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How to Obtain GRAS status: A Regulatory Perspective

Many companies, whether they market conventional foods, functional foods or dietary supplements, are concerned with obtaining GRAS (generally recognized as safe) status for ingredients contained in their products. Although manufacturers and distributors should still be aware of GRAS requirements, GRAS status is not necessarily required for all dietary supplement ingredients. This is important because some ingredients in dietary supplements must be either GRAS or an FDA-approved food additive. Yet in other instances, a company may wish to promote proprietary ingredients as GRAS for marketing purposes.

Obtaining GRAS status can be accomplished through three different methods. A company may obtain GRAS status for an ingredient through self-affirmation, the GRAS notification process, or GRAS affirmation petitions. Self-affirmation requires a company to conduct its own research on an ingredient to evaluate its safe use within a product. Such research usually involves animal and human studies, toxicology studies and other data collected through scientific studies. Although a company may use its own scientists to conduct and/or review such studies, a risk exists that the FDA may not agree with the scientist’s findings. Therefore, some companies choose to use outside researchers, as a neutral party, to perform the studies. Although evidence of foreign use of an ingredient may be submitted to the FDA to support GRAS status, it may not be sufficient to obtain such status without additional information.

The GRAS notification process was developed as a part of the FDA Modernization Act of 1997. Under this method, the FDA requires a company to identify the ingredient, state the ingredient’s intended purpose, and provide compiled data supporting safe use of the ingredient. The FDA then has 90 days to respond to the notification indicating whether it has any objections to use of the ingredient. The FDA may also request additional safety data within this 90 day period effectively extending this process to an unknown point in time. If the FDA does not respond within 90 days, the company may market its product containing such ingredients with little or no fear of FDA repercussions. Furthermore, if the FDA responds to the notification stating they have no objections or concerns regarding the ingredient, the company may also market the ingredient. However, a no objection response from the FDA does not necessarily mean that the ingredient is deemed GRAS by the Agency.

A company may seek GRAS status of an ingredient through a GRAS affirmation petition. This method has essentially become obsolete since the introduction of the GRAS notification process outlined above. This is primarily because the FDA requires submitting the same amount and type of data required for a food additive petition. These requirements are overly burdensome to most companies.

Ingredients that were approved by the FDA or the U.S. Department of Agriculture and used in products prior to 1958 are generally regarded as safe. However, this does not bar the FDA from changing its position on such ingredients and does not grant them GRAS status. Historically, the FDA has limited use of certain ingredients by decreasing allowable concentrations or mandating that the ingredient may only be used in certain food categories.

Although acceptable methods for obtaining GRAS status may seem a simple process, it involves more complex procedures and guidelines that may result in slight errors that can unacceptably delay product launch. Therefore, a company should consider consulting a regulatory attorney or consultant prior to applying for such status to assist in the process.

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