No Private Right of Action Under the FDCA in Big Sky Country

We have been to Montana only once.  Through various life events, we have traveled by highway from the San Francisco Bay Area to the Midwest multiple times, so we are somewhat familiar with the mountains of Utah, western railroad towns like Cheyenne and North Platte, and the long rolling expanse known as Nebraska.  We never ventured into Montana, however, until just a few years ago, when the Drug and Device Extended Family needed a pandemic get away.  So we climbed in our cars and caravanned more than 1000 miles to a rented house near a town called Big Sky.  It was just what we needed—remote and lovely by equal measures. 

Montana is perhaps best known as the home of Yellowstone National Park (at least part of it) and the location of General Custer’s last stand at Little Bighorn.  It has, however, much more to offer.  Glacier National Park is a destination of its own, and the Gallatin River has some of the best fly fishing in the world (which we did not try) and terrific whitewater rafting (which we did).  Montana is, of course, the fourth largest U.S. state, but also one of the least densely populated, with nearly as many deer, elk, and antelope as people.  We are told that famous people from Montana include daredevil Evil Knieval and football legend Joe Montana.  For Knieval, we believe it.  But Joe Montana from Montana?  We don’t think so.  We will need to see a birth certificate before we buy that one, preferably the long form.  Perhaps the best fun fact about Montana is that it is the only state with a so-called “triple divide,” which allows water to flow into the Pacific, Atlantic, and Hudson Bay. 

One thing that Montana surely lacks is an Attorney General with authority to enforce the Food Drug and Cosmetic Act.  This is not unique.  No more than any other non-federal entity, a state AG cannot privately litigate an alleged violation of the FDCA.  Take for example a recent Montana case involving tobacco, Grand River Enterprises Six Nations, Ltd. v. Knudsen, No. CV-23-48, 2024 WL 3228181 (D. Mont. June 28, 2024).  The plaintiff sold cigarettes in Montana under an agreement with the state, but the state sent the plaintiff a letter noting that the plaintiff had withdrawn certain tobacco products from FDA substantial equivalence review, resulting in them being considered misbranded and adulterated.  The state ultimately sent all Montana wholesalers a notice prohibiting them from selling the plaintiff’s products, which the plaintiff did not like.  Id. at *1-*2. 

The plaintiff cigarette seller therefore sued the state, and after multiple motions and a trip to the Ninth Circuit, the plaintiff won an order restoring its right to sell tobacco under its agreement with Montana.  Why?  Because the Montana AG expressly based its action against the plaintiff on purported violations of the FDCA, which is not allowed: 

The FDCA speaks in no uncertain terms concerning enforcement power: “. . . all such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States.” 

Id. at *4 (quoting 21 U.S.C. § 337(a)) (emphasis added).  This is one of our favorite provisions of the FDCA, and this district court faithfully applied it.  As a result, federal law preempted the Montana AG’s action because the AG was purporting to enforce the FDCA:

Federal law preempts the Attorney General’s removal of [Plaintiff] from the Montana Tobacco Directory in this instance . . . because an alleged violation of the FDCA served as the basis for the removal when the FDCA provides no private right of action. 

Id.  Moreover, the state could not bootstrap its way into an enforcement action by asserting that it was actually enforcing state law.  That is because its communications to the plaintiff had all stated that the plaintiff’s conduct was “in violation of federal law.”  As the court ruled,

The Attorney General’s post hoc justification that [Plaintiff] was removed from the Montana Tobacco Directory for violating state law and the [agreement with the state] proves unavailing when the Attorney General’s . . . notice of removal letter lists only a violation of federal law as the basis for [Plaintiff’s] removal.

Id.  This is the correct result for the correct reason.  The district court relied heavily on Buckman and its holding that the FDCA impliedly preempts state law claims based solely on a violation of the FDCA.  The result is also relevant to our drug and device world, where state AGs sometimes form views on what drugs should be sold within their states’ borders and which drugs should not.  In the absence of federal FDA enforcement, the message is nothing doing.