A Unanimous Supreme Court Delivers A Sharp Rebuke To The MAGA / Activist Wing In The Fifth Circuit... AGAIN -- On Vape Products.

We haven't mentioned this case before, but the activist/"rad" right Texas/Louisiana wing of the Fifth Circuit had ruled against the FDA -- despite a clear statutory command, of long-standing -- purportedly for not approving a certain novel brand of e-cigarette, or vape. In doing so, it went well-beyond the decision in the Texas trial court below, and ignored copious evidence that FDA had solid scientific bases for the decisions it made. [And an ADA challenge brought years later would not be the appropriate vehicle to complain about the FDA ruling, in any event.]

So, this morning, as expected, the Supremes reaffirmed FDA's primacy, when looking at novel devices that directly impact human health.

What is a little unexpected is that all NINE Justices agree that this is a central function of FDA. Even Thomas and Alito.

Here's the opinion, and a bit:

. . .The FDA has long had the responsibility to determine whether manufacturers may market new drugs, but it was the passage of the Family Smoking Prevention and Tobacco Control Act of 2009 (TCA) that first gave the FDA broad jurisdiction to regulate tobacco products.

Although the Act barred the FDA from banning all regulated tobacco products outright, see 21 U. S. C. §387g(d)(3), it prohibited a manufacturer from marketing any “new tobacco product” without FDA authorization, see §387j(a)(2)(A). One pathway to authorization of a “new tobacco product” is the submission of a premarket tobacco product application. See §387j(c)(1)(A)(i). The TCA requires the FDA to deny such an application unless an applicant shows that its product “would be appropriate for the protection of the public health.” §387j(c)(2)(A). . . .

That is. . . game over. Onward -- on a soggy gray day, here. Resolute -- just the same.

नमस्ते