70 F.4th 64
1st Cir.2023Background
- Plaintiffs Ferrari and Bohr purchased three Vitamin Shoppe dietary supplements (Glutamine; Creatine & Glutamine with Beta‑Alanine; BCAA & Glutamine) and sued under state law, alleging label statements about glutamine (muscle growth, recovery, immune support, anti‑catabolic effects) were false or misleading.
- Vitamin Shoppe moved for summary judgment, arguing the FDCA/DSHEA preempts state claims because the label statements are permissible structure/function claims under 21 U.S.C. § 343(r)(6) and satisfied the statute's substantiation and disclaimer requirements.
- Plaintiffs argued the labels refer to supplemental glutamine, so substantiation must be evidence about the supplemental form; they contend Vitamin Shoppe relied on evidence about naturally occurring glutamine and therefore lacks required substantiation.
- The district court found the statements are structure/function claims, the supplemental vs naturally occurring distinction is not meaningfully different on this record, and experts largely agreed glutamine performs the physiological roles claimed; it granted summary judgment for Vitamin Shoppe.
- On appeal the First Circuit reviewed de novo, focused on (1) whether the statements are structure/function claims and (2) whether Vitamin Shoppe had competent and reliable scientific substantiation that the claims are truthful and not misleading.
- The court affirmed: statements are structure/function claims, substantiation need only show the nutrient's physiological role (not that taking the product at label doses benefits the general population), and Vitamin Shoppe proffered competent evidence supporting the claims; state claims are expressly preempted.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether the label statements are structure/function claims under § 343(r)(6) | Statements reference the product and supplemental glutamine, so they are product benefit claims, not permissible nutrient function claims | Statements describe what glutamine does (protein synthesis, anti‑catabolic, recovery), fitting § 343(r)(6) structure/function definition | Held: statements are structure/function claims (labels describe nutrient's role) |
| Whether substantiation must be specific to supplemental (added) form of nutrient | Substantiation must be about supplemental glutamine because labels refer to supplemental/glutamine added to product | Substantiation can rely on general evidence about nutrient's physiological role | Held: substantiation should relate to the form claimed, but on this record supplemental vs natural glutamine is not meaningfully different; requirement satisfied |
| Whether Vitamin Shoppe had required substantiation (competent, reliable scientific evidence) | Evidence Vitamin Shoppe relied on concerns naturally occurring glutamine or used different doses/conditions, so it fails to substantiate labels as truthful and not misleading | Vitamin Shoppe presented studies showing glutamine supplementation can support immune health, protein synthesis, anti‑catabolic effects, and replenish stores; experts disagree mainly on dose | Held: Vitamin Shoppe met the § 343(r)(6)(B) substantiation standard; experts agreed glutamine can have claimed physiological effects (dispute was dosing) |
| Whether labels are misleading because taking the product at recommended doses provides no benefit | Labels omit material facts that at recommended doses the product is ineffective, rendering the claims misleading under § 321(n) | A claim about a nutrient's physiological role need not guarantee the product will benefit most consumers at label doses; that would collapse structure/function regime into drug‑level efficacy requirements | Held: omission of efficacy at recommended doses does not make a truthful nutrient function claim misleading here; no showing of omitted harmful/conflicting role |
Key Cases Cited
- Perham v. GlaxoSmithKline LLC (In re Zofran (Ondansetron) Prods. Liab. Litig.), 57 F.4th 327 (1st Cir. 2023) (context on FDCA consumer‑protection purpose)
- Kaufman v. CVS Caremark Corp., 836 F.3d 88 (1st Cir. 2016) (structure/function claims preemption framework under § 343(r))
- Dachauer v. NBTY, Inc., 913 F.3d 844 (9th Cir. 2019) (FDCA can expressly preempt nonidentical state labeling requirements)
- Greenberg v. Target Corp., 985 F.3d 650 (9th Cir. 2021) (manufacturer need only substantiate nutrient's function on human body, not product efficacy for general population)
- Kroessler v. CVS Health Corp., 977 F.3d 803 (9th Cir. 2020) (truthfulness standard for nutrient function claims can avoid preemption if nutrient does not have claimed effect)
- United States ex rel. Heineman‑Guta v. Guidant Corp., 718 F.3d 28 (1st Cir. 2013) (interpretive caution: do not read extra requirements into statute absent text)
- Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013) (drug regulatory regime includes efficacy requirement; illustrates contrast with dietary supplement regime)