Council for Responsible Nutrition v. James, 2025 WL 3165673 (2d Cir. Nov. 13, 2925), is a Second Circuit decision about a New York state restriction on the sale of certain dietary supplements to minors. This blog covers the case because the court’s decision includes a disturbing preemption holding.  This particular blogger covers the case because it addresses a recent matter of particular concern that has arisen in more and more cases — the extent to which the government can and should act as our food nanny. It also helps that the CRN case is a bit strange.

To begin with, the “James” named as a defendant is New York Attorney General Letitia James, who right now has at least one case that is probably causing her more worry than this one. CRN, the plaintiff, is a trade group representing the dietary supplement industry. CRN filed the lawsuit to enjoin enforcement of section 391-00 of the New York General Law, which prohibits selling dietary supplements to anyone under age 18 if the supplement is “labeled, marketed, or otherwise represented for the purpose of achieving weight loss or muscle building.”  CRN’s theory was that the statute violated the First Amendment’s free speech clause, was unconstitutionally vague, and was preempted by federal law.  The district court denied CRN’s motion for a preliminary injunction because CRN was unlikely to prevail on the merits, could not demonstrate irreparable harm, and showed no favorable balance of equities. The district court also dismissed CRN’s claims except for the First Amendment claim. The case went up to the Second Circuit. 

The Second Circuit affirmed the district court, holding that it had not abused its discretion in concluding that the plaintiff was unlikely to win on substance, there was no irreparable harm, and the public interest would not be served by an injunction. 

The free speech issue hinged on a commercial speech analysis under the Central Hudson test. The Second Circuit held that protection of minors’ health was a substantial government interest, that the statute directly advanced that interest because youth appeared to be misusing the supplements, and the statute was not overinclusive as it was reasonable for the Legislature to focus on the product’s marketing. The Second Circuit also held that requiring retailers to age-verify that purchasers were adults did not constitute compelled speech. In sum, the statute passed intermediate scrutiny for laws restricting commercial speech.  

The Second Circuit also held that CRN’s vagueness claim fell short of the burden of showing “that no set of circumstances exists” for which the law’s application would be unambiguous.  

Now we get to the preemption ruling.  We are not pleased. Why?  We are in the land of express food preemption in section 343-1(a) of the Food, Drug, and Cosmetic Act (FDCA), which provides that “no State or political subdivision of a State may directly or indirectly establish under any authority continue in effect as to any food in interstate commerce … (5) any requirement respecting any claim of the type described in section 343(r)(1) of this title made in the label or labeling of food that is not identical to the requirement of section 343(r) of this title.”  Section 343(r)(1), in turn, prohibits health-related claims regarding a product’s nutrients, while section 343(r)(6) makes certain exceptions for dietary supplements. That is pretty strong and clear preemption.  We might even call it “plain.” (Foreshadowing.)

As the Second Circuit saw it, the issue was whether the statute’s “age restriction, by being triggered by (among other things) a health claim made on a product label, is therefore a ‘requirement respecting’ such a health claim.”  The Second Circuit answered that question with a No, and how it got there is a little wobbly. Seemingly contrary to the Riegel  discussion of “requirement” always meaning the same thing in the FDCA (552 U.S. at 324, not even mentioned in the CRN opinion) the Second Circuit held that the meaning of “requirement” in the preemption clause of the food section of the FDCA is not “plain” and is therefore subject to narrowing under the presumption against preemption – notwithstanding the Supreme Court’s Franklin decision abolishing any presumption against preemption in express preemption cases.  According to the CRN decision, Franklin’s erasure of the presumption again preemption applies only if the statutory text is “plain.”  That seems to us to be sloppy, lazy reasoning. It is as if the Second Circuit was looking for an excuse to avoid the job of statutory interpretation. This approach seems to ignore, if not outright defy, Congressional  intent. 

Then, almost unbelievably, it gets worse.  The Second Circuit proceeds to lean on Bates (which is not even an FDCA case), to hold in CRN that incidental economic effects that “do[] not require a … maker to put anything in particular on a product label” do not count as “requirements.”  

After stumbling over the express preemption issue, the Second Circuit’s perfunctory treatment of the irreparable harm and public interest elements seems inevitable. Lost sales would not be irreparable harm and the industry pecuniary interests “pale in comparison to the State’s goal of protecting youth from products that unfettered access to dietary supplements present.”  It is hard to tell what is worse – the logic or the prose.