When most of us think of the First Amendment, commercial speech is probably not what springs to mind. A business talking about its products doesn’t fit our classic perception of free speech. It will never equal the “I Have a Dream” speech or stir inspiration in your soul. But it’s important. It really is. The Supreme Court says so:
"Advertising, though entirely commercial, may often carry information of import to significant issues of the day. And commercial speech serves to inform the public of the availability, nature, and prices of products and services, and thus performs an indispensable role in the allocation of resources in a free enterprise system. In short, such speech serves individual and societal interests in assuring informed and reliable decision-making."
Bates v. State Bar, 433 U.S. 350, 364 (1977).
And, generally, the worth of the information that is put into the commercial marketplace should be determined by the speakers and the audience hearing it, not the government:
"The commercial marketplace, like other spheres of our social and cultural life, provides a forum where ideas and information flourish. Some of the ideas and information are vital, some of slight worth. But the general rule is that the speaker and the audience, not the government, assess the value of the information presented."
Edenfield v. Fane, 507 U.S. 761, 767 (1993). This means that the government should not quiet commercial speech simply for paternalistic reasons: “The First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good.” 44 Liquormart, Inc. v. Rhode Island, 517 U.S. 484, 503 (1996).
Given its importance, we have discussed the FDA and its regulation of commercial speech often, and we recently saw yet another interesting opinion in this area, Fleminger, Inc. v. U.S. Dep’t of Health & Human Servs., No. 3:10cv855 (VLB), 2012 U.S. Dist. LEXIS 22892 (D. Conn. Feb. 23, 2102). The Fleminger case involved green tea. Its maker petitioned the FDA for authorization to make a “health claim,” which is a claim that relates nutrients in the product with a positive health effect. Here, the particular health claim was that the green tea may reduce the risk of breast and prostate cancers. Id. at *25.
Generally, the FDA will allow such a health claim if there is (i) “significant scientific agreement” supporting the claim or (ii) “credible evidence” (a lower level of evidence) supporting the claim, but then only if the claim is accompanied by an appropriate disclaimer on the lower level of the scientific evidence. The FDA calls this second category “qualified” health claims and readily admits that it arose from court rulings against the FDA in First Amendment cases. See
, e.g., Guidance for Industry: Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements
Fleminger involved a “qualified health claim.” It was “qualified” because the FDA found that the scientific evidence supporting it was “the lowest level” that could still allow such a claim. Id. at *26-28. Hardly a ringing endorsement from the FDA, but this is where the First Amendment steps in. The FDA can’t stop a company from making such a claim since it has sufficient supporting evidence. The FDA, instead, can require the company to include an appropriate disclaimer, but only one that doesn’t violate the company’s First Amendment rights.
The controversy in Fleminger did not involve the company’s health claim – that “Green tea may reduce the risk of breast and prostate cancers.” That is good. The FDA has recognized that the First Amendment does not allow it to simply strike down a health claim that has some support. The controversy in Flemering, instead, involved the disclaimer. The company wanted:
“The FDA has concluded that there is credible evidence supporting this claim although the evidence is limited.”
Id. at *34-35. The FDA believed that this disclaimer overstated the scientific evidence. It wanted:
“FDA does not agree that green tea may reduce the risk because there is very little scientific evidence for the claim.”
Id. at *33-34. The company balked and took the issue to court on First Amendment grounds.
The Fleminger opinion detailed the history of decisional law on the FDA’s regulation of commercial speech and, if interested, you should read the entirety of the opinion. We will limit our discussion, however, to the court’s consideration of whether the FDA’s rejection of the company’s disclaimer and imposition of its own disclaimer was a “reasonable fit” with the government’s interest in preventing confusion about health claims and advancing the public health.
First, the court addressed the company’s proposed disclaimer – “FDA has concluded that there is credible evidence supporting this claim although the evidence is limited.” The court struck this down as misleading and inaccurate, basing its decision on its deference to the FDA’s finding that there was “very little scientific evidence” to support the company’s health claim. Id. at *50-62. The court considered the FDA’s ranking of the evidence to be very different from the company’s claim that it was “credible . . . although . . . limited.” What is interesting, though, is that the FDA’s own guidelines define a “qualified health claim” as one that is supported by “credible but limited evidence.” Id. at *57. That language is very familiar. It’s almost the same language that the company used in its disclaimer. So how can the company’s disclaimer be inaccurate if it essentially tracks the description of qualified health claims found in the FDA guidelines?
Well, the court found a difference between consumers' everyday understanding of the word “credible” and its unique and technical meaning within the FDA guidelines. The court determined that a member of the public reading a disclaimer was more likely to understand “credible” to mean “offering reasonable grounds for being believed,” which is how Webster's dictionary defines it, than to mean the lowest level of evidence, which is how it applied under the FDA guidelines in this case. Id. at *53-54, 57-58. This reasoning didn't help the company. But it could help the defense in other products and device cases. We've seen plaintiffs' counsel try to use technical terms from FDA regulations and guidelines, such as "adulterated" or "misbranded," to create a false or overly negative impression with a jury. The reasoning of the Fleminger court, however, can possibly be used to block such efforts or get a curative instruction from the judge.
Next, the court addressed the FDA’s proposed disclaimer and upheld the portion stating that “very little scientific evidence” supported the company’s health claim. Id. at *67-70. This was sheer deference to the FDA’s findings. This ruling, however, is not surprising. The history of this case reveals that the FDA contoured the language of its proposed disclaimers to the case law as it developed. The FDA has been chastened over the years by previous losses in First Amendment litigation. The FDA has finally reacted and adjusted. “[T]he First Amendment requires that the FDA allow Fleminger’s claim,” but the FDA can require “the addition of short, succinct and accurate disclaimers as to the level of scientific support of the proposed health claim.” Id. at *68-69. Here, the FDA provided the court with the details of its analysis and findings on the level of scientific evidence and proposed a short, succinct clause to describe those findings.
But the court did not uphold the FDA’s entire disclaimer. The court struck down the FDA’s proposed language that “FDA does not agree that green tea may reduce that risk.” That is not a disclaimer. It’s an explicit announcement of the FDA’s own opinion that was to be inserted into the Company’s speech immediately after the company’s health claim. It would have had the impermissible “effect of negating any relationship between green tea and the reduction of breast or prostate cancer and therefore effectively swallow[ed] the entire claim.” Id. at *71. In essence, it was a way around the prohibitions of the First Amendment, and the court properly did not allow it.
The story ended fairly well. The company was allowed to exercise its First Amendment rights and state its health claim about green tea, and the FDA was not allowed to inject its own opinion into that claim. It’s probably not inspirational or moving. But it’s another step in what has become a very interesting area of the law.