Given below, is FDA's capsule summary of the section of the Orphan Drug Act that describes medical food for humans. A medical food for humans is appropriate for individuals who cannot tolerate certain substances traditionally used in food. For example, food for individuals with phenylketonia (who cannot metabolize the amino acid, phenylamine, which is commonly present naturally in food. Therefore, phenylalanine-free food is available as a "medical food".
The term medical food, as defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)) is "a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation."
Animals, mainly cats and dogs, cannot tolerate certain substances in food in a manner very analogous to the human condition. However, CVM, in its wisdom, decided that there was no such thing as medical food for pets - eliminating the classification.
CVM's refusal to recognize medical foods did not end the requirements by those animals with metabolic disease requiring specific medical requirements. However, pet food manufacturers continued to market medical foods, using the name "prescription diet" and sold these products through veterinarians.
Naturally, a lawsuit was launched. Anastasia Wullschleger filed a class-action complaint in Missouri state court against Royal Canin and Nestle Purina, alleging that their requirement for a prescription for specialized dog food was misleading and led to higher prices. The defendants removed the case to federal court, which remanded it back to state court, and then they appealed to the U.S. Court of Appeals for the Eighth Circuit, which determined that the antitrust and unjust-enrichment claims raised substantial federal issues and belonged in federal court. Upon returning to the district court, Wullschleger amended her complaint to remove references to federal law, dropped the antitrust and unjust-enrichment claims, and added a civil-conspiracy claim.
Despite these changes, the district court exercised federal-question jurisdiction and ultimately granted the manufacturers’ motion to dismiss, leading to a second appeal. Reviewing the case de novo, the Eighth Circuit concluded that amending a complaint to eliminate the only federal questions destroys subject-matter jurisdiction and thus returned the case to state court.
Today, the Supreme Court refused to take on the case, saying that it should stay in state court. Bottom line - prescription diets will still be on the shelves.
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