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Does FDA approved materials equal an automatically FDA approved product?

December 4, 2007
Question 

If a product is manufactured using an FDA approved resin and FDA approved colorant does that essentially mean that the resulting manufactured product is FDA approved ?

 

 

Answer 

The "mixture doctrine," as it has come to be known informally, clears physical blend of discrete substances if the respective substances are separately cleared by the Food and Drug Administration (FDA) for the intended application. Under this doctrine, such blends require no further FDA clearance provided that each substance in the mixture complies with any limitations applicable to the substance in its respective regulation. If there is a chemical reaction between the combined substances, as opposed to only a physical mixing, and the reaction has resulted in a new substance requiring its own regulatory clearance, the mixture doctrine does not apply.

It is important to note that any limitations, such as extractives limitations, relating to the individual components of a mixture are properly applied to the relevant individual components rather than to the mixture. However, limitations relating to end-use application of the mixture, such as food-type or temperature limitations, or extractable limitations on the finished food-contact article, must be applied to the mixture as a whole.

Concerning the use of "FDA approved," the agency has stated that it strongly objects to the phrase "Approved by FDA" in connection with the marketing or labeling of a product that has been processed through the food additives regulations (see Compliance Policy Guide (CPG) Section 500.300 or click here). However, a firm may state that it is selling a regulated food additive or that its chemicals are in compliance with the food additive provisions of the Federal Food, Drug, and Cosmetic Act.