before testing is undertaken and completed. This development is very significant since it removes the immediate, imminent and onerous burden with which so many companies have been struggling. It is unclear when FDA will come out with its HPHC final guidance. That could happen at any time but given the track record and given the changeover at FDA it could also take some time.”
That last part is important — while the guidance could come at any time, the FDA has often moved at a pace best described as “glacial”. There’s a fair chance we might not see these guidelines until August, 2022 — giving manufacturers extra time beyond the set deeming date to get into compliance.
Soupwire will continue to bring you the latest vape news on this FDA e-liquid compliance story as it develops