FDA is now a black box

The FDA communications teams have been trashed by the Trump administration. Likewise, the Freedom of Informaction Act (FOIA) response teams and policy teams.

What does this mean for public health and food safety?

Siobhan DeLancey, a 21-year veteran of the FDA, who for the last several years managed communications for the agency’s Center for Veterinary Medicine (CVM), didn’t mince words in her recent Opinion piece in Food Safety News.

There will be no more safety alerts, no bird flu updates, no information detailing what we’re doing about PFAS. No leverage to spur a recalcitrant company to do the right thing. No news about pesticides or antimicrobial use.

She went on to say,

[G]ood luck relying on a timely response to your FOIA request to reveal the inner working of the agency or gleaning information from the Federal Register. Guidances for Industry on how to comply with the law? Doubt you’ll see many in the next four years, and even if one gets through deregulation, how will you know?

On April 22, 2025, pet food safety advocate, Sue Thixton, reported in Truth About Pet Food that a pet owner had arranged for two samples of Answers Pet Food to be tested for the presence of gentamicin by an independent laboratory.

Gentamicin is an antibiotic whose use is discouraged in cattle due to its long retention time in animal tissue. The US Federal Register does not cite a permitted level of gentamicin in beef tissue. Canada lists a maximum residue limit of 0.1 parts per million (ppm) in muscle of cattle.

One of the samples—ANSWERS PET FOOD STRAIGHT BEEF—was found by the lab to contain 320.6 ppm of gentamicin. The second sample—Answers Pet Food Detailed Beef—contained 76.2 ppm.

According to Thixton’s post, multiple pets became very ill, but survived. She added, “It is unknown if a recall will be issued on these products.”

The following day, Answers Pet Food posted a multi-paragraph rebuttal on its Facebook page, calling the pet owner’s claim “baseless.”

Why is this story relevant?

Prior to January 22, 2025, when Trump took office, it would have been possible to contact the CVM communications team by email or phone, find out whether or not the agency was aware of the situation and, if necessary, point them to the posted report.

On several occasions in the past, eFoodAlert has done exactly that, with the result that a problem of which the CVM was previously unaware became flagged for follow-up.

One such occasion was the concern raised by multiple pet owners early in 2024 about Purina pet foods.

Now this avenue no longer exists.

There is no longer any way of communicating informally with the CVM or with other areas within the FDA.

There is no longer any way of learning in a timely fashion whether the CVM knows about this incident.

Even if the CVM investigates and discovers a problem, unless the company recalls the product, there will be no alert to consumers, because there is no one left to write the notice.

While it may still be possible to submit a Freedom of Information Act request to learn whether other pet owners have reported similary issues or whether there was an inspection of the manufacturing facility, the chances of receiving a timely response to such a request have dropped to nil, due to lack of personnel.

A final word

I have had dealings with Siobhan DeLancey and various other members of the FDA’s communications teams for almost two decades. I have always found them to be professional, thoroughly invested in the importance of their work, and eager to furnish whatever information and explanations permitted within the bounds of confidentiality requirements.

Without the assistance of Siobhan and her colleagues, and without the work of the FOIA teams, I never would have been able to research and write my two food safety books.

I shall leave the final word to Siobhan (again, from her Food Safety News piece):

We should all be frightened when the ability to communicate is taken away. The administration has become braver about suing or otherwise intimidating news media that run stories counter to its narrative. Now, it’s muzzling its own public servants. How long before it comes for you?

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‘Indiscriminate’ layoffs at FDA prompt food head to resign

February 18, 2025

Jim Jones, the FDA’s Deputy Commissioner for Human Foods, resigned in protest yesterday after dozens of staff members were terminated over the holiday weekend.

In his letter of resignation, quoted in part on several news sites, Jones pointed out that the fired employees were individuals with “highly technical expertise in nutrition, infant formula, food safety response,” and included ten staffers responsible for reviewing potentially unsafe ingredients in food.

A dollop of history

During the first Trump administration, FDA Commissioner Scott Gottlieb eliminated the position of Deputy Commissioner for Food, resulting in a fragmention of responsibilities and authority within this important sector of the FDA.

The 2022 Cronobacter sakazakii outbreak that was linked to Abbott Nutrition’s powdered infant formula products exposed serious flaws in the FDA’s organization and reporting structures.

In February 2023, FDA Commissioner Robert Califf revealed a rough plan for reorganizing the food side of the agency, including restoring the position of Deputy Commissioner for Human Food.

Jim Jones assumed that post in September 2023 with a mandate to implement the restructuring program.

It makes no sense

The Cronobacker sakazakii outbreak occurred in part because the FDA did not have enough trained personnel to provide effective oversight of the infant formula industry.

How does it make sense to terminate staffers with special expertise in infant formula oversight?

RFK, Jr., the newly confirmed Secretary for Health and Human Services, has touted his support for healthy eating, for reducing the number of additives in foods, and for tackling the role of processed foods in childhood obesity.

How does it make sense to terminate staffers with expertise in nutrition?

The FDA food safety investigation staff already was spread thin, and recalls and foodborne illnesses were up in 2024 over the previous year.

How does it make sense to terminate food safety response staffers?

FDA’s food program now a headless snake

Just as the body of a rattlesnake will continue to writhe after it is has been decaptitated, the FDA’s human food program will muddle on for a while.

Just don’t expect it to know where it’s going.

Italian mini-pastries sicken 87 in USA and Canada. CDC silent.

The US Food and Drug Administration (FDA) has traced a US outbreak of Salmonella Enteritidis to consumption of frozen mini-pastries imported from Italy.

Eighteen (18) people in California, Illinois, Massachusetts, North Carolina, New Jersey, New York, and Pennsylvania have been infected with the outbreak strain, which is identical to the strain that has infected 69 individuals in Canada.

One person in the US and 22 in Canada required hospitalization.

The US Centers for Disease Control and Prevention (CDC) has not posted any notice of this outbreak on its website.

The CDC website is currently undergoing modification, according to a notice featured prominently on each page of the agency website.

The Public Health Agency of Canada (PHAC) first reported on this illness outbreak on January 19, 2025, and updated its report on January 29th.

Outbreak cases in Canada have been reported in British Columbia (4), Alberta (3), Ontario (24), Québec (37), and New Brunswick (1).

The Canadian Food Inspection Agency (CFIA) linked the Canadian illnesses to consumption of Sweet Cream brand mini pastries, imported from Italy.

The Sweet Cream brand mini pastries were recalled in Canada on January 18, 2025. On January 29, 2025, a separate recall of certain D. Effe T. brand pastries (also from Italy) was announced after one of the outbreak illnesses was believed to be associated with consumption of this brand.

According to the FDA, these same pastries were imported into the US by two distributors, both of whom were contacted by the agency. One of the distributors had no remaining product on hand; the other quarantined all remaining product on hand and informed all of their downstream customers of the recall.

In the US, the mini pastries were distributed in Florida, New Jersey, New York, and Pennsylvania to food service locations such as hotel cafes, bakeries, institutions, and restaurants. The mini pastries were also served at catered events.

According to the FDA, the recalled products should no longer be available for sale.

Recommendations from the FDA

Food service customers who received the recalled product should follow FDA’s safe handling and cleaning recommendations and use extra care in cleaning and sanitizing any surfaces and containers that may have come in contact with recalled products to reduce the risk of cross-contamination.
Contact your healthcare provider if you think you may have developed symptoms of a Salmonella infection.

Recommendations from the PHAC

The following advice applies to individuals, as well as retailers, distributors and food service establishments such as grocery stores, bakeries, hotels, restaurants, cafeterias as well as facilities such as hospitals and retirement residences across Canada:

Check to see if you have the recalled products in your home or establishment by looking for the specific product name and size, UPC and codes in the recall alert.
Do not consume, serve, use, sell or distribute recalled products.
Throw out or return recalled products to the location where they were purchased. Consumers or establishments who are unsure if they have purchased the recalled products are advised to contact their retailer or supplier where the products were purchased.
Do not cook food for other people if you’ve been diagnosed with a Salmonella infection or any other gastrointestinal illness.
Contact your health care provider if you think you’re experiencing symptoms of Salmonella infection.