SUSTAINABLE GRAS™ for the CALIFORNIA DREAMIN’ NIGHTMARE

SUSTAINABLE GRAS™ for the CALIFORNIA DREAMIN’ NIGHTMARE

If California Assembly Bill 2034 passes, commencing July 1, 2027, if you are using a food, color or dietary ingredient in your product that does not conform to the requirements of the Federal Food and Drug Administration (FDA), you will be in violation of California law.[1] The Assembly bill requires the that substance must be approved by FDA as a food or color additive and have a regulation in the Code of Federal Regulations (CFR) or, prior sanction exemption[2] or, if a self-GRAS ingredient, it must undergo GRAS Notification and have a “letter of no objection” from FDA or, for a dietary (supplement) ingredient, a letter of approval for filing – otherwise the substance is, by California law, unsafe. This bill then gives rise to four critical questions.

            What is the rationale for this bill? While the notion of the dangers inherent in “ultra-processed” food identified by MAHA and Gov. Newsome’s Executive Order N-1-25 on ultra-processed foods, may have served as a springboard, this bill is targeting substances determined generally recognized as safe (GRAS) but not reported to FDA via the GRAS Notification process. Newsome’s Executive Order claims that over 10,000 chemicals are added to food in the US, while only 300 are approved for use in the European Union. One database[3] alleges that of 249 substances “GRASed”, only 49 (~20%) have undergone Notification. If the current number of FDA notified GRASes (1,290)[4] to non-notified is the same ratio, then 6,450 non-notified ingredients are present in the food supply. However, the greatest reservoir of unknown “GRASes” are those GRAS determinations made between the years 1958 when the Food Additives Amendment was passed permitting self-GRAS and 1998 when the GRAS Notification process became available.

            Thinking back to section 201(s) of the Food, Drug and Cosmetic Act, the Act provided two pathways for a finding of GRAS (1) (safe) use prior to January 1, 1958, and (2) scientific procedures; both are worth examining from a practical standpoint.  Realistically, approval of the GRAS was most often the assumption the ingredient had been safely used prior to January 1, 1958.  But how would the researcher know it was used safely – simply because the ingredient had been added to food for years? At that time of no computers or on-line databases – the investigator would have to comb through the local library’s set of the bound volumes of the Biological Abstracts or Chemical Abstracts, which summarized data from published works, each year of published works represented several volumes of the Abstracts. However, the value of the data may well be in question, because the scientific data was from the 1930’s to the middle 1950’s when the testing for safety was in its infancy, long before standardized animal testing protocols and before good laboratory practice regulations (GLPs). More importantly, how could it be known as safe when there was no system for memorializing adverse reactions, or a law mandating a reporting system for adverse reactions – would a company provide a pathway for responding to an adverse action report and risk a lawsuit or damage to the brand name? We don’t have to reach back too far to remember the scandalous days of no action being taken following receipt of reports of adverse reactions to dietary supplements. One manufacturer testified that there was no form or format to responding to an adverse reaction complaint – one manufacturer said that phone calls were written up on pink slips and thrown into a box along with letters describing adverse reactions – it is likely that the same practice was in play prior to 1958 for food ingredients. In fact, the Human Foods Complaint System wasn’t officially launched until October 2024.

The second pathway to compliance was “scientific procedures” – which, although it has never been defined, but is assumed to be an Acceptable Dietary Intake based on a no adverse effect level  (NOAEL) from animal testing  (e.g., a 90-day rodent study) and a safety factor of 100.[5] However, some researchers may have interpreted “scientific procedures” as referring to specifications of the ingredient; that is, were there protocols in place that directed any ingredient out of specifications, not be used? Worse, a GRAS determination was to be made by “…experts by training and experience…” (as designated by the Federal law),[6] but who were these experts and what did experts by training and experience include?         

It is easy to imagine that when manufacturers became aware of the need to conform to the law, “GRAS mills” and self-appointed experts sprang up and, even employees of manufactures’ jumped into the business of finding substances generally recognized as safe. Our experience has been that many of the home-grown GRAS determinations consist of a one-paragraph memo testifying to the GRAS status of a substance over the signature of the Quality Control Manager or even some person whose identity, sources and credentials have long been forgotten.

            What is the mandate for this bill? Simply, existing California law makes it unlawful for any person to adulterate any food and any food that is adulterated is unsafe.  Existing law deems, among other things, any food additive, color additive…as unsafe unless there is in effect a regulation, as specified, that limits the quantity and the use, or intended use, of the substance.[7]  In summary, the substance fulfils the criteria of unsafe “unless the substance and its intended use meet a specified condition, including, among others, that the substance and its intended use was introduced after January 1, 1958, and is used in accordance with the below-described notice, public listing, and licensing requirements.” [8] 

            What does California want? Commencing July 1, 2027, the bill “would require the individual to submit a notice to the [State] that includes the same information required for a specified federal notice” [9] to obtain a license to market in California; additionally, the State may require as often as quarterly, evidence of compliance for each chemical, new or existing. Once a notice is filed, within 60 days the State will determine if the information is complete, including if there were any restrictions on the substance or its use in other jurisdictions. If the notice is incomplete, the State may issue a rejection letter and decline to issue a license.  If the notice is complete, the state will issue a license and publish the notice in a publicly accessible database.

            When assessing the ‘new” ingredients, the State will require the following: (a) estimates of dietary exposure among Californians and the US population; (b) the cumulative effects of the substance and chemically and pharmacologically related substances; (c) hazard, dose response, and exposure; (d) the application of adequately protective safety factors to ensure an appropriate margin of safety to take into account uncertainties in hazard identification, dose response, exposure, and sensitivities; (e) whether the weight of the evidence shows that the substance has not been found to be carcinogenic; (f) whether the weight of the evidence shows that the substance has not been found to induce reproductive toxicity or developmental toxicity in humans or animals, including through an endocrine mode of action; (g) other information as the department may specify in regulation. This information will be publicly available for public comment.         

The bill gives the people of California an opportunity to object to a new substance. For substances introduced on or after July 1, 2027, the public is allowed 45 days to file an objection on the grounds of safety as described in the notice. Once the 45 days are completed, the state has 15 days to determine if a license shall be issued. If the State determines not to issue a license, the State will publish a letter describing why the license was not issued.

            Further, on or before July 1, 2030, the State will systematically reassess the safety and conditions of use of at least ten substances in each class of food additives, color additives, prior-sanction substances and dietary ingredients.

            What will California do with this information? Prior to publishing any information in the database, the State will redact information that has been designated by the submitter as a trade secret, except for that data needed to establish safety. According to the bill the database must (a) be searchable by members of the public, (b) the public must be able to download and print notices, including all safety information and State responses (c) include any licenses, safety information and supporting information related to each notice and, (d) accommodate reasonably anticipated and actual public use.

            Knowing that California is a bellwether state – meaning that, once California institutes a policy, it tends to spread across to other states and often to the federal government. Further, there do not appear to be any obstructions for this policy to go national to satisfy the outcry of the MAHA movement and an admittedly overdue re-examination of these early GRASes. But how to manage the outcome? Burdock Group and it’s Sustainable GRAS™ program is the answer.

            Burdock Group’s Sustainable GRAS™ program is a system used by several companies already. Knowing that the manufacturer of a substance is responsible for the safety of the substances it uses in its final product, these companies have asked Burdock Group investigators to assess the rigor of the supporting evidence of safety and exactly what California wants. We have the infrastructure to assess the following:

a)     Estimates of population exposure is generated by our proprietary software, using USDA’s What We Eat in America which provides us with indisputable data and an agreed upon most accurate assessment of intake. Use of serving size to calculate intake, while used by others, is too inaccurate for our needs.

b)     The acute, chronic and cumulative effects of substances can be found through the use of our scientific literature search capabilities – we are not confined to Google or PubMed access, but we use Scopus^® the largest scientific database in the world and available only through subscription. The information is not combed though by an intern, but a credentialed toxicologist for relevant information for the eventually trier of fact.

c)     Hazard, dose response and exposure can be a juggling act with which we are familiar.

As depicted in the illustration above, a decrease in exposure is not always the best method for mitigating risk, a precipitous decrease in exposure to satisfy and Acceptable Daily Intake may eliminate the technical effect of the substance. However, Burdock Group has a large toolbox of strategies to circumvent the loss of use of your ingredient.

d-f) A credentialed toxicologist will review potential for carcinogenicity, reproductive or developmental toxicity – including harm from endocrine effects.

g)    Other information as the State may specify in regulation will be resolved by a credentialed toxicologist.

And, we can get you prepared for the cyclic review as promised by the bill.

Be aware that this is not just a California issue, the Feds could demand a reassessment of the safety of any or all of your ingredients at any time. Remember also, YOU (according to the Park Doctrine [10]) are responsible for the safety of the substances you use or produce. There is no safety in numbers, despite the fact that many other companies may be lacking foresight and have not re-examined their ingredients. Also, if this program goes national, under Food Safety Modernization Act, the inspector can demand to see your documentation of the regulatory status of any ingredients on or in your final product.

We are here to help you and a free 30-minute consultation with us is only a phone call away 1 407-802-1400. Also, please use our connection at info@burdockgroup.com.

[1] Sherman Food, Drug, and Cosmetic Law.

[2] Prior sanctioned ingredients are substances that were approved for use in food or food packaging before September 6, 1958, and are exempt from being classified as food additives by the FDA. These ingredients must still comply with safety regulations to ensure they do not pose health risks. The problem is, that a prior sanction ingredients exemption was in response (by letter) to a request by company. These letters are not generally available.

[3]https://docs.google.com/spreadsheets/d/1KdlygCppko64yts1O4ZdpzWWfsZZ3yKp97d4ooHGHdQ/ edit?gid=0#gid=0  Last updated 2025Aug28

[4] As of 15March2026

[5] Lehman, AJ and Fitzhugh, OG (1954) 100-Fold margin of safety. Quarterly Bulletin of the Association of Food and Drug Officials of the United States. January 1954, pp. 33-35

[6]According to 21 CFR 170.23; https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-170/subpart-E/section-170.203 . According to 21 CFR § 170.30(a), “General recognition of safety may be based only on the views of experts qualified by scientific training and experience to evaluate the safety of substances directly or indirectly added to food”; https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-170/subpart-B/section-170.30; site visited April 3^rd, 2026.

[7] https://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=202520260AB2034 (site accessed 13March2026)

[8]https://trackbill.com/bill/california-assembly-bill-2034-food-safety-unsafe-additives-and-ingredient-disclosures/2816708/ (site accessed 13March2026)

[9] ibid

[10] The Park Doctrine, also known as the Responsible Corporate Officer Doctrine, allows corporate officers to be held criminally liable for violations of the Federal Food, Drug, and Cosmetic Act (FDCA) even if they were not personally aware of the misconduct. This strict liability means that executives can face prosecution for FDA violations based solely on their position and responsibilities within the company. United States v. Park, 421 U.S. 658 (1975)