Consumer Product FDA Classification

SITUATION

A client was unsure whether to market a new product as a food or a dietary supplement and sought our assistance in marketing the product in compliance with FDA regulations.

PROBLEM

The company did not know whether the product could be marketed as a food or dietary supplement, based on the ingredients in the product and the claims that they wanted to make in product labeling.

SOLUTION

We provided an ingredient review to determine whether the ingredients were Generally Recognized as Safe (GRAS) for use in foods or otherwise permitted for use in foods. Additionally, we provided label reviews to determine whether the intended use of the product and claims made in product labeling were such that the product must be marketed as either a food or dietary supplement. We then provided the client with an overview of the appropriate FDA classification of their product, based on all relevant factors.

BENEFITS

With an understanding of the FDA classification issues surrounding their product, the company was able to determine whether they were marketing the product under the appropriate FDA classification.

For more information, contact Katherine Giannamore at 305-780-1544 or [email protected].