Opinion ID: 176237
Heading Depth: 3
Heading Rank: 2

Heading: First Amendment challenge to the ban on composition claims

Text: The Processors contend that the Ohio rule violates the First Amendment by placing a prophylactic ban on composition claims such as rbST free, antibiotic-free, and pesticide-free. Both sides agree that the composition claims at issue constitute commercial speech and are thus afforded less extensive protection under the First Amendment than noncommercial speech. See Zauderer v. Office of Disciplinary Counsel of the Supreme Court of Ohio, 471 U.S. 626, 637, 105 S.Ct. 2265, 85 L.Ed.2d 652 (1985) (making the commercial-noncommercial distinction in the context of restrictions on attorney advertising). Under the commercial-speech framework, [t]ruthful advertising related to lawful activities is entitled to the protections of the First Amendment, In re R.M.J., 455 U.S. 191, 203, 102 S.Ct. 929, 71 L.Ed.2d 64 (1982), but the government is free to prevent the dissemination of commercial speech that is false, deceptive, or misleading, Zauderer, 471 U.S. at 638, 105 S.Ct. 2265. Prophylactic bans on commercial speech are evaluated under a four-part analysis first set forth in Central Hudson Gas & Electric Corp. v. Public Service Commission, 447 U.S. 557, 100 S.Ct. 2343, 65 L.Ed.2d 341 (1980). Pursuant to that analysis, a court first determines whether the speech concerns unlawful activity or is misleading. Id. at 566, 100 S.Ct. 2343. If a court finds in the affirmative on either prong, the speech is not entitled to First Amendment protection, and the analysis ends. Id. But if the court finds that the speech is entitled to First Amendment protection, it then makes three additional inquiries: (1) whether the asserted governmental interest is substantial, (2) whether the regulation directly advances that interest, and (3) whether the regulation is more extensive than necessary to serve the asserted interest. Id.
The district court in the present case concluded that the composition claims were misleading and therefore not entitled to any First Amendment protection. Misleading advertising may be prohibited entirely, including where the speech is inherently likely to deceive or where the record indicates that a particular form or method of advertising has in fact been deceptive. In re R.M.J., 455 U.S. at 202-03, 102 S.Ct. 929. Where speech is only potentially misleading, however, the Central Hudson framework applies. Id. at 203, 102 S.Ct. 929. Under these circumstances, the preferred remedy is more disclosure, rather than less. Bates v. State Bar of Ariz., 433 U.S. 350, 374-75, 97 S.Ct. 2691, 53 L.Ed.2d 810 (1977) (striking down a ban on price advertising for routine legal services in part because it seems peculiar to deny the consumer, on the ground that the information is incomplete, at least some of the relevant information needed to reach an informed decision). The district court held that the composition claims were inherently misleading because they imply a compositional difference between those products that are produced with rb[ST] and those that are not, in contravention of the FDA's finding that there is no measurable compositional difference between the two. This conclusion is belied by the record, however, which shows that, contrary to the district court's assertion, a compositional difference does exist between milk from untreated cows and conventional milk (conventional milk, as used throughout this opinion, refers to milk from cows treated with rbST). As detailed by the amici parties seeking to strike down the Rule, the use of rbST in milk production has been shown to elevate the levels of insulin-like growth factor 1 (IGF-1), a naturally-occurring hormone that in high levels is linked to several types of cancers, among other things. The amici also point to certain studies indicating that rbST use induces an unnatural period of milk production during a cow's negative energy phase. According to these studies, milk produced during this stage is considered to be low quality due to its increased fat content and its decreased level of proteins. The amici further note that milk from treated cows contains higher somatic cell counts, which makes the milk turn sour more quickly and is another indicator of poor milk quality. This evidence precludes us from agreeing with the district court's conclusion that there is no compositional difference between the two types of milk. In addition, and more salient to the regulation of composition claims like rbST free, the failure to discover rbST in conventional milk is not necessarily because the artificial hormone is absent in such milk, but rather because scientists have been unable to perfect a test to detect it. As recognized by the State's brief in the district court, given existing technology, it is currently impossible to test milk to determine whether the hormones present are natural hormones or recombinant hormones (such as rbST). The State further conceded this point at oral argument, acknowledging that conventional milk could contain rbST, but that no test has been able to verify if this is in fact the case. This uncertainty is also implicit in the FDA's 1994 Guidance. There, the agency stated that there [i]s no significant difference between milk from treated and untreated cows because [t]here is currently no way to differentiate analytically between naturally occurring bST and [r]bST in milk. 59 Fed.Reg. 6279, 6280 (emphasis added). The FDA thus appears to have left room for the fact that some compositional difference between the two types of milk may exist, leaving open the possibility that one day a method might exist to detect whether rbST is in fact present in conventional milk. Taken collectively, this evidence points to two distinct types of milk. On the one hand is milk from cows never given rbST, which in turn cannot produce milk that has rbST as a matter of fact. The composition claim rbST free is therefore demonstrably true as applied to this milk. On the other hand, milk from cows treated with rbST might contain the artificial hormone, although there is currently no way to determine whether that is the case. But even if rbST is not present in conventional milk, there is still evidence that it contains increased levels of IGF-1 and might be compositionally of a lesser quality. A compositional difference thus exists between the two types of milk, although the extent of this differencenamely whether conventional milk does in fact contain rbSTis still very much an open question. As such, the composition claim rbST free at best informs consumers of a meaningful distinction between conventional and other types of milk and at worst potentially misleads them into believing that a compositionally distinct milk adversely affects their health. Under these circumstances, we conclude that composition claims like rbST free are not inherently misleading. We must therefore apply the remaining three Central Hudson factors to assess the constitutionality of the Rule's prophylactic ban on the composition claims rbST free and artificial hormone free. As a separate matter, the Processors challenge on appeal the Rule's ban of composition claims related to antibiotics and pesticides. The State responds that antibiotics and pesticides are largely detectable in milk and that all milk is routinely tested for antibiotics, and the presence of any antibiotic in any amount renders the milk unacceptable for consumption. It added that cost considerations prevent the routine testing of every batch of milk. The State, however, did not present any evidence with regard to testing procedures used to detect antibiotics and pesticides. Evidence of this testing might well influence our determination as to whether the claims antibiotic free and pesticide free are inherently misleading. If the State's testing can detect these substances and prevent any amount of them from being present in conventional milk, then such claims would be inherently misleading because they falsely imply that conventional milk contains antibiotics and pesticides when in fact the State tests to ensure that it does not. But there is no evidence in the record to verify the State's contention. In light of this insufficiently developed factual record, the State has not shown that it is entitled to summary judgment on this challenge. We therefore remand the issue for further proceedings.
Having determined that the composition claim rbST free is not inherently misleading, we must review the State's ban on such claims under the final three Central Hudson factors: (1) whether the State's asserted interest is substantial, (2) whether the regulation directly advances that interest, and (3) whether the regulation is no more extensive than necessary to serve the asserted interest. See Central Hudson, 447 U.S. at 566, 100 S.Ct. 2343. All three of these factors must be met in order for the Rule to be upheld. See id. Turning to the first factor, we note that the Rule's purported purpose is to prevent the use of false or misleading labeling. See Ohio Admin. Code § 901:11-8-01(A). The Processors concede that this interest is substantial. But because the Rule is aimed at preventing consumer deception, the State bears the burden to demonstrate that the harms it recites are real and that its restriction will in fact alleviate them to a material degree. Ibanez v. Fla. Dep't of Bus. & Prof'l Regulation, Bd. of Accountancy, 512 U.S. 136, 146, 114 S.Ct. 2084, 129 L.Ed.2d 118 (1994) (citation omitted). In Ibanez, the Supreme Court declared unconstitutional the Florida Board of Accountancy's censuring of an attorney for referring to her designation as a Certified Public Accountant and as a Certified Financial Planner in her advertising materials and other communications with the public. The Court's ruling stemmed from the failure of the Board to point to any harm that is potentially real, not purely hypothetical and the complete absence of any evidence of deception. Id. at 145-46, 114 S.Ct. 2084 (citation omitted). In the present case, the record of deception is weak at best. The only evidence that the State points to is the FDA's Interim Guidance and consumer comments that it received in response to the proposed Rule. But the Guidance provides little support in this regard. The FDA suggests in the Guidance that the claim rbST free may imply a compositional difference between the two types of milk, 59 Fed.Reg. 6279, 6280 (emphasis added), but this statement does not establish that such a claim is necessarily misleading in every context. Furthermore, the FDA cited no evidence or studies in the Guidance to support its concerns regarding consumer confusion. The Guidance therefore does not constitute evidence of deception as required under Ibanez. Also unhelpful are the consumer comments that the ODA received after issuing the proposed Rule. The State received approximately 2,700 comments, of which the Processors estimate that only 70 were in support of the Rule. We agree with the State that some of these comments demonstrate consumer confusion regarding the use of rbST in milk production. One commenter, for example, asserted that she needed to know that the milk I drink has no added hormones, thereby indicating that she believed rbST to be present in conventional milk. But few if any of these commenters indicated that their confusion stemmed from the product labels. The commenter quoted above, for instance, was informed about rbST and milk production from conversations with her oncologist, not from reading the labels. Although there is not a complete absence of deception as there was in Ibanez, the proof falls far short of establishing that Ohio consumers have been misled by dairy-product labeling. We need not address this issue further, however, because we conclude that the Rule does not directly advance the State's interest and is more extensive than necessary to serve that interest. These last two steps of the Central Hudson test are complementary. They involve asking whether the speech restriction is not more extensive than necessary to serve the interests that support it. Lorillard Tobacco Co. v. Reilly, 533 U.S. 525, 556, 121 S.Ct. 2404, 150 L.Ed.2d 532 (2001) (citation omitted). Accordingly, there must be a reasonable fit between the legislature's ends and the means chosen to accomplish those ends, a means narrowly tailored to achieve the desired objective. Id. (citation, ellipsis, and internal quotation marks omitted). [I]f there are numerous and obvious less-burdensome alternatives to the restriction on commercial speech, that is certainly a relevant consideration in determining whether the `fit' between ends and means is reasonable. City of Cincinnati v. Discovery Network, Inc., 507 U.S. 410, 417 n. 13, 113 S.Ct. 1505, 123 L.Ed.2d 99 (1993). We agree with the Processors that the potential consumer confusion created by the composition claim rbST free could be alleviated by accompanying the claim with a disclaimer informing consumers that rbST has yet to be detected in conventional milk. Examples of possible disclaimers include a statement regarding the lack of evidence that conventional milk contains rbST, or even the disclaimer already required by the Rule to accompany production claims: The FDA has determined that no significant difference has been shown between milk derived from rbST-supplemented and non-rbST-supplemented cows. The district court rejected the use of a disclaimer to cure any confusion caused by the claim rbST free, reasoning that such a statement would only serve to confuse a consumer. In the district court's view, the label would contain contradictory informationit would say a product is `free' of rbST, but at the same time state that there is no rbST in other products, which defeats the purpose of making the claim in the first place. But this conclusion rests on the assumption that conventional milk has conclusively been shown to be free of rbST, when in fact that possibility remains an open question. The claim rbST free, when used in conjunction with an appropriate disclaimer, could assure consumers that the substance is definitively not in milk so labeled while also advising them that it has yet to be detected in conventional milk. There thus exists a method by which the potential difference between the two types of milk can be presented without also being deceptive. See In re R.M.J., 455 U.S. 191, 203, 102 S.Ct. 929, 71 L.Ed.2d 64 (1982) ([T]he States may not place an absolute prohibition on certain types of potentially misleading information ... if the information also may be presented in a way that is not deceptive.). For these reasons, we conclude that the Rule's prophylactic ban of composition claims such as rbST free is more extensive than necessary to serve the State's interest in preventing consumer deception. This provision of the Rule therefore cannot withstand scrutiny under Central Hudson.