Selecting a CRO – an Important Consideration on the Path to Determining GRAS for a Food Ingredient

By Shawna Lemke, EAS Independent Consultant

The noble pursuit of ensuring food safety is as old as time. Historians find evidence as far back as ancient Egypt and Rome of dietary laws, labeling and inspections put in place at least in part to address food safety. In the US, concerns about adulteration heightened in the late 1800s, made famous by Upton Sinclair’s novel “The Jungle”. The modern FDA has been built on these experiences and ever evolving and improved standards for food safety and inspection. A major shift in the FDA’s oversight came in 1958 with the Miller Food Additive Amendment to the Food, Drug and Cosmetic Act, which introduced requirements for proof of safety for any new additives in the food supply.

Under this law, any substance that is intentionally added to food is a food additive and is subject to premarket review and approval by FDA, unless the substance is “generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use…”. The topic of GRAS – “Generally Recognized as Safe” has been reviewed in articles and webinars before (all found archived on the EAS website). To briefly recap, the amount and quality of scientific evidence is not different for a GRAS food substance compared to a food additive. The GRAS process is based on scientific data that are generally available, typically through publication, the application of scientific principles for interpretation and corroborating unpublished scientific information. The same principles and general process apply to both food for humans and animals. As part of a GRAS assessment, it is important to thoroughly identify and characterize the substance and its production method, evaluate the dietary exposure under intended conductions of use, and evaluate the safety of the substance. Often times, companies elect to call a panel of experts qualified by scientific training and experience to review the GRAS assessment as a proxy for the larger scientific community. Finally, companies have a choice as to whether to notify FDA before proceeding to market.

There are many aspects to determination of GRAS for a food substance that require careful planning. This is where knowledgeable experts from EAS can guide. It’s important as you select a Contract Research Organization (CRO) to assist you that you think about the following:

• Do they have experts in development of food safety assessment approaches, including literature reviews, and design of regulatory study programs?
• Do they have experience in helping clients define intended uses and conducting the associated exposure assessments?
• Are they able to provide advice on setting up and documenting production practices and assuring safety in manufacturing?
• Do they have experience and diversity of expertise required to construct a GRAS dossier?
• Do they have experience convening and administratively managing a GRAS panel, including best practices on identifying experts and a network of potential panelists that are diverse in expertise and experience? Does the CRO pay careful attention to disclosure and management of potential conflicts of interest for panelists?
• Do have they experience submitting notifications to FDA and interacting with FDA follow-up questions? Do they have a good track record in obtaining “no further questions” letter?

The responsibility for ensuring marketed products are safe and compliant with regulatory requirements lies with the food ingredient manufacturer – make sure to partner with the right experts to support you.