Pearson v. Shalala

3 Analyses of this case by attorneys

  1. Please Pass the Prune Juice: Must FTC Toe FDA’s Line on Health Claims?

    Hyman, Phelps & McNamara, P.C.Riëtte van LaackMay 25, 2011

    Petitioners assert that the requirements in the FTC consent orders constitute a rule within the meaning of the Administrative Procedure Act that prevents Petitioners from communicating truthful and not misleading information about the health benefits of their product.As explained by Petitioners, it has been firmly established by Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999) and its progeny (cases litigated by Petitioners) that the First Amendment protects the right of a party to make a truthful and not misleading claim that characterizes the relationship of a nutrient to a disease – even where that claim is supported by evidence that falls short of significant scientific agreement. Petitioners argue that the holdings of these cases are equally applicable to FTC’s consent orders.

  2. GAO Report on Food Labeling Might Signal Renewed FDA Resistance to Qualified Health Claims

    Sidley Austin LLPJanuary 24, 2011

    Although the report primarily calls for greater Food and Drug Administration (FDA) authority and guidance in this area, it also contains noteworthy discussion relevant to litigation that led the Agency to begin allowing qualified health claims for conventional foods in 2002. In Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999), the D.C. Circuit Court of Appeals held that the First Amendment required FDA to consider whether qualifying language could negate the potential for a dietary supplement health claim to mislead, as an alternative to prohibiting such a claim altogether. FDA has since authorized a number of qualified health claims for conventional foods as well as supplements, but this GAO report is the second in recent years referring to post-Pearson research suggesting that consumers do not understand the differences between qualified health and unqualified claims.

  3. Alliance for Natural Health Scores First Amendment Victory on Qualified Health Claims

    Hyman, Phelps & McNamara, P.C.Ricardo CarvajalJune 1, 2010

    FDA argued that the former claim is misleading because it fails to specify the cancers on which selenium has an effect, and that the latter claim falsely implies that selenium has an effect on all cancers. Citing the principles established in Pearson I (Pearson v. Shalala, 164 F.3d 650, 652 (D.C. Cir. 1999)), the court found FDA’s action unconstitutional in the absence of “empirical evidence that any disclaimer would fail to correct the claims’ purported misleadingness.” If FDA cannot produce that evidence, then FDA must draft “one or more” disclaimers for those claims.