Hi-Tech Pharmaceuticals, Inc. v. HBS International Corp.
910 F.3d 1186
| 11th Cir. | 2018Background
- Hi-Tech (Georgia supplement maker) sued HBS (distributor of Allmax’s HexaPro) alleging HexaPro’s label falsely represents quantity/source of protein and thus violates Georgia’s Uniform Deceptive Trade Practices Act and the Lanham Act. The district court dismissed both claims.
- Product label states “Ultra-Premium 6-Protein Blend” and “25 G Protein Per Serving,” lists six whole-protein sources, separately advertises a “5 Amino Acid Blend,” and shows an amino-acid table that is internally inconsistent (44 g heading vs. 25 g itemization).
- Hi-Tech alleges HexaPro is “spiked” with free-form amino acids and non‑protein nitrogen such that bonded (whole‑protein) content is ~17.914 g per serving, not 25 g; the label does not reveal how much of the 25 g derives from whole proteins vs. free amino acids.
- District court held the Georgia claim was preempted by the FDCA/regulations and held the Lanham Act claim implausible because the label disclosed amino acids and ingredient breakdowns.
- On appeal, the Eleventh Circuit affirmed preemption of the state-law claim but reversed dismissal of the Lanham Act claim, finding Hi‑Tech plausibly alleged that a reasonable consumer could be misled about the source/amount of protein.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether state-law deceptive-practices claim is preempted by FDCA express-preemption | Hi‑Tech: Georgia UDTPA enforces truthful labeling; seeks to prevent misleading presentation of protein source/amount | HBS: State claim would impose labeling requirements different from federal rules and is therefore preempted | Held: Affirmed — claim expressly preempted because it would impose requirements not identical to FDCA/regulations |
| Whether Lanham Act false-advertising claim was plausibly pleaded (label is misleading) | Hi‑Tech: Label implies full 25 g protein comes from the six-protein blend; in fact only ~17.914 g is from bonded proteins due to spiking | HBS: Label discloses amino acids and ingredient list; no plausible consumer confusion; complaint lacks supporting test data | Held: Reversed — complaint alleges plausible misleading impression; factual protein allegation is not conclusory at pleading stage |
| Whether FDCA/regulations bar Lanham Act claim (genuinely irreconcilable conflict) | Hi‑Tech: Lanham claim challenges misleading impression, not FDCA-compliant protein calculation; both can co-exist | HBS: Allowing Lanham claim would conflict with FDA method of calculating protein and force untenable dual compliance | Held: Rejected HBS’s conflict argument — label can comply with FDA while clarifying sources/amounts; POM does not foreclose Lanham claims |
| Whether plaintiff forfeited appellate arguments by not addressing district-court points | Hi‑Tech: Preserved challenge to district court’s grounds; may raise on appeal | HBS: Hi‑Tech failed to respond below and thus waived arguments | Held: Rejected HBS — appellate review permitted; failure to address each district-court sub-argument below did not forfeit the appeal of the dismissal |
Key Cases Cited
- Bailey v. Wheeler, 843 F.3d 473 (11th Cir. 2016) (pleading facts accepted as true on Rule 12(b)(6) review)
- POM Wonderful LLC v. Coca-Cola Co., 573 U.S. 102 (2014) (FDCA does not generally preclude Lanham Act false-advertising claims)
- Ashcroft v. Iqbal, 556 U.S. 662 (2009) (pleading standard: plausible claims survive; legal conclusions not assumed true)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007) (plausibility standard for pleading)
- PhotoMedex, Inc. v. Irwin, 601 F.3d 919 (9th Cir. 2010) (Lanham Act claims barred when they would effectively seek enforcement determinations the FDA has not made)