The court confronted the issue of whether a product is really a food or a drug under the FDCA. Often, courts are faced with ambiguous statutes and have to draw on their perception of legislative intent.

Distinguishing a food from a drug has very significant regulatory implications. Food products are not subject to the premarket approval process as are drugs. Thus, in most cases, if the FDA has objections over the promotion of a food product, the agency has the burden of proving its claim, during which time the product continues to be marketed. On the other hand, the FDA can withdraw a product from the market deemed to be a drug simply because it is an unapproved new drug. The agency also would have no difficulty establishing that the product is misbranded because the product’s label would not be in compliance with drug labeling requirements.

As the definition of drug indicates, the critical issue in distinguishing whether a product is a drug is the intended use of the product. In determining the intended use of a product, courts will consider evidence beyond the label and labeling. Thus, a court considers advertising from television, radio, magazines, the Internet, and so forth. Because the health, safety, and welfare of the public are often at stake in these cases, courts will often apply the definition of drug liberally in favor of the FDA.

As you read this case, consider the difference in the intent and meaning of Section 321(g)(1)(B) and Section 321(g)(1)(C) of the drug definition. Why are foods specifically excluded from being drugs under part C and not part B? 

How did the court ultimately define food for the purpose of part C? 

If this case were brought today, would the product be considered a dietary supplement under DSHEA?