Where Did 0.85 Come From?
An Essay on Aluminum Adjuvants and the Science That Was Never Done
In May 2000, at a Workshop on Aluminum in Vaccines held in Puerto Rico, Dr. Michael Gerber from the National Institutes of Health posed a question to Dr. Norman Baylor of the Food and Drug Administration. The exchange, preserved in the workshop transcript, deserves to be read in full:
Dr. Gerber: “The standard of 0.85 milligrams of aluminum per dose set forth in the Code of Federal Regulations—can you tell us where that came from and how that was determined?”
Dr. Baylor: “Unfortunately, I could not. I mean, we have been trying to figure that out. We have been trying to figure that out as far going back in the historical records and determining how they came up with that and going back to the preamble to the regulation. We just have been unsuccessful with that but we are still trying to figure that out.”
A senior FDA official publicly admitted the agency could not explain the basis for its own regulation on aluminum content in vaccines. This was not a fringe question posed by an outsider. It came from an NIH official at an official government workshop. And the FDA’s answer was that they had searched their historical records and come up empty.
That was twenty-five years ago. In the intervening decades, the 0.85 mg limit has remained unchanged. It continues to govern vaccines administered to infants, children, and adults worldwide. And the question of where it came from—the foundational safety studies that would justify exposing newborns to this amount of injected aluminum—has never been answered.
Until now, no one had followed the documentary trail that regulators themselves claimed existed.
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The Documents That Exist
In 2025, a team of French researchers—Loïc Angrand, Romain K. Gherardi, and Guillemette Crépeaux—published the results of a detailed investigation into the regulatory history of aluminum limits in vaccines. Their paper, appearing in Environmental Toxicology and Pharmacology, traces the documentary trail that regulatory agencies had apparently never followed.
The researchers began with the 2011 Federal Register, where they found this statement: “The aluminum content per dose in the formulation of a licensed biological product, as specified in § 610.15(a), reflects the NIH Minimum Requirements for Diphtheria Toxoid (1947) and Tetanus Toxoid (1952).”
These two documents—the 1947 and 1952 NIH Minimum Requirements—are the foundational texts cited as the basis for current aluminum limits. The researchers set out to obtain them.
A Freedom of Information Act request (Case Number 63550) was submitted to NIH and the National Library of Medicine in February 2025, requesting copies of these documents. On March 7, 2025, the NLM responded: “The NLM and Office of NIH History and Stetten Museum searched its files and no records responsive to your request were located.”
The recommendation was to check with the FDA History Office, “as the Department of Biological Standards became the FDA.” When contacted, the FDA’s Foreign Regulatory Communications Coordinator replied: “I was unable to find the information that you are seeking. You may be able to obtain the requested documents by submitting a Freedom of Information Act (FOIA) request to the National Institutes of Health (NIH).”
A circular response: NIH directing them to FDA, FDA directing them back to NIH.
Eventually, after persistent efforts, the researchers obtained both documents from the FDA—8 pages and 19 pages respectively.
What the Documents Actually Say
The analysis of these foundational texts reveals something straightforward: they are not about aluminum safety. They are not about aluminum toxicity. They are about manufacturing diphtheria and tetanus toxoids.
The 1947 document on diphtheria toxoid and the 1952 document on tetanus toxoid describe composition, production methods, and quality criteria for the toxoids themselves. They address cultivation techniques, detoxification using formaldehyde, identity tests, and sterility requirements.
The only reference to general safety testing describes a brief animal observation: “A safety test shall be made on the contents of a final container... The parenteral injection... shall cause neither significant symptoms nor death. At least 2 animals of each species are used and the observation period is not less than 7 days.”
Seven days. Two animals per species. This is the extent of safety testing described in the documents that supposedly establish safe aluminum limits for human infants.
On the subject of aluminum itself, the documents contain a single relevant statement: “In all instances the amount of aluminum used shall be the minimum needed to accomplish the purpose intended.”
This is a statement about efficacy—using enough aluminum to achieve the desired immune response—not about the maximum amount that can be safely injected. The documents do not evaluate aluminum toxicity. They do not establish a toxicological threshold. They do not consider cumulative exposure, developmental windows, or long-term effects.
The researchers’ conclusion is direct: “Neither document discusses Al toxicity.”
From Efficacy Limit to “Safety Standard”
The historical record allows us to trace how an efficacy-based recommendation became encoded as regulatory law and eventually treated as a validated safety threshold.
In 1966, a Canadian study referenced allowances by British, Canadian, and American regulators for 15 mg of potassium alum per dose of toxoid—corresponding to 0.85 mg of elemental aluminum. This amount was derived from data on immunological effectiveness, not toxicological safety.
In 1968, the NIH codified this figure in the Federal Register, stating that an adjuvant “shall not contain more than 0.85 milligrams of aluminum.”
In 1972, regulatory authority over biological products transferred from NIH to FDA. The maximum aluminum levels remained unchanged.
In 1981, the FDA aligned regulations with World Health Organization standards for hepatitis B vaccines, maintaining the 0.85 mg limit while permitting up to 1.25 mg in certain circumstances with approval.
The 2011 Federal Register explicitly cited the 1947 and 1952 NIH documents as the basis for current standards—the same documents that, as we now know, contain no toxicological evaluation of aluminum.
At no point in this seven-decade regulatory history did anyone conduct or cite studies establishing safe thresholds for injected aluminum in humans. The limit was set based on what worked immunologically. It was transferred between agencies. It was aligned with international standards. And it came to be treated as a safety benchmark—a threshold below which harm is assumed not to occur.
Two years after Baylor’s admission that the FDA could not explain the origin of the 0.85 mg standard, he co-authored a paper with two other FDA officials stating: “The amount of 15 mg of alum or 0.85 mg aluminum per dose was selected empirically from data that demonstrated that this amount of aluminum enhanced the antigenicity and effectiveness of the vaccine.”
Selected empirically for efficacy. Not derived from toxicological studies. Not validated for safety. The FDA itself acknowledges the standard was set based on what boosted immune response, not on what was proven safe to inject.
The Studies That Were Never Conducted
The absence of foundational safety studies is not merely a historical artifact. It reflects an ongoing gap that regulatory agencies have acknowledged but never filled.
In 2015, researchers from the Centers for Disease Control and Prevention published a paper examining cumulative and episodic vaccine aluminum exposure in young children. The paper, led by Jason Glanz, contained a remarkable admission: there was “complete absence, in children as well as in adults, of population-based studies on the long-term tolerance” of aluminum-based adjuvants.
The CDC was not claiming such studies had been conducted and showed safety. They were acknowledging such studies had never been done—while demonstrating that the data to conduct them existed.
In 2019, FOIA requests were submitted to both NIH and CDC asking for “copies of any human or animal studies involving the subcutaneous or intramuscular injection of aluminum adjuvant relied upon by the NIH to establish the safety of injecting infants and children with aluminum hydroxide, aluminum phosphate or amorphous aluminum hydroxyphosphate sulfate.”
The NIH response: “The NIH Office of Intramural Research (OIR), National Institute of Allergies and Infectious Diseases (NIAID), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) searched their files and no records responsive to your request were located.”
The CDC and Agency for Toxic Substances and Disease Registry response: “A search of [the agency’s] records failed to reveal any documents pertaining to your request.”
No records. From either agency. For studies establishing the safety of a practice that has continued for a century.
What Happens When Someone Runs the Study
The rarity of proper safety studies makes the exceptions worth examining closely.
In 2010, Chinese researchers published a large multicenter, double-blind, randomized trial comparing anti-H1N1 vaccines with and without aluminum hydroxide, alongside an aluminum-free placebo. This study—involving 12,961 participants—represents the only major trial to have included a true neutral placebo when evaluating aluminum-adjuvanted vaccines.
The results were unambiguous. Across all tested antigen doses, the vaccine containing aluminum produced significantly more adverse events than both the placebo and the same vaccine formulated without aluminum. The methodologist Peter Gøtzsche calculated from this data that aluminum-based adjuvant increased the frequency of severe adverse events by 2.5 to 3 times.
The study had limitations—it observed participants for only three days after each dose and therefore could not assess long-term or cumulative effects. But within its observational window, it demonstrated measurable harm attributable specifically to the aluminum adjuvant.
This finding stands largely alone. The standard practice in vaccine trials is to use aluminum-containing solutions as “placebos”—a methodology that renders the specific effects of aluminum invisible by comparison. When both test and control groups receive aluminum, any adverse effects common to both will not appear as a signal.
Dr Christopher Exley, a leading aluminum researcher, has argued that aluminum adjuvants should not be used as placebos in clinical trials for precisely this reason: it eliminates the baseline needed to detect adjuvant-specific harms.
The predictable response to concerns about injected aluminum is comparison to dietary intake—the argument that 0.85 mg is trivial relative to what we consume in food and water. This comparison is pharmacokinetically meaningless. Ingested aluminum passes through the gastrointestinal tract, where the vast majority is excreted without absorption. Injected aluminum bypasses this barrier entirely, entering tissue directly as particulate matter that immune cells engulf and transport throughout the body, including to the brain. These are not equivalent exposures.
In 2022, a systematic review pooled 102 randomized controlled trials comparing aluminum adjuvants to placebo or no intervention. The conclusion: serious adverse events may be increased, with a risk ratio of 1.18—but the evidence was graded “very low certainty” and the trials were underpowered to detect rare harms. After nearly a century of use in billions of doses, the best available meta-analysis cannot determine whether aluminum adjuvants cause serious harm. The authors of that review did not frame this as reassuring. They framed it as uncertainty. The field has simply never produced the high-quality, adequately powered trials that would be standard for any other long-term injected product.
The Danish Study: A Contemporary Example
In July 2025, Andersson et al. published a cohort study in Annals of Internal Medicine examining early-life exposure to aluminum-adjuvanted vaccines and 50 chronic diseases in 1.2 million Danish children. The study concluded that no association was found between aluminum exposure and increased disease risk.
Media coverage presented this as reassuring evidence of aluminum adjuvant safety. The study was cited as demonstrating what parents and physicians had long assumed: that these compounds are safe.
Within days, however, researchers with expertise in aluminum toxicology, epidemiology, and vaccine safety began identifying fundamental methodological problems. Their critique, published in the Journal of Trace Elements in Medicine and Biology, argues that the study’s design prevented it from detecting the harms it claimed to rule out.
I interviewed the lead author, Guillemette Crépeaux, in March 2024—well before either of these papers appeared. Her research team at INSERM has spent over a decade investigating aluminum adjuvant toxicity, and she is among the foremost experts in the field. Among her co-authors is Christopher Exley, whom I interviewed in April 2024. Exley spent three decades researching aluminum’s role in biological systems before being removed from his position at Keele University—a consequence of following the science where it led. The critique they and their colleagues published represents a systematic examination of why the Danish study’s conclusions cannot be supported by its methodology.
The Exposure Problem
Any study claiming to assess dose-response relationships depends on accurate measurement of exposure. The Danish study inferred aluminum exposure solely from vaccine records and manufacturer-reported aluminum content.
Published research has demonstrated significant variability between vaccine batches—actual aluminum content can differ substantially from labeled amounts. One analysis found that the aluminum content in certain pediatric vaccines was consistently four times lower than expected, with comparable variability observed across different products.
This variability renders exposure estimates unreliable. Children recorded as receiving identical aluminum doses may have received vastly different actual amounts. In a study examining narrow exposure increments (0-4.5 mg, assessed per 1 mg), even small misclassifications distort risk assessment.
The problem compounds further. The Danish study made no distinction between different types of aluminum adjuvants—aluminum oxyhydroxide, aluminum hydroxyphosphate, and amorphous aluminum hydroxyphosphate sulfate—despite significant differences in their physicochemical properties affecting how they behave in the body.
No adjustment was made for recipient body weight. An infant receiving 0.5 mg of aluminum at two months experiences a profoundly different body-weight-adjusted exposure than the same infant receiving the same amount at eighteen months.
The timing of exposures was collapsed into a cumulative measure, obscuring potentially critical windows of developmental susceptibility. The role of the immature blood-brain barrier in early infancy—a period when multiple aluminum-containing vaccines are administered—was not addressed.
Maternal vaccination during pregnancy, which could affect fetal aluminum burden, was not considered. Formula-fed infants receive substantial dietary aluminum that could confound estimates. Children who experienced adverse reactions early in the vaccination schedule may have had subsequent vaccines delayed or declined, potentially misclassifying them as “low exposure” when they were in fact vaccine-injured.
The Missing Control Group
The study included no children with zero aluminum exposure. Every child in the cohort received at least some aluminum-adjuvanted vaccines. This design makes it impossible to detect baseline toxicity—effects that occur at any exposure level—or to establish what health outcomes look like in an unexposed population.
The only comparison possible is between children with varying degrees of exposure. If aluminum causes harm at all exposure levels studied, this design will not detect it. The harm becomes invisible by being universal.
The analogy is straightforward: if you only compare people who smoke twenty cigarettes a day to those who smoke thirty, you will never detect that smoking itself causes cancer. You need non-smokers in your study. The Danish study has no non-smokers.
This is not a minor limitation. It is a structural feature that prevents the study from answering the question it claims to address.
What the Data Actually Shows
The published results contain findings that contradict the reassuring conclusions.
The statistical analysis found that increased aluminum exposure appeared to reduce risk for twelve categorical diseases. According to the authors’ own analysis, each additional milligram of aluminum was associated with reduced risk of ulcerative colitis (38.9%), erythema nodosum (35.1%), asthma (4.2%), various allergic conditions (11-19%), and multiple neurodevelopmental outcomes including autism spectrum disorder (7.5%) and ADHD (11.1%).
These protective effects are biologically implausible. There is no known mechanism by which injected aluminum would protect against autoimmune, allergic, or neurodevelopmental conditions. The appearance of such effects indicates systematic bias in the analysis—confounding factors that distort the true relationship between exposure and outcome. The likely culprits are identifiable: healthy user bias (families who complete full vaccination schedules tend to be healthier and more resourced overall), exposure misclassification (the batch variability problem means recorded doses don’t reflect actual doses), and survivor bias (children who experience early adverse reactions may drop out of the schedule and be misclassified as “low exposure” when they are in fact vaccine-injured).
When the researchers who authored the critique reconstructed comparisons using supplementary data, they found different results. Children who received no aluminum-containing vaccines in their first two years showed 25.7% lower odds of atopic dermatitis and 49.6% lower odds of allergic rhinoconjunctivitis compared to exposed children.
The supplementary data on Asperger syndrome showed positive associations with aluminum exposure across eleven different analyses, reaching statistical significance in subgroup analyses of children born after 2006 and those receiving higher cumulative doses. The risk difference analysis found significantly higher rates of multiple neurodevelopmental outcomes in children receiving >3-4.5 mg aluminum compared to those receiving >1.5-3 mg, including an additional 9.73 neurodevelopmental cases per 10,000 children.
These findings—buried in supplementary materials—were not emphasized in the paper’s conclusions. When commenters noted the contradiction, the authors performed a reanalysis excluding 38% of one comparison group, citing a technical statistical concern. The significance disappeared.
The Pattern
The Danish study did not emerge in isolation. It represents the contemporary manifestation of a pattern that has persisted for nearly a century.
In 1947 and 1952, documents established aluminum levels based on efficacy, not safety. Those documents were cited as the foundation for regulations that endure today.
In 2000, when asked to explain the basis for aluminum limits, the FDA could not do so.
In 2015, the CDC acknowledged the complete absence of population-based studies on long-term tolerance of aluminum adjuvants.
In 2019, FOIA requests to NIH and CDC for studies establishing safety of injected aluminum in children returned no records.
In 2025, a large cohort study was designed and conducted in a manner that could not detect the harms under investigation: no true control group, unreliable exposure measurement, exclusion of vulnerable subpopulations, follow-up periods too short to capture relevant outcomes.
At each juncture, the question of aluminum adjuvant safety has been evaded rather than answered. The regulatory framework rests on documents that do not address toxicity. The agencies responsible for safety acknowledge they have no supporting studies. And when research is finally conducted, it is designed in ways that preclude meaningful conclusions.
Whether this pattern reflects institutional inertia, liability concerns, or something more deliberate, the result is the same: the foundational safety claim—that aluminum adjuvants in vaccines have been proven safe—rests on no toxicological or long-term, placebo-controlled human studies capable of establishing a safe dose for infants.
The Evidentiary Void
The confidence surrounding aluminum adjuvant safety is not supported by the underlying evidence. It is an inherited assumption that has been transmitted through decades of regulatory practice without ever being validated.
This is not a claim about what aluminum adjuvants do or do not cause. It is a simpler observation: the studies that would establish safety have not been conducted. There are no long-term, placebo-controlled trials in infants. There are no population-based studies with true unexposed controls. The regulatory limit was not derived from toxicological data. The agencies responsible for ensuring safety have been unable to produce supporting documentation when asked.
The evidentiary void is not controversial. It is documented in the agencies’ own responses to FOIA requests, acknowledged in published papers by CDC researchers, and confirmed by the analysis of the foundational regulatory documents.
What remains controversial is what to do about it.
Guillemette Crépeaux and her colleagues conclude their critique of the Danish study with a quotation from Primo Levi: “If not now, when?”
The question applies to the broader situation. Aluminum-based adjuvants have been used in vaccines since 1932. Nearly a century later, the fundamental studies establishing their safety in infants and children have not been conducted. The regulatory framework rests on documents that address manufacturing efficacy, not biological harm. The single large trial that used a true neutral placebo found significantly elevated adverse events in the aluminum group.
How much longer does the question remain unanswered before the absence of an answer becomes the answer?
How to Explain This to a 6-Year-Old
Imagine you’re playing a game where you have to follow the rules. One of the rules says you can only have a small cup of juice—not too much. You ask the grown-up, “Why that much? Who decided?”
The grown-up says, “That’s the rule.”
You ask, “But did someone check if that much juice is okay for kids like me?”
The grown-up looks in their folder. Then they look in another folder. Then they ask another grown-up. Nobody can find where the rule came from. Nobody can find anyone who checked if it was okay.
But they keep giving kids that much juice anyway.
That’s what happened with something called aluminum that’s put in some medicines. A long time ago, someone decided how much to use—but they decided based on whether it worked, not whether it was safe. Then everyone forgot to check if it was safe. They just kept using the same amount.
When scientists finally asked “Where did this rule come from?”, the people in charge couldn’t answer. They looked in their files and said, “We don’t have that.”
But they’re still following the rule.
A Note on the Researchers
The work documented here represents years of effort by researchers operating without the institutional support typically available for vaccine-related research. Guillemette Crépeaux’s team at INSERM has pursued these questions despite limited funding, publishing challenges, and the professional risks that accompany research in contested areas. Christopher Exley, after twenty-nine years at Keele University building one of the world’s leading aluminum research programs, lost his position and laboratory—a pattern familiar to scientists whose findings threaten powerful industries.
The Angrand paper required persistent FOIA requests across multiple agencies, including circular referrals and initial non-responses, to obtain documents that should have been foundational to regulatory policy.
The Crépeaux critique assembled expertise from researchers across multiple countries and institutions—toxicologists, epidemiologists, specialists in neurodevelopmental disorders and autoimmunity—to provide the systematic methodological analysis that the original study warranted.
This is what independent science looks like: painstaking, underfunded, and willing to ask questions that institutional science has declined to pursue.
As the World Health Organization stated in 2004: “Adjuvant safety is an important and neglected field.”
Twenty years later, the neglect continues.
References
Angrand L, Gherardi RK, Crépeaux G. Regulatory limits of aluminium content of vaccines have not been set based on toxicological studies. Environmental Toxicology and Pharmacology. 2025;119:104812. doi:10.1016/j.etap.2025.104812
Crépeaux G, Hammond JR, Handley JB, Hooker B, Jablonowski K, Luján L, Lyons-Weiler J, Nosten-Bertrand M, Shaw CA, Shoenfeld Y, Tomljenovic L, Exley C. Aluminium adjuvants and childhood health: a call for science. Journal of Trace Elements in Medicine and Biology. 2026;93:127810. doi:10.1016/j.jtemb.2025.127810
Andersson NW, Bech Svalgaard I, Hoffmann SS, Hviid A. Aluminum-adsorbed vaccines and chronic diseases in childhood: A nationwide cohort study. Annals of Internal Medicine. 2025. doi:10.7326/ANNALS-25-00997
Baylor NW, Egan W, Richman P. Aluminum salts in vaccines—US perspective. Vaccine. 2002;20(3):S18-S23. doi:10.1016/S0264-410X(02)00166-4
Glanz JM, Newcomer SR, Daley MF, et al. Cumulative and episodic vaccine aluminum exposure in a population-based cohort of young children. Vaccine. 2015;33:6736-6744. doi:10.1016/j.vaccine.2015.10.005
Liang XF, et al. Safety and immunogenicity of 2009 pandemic influenza A H1N1 vaccines in China: a multicentre, double-blind, randomised, placebo-controlled trial. Lancet. 2010;375:56-66. doi:10.1016/S0140-6736(09)62003-1
Gøtzsche P. Vaccines: truth, lies and controversy. People’s Press; 2020.
Exley C. Aluminium-based adjuvants should not be used as placebos in clinical trials. Vaccine. 2011;29:9289. doi:10.1016/j.vaccine.2011.09.092
Krauss SR, Barbateskovic M, Klingenberg SL, et al. Aluminium adjuvants versus placebo or no intervention in vaccine randomised clinical trials: a systematic review with meta-analysis and trial sequential analysis. BMJ Open. 2022;12(6):e058795. doi:10.1136/bmjopen-2021-058795
Masson JD, Crépeaux G, Authier FJ, Exley C, Gherardi RK. Critical analysis of reference studies on the toxicokinetics of aluminum-based adjuvants. Journal of Inorganic Biochemistry. 2018;181:87-95. doi:10.1016/j.jinorgbio.2017.12.015
Shardlow E, Linhart C, Connor S, Softely E, Exley C. The measurement and full statistical analysis including Bayesian methods of the aluminium content of infant vaccines. Journal of Trace Elements in Medicine and Biology. 2021;66:126762. doi:10.1016/j.jtemb.2021.126762
Gherardi RK, Crépeaux G, Authier FJ. Myalgia and chronic fatigue syndrome following immunization: macrophagic myofasciitis and animal studies support linkage to aluminum adjuvant persistency and diffusion in the immune system. Autoimmunity Reviews. 2019;18(7):691-705. doi:10.1016/j.autrev.2019.05.006
Workshop on Aluminium in Vaccines. National Vaccine Program Office, Department of Health and Human Services. Puerto Rico; May 11, 2000.
Federal Register, Vol. 33, No. 6 / Wednesday, January 10, 1968 (p.369).
Federal Register, Vol. 76, No. 71 / Wednesday, April 13, 2011 / Rules and Regulations (p.20513-14).
NIH. Minimum Requirements for Diphtheria Toxoid, 4th Revision. 1947.
NIH. Minimum Requirements for Tetanus Toxoid, 4th Revision. 1952.
World Health Organization. Global Advisory Committee on Vaccine Safety. Weekly Epidemiological Record. 2004;79(29):269.
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How do people ignore aluminum in vaccines? Escapes me. We, or I, now know about aluminum pots, canned beverages, aluminum in baking pow, talc, all kinds of foods, and rid them from our lives, yet, injecting aluminum directly into the blood stream is somehow not toxic.
Haven't people seen the non-stop commercials on child cancer, to please donate, when we as parents gave our children cancer. Does anyone know a slow drip of formaldehyde causes leukemia. Sixty does of vaccine is a slow drip. I go nutz when I see these commercials.
How do have time to crank out all these essays?. I think your work is extraordinary.