Whether § 337's explicit bar on private enforcement of the FDCA precludes a private action seeking to enforce FDCA food labeling regulations by asserting a state statute that incorporates FDCA regulations wholesale?

When enacting the Food, Drug, & Cosmetic Act of 1938 (“FDCA”), Congress expressly barred private enforcement of the act and its regulations (the provision now found at 21 U.S.C. § 337(a)). Despite amending the FDCA several times in the 86 years since enactment, Congress has never repealed the act’s express prohibition on private enforcement. After Congress passed the Nutrition Labeling and Education Act of 1990 (“NLEA”), which amended the FDCA by creating a national standard for food labeling, California amended its own food labeling law. With a mere 38 words, California’s Sherman Food, Drug, and Cosmetic Law (“Sherman Law”) automatically adopts all of the FDCA’s current and future food labeling regulations as state law. The Ninth Circuit found that the Sherman Law has now transformed the hundreds of pages of federal food labeling regulations into independent state food labeling requirements not subject to § 337’s ban on private enforcement of the FDCA. In other words, according to the Ninth Circuit, an allegation that a defendant has violated the FDCA or federal regulations promulgated thereunder is now privately § 337’s express bar on private enforcement —simply because, in California, federal laws can be cross -cited as state laws. The question presented is: 1. Whether § 337’s explicit bar on private enforce ment of the FDCA preclude s a private action seeking to enforce FDCA food labeling regulations by asserting a state statute that incorporates FDCA regulations wholesale?