If the CPSC Regulated Vaccines, COVID Vaccine Would Likely be Recalled (Opinion)

Recently HHS Secretary Kennedy announced that the COVID vaccine is being removed from the immunization schedule for healthy children and pregnant women. As someone personally injured by the COVID vaccine, I’m happy to see this step in the right direction of exposing the dangers of this vaccine which was rushed to market, and hope to see further restrictions take effect regarding approval of usage of the vaccine.

Today, the COVID vaccine for healthy children and healthy pregnant women has been removed from @CDCgov recommended immunization schedule. Bottom line: it’s common sense and it’s good science. We are now one step closer to realizing @POTUS’s promise to Make America Healthy Again. pic.twitter.com/Ytch2afCLP

— Secretary Kennedy (@SecKennedy) May 27, 2025

In case you haven’t noticed, we write articles about consumer product recalls in addition to other news articles. These recalls come from the Consumer Product Safety Commission (CPSC), which is tasked with a singular goal: protecting Americans from products that pose unreasonable risks of injury or death. Processing the most recent batch of recalls got me thinking – what would happen if the COVID vaccine was under the CPSC’s jurisdiction instead of FDA/HHS/CDC? While this agency doesn’t regulate pharmaceuticals, its clear and aggressive standards for identifying hazardous products raise a compelling question: if COVID-19 vaccines—for this example Moderna’s mRNA-1273—were classified as consumer products under the CPSC’s jurisdiction, would they meet the threshold for a recall?

To answer that, it’s important to understand what triggers a recall under the CPSC’s purview. A manufacturer is required to report a product within 24 hours if it contains a defect that could create a substantial product hazard, or if it presents an “unreasonable risk of serious injury or death.” A “Class A Hazard,” the highest priority, is defined as a defect that makes death or grievous injury likely. When the CPSC sees even a remote risk of such outcomes, and especially if hundreds of such cases have occurred, it’s well within its mandate to launch a recall.

Applying these standards to the Moderna COVID vaccine reveals an uncomfortable reality. According to a comprehensive FDA benefit-risk analysis of the Moderna vaccine for males aged 18–64, the vaccine can cause vaccine-attributable myocarditis and pericarditis, particularly in males aged 18–25. For every one million vaccinated young men in this age group, approximately 128 myocarditis/pericarditis cases were predicted—110 requiring hospitalization. While no deaths or ICU admissions were reported in the model, the rate and severity of these cardiac events far exceed the type of risk typically tolerated by the CPSC for consumer goods.

Contrast that with how the CPSC handles physical products. If a bicycle helmet, for example, caused serious injury in even a fraction of this number, the agency would likely demand immediate recall and issue a press release urging consumers to stop using it. Similarly, if a children’s toy carried a foreseeable risk of 100+ hospitalizations per million users, companies would be racing to cooperate with the CPSC under its Fast Track Recall Program.

Supporters of the vaccine often cite the FDA’s cost-benefit framework, which considers the number of hospitalizations and deaths prevented by the vaccine. But the CPSC’s mandate isn’t to weigh social benefits against risks; it’s to act when a product puts any individual at serious risk, especially when safer alternatives or mitigation measures are possible. The fact that myocarditis from the Moderna vaccine overwhelmingly affects a specific demographic—young, healthy males who are at relatively low risk of serious COVID outcomes—would, in CPSC terms, be seen as an elevated, disproportionate risk.

From a regulatory philosophy standpoint, the FDA’s approach to vaccine authorization hinges on the “greater good” in the face of public health emergencies. The CPSC, on the other hand, is inherently individualistic in its orientation: if your child’s crib poses a life-threatening risk to one baby in 100,000, it’s still getting pulled from shelves. That divergence underscores a broader debate between collectivist health mandates and the individual rights that underscore product safety law.

The core principle behind the medical industry is “do no harm.” Not “do a little harm for the greater good.” Why has the medical industry lost sight of its fundamental primary goal?

Article by Ken Buckler, President of RFHC. All opinions are his own and do not reflect those of our clients or sponsors.

Based upon information from the FDA benefit-risk assessment publication and the CPSC Recall Handbook.

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