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

Rule:

Under the Food, Drug, and Cosmetic Act, 21 U.S.C.S. § 301 et seq., the definitions of food and drug are normally not mutually exclusive; an article that happens to be a food but is intended for use in the treatment of disease fits squarely within the drug definition in 21 U.S.C.S. § 321(g)(1)(B) and may be regulated as such.

Facts:

Plaintiffs were manufacturing and marketing a product known as "starch blockers" which "block" the human body's digestion of starch as an aid in controlling weight. On July 1, 1982, the Food and Drug Administration ("FDA") classified starch blockers as "drugs" and requested that all such products be removed from the market until FDA approval was received. The next day plaintiffs filed two separate complaints in the district court seeking declaratory judgments that these products were food under 21 U.S.C. § 321(f) and not drugs under 21 U.S.C. § 321(g). The district court held that starch blockers were drugs under 21 U.S.C. § 321(g), and plaintiffs were permanently enjoined from manufacturing and distributing the products. 

Issue:

Could the starch blockers be considered “drugs” under 21 U.S.C. § 321(g)? 

Answer:

Yes.

Conclusion:

On appeal, the court affirmed because the blockers were not consumed primarily for taste, aroma, or nutritive value under 21 U.S.C.S. § 321(f)(1), were not chewing gum under 21 U.S.C.S. § 321(f)(2), and were not components of food under 21 U.S.C.S. § 321(f)(3). The blockers fit the qualifications for drugs because they were articles other than food as required by 21 U.S.C.S. § 321(g)(1)(C) and were intended to affect the structure of the body.