Federal Question- Nutrilab, Inc., manufactures and markets a product known as St
ID: 390620 • Letter: F
Question
Federal Question- Nutrilab, Inc., manufactures and markets a product known as Starch Blockers. The purpose of the product is to block the human body's digestion of starch as an aid in controlling weight. The U.S. FDA classified Starch Blockers as a drug and requested that it be removed from the market until the FDA approved its use. The FDA claimed that it had the right to classify new products as drugs an prevent their distribution until their safety is determined. Nutrilab disputed the FDA's decision an wanted to bring suit to halt the FDA's actions. Do the federal courts have jurisdiction to hear this case? Nutrilab, Inc v Schweiker, 713 f.2d335, Web 1983 U.S. App. Lexis 25121(United States Court of Appeals for the Seventh Circuit)
Explanation / Answer
When we are trying to shed pounds and the scale isn’t moving in the right direction, we may be tempted to try something like a no prescription weight loss supplement!!
Some of these supplements are called "starch blockers" or "carbohydrate blockers." Starch blockers are Amylase Inhibitors ( proteins that are obtained from some kind of raw kidney beans & amylase is an enzyme produced by the body which is utilized in digesting starch).
Kidney beans, from which alpha-amylase inhibitor is derived, are dangerous if eaten raw. By August 1982, FDA had received seventy-five reports regarding adverse effects of starch blockers, including complaints of gastro-intestinal distress such as bloating, nausea, abdominal pain, constipation and vomiting. As per the case, Nutrilab
Defining food as articles used primarily for taste, aroma, or nutritive value would not be contrary to National Nutritional Foods Ass'n v. FDA, 504 F.2d 761 (2d Cir.1974). In that case, the FDA attempted to regulate as drugs all vitamin and mineral products in excess of the upper limits of the U.S. Recommended Daily Allowances ("RDA"). To bring these products within the Section 321(g)(1)(B) drug definition, the FDA had to show that the manufacturer's intended use was for treatment of a disease. Because the hearing record disclosed no food or nutrition use of nutrients at such high levels, the FDA inferred that the products were intended for therapeutic use. The court found first, that a significant number of persons have indisputable nutritional need for potencies exceeding the upper limits; and second, that to find actual therapeutic intent under part B of Section 321(g)(1) requires something more than evidence of uselessness as a food for most people. 504 F.2d at 789. This holding does not invalidate a definition of food that is based in part on consumption for nutritive value. See also United States v. "Vitasafe Formula M", supra, 226 F.Supp. at 278; United States v. Nutrition Service, Inc., supra, 227 F.Supp. at 385.consider starch blockers to be food, no testing as required to obtain FDA approval as a new drug has taken place. If starch blockers were drugs, the manufacturers would be required to file a new drug application pursuant to 21 U.S.C. § 355 and remove the product from the marketplace until approved as a drug by the FDA.
This double use of the word "food" in Section 321(f) makes it difficult to interpret the parenthetical "other than food" exclusion in the Section 321(g)(1)(C) drug definition. As shown by that exclusion, Congress obviously meant a drug to be something "other than food," but was it referring to "food" as a term of art in the statutory sense or to foods in their ordinary meaning? Because all such foods are "intended to affect the structure or any function of the body of man or other animals" and would thus come within the part C drug definition, presumably Congress meant to exclude common-sense foods. Fortunately, it is not necessary to decide this question here because starch blockers are not food in either sense.*The tablets and pills at issue are not consumed primarily for taste, aroma, or nutritive value under Section 321(f)(1); in fact, as noted earlier, they are taken for their ability to block the digestion of food and aid in weight loss. In addition, starch blockers are not chewing gum under Section 321(f)(2) and are not components of food under Section 321(f)(3). To qualify as a drug under Section 321(g)(1)(C), the articles must not only be articles "other than food," but must also be "intended to affect the structure or any function of the body of man or other animals." Starch blockers indisputably satisfy this requirement for they are intended to affect digestion in the people who take them. Therefore, starch blockers are drugs under Section 321(g)(1)(C) of the Food, Drug, and Cosmetic Act. And hence Federal courts cannot challenge FDA decision.
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