Aluminum: Has The FDA Got It All Wrong?

The FDA believes it's safe to inject babies with neurotoxic metals.

According to a U.S. Food and Drug Administration PDF file, “Study Reports Aluminum in Vaccines Poses Extremely Low Risk to Infants,” released over the Internet about a study’s results titled “Updated aluminum pharmacokinetics following infant exposures through diet and vaccination” in press (2011), there’s much to discuss that apparently either has been omitted in the PDF, is mixed up in researchers data, or researchers are confused about biochemistry, in my opinion.

For starters, pharmacokinetically speaking, they probably are mixing the proverbial apples and oranges because dietary aluminum absorption should NOT be compared with intramuscularly or subcutaneously injected aluminum, which travel different pathways through the body. There is an instructional PDF describing both injections at

Additionally, to understand the above better, a noteworthy comparison would be the way air/oxygen functions. A human breathing air works fine for the body, lungs, and cardiovascular system, but what happens if or when air enters a vein, a different route into the body from the normal physiological aspect. Depending upon extenuating circumstances, e.g., quantity of air gas involved, the air causes what’s known as an “air embolism” that causes cardiac arrest resulting in death. That’s why hypodermic needles always are ‘primed’ with a squirt to get the air out—they don’t want to take any chances, and rightfully so.

Before we go any further, it is incumbent upon this writer to note that the following U.S. government web site lists the 1991 article “The health effects of aluminum—a review” [Cooke, K. & Gould, MH, Dept. of Civil Engineering, Queen’s University of Belfast] wherein the Abstract pointedly says this about aluminium [European, USA: aluminum]:

This review covers the occurrence of aluminium in soil, air, water and food. In addition, aluminium levels in body tissues and its movement within the body have been considered. The adverse effects of aluminium that have been reported in recent years include Alzheimer’s disease, dementia and hyperactivity and learning disorders in children. [Emphasis added]

It seems the authors were not bashful in 1991 in pointing out the adverse effects in children, e.g., hyperactivity and learning disorders that were starting to escalate in USA children, which coincided with the upsurge in mandated vaccines/vaccinations.  Coincidences?  Or, should we connect the dots?

Concomitant with mandating a doubling of vaccines/vaccinations in infants, toddlers, and children during the 1980s and 1990s, the push also was on to vaccinate senior citizens annually for influenza (flu) and pneumonia.  Those 65 years of age and older are advised to get two PPSV doses  (pneumonia vaccine) per the World Health Organization and the U.S. CDC.  Coincidentally, a heretofore-unknown-pandemic-like outbreak of Alzheimer’s has been affecting senior citizens, something that neither the scientific nor medical literature document prior to recent times, and which, incidentally, coincides with vaccinating senior citizens annually with flu vaccines that contain aluminum.

In my May 26, 2011 article on, “Aluminum in Vaccines: Where Are The Safety Studies?” I said,

One of the more compelling facts about aluminum is that it is a blood brain barrier neurotoxin as reported by W. Zheng in 2001 and Bioport Corp. in 2002. Additionally, there are many studies confirming its ability to activate brain microglia and increase inflammatory cytokines thereby contributing to brain excitotoxicity as reported by C. Garrel, et al., in 1994; M. Tsunoda in 1999; C. Struys-Ponsar, et al., in 2000; A. Campbell, in 2004; M.S. Petrik, et al., in 2007; Blaylock and Strunecka in 2009; C.A. Shaw, et al., in 2009; and X. Li, et al., in 2009.

Additionally, I cited

…Tomljenovic and Shaw, [“Aluminum Vaccine Adjuvants: Are they Safe?”] In spite of these above data [regarding parenteral exposure], infants and children up to 6 months of age in the U.S. and other developed countries receive 14.7 to 49 times more than the FDA safety limits for aluminum from parenteral sources from vaccines through mandatory immunization programs.

Table 2, which accompanies that statement, indicates that in the United States the “Estimated total aluminum body burden (pg/kg bw/day) per vaccination” is as follows:

At birth        73.5 pg/kg bw/day      [14.7 times FDA safety limit] 1 month      -0-
2 month      245                                [49 times FDA safety limit] 3 month      -0-
4 month      171.1                              [34.22 times FDA safety limit] 5 month      -0-
6 month      161.2                              [32.24 times FDA safety limit]

FDA Safety limit for aluminum from parenteral sources is 5 pg/kg bw/day. [Emphasis added]

Apparently, the new CDC aluminum study now being printed, according to the PDF file, asserts:

The FDA study found that the maximum amount of aluminum an infant could be exposed to over the first year of life would be 4.225 milligrams (mg), based on the recommended schedule of vaccines. Federal Regulations for biological products (including vaccines) limit the amount of aluminum in the recommended individual dose of biological products, including vaccines, to not more than 0.85-1.25 mg. For example, the amount of aluminum in the hepatitis B vaccine given at birth is 0.25 mg.

Now compare the FDA figures with the professors Tomljenovic and Shaw’s figures, which I think are more accurate than the FDA’s.  Why do I contend that?  Because Big Pharma fees do not support Tomljenovic and Shaw.  They are independent researchers affiliated with the University of British Columbia, Canada.

Somehow the new FDA paper being published on aluminum in vaccines not impacting children was due to Using the updated parameters, [that’s the problem, I think, updated parameters] the authors found that the body burden of aluminum from vaccines and diet throughout an infant’s first year of life is significantly less than the corresponding safe body burden of aluminum, based on the minimal risk levels established by the Agency for Toxic Substances and Disease Registry.

Maybe someone ought to remind the FDA researchers about this: FDA Safety limit for aluminum from parenteral sources is 5 pg/kg bw/day. What has it changed to as a result of the new FDA study?  We’ll have to wait for the paper to be published.

Somehow this new FDA treatise on aluminum brings to mind something that may parallel another vaccine issue, mercury (Hg) and what’s known as the Simpsonwood Meeting Report that is documented in the monograph I co-edited titled, Vaccines & Vaccinations: The Need for Congressional Investigation, which can be read in its entirety on at

Furthermore, I’d like to point out what I think the parallels possibly could be:

The Simpsonwood Conference: Mercury-Autism Coverup!

by Thinktwice Global Vaccine Institute on Wednesday, November 25, 2009 at 9:57am

In June 2000, a top-secret meeting of health officials and government scientists occurred at the secluded Simpsonwood conference center in Norcross, Georgia. Although the Centers for Disease Control and Prevention (CDC) convened the meeting, no public announcement was made of the gathering. Just 52 private invitations were issued. Participants included high-level officials from the CDC, FDA, top vaccine specialists from the World Health Organization, and representatives from every major vaccine manufacturer, including Merck, GlaxoSmithKline, Wyeth and Aventis Pasteur. All of the participants were repeatedly warned that the scientific data under discussion was “embargoed.” Note-taking and photocopies of documents were strictly prohibited. No papers could leave the room.  …

The federal health officials and industry representatives had assembled to discuss an alarming new study that confirmed a link between thimerosal (mercury) in childhood vaccines and neurological damage, including recent dramatic increases in autistic spectrum disorders. Tom Verstraeten, a CDC epidemiologist, had analyzed the agency’s massive Vaccine Safety Datalink (VSD) database (distinct from VAERS) containing thousands of medical records of vaccinated children and was “stunned” by what he saw:

“We have found statistically significant relationships between exposure [to mercury in vaccines] and outcomes. At two months of age, developmental delay; exposure at three months, tics; at six months, attention deficit disorder. Exposure at one, three and six months, language and speech delays—the entire category of neurodevelopmental delays.” Verstraeten also discussed previous studies showing a link between mercury and neurodevelopmental disorders. Since 1991, when the CDC and FDA started requiring newborn infants to receive multiple doses of thimerosal-laced hepatitis B vaccines, thimerosal-laced haemophilus influenzae type B (Hib) vaccines, and the already mandated thimerosal-laced diphtheria, tetanus and pertussis shots (via DPT and DTaP), cases of autism skyrocketed.  [Similar to what’s happening with aluminum and thus the new FDA report was generated, I believe.]

Dr. Bill Weil, with the American Academy of Pediatrics (AAP), told the group, “You can play with this all you want,” but the results “are statistically significant.” Dr. Richard Johnston, an immunologist and pediatrician, exclaimed, “I do not want my grandson to get a thimerosal-containing vaccine until we know better what is going on.” Yet, instead of taking quick action to warn parents and recall the unsafe shots, this shameless group of 52 vaccine proponents spent the next two days calculating how to cover up the truth.

“We are in a bad position from the standpoint of defending any lawsuits,” said Dr. Robert Brent, a pediatrician. However, Dr. Robert Chen, head of vaccine safety for the CDC, congratulated his group for their apparent success thus far at concealing the facts, and expressed relief that “given the sensitivity of the information, we have been able to keep it out of the hands of, let’s say, less responsible hands.” Dr. John Clements, WHO vaccine advisor, was more blunt, declaring that perhaps the CDC study “should not have been done at all because the outcome could have, to some extent, been predicted.” He stated that “the research results have to be handled,” and warned that the study “will be taken by others and used in ways beyond the control of this group.”

How to “handle” undesirable scientific data:

At the Simpsonwood gathering, a plot was hatched. To begin, the CDC relinquished control of its vast database on childhood vaccines—the very same database Tom Verstraeten used to confirm a link between thimerosal-laced vaccines and autism.

Although the VSD database was public property—developed at taxpayer expense—it was turned over to a private health insurance agency, ensuring that it could not be accessed by non-collaborators for additional research. Three years later, Verstraeten had reworked the data and published a new version of his original study in the November 2003 issue of Pediatrics. However, this time “no consistent significant associations were found between thimerosal-containing vaccines and neurodevelopmental outcomes.” [Dr. Mark Geier, an independent scientist, eventually gained access to the VSD data. His findings were published in a recent issue of the Journal of the Neurological Sciences.]

After the Simpsonwood gathering, the CDC also instructed the Institute of Medicine (IOM), i.e., the National Academy of Sciences, to produce a new study with contrived results: no correlation between thimerosal and brain disorders. According to Dr. Marie McCormick, who chaired the IOM’s Immunization Safety Review Committee in January 2001, the CDC “wants us to declare, well, that these things are pretty safe.” In fact, “we are not ever going to come down that [autism] is a true side effect” of thimerosal. In transcripts of the meeting, the committee’s chief staffer, Kathleen Stratton, predicted that the IOM would conclude that the evidence was “inadequate to accept or reject a causal relation” between thimerosal and autism. Apparently, that was what “Walt wants”—a reference to Dr. Walter Orenstein, director of the CDC’s National Immunization Program.

To complete the deception, the CDC would need additional “proof” that thimerosallaced vaccines are safe. They never intended to conduct honest science; rather, their goal was to establish a plausible defense, insulate manufacturers against liability, while producing justification for continuing mandatory vaccine campaigns. For example, in May 2001, Dr. Gordon Douglas, then-director of strategic planning for vaccine research at the National Institutes of Health, assured a Princeton University gathering that “four current studies are taking place to rule out the proposed link between autism and thimerosal.” Furthermore, “in order to undo the harmful effects of research claiming to link the [measles] vaccine to an elevated risk of autism, we need to conduct and publicize additional studies to assure parents of safety.” Douglas formerly served as president of vaccinations for Merck.

The Simpsonwood gathering places all CDC-sponsored research into question.

FYI: The Food and Drug Administration is an affiliate in the U.S. Health and Human Services agency’s Centers for Disease Control and Prevention, the CDC.

To read the rest of the article, please see pages 10 and 11 in the monograph.

Now, what everyone in science, medicine, and consumers in particular, should be demanding to know is this: Is the FDA’s new aluminum study another Simpsonwood-like sham?

Before I end this rebuttal to the FDA’s new and continuing farce position paper on aluminum in vaccines, I’d like to share two comments a PhD researcher gave me when I told her I was writing this article.  She probably wants to remain anonymous for now, but these are her comments, not mine:

They [vaccine manufacturers] routinely put aluminum in the so-called “placebo” when they run vaccine trials, such that the placebo itself has adverse reactions that can make it look as if the vaccine has fewer adverse reactions.

Aluminum injected via the vaccine gets no chance to be kept out by the normal biological mechanisms in place at surface membranes. Any ingested aluminum is typically kept out of the blood stream (at the level of at least 99% I believe). [Only 1% of ingested aluminum gets into circulation in the body.] So you have to at least divide by 100 in comparing aluminum amounts in vaccines with aluminum in food sources.

[Hello, FDA researchers…]

Many of the vaccines prescribed and given to infants, toddlers, teens, and adults have aluminum in them. There are four types of aluminum that can be used in vaccines.  You can find them in the monograph listed on pages 16-22 as taken from the CDC’s PinkBook Vaccine Excipient & Media Summary.  Please check that out, because as a parent you should know that information.

Personally, I think the FDA’s new paper and position on aluminum is nothing short of pseudo-science that must be generated to cover their backsides because of all the damage being perpetrated against innocent children for decades losing their capability to be viable human beings.  That has to stop now, FDA.  Congress, where are you?  Come out from under the pile of money you get from Big Pharma and do your duty to We, the people.


Photo Credit: Takoma Biblelot

About the author

Catherine J. Frompovich

Catherine J Frompovich is a retired natural nutritionist who earned advanced degrees in Nutrition and Holistic Health Sciences, Certification in Orthomolecular Theory and Practice plus Paralegal Studies. Her work has been published in national and airline magazines since the early 1980s. Catherine authored numerous books on health issues along with co-authoring papers and monographs with physicians, nurses, and holistic healthcare professionals. She has been a consumer healthcare researcher 35 years and counting. Catherine is an editor and writing consultant who helps authors get into publication. For numerous semesters she taught several writing courses for a suburban Philadelphia school district’s Adult Evening School. Her passion is assisting and guiding authors into print. Catherine’s latest book, A Cancer Answer, Holistic BREAST Cancer Management, A Guide to Effective & Non-Toxic Treatments, will be available on and as a Kindle eBook sometime in July 2012. Two of Catherine’s more recent books on are Our Chemical Lives And The Hijacking Of Our DNA, A Probe Into What’s Probably Making Us Sick (2009) and Lord, How Can I Make It Through Grieving My Loss, An Inspirational Guide Through the Grieving Process (2008).