Courts have said over and over again that there’s no private right of action under the Food, Drug and Cosmetic Act. There’s a footnote four pages long to that effect in Bexis’ book (§4.01[1], note 14). Still people don’t seem to get it. Instead, they try to take over the FDA’s function of enforcing the Act through various subterfuges, such as calling the attempt at private enforcement “negligence per se.” Some courts, unfortunately, let plaintiffs get away with this; others don’t.

All too often, the attempts to usurp the FDA’s function are glaringly blatant. Thus, we are gratified by the decision the other day in Fraker v. KFC Corp., 2007 U.S. Dist. Lexis 32041 (S.D. Cal. Apr. 27, 2007), holding that a private plaintiff can’t declare food “misbranded” just because that plaintiff doesn’t like transfats. We approve of this decision on both legal and philosophical grounds. Legally, we like the Fraker court’s forthright identification of the suit as a preempted attempt at private enforcement of the FDCA. Philosophically we like Fraker because we believe that people are entitled to make up their own minds how to live their lives as long as they’re not hurting other people. The nanny state is bad enough, but nanny plaintiffs are worse – since nobody elected them.

In the FDCA, Congress directly addressed the issue of who can determine when and how the Act is violated. Except in one circumstance that authority lies squarely with the FDA. “[A]ll such proceedings for the enforcement, or to restrain violations of this chapter shall be by and in the name of the United States.” 21 U.S.C. §337(a). There’s only one exception. States my bring enforcement actions in the name of the affected state, after notice to the FDA, to enforce certain sections of the act concerning food present within that state’s borders. 21 U.S.C. §337(b). That’s it. Otherwise, private citizens may bring citizen’s petitions to induce the Agency to act, but they cannot sue for alleged violations of the Act.

The Supreme Court relied on §337(a) in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), as part of its rationale for why private “fraud on the FDA” claims were preempted. This section, the Court held, demonstrates the intent of Congress that private litigation not interfere with how the FDA does its job: “The FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions.” 531 U.S. at 349 n.4. And again, in light of §337(a), “we have clear evidence that Congress intended that the MDA be enforced exclusively by the Federal Government.” 531 U.S. at 352. Fraud violates the FDCA, thus it’s the government’s business – not that of private litigants asserting state (or for that matter, federal) law. “For the reasons stated above, we think this sort of litigation would exert an extraneous pull on the scheme established by Congress, and it is therefore pre-empted by that scheme. Id. at 353.

In Fraker, plaintiffs who wanted to ban the Colonel from selling fried chicken alleged that various KFC promotional statements in its advertising amounted to consumer fraud and, breach of warranty, and misrepresentation because fried chicken contained transfats that are bad for you – raising cholesterol levels, making you fat, and raising heart disease risks. Anything with transfats should be banned, the plaintiffs alleged. 2007 U.S. Dist. Lexis 32041, at *3 (“only safe level of trans fat in the diet is zero”) (quoting complaint).

The court quite properly found that statements such as KFC “provides the best food,” and “fast food” can be “part of a sensible balanced diet” amounted to mere “puffery” and could not possibly amount to a warranty, representation, what have you of anything. Id. at *7-8 (“No reasonable consumer would rely upon the statements as specific representations as to health, quality, or safety”).

But our self-appointed defenders of society from the perils of poultry would not quit. No, they argued, these statements amount to “actionable health claims in violation of 21 C.F.R. §101.14.” 2007 U.S. Dist. Lexis 32041, at *8. They claimed they could enforce §101.14 as “negligence per se” and under certain state statutes allowing for private enforcement of statutory violations. Id. at *8.

Not so fast, said the court. You can’t try to do indirectly under state law what §337(a) and Buckman say can’t be done directly under the FDCA. As in Buckman, the attempt to bring a private action for misbranding was preempted. Why? Well, as did the regulation of medical devices in Buckman, “the FDCA presents a comprehensive regulatory scheme of branding and labeling of food products.” 2007 U.S. Dist. Lexis 32041, at *10.

To overlay the state law tort system over the FDCA would significantly increase the burdens on the FDA to ensure uniform enforcement of its administrative duties. Accordingly, to the extent Plaintiff contends that alleged violations of the FDCA and Sherman Law give rise to viable state law claims, such claims are impliedly preempted by the FDCA.

Id. at *11. Thus the right to eat fried chicken (and by extension, donuts, french fries, and any other food that some vegan with a lawyer might claim is unhealthy) has been preserved in California – at least pending review by the Ninth Circuit.

Finally the court rejected plaintiffs’ argument for a stay. California apparently is a hotbed of private, would-be regulation of the food supply, and a similar attempt to restrict the sale of certain fish was declared preempted in the state court system and is on appeal in the California Supreme Court. In re Farm Raised Salmon Cases, 48 Cal. Rptr. 3d 449 (App. 2006), review granted (Cal. Dec. 13, 2006). Noting that nothing a state court might say about preemption was binding on a federal court, the court granted the motion to dismiss.

We think the District Court got Fraker exactly right. We look around and see, time and time again, some group of “activists” trying to overrule the FDA and impose their policy choices on the rest of us through litigation. The Scientologists have tried this with a number of psychoactive drugs, and other groups have attacked dental amalgam, thimerosal, and more recently various kinds of foods they don’t think we should eat. If the FDA isn’t allowed to decide these questions – and to ensure that its decisions stick – we will all find our freedom of choice restricted by litigants using the courts to make social policy. We never thought we’d consider preemption to have a civil liberties aspect to it, but it does.