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By George A. Burdock, Ph.D. and Mr. Johnel Lagabon Occasionally, a GRAS needs to be amended. Other than expanding the list of food categories in which the ingredient may be used (a welcome reason), the need for amending a GRAS is often that the identity or specification of the primary ingredient has changed for one reason or another – an unfortunate circumstance. If the ingredient has changed to the point it no longer conforms to the original specifications, the GRAS is no lo

By: Johnel Lagabon and George A. Burdock, Ph.D. In the process of compiling a GRAS dossier, often so much emphasis is placed on showcasing the safety data that communicating the rationale behind the conclusion of safety becomes an afterthought. This lack of a convincing rationale can have disastrous results, ranging from prolonged review times by regulators to a request for conduct of additional studies to “tie up loose ends” or one more study to respond to a rhetorical hypot

“Why should I invest in a GRAS when everyone is already selling my ingredient?” Well, to be frank – it’s the law. “Any substance that is intentionally added to food is a food additive, that 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, or unless the use of the substance is otherwise excepted from the definition of a

Does the Food and Drug Administration (FDA) have the regulatory tools and experience necessary to regulate cell-cultured “meat”? In a public meeting on July 12, 2018, FDA discussed how meat produced using cell-culture technology fits under its current regulatory framework for food safety.1,2 Does this mean that FDA does not view cell-cultured “meat” to be a “meat food product,”3 which would traditionally be regulated under the jurisdiction of the United States Department of A

“Let food be thy medicine and medicine be thy food” — Hippocrates of Cos (ca.460 BC – ca. 370 BC) The Drug-Like Properties of Foods Many foods have drug-like properties. For example, foods with vitamin C (such as citrus fruit) can cure scurvy, the dreaded disease of 17th Century sailors; likewise, seafood can cure (thyroid) goiters because seafood represents a unique source of iodine; most obviously, food can cure malnutrition and starvation and protein-containing foods are a

You would think any application of the GRAS1 process would be a legitimate pathway to federal compliance unless expressly prohibited by statute (e.g., color additives, dietary supplements) or by regulation (e.g., 21CFR2§184.1(b)(2));3 the latter of which requires a food additive petition (FAP) be filed for any additional use, use levels or changes to the manufacturing process of an otherwise GRAS affirmed substance.4 So far, so good for many food ingredients, until you get to

The cosmetics industry has been largely self-regulating since passage of the Food, Drug, and Cosmetic Act of 1938; however, the proposed Modernization of Cosmetics Regulation Act (MCRA) of 2018, will change the standards of cosmetics production and safety to that approximating food ingredients — a move that may be very costly and disruptive for some cosmetics companies. So, what is the history of cosmetics regulation and what can we expect from the MCRA? A Short History of Co

The week of November 13, 2017, is notable because FDA released two documents relating to guidance for conclusions of GRAS1 status and draft guidance for conduct of GRAS Expert Panels.2 Both of these documents revise and expand on “Substances Generally Recognized as Safe: Final Rule” (81 FR 54869, August 17, 2016). In December, our newsletter discussed the guideline for Regulatory Framework,3 this month we will discuss draft guidance for the conduct of GRAS Expert Panels (GEP)

A newsletter article published in the Burdock Advisor a year ago1 described an existential threat to the AAFCO system of approval of Feed Ingredient Definitions (FID). The threat arose as a result of the FDA’s Center for Veterinary Medicine (CVM) determination that an FID does not confer federal compliance. According to CVM, as many as 500 ingredients in AAFCO’s Official Publication (OP) may be affected. Today’s article also describes a pathway for AAFCO to survive another th

Is there a regulation or order related to food that you would like the U.S. Food and Drug Administration (FDA) to issue, amend or revoke? Or is there another form of administrative action you think FDA should take or refrain from taking? Recently, FDA has issued several new or revised regulations and guidance documents which impact the food industry, such as revisions to food labeling (nutrition and supplement facts panels) (21 CFR 101.108(c)), current good manufacturing prac

Quantity & Quality of Evidence The first, “Regulatory Framework,” brings up some interesting issues, if not in a slightly overbearing manner ─ more like warnings than counseling by an elder. For example, in the Introduction section there were several (sharp) bullet points reminding the reader of his/her responsibilities, including statements that FDA is releasing this guidance to: “Remind you that a GRAS conclusion based upon scientific procedures requires the same quantity a

After working with the Burdock Group to recently obtain a successful self-contained GRAS (Generally Recognized As Safe) determination for its oxalate-reducing enzyme, biotechnology company Captozyme licensed the rights for commercialization to Entring LLC, which will make it available for purchase this fall as a food ingredient. Consumers seeking a low-oxalate diet can add the virtually tasteless, odorless powder to a variety of oxalate-packed foods and beverages to help redu

The above dialogue is a common one in consulting and usually refers to an opinion on the safe use of an ingredient, or a GRAS determination. The manufacturer has a new ingredient that he intends to add to food or use as a dietary supplement, but doesn’t have the depth of bench on his staff to generate a supportable opinion on safety. He needs the documentation in case the unthinkable happens — the FDA, FSIS or a third-party auditor asks for his supporting documentation on the

*This article will be published in the Summer issue of IngredientsOnline.com Food ingredient regulation in the United States (U.S.) is unique among other regulatory domains in the U.S. and worldwide by incorporating two equally legitimate and parallel processes of compliance to the law – one that is government managed (a Food Additive Petition or FAP) and another that is a self-approval system (Generally Recognized As Safe or GRAS). Further, once a GRAS determination has been

To be compliant with federal law, an ingredient added to food (including pet food) must be approved by FDA for its intended use as a food additive if the ingredient has not been determined generally recognized as safe (GRAS) for its intended use by experts in the field of food safety. Once the safety testing data is complete, food additive approvals can take 2-4 years; whereas a GRAS determination may only take six months for the same ingredient. FDA recently released its Fin

The FDA’s new guidance document on new dietary ingredient notifications (NDINs) and related issues (1) contains answers to several questions, one of which is “what safety factors should be used for determining adequate daily intake (ADI) levels of the dietary ingredient if only animal studies are available?” The answer to this question may be surprising to most in the dietary supplement and food industry, as the revised draft guidance document recommends far more rigorous pre

The American Association of Feed Control Officials (AAFCO)[1] was formed in 1909 by officials from individual State governments at a time when Federal oversight of animal feed ingredients and standards was virtually non-existent.  Following passage of the Food Additives Amendment (FAA) in 1958, which put the Center for Veterinary Medicine (CVM) in charge of vetting animal feed ingredients, CVM saw the successful process AAFCO had developed for defining ingredients for consist

The finalized GRAS rule and associated Federal Register Notice1 emphasizes the FDA’s opinion that dietary exposure is a factor that must be considered in determining safety, regardless of whether the conclusion of GRAS status is through scientific procedures or experience based on common use in food, or even if a GRAS conclusion is notified or not.  While we agree with the assertion that exposure is integral to a safety determination, the new requirements for how exposure ass

What makes for a successful Generally Recognized as Safe (GRAS) determination?  In the recent past many questions have been posed about the GRAS process, the degree of transparency of the process, and the information necessary to determine that a substance is GRAS for its intended use. Within the past month, FDA released the Final Rule for the process by which a person may notify the FDA of the conclusion of GRAS status. Within this Rule, the FDA has attempted to clarify (whi

What makes for a successful Generally Recognized as Safe (GRAS) determination?  In the recent past many questions have been posed about the GRAS process, the transparency of the GRAS process, and the information necessary to determine that a substance is GRAS for its intended use. Over the next few issues of the newsletter, we will work to address these questions. Estimates vary on how many GRAS determinations are made, but only a fraction are made public. GRAS determinations