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The FDA;s new legal challanges

Vapers Now Giving The FDA New Legal Challenges


The USA, the land of the free, is busy trying to make vapers less free than in any other country outside the Middle East. The FDA’s new Deeming Regulations will drown the industry in fees and paperwork, wiping out the majority of liquid makers and eliminating thousands of products from the market. The agency openly says it’s more likely to approve closed system devices – cigalikes – than anything with a refillable tank. As things stand, in August 2018 the vapor products market as we know it will cease to exist.

Vapers aren’t willing to let things stand. A federal court hearing on Tuesday, October 11 marked the latest move in a fightback against excessive government regulations as both consumers and manufacturers launched a bid to revise the law.

Industry and advocacy combined

Tuesday’s case has its origins in June. Two previous lawsuits, one brought by liquid maker Nicopure and the other by a coalition of advocacy groups, were combined into a single case by DC District Court judge Amy Berman Jackson. Both cases are challenging similar aspects of the Deeming Regulations and both were filed in the DC District Court, so merging them makes sense. It also means the FDA is faced by the combined strength of both legal teams.

Nicopure’s counsel Benjamin Block argued that the FDA is exceeding its powers by deeming a product to be tobacco simply because of its intended use. As he pointed out, vapor products do not contain any tobacco – and, while most liquids contain nicotine, not all do. While the argument that something becomes a tobacco product just because it contains a chemical extracted from tobacco is pretty dubious already, Block focused on the FDA’s extension of the rule to cover products that don’t contain nicotine in the first place, including 0mg liquids and hardware. As Block said to Judge Jackson, “Congress did not say, ‘We are giving you the keys to the kingdom’ – authority to regulate tobacco products doesn’t mean authority to reclassify things as tobacco products for the sole purpose of regulating them.

The FDA argue that the only reason vapor products exist is to deliver nicotine to users, and that this is enough to classify them as tobacco products. Judge Jackson appeared to accept that line of reasoning, and to be skeptical of the plaintiffs’ viewpoint; she asked Block if there is “anything else in the universe that anyone would do with a vaping device other than put a liquid in it and vape with it?” Clearly, the answer is no, but there’s no chain of logic that leads from there to a battery holder being a tobacco product.

Is two years long enough to get approval?

On the technicalities of the Pre Market Tobacco Application process, the plaintiffs may be on safer ground. Jackson challenged the FDA’s legal team on the time limit for PMTA submissions. Currently, this is two years; by the FDA’s own estimates the required paperwork will take around 1,700 hours to complete, while most industry analysts believe the real figure is at least 5,000 hours. Even at the lower end, this is a lot of time for a small business to dedicate to filling in forms – almost a year’s full-time work for one person, for each product. The reality is that many companies won’t be able to get it done inside the two-year window.

Jackson has two options here. One is to order the FDA to extend the time limit, which would buy some breathing space but really is just kicking the can down the road. The other is to scrap the limit altogether. That would make the whole PMTA system pointless, so it’s unlikely she’ll take that course.

Grandfathering – 2007 is too early

The best option for the industry – and for vapers – is to change the predicate date for grandfathered products. Any vapor product that’s “substantially equivalent” to one that was on sale before the predicate date can stay on the market without a PMTA; the problem is that the predicate date is February 17, 2007. No product on the market now is even close to equivalent to anything that was available then.

As Judge Jackson pointed out, the FDA doesn’t actually have the authority to change the predicate date; it’s mandated by Congress as part of the 2009 Tobacco Control Act. The best hope for changing the date is the Cole-Bishop Amendment. The House Appropriations Committee allowed this to go forward in April; if it’s passed the predicate date will move forward to August 8, 2016 – the date the Deeming Regulations came into force. The industry would still struggle to introduce safer and more effective products, but everything that was on the market by early August would still be available.

An uphill struggle

As for the current legal challenge, the plaintiffs aren’t letting their hopes rise too high yet. Dimitris Agrafiotis of the Tennessee Smoke-Free Association, part of the advocacy coalition, believes Jackson doesn’t understand the market as well as she could. He fears this could tip her towards the FDA side. She’s also suggested that the number of companies that will be harmed by the law is a sign that it’s necessary, rather than that it’s excessive. On the other hand, Judge Jackson has shown she’s willing to challenge government rulings in the past. If she gets up to date on the facts it’s probably those that will swing her decision, rather than political factors.

It’s unlikely Jackson will rule on the case before the end of the year, so vapers and the industry are going to have to live with the uncertainty for a while longer. Whatever happens with this case, however, there will certainly be more legal moves to block the FDA’s deeming regulations. A coalition of cigar associations is also challenging the FDA’s regulations, and again they’ve filed through the DC District Court. Judge Jackson might not be an expert on vaping and tobacco control now, but it looks like she’s going to have plenty of chances to learn.



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