§4.2 Judicial Rulings

• Jurisdiction: United States
• Publication year: 2022

§4.2 Judicial Rulings

Following the '58 Amendment, the courts continued to develop the law for dietary supplements until superseded by the legislature in 1993.¹¹

The court in National Nutritional Foods Ass'n v. Kennedy¹² verified the Commissioner's authority to regulate vitamins and minerals as food additives. In another case, the term 'component" was interpreted by the court to mean one or two ingredients that are part of several ingredients in a dietary supplement.¹³ In this way, ingredients that were classified as "foods" could also be classified as "food additives."

Dietary supplement manufacturers attempted to avoid classification as a food additive which would require proving to the FDA that the ingredient is safe.¹⁴ An ingredient classified as a "food" could only be prevented from sale if the FDA proved by a preponderance of evidence that the food is "injurious to health."¹⁵

The number and types of ingredients that comprised a dietary supplement were important to an ingredient's classification as a "food additive." In United States v. Two Plastic Drums of Article of Food,¹⁶ the claimant extracted black currant oil (BCO) from black currant berries for inclusion into a gelatin capsule. The FDA claimed BCO to be merely a food additive as opposed to a food because, following inclusion into the gelatin capsule, BCO became a "component" of the product. The court, in holding BCO as used in the dietary supplement to be a "food" only, but not a food additive, emphasized BCO was placed in the capsule without other ingredients or with preservatives.¹⁷ On appeal, the Seventh Circuit Court of Appeals affirmed the lower court's judgment of BCO being a food and not a food additive.¹⁸ The court stated:

"The term 'component,' commonly . . . defined as a 'constituent part' or 'ingredient' loses its meaning when applied to foods used in conjunction with inactive ingredients . . . Here, the dietary supplement is nothing but BCO combined with glycerin and gelatin-two inactive substances used for marketing BCO in capsule form. The gelatin and glycerin do not interact with or change the character of the BCO, but merely act as a container . . . The BCO in question is the dietary supplement is the BCO."¹⁹

The key test to determine whether an ingredient was a food additive was "Is the intended use of the ingredient to affect food?"²⁰ If so, then it can be considered a food additive. If it is not intended to affect food, such as BCO not being used to affect glycerin or...