Compliance with FDA’s GRAS Requirements

Legal Advice for Food Products Manufacturers regarding GRAS Status of Ingredients

Generally, substances that are intentionally added to food – including “other ingredients” in dietary supplements – are regulated as “food additives” subject to premarket review and approval by FDA, unless the substances are “generally recognized as safe” (GRAS) by qualified experts. FDA regulations define “safe” to mean that there is a reasonable certainty in the minds of competent scientists that a substance is not harmful under its intended conditions of use.

Substances that were used in food prior to 1958 may qualify as GRAS based solely on experience founded on common use. For all other substances, GRAS classification depends upon the existence of adequate scientific evidence demonstrating that the substance is safe under the conditions of its intended use. The specific evidence that is required to demonstrate safety depends on the nature of the substance and its intended use.

The attorneys of Ullman, Shapiro & Ullman are experienced in advising manufacturers of food products with regard to FDA’s GRAS requirements and can provide valuable guidance through the GRAS determination process. This may include reference to FDA regulations and/or working with and putting our clients to assemble a team of qualified scientific experts working as GRAS consultants who will review the existing scientific literature to make a GRAS determination. Our attorneys will also be able to provide strategic consultation with clients on marketing strategy for their ingredients and the advisability of submitting a GRAS Notification to FDA.

For specific advice about compliance with FDA’s GRAS requirements, contact Ullman, Shapiro & Ullman.