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Specializing in FDA Regulatory Matters

Generally Recognized as Safe (GRAS)

Before a substance can be legally added to food in the U.S., with rare exceptions, it must be either an approved food additive, prior-sanctioned, or determined to be generally recognized as safe (GRAS) for use in food. Today, many people choose the GRAS option as the way to meet this requirement.

The GRAS route offers two options:

  • GRAS Notification whereby a prepared notice is submitted to FDA; FDA reviews the notification and issues a letter.
  • Independent (self) GRAS determination where the stakeholder makes the determination that the use of the substance is GRAS. FDA is not involved in this effort.

Each approach has advantages and disadvantages. EAS Consulting Group, LLC will discuss the pros and cons with you and work with you to determine the best option for you.

EAS Consulting Group, LLC has a long and successful history of leading companies through the GRAS process. EAS has expert consultants in the areas of toxicology and regulatory requirements to take you through the steps of a GRAS determination. If the GRAS option is not feasible or preferred, EAS can help you with other options, e.g., food additive petition, food contact notification, threshold of regulation, etc.

The cost involved in GRAS determinations will vary depending on several factors and the needs of the client. The steps involved usually include the following:

  • Feasibility Assessment. EAS will evaluate the available data provided by the client to determine if it is sufficient to support a GRAS determination. If not, EAS will identify the deficiencies and advise the client as to what it considers to be necessary to achieve GRAS status. EAS will also conduct a comprehensive literature search if required.
  • Draft GRAS document. EAS will draft the GRAS document as a GRAS Notification or an independent GRAS determination.
  • Expert Panel (if necessary). EAS will identify and assemble the expert panel to review the GRAS document.
  • Finalize GRAS document. For a GRAS Notice, EAS will submit the document to FDA, monitor progress and respond to any FDA questions as necessary. For an independent GRAS determination,

EAS will submit the document to the client along with any supporting documents

EAS can provide a cost estimate after discussing the project with the client.