## Facts

- Nutrilab, Inc. and Bio-Tech Laboratories, Inc. manufactured and marketed “starch blocker” tablets and capsules as weight-control aids that “block” digestion of starch.
- The products contained a protein extracted from raw kidney beans that acts as an alpha-amylase inhibitor, preventing the body’s starch-digesting enzyme from functioning and allowing undigested starch to pass through.
- On July 1, 1982, the FDA classified starch blockers as “drugs” and requested their removal from the market pending FDA approval.
- Plaintiffs sued for declaratory relief that the products were “foods” under 21 U.S.C. § 321(f) rather than “drugs” under 21 U.S.C. § 321(g); the government counterclaimed and sought injunctive relief.
- The district court held the products were “drugs,” permanently enjoined manufacture and distribution, and ordered destruction of inventory (stayed pending appeal).
- Plaintiffs had not conducted new-drug testing or filed a new drug application because they viewed the products as foods.
- By August 1982, the FDA had received 75 adverse-event reports associated with starch blockers, including bloating, nausea, abdominal pain, constipation, and vomiting.

## Issues

1. Whether starch blocker tablets and capsules are “foods” under 21 U.S.C. § 321(f) or “drugs” under 21 U.S.C. § 321(g)(1)(C) under the FDCA.

## Decision

- The Seventh Circuit affirmed the district court.
- The court held starch blockers are “drugs” under 21 U.S.C. § 321(g)(1)(C) because they are intended to affect a function of the body (digestion).
- The court rejected the argument that the products were “foods” merely because their active ingredient was derived from an edible source (kidney beans).

## Legal Principles

- Under 21 U.S.C. § 321(g)(1)(C), an article “intended to affect the structure or any function of the body” is a drug unless it qualifies as “food.”
- “Food,” in ordinary statutory usage, refers to items consumed primarily for taste, aroma, or nutritive value, rather than for a targeted physiological effect.
- The “other than food” language in the drug definition excludes common, ordinary foods used in the usual manner; it does not exempt concentrated derivatives or pill-form products aimed at altering bodily functions.
- Classification turns on intended use and how the product is consumed and marketed, not solely on its source or ingredients.
- Products marketed to inhibit enzymes and modify digestion for weight control fall within the FDCA’s drug category and may be subject to premarket approval requirements.

## Conclusion

Because starch blockers were marketed and used to inhibit alpha-amylase and thereby alter digestion to reduce calorie absorption, the court treated them as “drugs” rather than “foods” under the FDCA and upheld the permanent injunction against their distribution absent FDA approval.


Nutrilab, Inc. v. Schweiker, 713 F.2d 335 (7th Cir. 1983)