Generally Recognized as Safe (GRAS) is the acronym used by industry and FDA for any substance that is intentionally added to food, and meets the “general recognition of safety” regulatory requirements either through scientific procedures or through experience based on common use in foods prior to 1958 (21 CFR 170.3 and 21 CFR 170.30).
Since the 1958 Food Additives Amendment was enacted, a number of food additives have already been evaluated for safety in use and been affirmed as GRAS. The first list of GRAS substances was published on December 9, 1958 in the Federal Register. Often referred to as the “GRAS list,” the most current version appears in the Code of Federal Regulations (CFR) in 21 CFR 182, 21 CFR 184, and 21 CFR 186. In addition, certain food additives received regulatory approval for use by FDA or the United States Department of Agriculture (USDA), and many—but not all—of which are listed in 21 CFR 181.
In 1969, FDA established the Select Committee on GRAS Substances (SCOGS) to perform systematic review of GRAS substances. Between 1972 and 1982, SCOGS reviewed over 400 substances that were the subject of 151 reports. FDA subsequently reviewed the SCOGS reports, determined if the information therein supported a GRAS conclusion, and amended 21 CFR 184 and 21 CFR 186 when a GRAS conclusion was affirmed. FDA maintains a SCOGS database on its website.
FDA also instituted a GRAS affirmation petition process in 1972, where manufacturers could ask FDA to consider the GRAS status of ingredients that were not already included in FDA’s previous reviews. In 1997, FDA proposed the institution of a voluntary GRAS notification process to replace the GRAS affirmation petition process.
On August 17, 2016, FDA published the Final GRAS Rule in the Federal Register, which became effective on October 17, 2016. In the Final Rule, FDA summarized the history of the GRAS process, outlined the criteria required for a GRAS conclusion, and provided additional information on FDA’s review and response process. Most recently, on November 15, 2017, FDA issued draft guidance on “Best Practices for Convening a GRAS Panel.” The draft guidance was intended for comments only (the comment period closed in May 2018), and a final rule has not been implemented.
Since the first submission was received in 1998, FDA has filed more than 850 GRAS notifications. FDA’s searchable GRAS Notice Inventory lists the GRAS Notices that have been voluntarily submitted, along with information regarding the ingredient, notifier, and conditions of use. For those GRAS Notices (GRNs) that have received a “no questions” letter from FDA, a link to the correspondence is provided. Historically, links to the releasable information for a GRAS Notice have also been provided with each GRN entry in the database; however, more recently, FDA has not consistently provided a link on their website. For those entries without an active link to the GRN, information releasable under the Freedom of Information Act (FOIA) can be obtained—for a fee—via a formal request submitted on FDA’s website. From experience, these requests typically take 3-4 weeks to process.
Based on FDA’s GRN Inventory list as of 6/14/19, there are currently 50 GRNs pending review and response from FDA, the oldest of which was received by FDA on January 24, 2018. These GRNs cover a variety of substances including enzyme preparations, sweeteners, proteins, oils, and oligosaccharides. Upcoming blog posts will discuss some of the more common ingredients and categories, as well as some possible up-and-coming ingredients of interest.
Next week’s blog post will cover How to Determine the Appropriate FDA Category for an Ingredient.
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