As many are aware, Nicopure and the Right 2 Be Smoke Free Coalition has a joint lawsuit against the FDA due to its hideous regulations over the vapor products industry. For the first time, we are going to get to see the FDA finally explain themselves and what they’re doing in a response to the joint lawsuit.
However, all the FDA did was respond with mumbo jumbo. Meaning vague answers to questions, sentences that were designed to look professional and sound technical, but offered no value, and even responses that will leave you scratching your head in confusion, such as this:
To begin, Plaintiffs argue that the FDA should refrain from regulating e-cigarettes at all, pending further study. Nicopure Br. 23. Specifically, they contend that, before exercising the deeming authority, the FDA was required to “collect[] sufficient data” about e-cigarettes and “reach a conclusion . . . regarding the[ir] health effects.” Id. But, as the FDA explained, this argument conflates the statutory standards in sections 901 and 906, which are entirely “separate authorities.” 81 Fed. Reg. at 28,983. Under section 901, the FDA may subject “any” tobacco product to the Tobacco Control Act as it “deems” fit.
As you see from this response, there is no true explanation, just a response letting you know that they can say any product falls under the Tobacco Control Act if they want it to. And, then we also have to deal with things like this:
Contrary to Plaintiffs’ assertion, see Nicopure Br. 41, the FDA has also shown that the MRTP premarket review requirement advances its interest in protecting the public health. The Case 1:16-cv-00878-ABJ Document 42-2 Filed 08/16/16 Page 96 of 102 82 FDA has sufficient information to conclude that e-cigarette use has negative health effects.
First things first, let’s go ahead and call bullshit. I’ve merely scanned over the response, and all I see is bullshit explanations from the FDA.
If you would like to see the full response from the FDA, go here: FDA Response
