MAHA Successes May Depend on Manufacturers' Negligence. The Answer: SUSTAINABLE GRAS™

The Burdock Group Advisor

The MAHA Strategy Report for Make Our Children Healthy Again (The-MAHA-Strategy-WH.pdf) is a mandate to weed out the possible causes of chronic disease(s) in children; for example: vaccines, air pollution, microplastics in food and water, sedentary lifestyle, etc. (see figure).

While this mandate is laudable, the brush is too broad; for example, how can the government control the amount of exposure to microplastics, heavy metals from produce or bacteria and viruses on pets or in daycare centers? Likewise, how can the government force parents to abandon a sedentary lifestyle or avoid over-medication, cook food appropriately and ensure proper nutrition?

Unable to control most of the suspected causes of chronic disease in children and desperate to “pin the tail on the donkey” to show progress towards at least some of this important mandate, a witch hunt may be triggered, and the government will start looking things that it can control and the first one that comes to mind are food ingredients.

Laying the groundwork for the eventuality of an attack on food ingredients, the MAHA Strategy includes a policy update (View Rule) requiring all GRAS conclusions to be notified to the FDA — a proposed rule has already been announced (PR). Eventually, however much people might be satisfied with the initial steps such as notification of all new food ingredients, new ingredients were never the problem – the problem is with the long-ago “approved” ingredients added to food i.e., the “old GRASes” before the GRAS notification process was ever in existence.

Our experience has been that many of these old GRASes are no longer in company files, especially for companies that have been bought and sold a time or two. As often, the purchaser was never given any record from the vendor regarding the GRAS and any of the details of the manufacturing process, specifications, permitted food groups and concentrations, etc. The substance was sold and purchased on an article of faith that its manufacture and use conformed to the FD&C Act.

Nonetheless, these substances with their old GRASes are still integral to your operation; however, FDA inspectors may question the safety and legitimacy of use of any substance in your manufacturing process, including those substances that are the subject of these old GRASes. Remember, FDA inspectors (courtesy of the Food Safety and Modernization Act) can demand to see any information regarding the legitimate use of any product used in the manufacturing process. Bottom line - it will not be too long before FDA will start looking at these long-used and presumably safe ingredients.

Further, while some changes in process and product are permitted, it is important that your current process aligns with what was described in the original GRAS dossier, despite well-intentioned improvements made with the process and/or if its use has been expanded to additional products. Any modifications that could affect the composition or characteristics of the final product may require an amendment to your original GRAS conclusion and avoid a demand for a recall, possibly resulting in irreconcilable damage to the brand.

For these old GRAS determinations, made early in the evolution of the GRAS process, the supporting safety evidence was often very weak, if present at all, which could provoke immediate action by the FDA, demanding a recall. Even with GRASes whose safety documentation was adequate for the time, how much and to what degree has testing changed to prove safety? Also, your manufacturing process may have changed over the years; that is, including the specifications of the ingredients used, processing equipment, or production oversight. The bottom line – are you still manufacturing the same substance you did when the safety data was generated, and the product was GRASed?

From 1972 – 1980, the Select Committee on GRAS Substances (SCOGS) reviewed 370 food ingredients and published 115 reports on their findings. Unfortunately, the Select Committee only had access to safety data generated in the early 1970’s and before, all of which was generated prior to Good Laboratory Practice (GLP), guidelines mandating on how studies should be performed. The GLP guidelines were promulgated in response to the several scandals involving the sloppy, questionable and fraudulent data produced by laboratories. Many of the “Old GRASes” were based on data generated prior to initiation of GLPs. Bottom line – much of the data used by SCOGS and others would not be permitted for use in support of a GRAS today

What is the relationship of this information to you? It is important to note that the person (or company) responsible for the safe use of ingredients is the user – not the FDA!

At this point in time Burdock Group is announcing its SUSTAINABLE GRAS™ program. The SUSTAINABLE GRAS™ program would provide you with a basic review of the legitimate use of your product in interstate commerce.

Level 1 – Foundational Review: A baseline assessment of the legitimacy of your ingredient’s use in interstate commerce.

Sustainable GRAS™ — Level 1 Substance Review

Focus: Foundational Compliance Check

Tasks:

• Review your documentation on source, specifications, technical effect  and safety.

• Confirm the identity of the substance – the proper CAS name and the name in commerce.

• Determine if there are any legally enforceable specifications (e.g., USP or CFR), uses or prohibitions. If cited in a regulation (i.e. in the CFR) we will refer to the original Federal Register notice to determine if the use of your ingredient is in conformance with the original findings of FDA.

• Assess whether the substance is eligible for GRAS status e.g., is it  actually a mixture rather than a single substance or is it an “interim food additive?”

• Check published use levels or food group limitations. Is it used in meat or alcoholic beverages or substances with a standard of identity?

• Search FDA website for adverse reaction reports or warning letters.

• Determine regulatory status in the U.S. and EU.

• Evaluate claims associated with the substance (e.g., “natural,” “nutritive,” or other marketing claims).

👉 Purpose: Establish a documented baseline for compliance and risk awareness.

For Level 2 Sustainable GRAS™, Burdock Group will perform a “deep dive.” First, a triage of your ingredients would be undertaken to determine which ingredient and how often it should be reviewed, then dive in, taking on the tasks as presented in the second table (Level 2 Substance Review).  This level of substance review can be ongoing, searching the scientific literature, adverse event warnings and other threats to your product(s) according to a pre-determined dictated by risk.

Level 2 – Comprehensive Review: A deeper, continuous process including triage of all ingredients, prioritized reviews, and ongoing monitoring of scientific literature, adverse event reports, and regulatory developments.

Sustainable GRAS™ — Level 2 Substance Review

Focus: Proactive Risk Management

Includes all Level 1 tasks, plus:

• Ingredient triage: prioritize substances most likely to be scrutinized by FDA.

• Broader FDA monitoring: search for adverse reaction reports specific to the product and related categories.

• Literature monitoring: continuous search of scientific publications for emerging safety or risk data.

• Competitor benchmarking: review how similar substances are being regulated or challenged.

• Global watch: monitor evolving regulatory requirements beyond the U.S. and EU (e.g., Codex, Asian markets).

• Manufacturing/process check: assess whether changes in production or specifications may impact safety status.

• Ongoing monitoring: adverse event reports, recalls, warning letters, and regulatory shifts tracked continuously.

👉 Purpose: Provide an early-warning system to anticipate risks, safeguard brand reputation, and ensure long-term compliance.

Looking Ahead

MAHA’s broad mandate may ultimately zero in on the most accessible regulatory target: food ingredients. For manufacturers relying on legacy GRAS determinations, this creates a clear vulnerability but also an opportunity.

By adopting a Sustainable GRAS™ strategy, companies can stay ahead of regulatory pressure, protect their brands, and ensure the continued safe use of ingredients that form the backbone of their products.

We invite you to contact Burdock Group for a complimentary 30-minute consultation to discuss the MAHA movement, potential vulnerabilities in the industry, and how Sustainable GRAS™ can safeguard your business and your brand.

Sustainable GRAS™ is a trademarked name by Burdock Group 2025