Imagine that the Federal Food, Drug, and Cosmetic Act (FDCA) is a college freshman, and that the First Amendment is another college freshman. Then imagine that they are both assigned to the same dorm room. Will they peacefully coexist? Will they like and support each other? Or will they develop a pathological distrust and spend their time trying to sabotage each other?
A recent court decision suggests that “distrust” might characterize this relationship. The decision is United States v. Caronia, Docket No. 09-5006-cr (2d Cir. Dec. 3, 2012). In this blog entry, we discuss what this decision may mean and whether it has any implications for food labeling law.
United States v. Caronia
In United States v. Caronia, the court reviewed the conviction of a pharmaceutical sales representative, Mr. Caronia, for conspiracy to introduce a misbranded drug into interstate commerce. The conviction had been based on Mr. Caronia’s promotional statements about off-label use of the drug.
In the majority opinion, the court distinguished between two distinct functions that promotional statements may have under the FDCA: (1) promotional statements as evidence of intended use, and (2) promotional statements as per se misbranding.
The government contended that it prosecuted Mr. Caronia only under function (1). That is, according to the government, Mr. Caronia’s statements functioned solely as evidence of how he (and his employer) intended the drug to be used. Based on such evidence, the drug had intended uses beyond the use covered by FDA’s approval, and therefore the government took the position that the drug was not labeled with adequate directions for the off-label uses and was misbranded.
The court, however, looked closely at the government’s approach to the case and concluded that Mr. Caronia’s conviction rested on function (2). Specifically, the government “repeatedly argued that Caronia engaged in criminal conduct by promoting and marketing the off-label use of Xyrem, an FDA-approved drug.” Slip op. at 28. In other words, “the government has treated promotional speech as more than merely evidence of a drug’s intended use — it has construed the FDCA to prohibit promotional speech as misbranding itself.” Id. at 10.
The court seems to be saying that, if speech is to be used as evidence of intent, it must be analyzed as evidence. That is, its evidentiary strength must be weighed and a conclusion reached about the intended use of the drug based on that weight. If the evidence is adequate to establish intended use, then a misbranding charge (based on lack of adequate directions for use) might apply. However, the court appears to be saying that the government cannot simply assume that, because there has been promotion for an unapproved use, the drug is necessarily misbranded.
In particular, the court highlighted the fact that this was a criminal violation. Indeed, the court observes that, where criminal charges apply, “even more careful scrutiny is warranted.” Slip. op. at 34. The government cannot analyze Mr. Caronia’s speech as constituting misbranding by itself, the court says, because this would be inconsistent with the First Amendment.
The court leaves open the possibility that the government might, in some future case, use a defendant’s speech as evidence of the intended use of a drug. The court says, for example, “Even assuming the government can offer evidence of a defendant’s off-label promotion to prove a drug’s intended use and, thus, mislabeling for that intended use, that is not what happened in this case.” Id. at 27-28. The words “even assuming” seem a little skeptical about whether that assumption is valid … but the court does not decide this issue one way or the other.
Importantly, in leaving open the possibility of analyzing speech as evidence of intended use, the court seems to be laying the groundwork for future decisions in which it might analyze whether some types of speech about off-label uses do or do not create a new intended use.
The dissent disagrees that the government prosecuted Caronia for his speech and argues that, in fact, the government used Caronia’s speech only as evidence of intended use. Moreover, the dissent “fail[s] to see how the majority’s reasoning would ever allow such speech to support a conviction ….” Dissenting slip op. at 8. The dissent goes on to say that, under the majority opinion, “a mislabeling charge simply may not rest on off-label promotion.” Id. at 12. As discussed above, however, it may be possible to read the majority’s opinion more narrowly.
Does Caronia have any Implications for Food Labeling Law?
The short answer is “yes,” though indirectly.
As discussed above, Caronia can be read as applying narrowly only to a situation where –
- the government brings criminal charges,
- based on promotional statements for off-label use of an approved drug,
- and does not clearly analyze those promotional statements as being evidence of the intended use of the drug.
Even this narrow interpretation, however, indicates the Second Circuit’s willingness to subject a law to “heightened scrutiny” if it disfavors certain speech (e.g., marketing) and certain speakers (e.g., pharmaceutical companies). In this regard, Caronia relies heavily on Sorrell v. IMS Health Inc., 131 S.Ct. 2653 (2011).
In Sorrell, the Supreme Court evaluated a Vermont statute that prohibited the use of prescriber-identifying information for pharmaceutical marketing. The statute thus disfavored speech with marketing content and disfavored specific speakers, namely pharmaceutical manufacturers. Citing Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n of N.Y., 447 U.S. 557 (1980), the Supreme Court said that this approach required heightened scrutiny and that it was invalid because, at a minimum, under a commercial speech inquiry, the state did not meet its burden of showing that the statute directly advances a substantial governmental interest and that the measure is narrowly drawn to achieve that interest. In doing so, the Court said:
- “… [T]he distinction between laws burdening and laws banning speech is but a matter of degree and … the Government’s content-based burdens must satisfy the same rigorous scrutiny as its content-based bans.” Sorrell, 131 S. Ct. at 2664.
- “The First Amendment requires heightened scrutiny whenever the government creates a regulation of speech because of disagreement with the message it conveys.” Id.
- “A consumer’s concern for the free flow of commercial speech often may be far keener than his concern for urgent political dialogue. … That reality has great relevance in the fields of medicine and public health, where information can save lives.” Id.
(Internal quotations and citations omitted.)
How do the requirements of the FDCA governing nutrient content claims and health claims for foods fare under the principles of Caronia and Sorrell discussed above?
- The FDCA prohibits nutrient content claims and health claims unless they are covered by an FDA regulation or an authoritative statement notification. They thus disfavor certain speech (marketing) and certain speakers (food manufacturers), and place a burden on speech that, under Sorrell, must satisfy the same rigorous scrutiny as a content-based ban.
- Nutrient content claims and health claims are important to the public health, therefore there is a legitimate concern for the free flow of this type of commercial speech (as suggested by the Supreme Court in Sorrell).
- Under the principles suggested by Caronia, because the FDCA provides that truthful and not misleading nutrient content claims and health claims for foods cause a food to be misbranded merely because they have not first been pre-authorized under the FDCA, this is arguably inconsistent with the First Amendment. (For example, it might be argued that the FDCA should permit nutrient content claims and health claims that are generally recognized as truthful and not misleading, rather than requiring pre-authorization by means of a petition or notification to FDA, because such pre-authorization is not sufficiently narrowly drawn under Central Hudson.)
- It might be possible to use nutrient content claims or health claims as evidence of the intended use of a product. If the weight of such evidence is that the product is intended for use as a drug, then FDA may conclude that the product is misbranded because it fails to bear adequate directions for use, and may also conclude that the product is in violation of law because it is an unapproved new drug. On the other hand, if the weight of the evidence does not tip in favor of intended drug use, then the product remains a food.
Point 4 above is consistent with the approach in Whitaker v. Thompson, 353 F.3d 947 (D.C. Cir. 2004), which held that the use of speech to infer intended use under the FDCA is constitutionally valid. The D.C. Circuit explained that the First Amendment allows “the evidentiary use of speech to establish the elements of a crime or to prove motive or intent.” Id. at 953 (citation omitted). The speech at issue in Whitaker represented a dietary supplement for use in the treatment of an existing disease and the court concluded that this type of speech could be used to infer intended use as a drug. However, the court did not suggest that all health claims for foods necessarily imply intended drug use. In fact, it is possible that a health claim for a food might be made in a way that does not imply that the food is intended for use as a drug.
Consider the following hypothetical claims for foods:
- “X is packed with blueberry antioxidants.” – a nutrient content claim that is unauthorized by FDA, or
- “X, like other foods, may help prevent heart disease as part of a diet low in trans fat, saturated fat and cholesterol. X is not a drug and should not be used as or substituted for any medication.” – a health claim that is unauthorized by FDA.
So long as these claims are truthful and not misleading and do not, in context, suggest that the food is intended for use as a drug, they might arguably be protected under the First Amendment, even if they are inconsistent with the FDCA.
Ultimately, like most college roommates, the FDCA and the First Amendment can probably learn to peacefully coexist – even if there will always be some tension between the two.