Ah, but a man's reach should exceed his grasp,
Or what's a heaven for?
from Andrea del Sarto, by Robert Browning
PART ONE: The FDA’s Position on Jurisdiction Over In-State Food Producers
When the news broke on January 6 that Chipotle Mexican Grill had been served with a grand jury subpoena as part of a criminal investigation into a norovirus outbreak at one of its California restaurants, Bill Marler walked into my office and asked the obvious question: How does a federal agency—here the FDA—have jurisdiction over what happened at a restaurant if none of the food made there is ever sold in interstate commerce? Indeed, Bill had been quoted that same day in the New York Times, stating that, “It’s perplexing, because I’ve never seen this before.”[1] The Times article also pointed out that:
The move could represent a highly unusual step by the federal authorities, which generally have tended to focus on manufacturers or farmers, rather than restaurants, in investigations of food-borne illnesses, food safety experts said. In the past, the authorities have intervened when contaminated food crosses state lines, they said.
But this norovirus outbreak at a California Chipotle was plainly localized, and caused by contaminated food that never crossed a state line. Indeed, a majority of the food probably did not even cross the street, given how commonly customers purchase their food and eat it right there in the restaurant. Consequently, there is no question that food that caused the outbreak did not enter “interstate commerce,” a requirement that is widely understood to be a precondition for the FDA to take enforcement action under the Federal Food, Drug, and Cosmetic Act. That understanding is based on the fact that the Act, which is the sole source of the FDA’s authority, prohibits only the “introduction or delivery for introduction into interstate commerce of any food…that is adulterated or misbranded.” 21 U.S.C. § 331(a).[2] Thus, presumably, food that did not enter into interstate commerce would be beyond the FDA’s authority. So then how could FDA take action against Chipotle for the California norovirus outbreak?
First, courts have historically given FDA significant leeway in enforcing the Act given its broadly intended public health purpose. For example, in a case that reversed the dismissal of six criminal charges against the owner of a food storage warehouse overrun with vermin, the U.S. Supreme Court explained that that the purpose of the Act was “to safeguard the consumer from the time the food is introduced into the channels of interstate commerce to the point that it is delivered to the ultimate consumer.” U.S. v. Wiesenfeld Warehouse Co., 376 U.S. 86, 92, 84 S. Ct. 559, 563 (1964).[3] The Court also recognized that in enacting food and drug legislation, Congress had been concerned “with protecting the lives and health of human beings, under circumstances in which they might be unable to protect themselves.” Id. at 91.
The broad protective purpose of the Act was discussed in similarly expansive terms, and also quite eloquently, in an earlier case where the Supreme Court first affirmed that executives of a corporation (and not just a corporation itself) could be found guilty of misdemeanor violations of the Act, even if completely unaware of the wrongdoing. There, Justice Frankfurter wrote:
The purposes of this legislation thus touch phases of the lives and health of people which, in the circumstances of modern industrialism, are largely beyond self-protection. Regard for these purposes should infuse construction of the legislation if it is to be treated as a working instrument of government and not merely as a collection of English words.
U.S. v. Dotterweich, 320 U.S. 277, 280, 64 S. Ct. 134 (1943) (affirming the conviction of drug company’s president and general manager for shipments of misbranded and adulterated drugs). Consequently, the Court held that the Act “dispenses with the conventional requirement for criminal conduct—awareness of some wrongdoing. In the interest of the larger good it puts the burden of acting at hazard upon a person otherwise innocent but standing in responsible relation to a public danger.” Id. at 281 (citation omitted).[4]
Given the crucial public health purposes of the Act, it would be difficult to question the logic of imposing the Act’s criminal penalties on a restaurant that caused a significant outbreak of foodborne illness through the sale of adulterated food. But given that the Act was enacted to prohibit the sale of adulterated food in interstate commerce, there remains the question whether the FDA possesses the authority (or jurisdiction) to enforce the Act against a restaurant where the adulterated food was manufactured, sold, and consumed entirely with a state. Logic would appear to say that the answer to this question must be no. But not according to the FDA.
In a position first announced on November 10, 1978, and then twice revised (for the last time on August 31, 1989), the FDA addressed the “defense” that it lacked jurisdiction over any “finished product [that] has not itself been shipped in interstate commerce” as defined by the Act. As set forth in the FDA Compliance Policy Guidance manual, the FDA policy is as follows:
The Food & Drug Administration has jurisdiction over all products made from interstate components regardless of the amount present, even though the finished product has not moved in interstate commerce. Action may be taken against the product or the responsible firm when violative finished products are encountered, or when conditions of manufacture result in nonviolative interstate ingredients becoming adulterated or misbranded. The importance and the amount of the ingredient in the product, as well as the seriousness of the violation, will be considered in arriving at the decision to take action.
CPG Section 100.200, FDA Jurisdiction Over Products Composed of Interstate Ingredients.[5] In short, so long as the finished products are composed in any respect or amount with an ingredient that has been shipped in interstate commerce, the FDA claims by its policy to have jurisdiction over the both finished products and the manufacturer of those products. And that would then be the basis for the FDA claiming to have enforcement authority over the Chipotle restaurant.
In support of this policy, the FDA identifies five court cases “involving this question [that] establish that FDA clearly has jurisdiction over finished products made from interstate components.” Id. But before taking an in-depth look (in Part II) at the court cases upon which the FDA relies, it should be pointed out that, if the FDA position is legally solid, then one avenue of defense for Chipotle will clearly not be available. On the other hand, if the FDA position is subject to a potentially successful legal challenge, then Chipotle might be in a position to avoid criminal penalties, or successfully defend against them. Consequently, in Part II of this essay, I will weigh the strength of the FDA’s position (and the cited cases on which it is based) against the arguments that might be marshaled against efforts to charge Chipotle with crimes based on alleged violations of the Federal Food, Drug, and Cosmetic Act.
[1] Rachel Abrams, “Chipotle is Subpoenaed in Criminal Inquiry Over Norovirus Outbreak,” New York Times, Jan. 6, 2016, online at http://www.nytimes.com/2016/01/07/business/chipotle-outbreak.html
[2] The Act also defines “interstate commerce,” stating that it is “commerce between any State or Territory and any place outside thereof.” 21 U.S.C. § 321(b).
[3] The warehouse held food that had been already shipped in interstate commerce, but prior to its distribution for sale to consumers. The District Court had dismissed the criminal charges on the grounds that the Act did not apply to the mere “holding” of food articles, such as that which occurs in a post-shipment storage warehouse.
[4] Rejecting the argument that the imposition of strict liability imposed an unfair hardship on corporate officials in holding them criminally responsible despite no active involvement or knowledge of the crimes, Justice Frankfurter further wrote:
Hardship there doubtless may be under a statute which thus penalizes the transaction though consciousness of wrongdoing be totally wanting. Balancing relative hardships, Congress has preferred to place it upon those who have at least the opportunity of informing themselves of the existence of conditions imposed for the protection of consumers before sharing in illicit commerce, rather than to throw the hazard on the innocent public who are wholly helpless.
Dotterweich, 320 U.S. at 285. The Supreme Court later reaffirmed this strict approach in the decision that created what has come to be known as the Park Doctrine, holding that “the public interest in the purity of food is so great as to warrant the imposition of the highest standard of care on distributors.” U.S. v. Park, 421 U.S. 658, 671, 95 S. Ct. 1903 (1975). For that reason, “[c]orporate agents vested with responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act bear a ‘responsible relationship’ to, or have a ‘responsible share’ in, violations.” Id. at 672 (quoting U.S. v. Dotterweich, supra).
[5] http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm073820.htm
