FDA Supplement Expiration Date Rules

In the United States, all labeling procedures for food, drugs, cosmetics, medical devices and health supplements are guided by the federal Food and Drug Administration (FDA). The rules for what must be contained on a label differ depending on how the FDA classifies a product. Whether an expiration date must appear on the label depends on this classification and differs for "dietary supplements" and "foods."

Role of the FDA

• The FDA determines the rules manufacturers of health supplements must follow if they market their products in the United States. However, unlike with drugs, the FDA does not pre-approve a health supplement before it is on the market. Ensuring safety and accuracy of labeling remains the responsibility of the manufacturer. The FDA monitors safety and claims of supplements already on the market, but has no pre-approval process.

The FDA's Definition of a Dietary Supplement

• The difference between foods and dietary supplements was defined by the FDA in 1994. Although most dietary supplements are related closely to foods, they are differentiated as oral products intended to supplement an individual's diet. The most common dietary supplements are "vitamins, minerals, herbs or other botanicals, amino acids and substances such as enzymes, organ tissues, glandulars and metabolites."

Supplement Expiration

• Whether or not a supplement has an expiration date entirely depends on the specific supplement. The FDA does not require dietary supplements to have expiration dates. Rather, the FDA recommends that supplement manufacturers include an expiration date, "if it is supported by valid data demonstrating that it is not false or misleading."