Infant Formula Testing: Urgent Botulism Petition Filed

Food-safety attorney Bill Marler has petitioned the Food and Drug Administration to add botulism to the list of organisms covered by federal infant formula testing requirements, opening a public comment period that runs through Oct. 30.

Marler, of the firm Marler Clark, filed the petition through a Publisher's Platform column published Oct. 19 by Food Safety News. The proposal would require manufacturers to test for Clostridium botulinum, the bacterium behind the illness, in finished formula and ingredients.

The FDA commissioner can amend the testing list without new legislation, meaning the agency could act on the petition through its existing authority. The FDA petition does not ask the agency to ban any product or brand.

Citizen petitions are a formal mechanism allowing any person to ask the FDA to change its regulations. The agency must respond to a petition, though it faces no fixed deadline for doing so — leaving the timeline for a decision open.

What the Infant Formula Testing Petition Proposes

Under the proposal, manufacturers would test thirty 200-gram samples of finished product for the organism, alongside testing of ingredients. Environmental monitoring would serve as a secondary control, checking production facilities for the bacterium's presence.

The petition's backers frame the change as closing a gap in infant formula safety. Powdered formula is not sterile, and infants are considered especially vulnerable to foodborne pathogens — a combination the petition argues warrants adding the bacterium to the mandatory testing list.

The illness is caused by a toxin produced by Clostridium botulinum. In infants, the illness can cause muscle weakness and breathing difficulty and requires prompt medical treatment — which is why the petition argues that early detection in formula matters.

Under current rules, manufacturers already test finished formula for a defined list of organisms; the petition would simply add one more. The change would apply across the industry rather than targeting any single company or product.

If the FDA adds botulism to the list, a recent law would automatically raise the stakes for manufacturers. Senate bill S. 272, which passed unanimously in April, requires companies to notify the agency within one business day when testing detects any organism on the list — a requirement that would extend to findings of the bacterium.

Why Infant Formula Testing Rules May Expand

The one-business-day notice rule in the Senate bill was designed to speed up the FDA's response to contamination events. Lawmakers passed the measure unanimously, signaling rare bipartisan agreement that faster notice protects infants.

The unanimous April passage of S. 272 showed Congress wants faster warning when contamination is found. Extending the one-business-day notice to the organism would put the bacterium under the same rapid-reporting regime as the organisms already on the list.

For manufacturers, the practical question is what compliance would cost. Running thirty 200-gram finished-product tests, plus ingredient screening and environmental monitoring, would add laboratory workload — though supporters of the change argue that the expense is modest compared with the cost of a contamination crisis.

Comments on the FDA petition are being sought by email to bmarler@marlerclark.com by Friday, Oct. 30, 2026. The comment period gives manufacturers, consumer advocates and parents a chance to weigh in before the FDA decides whether to amend its testing list.

For now, the proposal remains just that — a proposal. But with the commissioner's authority to act without Congress and a unanimous Senate vote underscoring the appetite for tougher oversight, the petition has put botulism squarely on the FDA's agenda.

The FDA has not indicated when it will respond. If the agency agrees, manufacturers would need to build testing for the bacterium into their quality systems — a change supporters describe as a straightforward strengthening of infant formula safety.