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Tennessee Conservative News [By David Seal] –
Health advocates are still waiting for evidence that would indicate compliance by the Tennessee Department of Health (TDH) on a bill that was signed into law on March 28, 2025. The Restore Trust in Public Health Messaging Act is designed to keep public health messaging on-label for vaccines, masks, and Emergency Use Authorized (EU) products.
In short, if the manufacturer of a product can’t say it, neither can TDH. For example, if Pfizer can’t claim or imply that a COVID shot is safe for use in pregnancy (which it cannot, because the label says there is inadequate safety data), then neither can the TDH.
But the TDH is in defiance of the new law according to health advocate Bernadette Pajer who authored the legislation.
After noticing alleged violations of the law, she reported her findings to the Tennessee Attorney General’s Office, the bill sponsors, and the chair of the Senate Health Committee.
The AG’s office acknowledged receipt of her complaint in a January 16, 2026, email but did not offer any information on potential investigations or outcomes based on her alleged report of violations.
The AG’s office email stated “Dear Ms. Pajer: We have received your inquiry and will contact you should we need additional information. Best regards, The Office of the Tennessee Attorney General”
In fact, as of the date of this news report, Pajer contends that TDH appears to be completely out of compliance with every aspect of the new law, and now an FDA warning letter to the makers of an immunization product given to newborns provides further evidence that TDH is undermining rather than restoring public trust in their messaging.
Pajer explains that Beyfortus (RSV-mAb [Nirsevimab]) is not a traditional vaccine, but it is on the CDC’s Pediatric Vaccine & Immunization Schedule for newborns. It is a monoclonal antibody injection, and approved labeling states that it is “indicated for the prevention of RSV lower respiratory tract disease.” Key here is what it is not indicated for. Beyfortus is not indicated for the prevention of upper respiratory tract (RSV) infection or transmission according to the product label linked at the end of this paragraph. This distinction is important for practitioners and patients so that they do not assume that a child who received a monoclonal antibody is incapable of becoming infected, experiencing illness, or transmitting the illness to others.
Link to product label for Beyfortus:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761328s000lbl.pdf
Yet TDH messaging claims otherwise.
On 12/28/2025, Pajer filed a complaint with the state Attorney General’s Office https://www.tn.gov/attorneygeneral/contact-us/public-health-messaging.html regarding a TDH webinar (https://www.train.org/tn/course/1132847/details) in which the following statements were made by TDH employees about Beyfortus:
- “So it’s kind of setting the scene for why we’re really focused on prevention of RSV in infants”
- “So administering these at birth protects newborns from RSV, which is what we want to do.”
- “provides immunity immediately after birth”
Pajer states that these statements allegedly violate 68-1-1702(a)(1), the prohibition on messaging that conflicts with or does not accurately reflect the U.S. Food and Drug Administration (FDA) – approved or FDA – authorized labeling. So far, the offending webinar has not been removed from access and TDH has not notified attendees of the misleading statements, as is required by law.
At the federal level, on 07/15/2026 the (FDA) sent a warning and action letter to the makers of Beyfortus, Sanofi Vaccines US Inc., stating similar language violations of FDA’s own labeling laws, which, like Tennessee’s law that pertains to TDH, prohibits manufacturers from making claims unsupported by product labeling.
FDA said the following claims were misleading:
- “HELP PREVENT RSV DISEASE IN INFANTS WITH BEYFORTUS® AND SEE HOW YOU CAN AFFECT POPULATION HEALTH”
- “As you may know, immunizing infants to help protect against the risk of RSV disease remains important through the entirety of the RSV season.”
- “Beyfortus is a monoclonal antibody that helps prevent RSV disease starting from Day 1 after injection.”
- “Your efforts in immunizing infants against RSV disease can impact the population health burden in your community.”
And then FDA wrote:
“These claims and presentations create a misleading impression about the indication for Beyfortus. Specifically, they suggest the use of Beyfortus for the general prevention of Respiratory Syncytial Virus (RSV), including both upper and lower respiratory tract disease, when this is not the case. According to the INDICATIONS AND USAGE section of the FDA approved Prescribing Information (PI) (in pertinent part), “BEYFORTUS is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease…” By failing to adequately communicate the indication for Beyfortus, the emails create a misleading impression about the drug’s FDA-approved indication.”
The link provided here is the full FDA letter, referenced above, to the Beyfortus manufacturer: https://www.fda.gov/media/193721/download?attachment
FDA’s warning letter demonstrates just one of many violations by TDH of the Restore Trust in Public Health Messaging Act and why compliance is so important. TDH should not be misleading consumers or health care providers about the capabilities or risks of immunization products.
The Tennessee Conservative News will gladly provide follow-up reporting if the Tennessee Department of Health or the Tennessee Attorney General’s Office wishes to make a statement concerning compliance with, or potential violations of, the Restore Trust in Public Health Messaging Act.
About the Author: David Seal is a retired Jefferson County educator, recognized artist, local businessman, 917 Society Volunteer, and past Chairman of the Jefferson County Republican Party. He has also served Jefferson County as a County Commissioner and is a citizen lobbyist for the people on issues such as eminent domain, property rights, education, and broadband accessibility on the state level. David is also a 2024 winner of The Tennessee Conservative Flame Award & has received an accolade from the Institute For Justice for successfully lobbing the TN legislature to protect property rights. David can be reached at david@tennesseeconservativenews.com.
