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Whitaker v. Thompson

January 9, 2004

JULIAN M. WHITAKER, ET AL., APPELLANTS
v.
TOMMY G. THOMPSON, SECRETARY, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, ET AL., APPELLEES



Appeal from the United States District Court for the District of Columbia (No. 99cv03247)

Before: Randolph and Roberts, Circuit Judges, and Williams, Senior Circuit Judge.

The opinion of the court was delivered by: Williams, Senior Circuit Judge

Argued November 10, 2003

When substances aimed at the treatment or prevention of disease are marketed, their regulation by the Food and Drug Administration ("FDA") commonly turns on the nature of the claims made about the substance. Items to be sold with "drug claims," including foods and dietary supplements, are subject to extensive testing; foods or dietary supplements that merely make "health claims" pass muster far more easily. This case turns primarily on whether the FDA faithfully applied the Federal Food, Drug and Cosmetic Act ("FFDCA"), 21 U.S.C. § 301 et seq., in its analysis of a petition by Dr. Julian Whitaker and others (for simplicity's sake, "Whitaker") to approve their intended marketing of "saw palmetto," an extract from the pulp and seed of the dwarf American palm, Serenoa repens, under a label that they argued was a "health claim."

Whitaker proposed a label stating: "Consumption of 320 mg daily of Saw Palmetto extract may improve urine flow, reduce nocturia and reduce voiding urgency associated with mild benign prostatic hyperplasia (BPH)." Petition, May 25, 1999, p. 18. BPH is a non-cancerous enlargement of the prostate that affects almost half of men over 50. The FDA denied the petition. In explaining the decision, it drew a distinction between claims regarding use of a product to maintain health and to "prevent" disease, on the one hand, and claims that a product could "treat" a disease, on the other. The former could qualify as "health claims," but the latter would always be considered "drug claims." May 26, 2000 FDA Letter ("FDA Letter") at 2, 7-10. As BPH is classified as a disease despite its comparative ubiquity, and the proposed label indicated an intent to treat it, the FDA decided that saw palmetto could not be marketed under that label without approval as a drug. Whitaker challenged the FDA's decision in district court on statutory and First Amendment grounds. The district court granted the FDA's motion to dismiss, Whitaker v. Thompson, 239 F. Supp. 2d 43 (D.D.C. 2003), and Whitaker appealed. We affirm.

The statutory claim

The FFDCA definition of "drug" includes "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease," 21 U.S.C. § 321(g)(1)(B), which would seem by its plain terms to cover the marketing of a substance intended to mitigate the symptoms associated with BPH. But that apparent simplicity is undermined by language added in 1990 by the Nutrition Labeling and Education Act ("NLEA"), Pub. L. No. 101-535, 104 Stat. 2353, which created a separate procedure authorizing "health claims" for food (or for dietary supplements classified as food). The general purpose of the NLEA appears to have been to allow the dissemination -- subject to a regulatory approval process -- of certain dietary and health information on food products without requiring that those products be regulated as drugs. Specifically, the NLEA amended the FFDCA to authorize the sale of dietary supplements pursuant to "health claims" that "characterize[ ] the relationship of any nutrient - to a disease or health-related condition," id. § 343(r)(1)(B), so long as the dietary supplement is "subject to a procedure and standard, respecting the validity of such claim, established by regulation of the Secretary," id. § 343(r)(5)(D). Whitaker insists, with some justification, that the label he proposed fits within the plain terms of the "health claim" definition.

Thus, although the consequences of classification as a "drug claim" or a "health claim" are quite substantial, Congress has given definitions that at least partially overlap. And it has given little guidance as to how the FDA should sort out claims that seem to fit both definitions. On the one hand, as the FDA points out, the statutory definition of "dietary supplement" plainly contemplates that dietary supplements may fall under the § 321(g) definition of "drugs": it says that a dietary supplement shall be deemed to be a "food" "[e]xcept for purposes of [§ 321(g)]," which defines "drugs" and "counterfeit drugs." 21 U.S.C. § 321(ff). On the other hand, the last sentence of § 321(g)(1), which defines drugs, explicitly states that a "dietary supplement for which a [health claim under § 343(r)] is made - is not a drug - solely because the label or the labeling contains such a statement." Id. § 321(g)(1). This is the statutory provision most directly relevant to the relationship between health claims and drug claims, but there are at least three ways it might be read, all of them problematic.

First, the last sentence of § 321(g)(1) might mean that a § 343(r) health claim cannot by itself establish that a product is "intended" to cure, mitigate, prevent, or treat disease, but such a statement may be used in conjunction with other evidence to establish such intent. Under this view, a health claim would be relevant but not sufficient to establish that a product is a drug. Though this construction provides a grammatically plausible reading of "solely," it is not pressed by any of the parties; in practice it might not make sense, as a product's label may often be the only readily available evidence of the product's intended use.

Second, the sentence in question might mean that a product for which a "drug claim" is made under § 321(g)(1) is not automatically exempt from drug regulation just because the product label also makes a separate health claim under § 343(r). This view, urged by amicus American Herbal Products Association, founders on the broad definition of health claims advanced by Whitaker. Such claims appear coextensive with -- or perhaps even broader than -- § 321(g) drug claims. The amicus's own brief demonstrates the problem. The amicus seeks to illustrate its reading of the "solely" language, saying that it means only that "use of an authorized health claim on the label of a dietary supplement ( e.g., folate reduces the risk of neural tube defects) does not give a manufacturer blanket immunity to include other claims for the product that would otherwise be classified as drug claims ( e.g., folate cures cancer)." But if § 343(r) covers anything that characterizes the "relationship" between a nutrient and a disease, then "folate cures cancer" is just as much a health claim as "folate reduces the risk of neural tube defects." Amicus's interpretation of "solely" is sensible only if there are "drug claims" for foods or dietary supplements that are not also "health claims," but Whitaker's broad interpretation of health claims, and indeed the literal wording of § 343(r)(1)(B) itself, foreclose that possibility.

Finally, the "solely" language in § 321(g) might mean that while a claim that would qualify as a health claim may be considered a drug claim, such a claim is not necessarily a drug claim. Under this reading, in other words, the statute allows some health claims to be exempted from the drug claim definition; but as this class is not defined, it implicitly leaves the choice to the FDA. This interpretation, urged by the FDA, is plausible, but it too is problematic. The statute on its face supplies no guiding principle for determining which health claims should be exempt, and nowhere else evinces an intent to give the FDA unfettered discretion to make so drastic a choice.

Because we are reviewing an agency's interpretation of the statute it is entrusted to administer, and the agency reached its interpretation after a relatively formal process with public notice and comment, cf. United States v. Mead Corp., 533 U.S. 218, 230-31 (2001) (expressing assumption that Congress "contemplates administrative action with the effect of law when it provides for a relatively formal administrative procedure"), we review under the familiar framework established by Chevron, U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984). We first ask whether, applying the "traditional tools of statutory construction," id. at 843 n.9, we can discern "the unambiguously expressed intent of Congress," id. at 843. If the statute is ambiguous, then we defer to the agency's interpretation so long as it is reasonable. Id. at 843-45.

As the discussion above suggests, we see no basis for finding any "unambiguously expressed intent of Congress." We thus turn to the FDA's rationale for classifying certain types of health claims as drug claims in order to decide whether the FDA's approach is reasonable in light of the statute's structure, history, and purposes.

The FDA gave several reasons for classifying claims regarding cure, mitigation, or treatment of an existing disease ("treatment claims") as drug claims and for exempting only health claims that concern reducing the risk of contracting a disease ("prevention claims"). First, the agency reasoned that the legislative history of the NLEA demonstrated an understanding that the health claim provision was intended for claims of prevention rather than ones of treatment. The agency noted statements in the legislative history indicating that the purpose of the health claims provision was to promote long-term health maintenance and prevention of disease, but found nothing suggesting that legislators enacting this provision contemplated treatment of a person's existing disease with dietary supplements. See FDA Letter at 5-6, citing 136 Cong. Rec. H5843 (statement of Rep. Moakley); 136 Cong. Rec. H12,954 (statement of Rep. Moakley); 136 Cong. Rec. H5843 (statement of Rep. Madigan); 136 Cong. Rec. S16,609 (statement of Sen. Metzenbaum); 136 Cong. Rec. S16,610-11 (statement of Sen. Hatch). Indeed, all the specific examples of "health claims" mentioned in the NLEA's legislative history involved prevention rather than treatment. See id. at 5, citing H.R. Rep. No. 101-538 at 8, 20, reprinted in 1990 ...


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