What is the definition of an adulterated product according to FDA regulations?

The definition of an adulterated product according to FDA regulations focuses on the quality and safety of the product. A product is deemed adulterated if it contains filthy, putrid, or decomposed substances. This definition underscores the FDA's commitment to ensuring that products, particularly food, drugs, and cosmetics, are safe for consumption and free from harmful contaminants. Adulteration can significantly affect the product's integrity and poses risks to public health.

By identifying a product that has been compromised by unwholesome materials, the FDA aims to protect consumers from the dangers that such adulterated products may present. The use of terms like "filthy," "putrid," or "decomposed" is crucial, as they indicate a clear deviation from sanitary and quality standards.

In contrast, options referring to products containing approved additives, those meeting Good Manufacturing Practices (GMP), or being manufactured in sterile conditions do not directly relate to the concept of adulteration. Such characteristics may indicate compliance with safety standards but do not inherently account for the cleanliness or integrity of the substances used in the product. Thus, the presence of unsafe or unsanitary components captures the essence of adulteration in FDA regulations.