Which factors determine the expiration period of a product?

The expiration period of a product is primarily determined by stability studies and negotiations with regulatory authorities such as the FDA. Stability studies are scientific assessments undertaken to determine how the quality of a product varies with time under the influence of environmental factors such as temperature, humidity, and light. These studies help establish the shelf life and the date until the product can be expected to remain safe and effective for use.

Negotiations with the FDA come into play because the agency requires evidence from stability studies to support the proposed expiration dates. Companies must provide comprehensive data to ensure that the product will maintain its intended quality and efficacy throughout its shelf life. Hence, the regulatory approval process takes these scientific findings into account, leading to a definitive expiration date that meets regulatory standards.

Other choices, while they may influence the business strategy or marketing approach of a product, do not directly determine the expiration period in the same robust and scientifically validated manner that stability data and regulatory negotiations do.