FDA Refuses to Enforce EUA Advertising Restriction — But Also Insists it Must Keep the Provision!

During the pandemic, ICAN witnessed many instances where state and federal public health entities falsely referred to COVID-19 vaccines released under Emergency Use Authorization (EUA) as “approved” or “safe and effective” in direct violation of federal law and the conditions of the vaccines’ EUAs. ICAN’s attorneys sent two petitions to the FDA demanding it either enforce the terms of its own EUAs that prohibit advertisements with this illegal language or rescind the advertising restrictions entirely.  FDA chose to do neither.

Lead Counsel, Aaron Siri, Esq. lays out the details here:

The COVID-19 vaccine EUAs issued by the FDA includes an important advertising condition that states:

All descriptive printed matter, advertising, and promotional material relating to the use of the COVID-19 Vaccines clearly and conspicuously shall state that: This product has not been approved or licensed by FDA.

However, in the early days of the COVID-19 vaccines, ICAN documented and took action on numerous instances where this provision being blatantly violated. For example, in January 2021, the New York State’s COVID-19 website included a graphic for government officials, health care providers, and the public to use on social media that said, “The COVID-19 vaccine went through the same rigorous approval process that all vaccines go through.” New York removed this claim after ICAN’s attorneys wrote a letter pointing out they were violating federal law.

In March 2021, the Michigan Department of Health and Human Services posted a message on its Facebook page which stated, in part, “[E]ach COVID-19 vaccine had to pass through the same thresholds of research and testing as every other vaccine. And it’s important to know that all three of the approved COVID-19 vaccines were proven to be safe and 100% effective….” Once again, Michigan promptly removed the information after ICAN’s attorneys wrote to them demanding its removal.

But when it became clear that correcting this misinformation was becoming a game of whack-a-mole, ICAN’s attorneys submitted a petition to the FDA demanding it take steps to enforce federal law and the conditions of the EUAs it issued by ensuring that the COVID-19 vaccines were not be promoted as “approved.”

When FDA failed to take any substantive action, ICAN’s attorneys submitted a second petition on August 12, 2022, this time requesting that FDA, in light of the confusion caused by its refusal to enforce its own EUA conditions, remove the advertising condition from the COVID-19 vaccine EUAs entirely.

One of these two citizen petitions should have been granted—either enforce the condition of the FDA’s own EUAs or remove the condition. So, what did FDA ultimately do? In a combined response to both petitions, it chose neither. To the first petition, it declared, “The Agency makes decisions regarding whether to pursue enforcement actions on a case-by-case basis, considering all relevant facts and circumstances…. At this time, we are not taking the actions you requested.” To the second petition, it stated, “[T]he August 2022 Petition does not identify any legal requirement for FDA to remove this condition of authorization from any of the Authorized COVID-19 Vaccines as requested. For these reasons, FDA denies this request.”

The FDA wants to have its cake and eat it too. It doesn’t feel the need to enforce the provisions, but it also wants to give the appearance of caring about safety by keeping them in place—its response to ICAN’s two petitions reveal this for exactly what it is: theater. Rest assured that ICAN will continue to expose this kind of hypocrisy.

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See below for more instances where ICAN uncovered instances where “health” agencies made unsupported claims to the public: