American retailers of e-cigs and vaping technology are beginning to see a light at the end of the FDA tunnel of over-regulation. Late yesterday afternoon, headlines of “Congress saves vaping” began to appear all over social media after the House Appropriations Committee passed an FDA amendment to the highly controversial regulatory proposal. As vapers breathe a sigh of relief, the amendment is heading to the Senate for a vote.
The original version of the FDA regulations required all electronic cigarette devices to adhere to certain “deeming regulations,” the most severe of which was the need to complete a Pre-Market Tobacco Application (PMTA) process for all products that came to market after the predicate date of February 15, 2007. The process would have potentially cost retailers perhaps millions of dollars per device, and approval could take several years, if it ever came at all. In fact, according to Committee Chairman Re, Robert Aderholt, only one product in the past six years has successfully passed the PTMA approval process.
For an industry whose technology is advancing by leaps and bounds, the combination of excessive PMTA fees-per-product and an approval process that has no predetermined timeline would be a death sentence. As vape shop owners, retailers, wholesalers, and distributors took to the Internet to express their outrage, the proposed FDA regulations stalled on Capitol Hill for several months – until yesterday.
Perhaps partially due to the public outcry, Rep. Tom Cole of Oklahoma proposed an FDA amendment that would change the previous predication date to the date of the FDA’s final deeming ruling, which should occur sometime within the next month. The amendment passed by a margin of 31-19. By simply changing the predicate date, it is estimated that over 99% of all vaping products currently on the market will be saved from the threat of a costly and lengthy PMTA approval process.
The new FDA amendment also contains new wording that requires a few other responsibilities for the vaping industry:
- A requirement for the development, implementation, and enforcement of consumer safety regulations regarding e-cig batteries.
- A requirement to label all vaping products with the warning, “underage sale prohibited” and “keep out of reach of children.”
- Labeling of nicotine content percentages.
- Certain restrictions on advertising methods involving children.
- Retailers of vaping products must register with the FDA unless they are already subject to an active registration under state law relating to tobacco products.
There is also a strange notation in the new amendment relating to the requirement of “face-to-face sales.” But at this time, the intent behind the wording seems a bit unclear. While the House of Representatives seems to be on the side of the vaping industry, the bill still needs to be approved by the Senate, which could result in new changes being implemented at the last minute. But most industry insiders agree that Rep. Cole’s FDA Amendment is definitely a step in the right direction.
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