The FDA’s deeming rule went live yesterday, 8th August 2016. You will see a blizzard of expert comment about what it all means (feel the pain of Phil Bursado – see 8/8). In essence, FDA requires an enormously burdensome Pre-Market Tobacco Application (PMTA) to be filed and accepted by FDA for any new product from now on. So that’s the end of innovation, including pro-health and pro-safety innovation. For all products currently on the market, a PMTA has to be filed within two years, with a further year for FDA to review – that will wipe out most products and most smaller firms and open the way to the black market. (For the official view, see FDA overview and Q&A)
When thinking about this regulation from a public health point of view, there are two quotes I think everyone should have in mind: Continue reading “FDA shoots itself in the foot, cigarette trade celebrates, public health loses – a summary in two quotes”
A recent editorial in the journal Tobacco Control discusses what’s wrong with the FDA. In fact, the editorial is more telling about what’s wrong with tobacco control.