Nutrilab, Inc. v. Schweiker
713 F.2d 335 (1983)
Premium Feature
Subscribe to Lexplug to listen to the Case Podcast.
Rule of Law:
An article intended to affect a function of the human body is a "drug" under the Federal Food, Drug, and Cosmetic Act if it is not primarily consumed for its taste, aroma, or nutritive value, which would classify it as a common-sense "food."
Facts:
- Plaintiffs manufactured and marketed products known as 'starch blockers,' which were sold as an aid for weight control.
- The products consist of a protein extracted from a specific type of raw kidney bean, which is dangerous if eaten raw.
- This protein functions as an alpha-amylase inhibitor, which prevents the human body's enzymes from digesting starch.
- When ingested during a meal, the product allows undigested starch to pass through the body, thereby preventing the absorption of calories.
- The Food and Drug Administration (FDA) received seventy-five reports of adverse effects from people who had taken starch blockers, including nausea, vomiting, and abdominal pain.
- Plaintiffs considered starch blockers to be food and therefore did not conduct the safety and efficacy testing required for new drugs.
Procedural Posture:
- On July 1, 1982, the Food and Drug Administration (FDA) classified starch blockers as 'drugs' and requested manufacturers remove them from the market.
- The following day, plaintiffs (manufacturers) filed two complaints in the U.S. District Court for the Northern District of Illinois, seeking a declaratory judgment that their products are 'foods'.
- The cases were consolidated, and the government counterclaimed for a temporary restraining order, which the court denied.
- At the preliminary injunction hearing, the parties agreed to treat the hearing as a trial on the merits.
- The district court held that starch blockers were drugs, permanently enjoined plaintiffs from manufacturing and distributing the products, and ordered the destruction of existing inventories.
- Plaintiffs, the manufacturers, appealed the district court's decision to the U.S. Court of Appeals for the Seventh Circuit.
Premium Content
Subscribe to Lexplug to view the complete brief
You're viewing a preview with Rule of Law, Facts, and Procedural Posture
Issue:
Do starch blockers, products derived from kidney beans and marketed to inhibit the digestion of starch for weight control, qualify as "drugs" under section 321(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act?
Opinions:
Majority - Chief Judge Cummings
Yes. Starch blockers qualify as drugs under the Federal Food, Drug, and Cosmetic Act. The Act's definition of a drug in § 321(g)(1)(C) includes articles 'intended to affect the structure or any function of the body' but excludes 'food.' To determine if starch blockers are excluded as 'food,' the court interprets the statutory term 'food' in § 321(f) to mean articles consumed in the ordinary way—primarily for taste, aroma, or nutritive value. Starch blockers are not consumed for these purposes; they are consumed specifically for their physiological effect of blocking digestion. Because they are not 'food' in this common-sense meaning and are intended to affect a bodily function, they fall squarely within the definition of a drug.
Analysis:
This decision clarifies the regulatory boundary between food and drugs, particularly for dietary supplements and weight-loss products. By establishing the 'taste, aroma, or nutritive value' test for common-sense food, the court prevents manufacturers from circumventing the FDA's stringent drug approval process simply because a product is derived from a food source. This precedent strengthens the FDA's authority to regulate products that make physiological or functional claims, ensuring that such products undergo safety and efficacy testing before reaching the market. The ruling has a lasting impact on the dietary supplement industry, requiring careful consideration of a product's intended use and primary purpose in its classification.
