CHD Citizen Petition update: We might have made history on Regulations.gov

Analysis of historical public engagement metrics on Regulations.gov: Citizen Petitions and administrative procedure

Readers, I am humbled and awed by you response to the Citizen Petition to revoke BLA licensure for Pfizer and Moderna mRNA shots which I co-authored with Children's Health Defense, including Ray Flores, Kim Mack Rosenberg, Mary Holland and Brian Hooker. The “citizen petition” mechanism is exercised through the Food and Drug Administration (FDA) under 21 CFR § 10.30 and tracking thereof via the federal portal Regulations.gov.

This petition received 100K+ public comments in one day after it was filed on December 8 and posted on December 9, 2025. By next midnight its comment counter showed 100,953 comments from individuals, of course many of my readers, and I cannot thank you enough! On Thursday and most of Friday the comment count appeared “stuck”. It eventually moved up by about 2,200 comments late on Friday.

The system is supposed to log every individual comment into the docket and it appears that we tripped some circuit breakers. At the time of this writing, only 775 comments have been reviewed and posted publicly. If the government takes the same time to process the rest of the comments received on Wednesday, December 11, it will take about 5 month to review and post the comments just from that one day!

I have never had an experience with this mechanism of petitioning the government. I decided to to run an analysis on how this public response compares to the historical record on Regulations.gov.

To create this report, I asked a friend who has a rather expensive set of professional AI tools to make an exhaustive analysis of the volume of public comments typically associated with these petitions. My question was, what is the average number of public comments received with citizen petitions on Regulations.gov and what are the “all-time high” metrics?

The results indicate that we might have made history on Regulations.gov. with the largest number of individual public comments received in one day, and maybe for total comments, too.

The vast majority of citizen petitions are technical legal instruments used primarily by regulated industries—specifically pharmaceutical manufacturers—to adjudicate highly specific scientific disputes. These dockets typically exhibit negligible public engagement, with comment counts ranging from zero to fewer than 30.

In contrast, a tiny subset of petitions addressing public health, political, or social issues generates massive waves of public engagement.

The Prior All-Time Record Holder: “Just Label It” (FDA-2011-P-0723)

The all-time record for public engagement on a citizen petition initiative is held by the “Just Label It” campaign (Docket FDA-2011-P-0723), which claimed a total of over 1.1 million signatories in 2011-2012 regarding the mandatory labeling of GMO foods. However, the “real” number of individual comments was 200K-300K due to many form letters submitted instead of individual comments.

In October 2011, the Center for Food Safety (CFS), in partnership with a broad coalition of organic food companies, environmental groups, and consumer advocates, filed a legal petition (Docket FDA-2011-P-0723). The petition demanded that the FDA require mandatory labeling for all foods produced using genetic engineering (GE), arguing that the lack of labeling was misleading to consumers under the FD&C Act.

To drive public engagement, the “Just Label It” coalition launched a massive public facing campaign designed to flood the FDA with comments. They utilized:

• Digital Tools: One-click submission forms on partner websites.

• Coalition Building: Over 450 partner organizations pushed the petition to their email lists.

• Media Integration: A sophisticated PR campaign framed the issue as a fundamental “Right to Know”.
  
  

By March 2012, the coalition announced they had submitted 1.1 to 1.2 million comments to the FDA, claiming the record for the “largest number of comments on a food petition in the history of the FDA”. However, the actual counter on the Regulations.gov docket displayed a number in the low hundreds of thousands (~300K+). The discrepancy was due to the FDA data processing protocols. There is a downside to using form letters and digital tools to generate mass signature campaigns. The agency “deduplicates” mass form letters. If 100,000 people sign the exact same text, the Dockets Management Staff may post a single representative example of that comment and internally note the volume. The displayed count on the website reflects the number of unique entries posted, not the raw volume of mail received. The FDA spokesperson at the time clarified, “Because that’s the case for all dockets... it’s impossible for me to compare the claim of 1 million comments to other dockets” without knowing how the campaign defined a comment.

In contrast, our petition with CHD did not use any sophisticated digital tools to drive signatories of form letters to Regulations.gov. In fact, I am told that CHD used to do that, too, as did many other advocacy organizations. However, on August 8 of this year, the Trump administration (specifically, the GSA) disabled the part of the regulations.gov API that allowed us to use tools such as One Click Politics to easily collect users’ information and comments (usually pre-written) and submit those directly to the appropriate docket on the site on their behalf. That means that users must now submit their comments directly on the site themselves. In my opinion this is a much more honest way to collect public commentary.

The Second All-Time High Comments: Menthol Cigarette Ban (FDA-2013-P-0435)

This petition was a decades-long campaign to ban menthol cigarettes, which has generated hundreds of thousands of comments across several related dockets.

In April 2013, the Public Health Law Center and other groups filed a citizen petition (FDA-2013-P-0435) calling on the FDA to remove menthol from the market, citing the Tobacco Control Act and the report of the Tobacco Products Scientific Advisory Committee (TPSAC). While the initial petition docket received over 1,000 comments, the petition triggered a cascade of regulatory actions that subsequently generated a large public engagement. Ultimately, when the FDA moved to ban menthol in 2022 (partially in response to litigation over the 2013 petition), the rulemaking docket (FDA-2021-N-1349) received 175,539 comments. While some of these counts belong to rulemaking dockets rather than the petition docket itself, the petition was the legal trigger for the entire sequence.

In conclusion, let me just say this - I am truly humbled and awed at the power of us, little people. We have gathered now at least 102,250 comments, in 1-2 days and we did not have a massive PR budget or campaign with 450 partnering organization. In fact, we had no budget and relied on CHD and my personal outreach effort, which we are going to continue of course. Together with you and CHD followers have delivered the message to the government and its pharma accomplices to take the mRNA poison and shove it where the sun doesn’t shine. I am proud of being part of THIS team.

If you have not yet submitted your comment to our docket, please do so. Here is a direct link to submit a comment. Put it under “Drug Industry” category in the drop own menu. Comments can be 5000 words and up to 200 Mb attachment. You can tell the story of your injury or loss of a loved one to the mRNA shots. You can submit your own analysis of data or documentation or anything else you feel relevant. Please continue asking people to contribute comments. Let’s clog Regulations.gov and make the docket management staff busy and employed for centuries if we can, shall we?

Art for today: Two Roses, oil on panel 12x16 in.