y petitioning the FDA unless they are exempted or otherwise specifically addressed by existing FDA regulations. While the statutory period for review is 180 days, in reality, the food additive petition process can take multiple years to obtain approval. Because the GRAS process, described below, is significantly faster, an early gating issue will be whether your new ingredient can go down the GRAS pathway or whether it will be considered a food additive. More information on the food additive petition process can be found here.GRAS – A Pathway with Two Forks in the RoadA substance that is generally recognized as safe has either been scientifically proven to be safe based upon testing by qualified experts with adequate data that is at least equivalent to what it would take to obtain FDA approval or, for older substances in use prior to 1958, through experience based on long-term common food use and general recognition of safety based on common knowledge amongst the scientific community (21 CFR 170.30).A GRAS determination is the obligation of the ingredient manufacturer. While there are two distinct pathways to determine GRAS status (so-called “self-affirmation” and the “GRAS notification” pathway), it is up to the manufacturer to decide which pathway to pursue and to ensure it complies with FDA requirements.In both instances the statutory requirement that must be met is the same. However, in the self-affirmation pathway, a manufacturer prepares a GRAS dossier which is then submitted to a third-party GRAS panel. (The composition of a GRAS panel can vary based on the ingredient and Foley has experience with consulting groups who assist the selection of a GRAS panel). The panel then evaluates whether the ingredient may be deemed GRAS or not. (For guidance on best practices for convening a GRAS panel, see here.) If the panel determines the ingredient is GRAS, the ingredient may be commercialized without any FDA involvement. However, although this is a legally sufficient process, for

87 Fed. Reg. 17941. The rule reinstates paragraph (g) of 21 C.F.R. Section 170.30, concerning the “Eligibility for classification as generally recognized as safe (GRAS),” which reads as follows:(g) A food ingredient that is not GRAS or subject to a prior sanction requires a food additive regulation promulgated under section 409 of the act before it may be directly or indirectly added to food.Nanotechnology For Food and Medical Product Applications Conference: The 12th annual Global Summit on Regulatory Science, co-hosted by the Singapore Food Agency (SFA) and the Global Coalition for Regulatory Science and Research with involvement from FDA, will be held October 19-21, 2022, in Singapore and virtually.

The majority opinion noted FDA’s regulation that a substance meets this standard only when, based on “common knowledge throughout the scientific community knowledgeable about the safety of substances directly or indirectly added to food,” there is “reasonable certainty that the substance is not harmful under the conditions of its intended use.” 21 C.F.R. § 170.30(a). According to the opinion, FDA “need only show the lack of the proper reputation . . . for safety of the [substance] among the appropriate experts, or that what reputation there is, is not based on adequate studies.”

(21 CFR 170.3; 21 CFR 170.30; 21 U.S.C. § 201(s); 21 U.S.C. § 409)On June 16, 2015, the Food & Drug Administration issued an order that partially hydrogenated oils (PHOs) are no longer GRAS for any human food.Under the June 16 order, food manufacturers will have three years to either remove PHOs from their food products or petition the FDA for permission to use PHOs, in accordance with 21 U.S.C. § 348(b). The FDA’s order does not contain an express preemption clause and does not contain any other protections against civil litigation during the three-year compliance period.

Unapproved additives are deemed “adulterated” and are illegal to sell, rendering manufacturers subject to regulatory action. (21 CFR 170.3; 21 CFR 170.30; 21 U.S.C. § 201(s); 21 U.S.C. § 409)On June 16, 2015, the Food & Drug Administration issued an order that partially hydrogenated oils (PHOs) are no longer GRAS for any human food.Under the June 16 order, food manufacturers will have three years to either remove PHOs from their food products or petition the FDA for permission to use PHOs, in accordance with 21 U.S.C. § 348(b). The FDA’s order does not contain an express preemption clause and does not contain any other protections against civil litigation during the three-year compliance period.

Because the notice raises several issues that were not explicitly addressed in the 1997 proposed rule, it should be carefully reviewed by anyone with an interest in FDA’s voluntary GRAS notification process, including those with long-pending GRAS affirmation petitions. Note also that the agency requests input on issues relating to the GRAS notification process for animal feed and pet food ingredients newly implemented by CVM. Among the issues on which FDA requests comments:FDA’s proposed revisions to the regulation that states the eligibility criteria for GRAS classification (21 C.F.R. § 170.30);incorporation by reference of previously submitted data in a GRAS notice;requests to cease evaluation of a GRAS notice;inclusion in a GRAS notice of information claimed to be confidential;submission of specific descriptive information such as biological source, known toxicants, and particle size (the latter recommended by GAO due to concerns about nanotechnology) submission of information about dietary exposure;submission of species-specific information in the case of animal feed ingredients; coordination of FDA’s evaluations with USDA/FSIS;potential issuance by FDA of guidance on conflicts of interest among GRAS expert panelists (as recommended by GAO);potential issuance by FDA of additional guidance on documentation of GRAS conclusions (as recommended by GAO); andFDA’s disposition of pending GRAS affirmation petitions.Any public comments submitted previously to FDA in response to the 1997 proposed rule need not be resubmitted. New public comments are due by March 28, 2011.

Yet these factors are at the crux of FDA’s conclusion that the use of caffeine in the alcoholic beverages that are intended for adults (> 21 years of age in most states) targeted by the warning letters is not GRAS:GRAS status is not an inherent property of a substance, but must be assessed in the context of the intended conditions of use of the substance (section 201(s) of the Act [21 U.S.C. § 321(s)]). The assessment includes a consideration of the population that will consume the substance (21 CFR 170.30(b); section 409(b) of the Act [21 U.S.C. § 348(b)]). Therefore, the scientific data and information that support a GRAS determination must consider the conditions under which the substance is safe for the use for which it is marketed.