Currently browsing posts about: FDA

Here’s the chronology:

In June, Texas passed the “Make Texas Healthy Again” bill which required food companies to put warning labels on products containing any of 44 ingredients such as artificial additives, dyes, and chemicals.  As I wrote at the time, the label would have to say:

WARNING: This product contains an ingredient that is not recommended for human consumption by the appropriate authority in Australia, Canada, the European Union, or the United  Kingdom.

In December, the American Beverage Association, joined by other food industry groups, sued Texas over this.

In February, a federal district court issued an injunction on First Amendment grounds.

Also in February, Texas issued a final rule on the labeling law.  But this says that “ingredients considered generally recognized as safe or determined to be safe by the FDA or USDA are not subject to the rule requirements.”

Oops.  I’m pretty sure that most of those 44 ingredients are considered GRAS by the FDA.

It will be interesting to watch what the courts decide on this one too.

Interesting times we live in.

Two recent reports say that the FDA is a mess as a result of staff cuts, loss of expertise, and leadership vacuums—a national tragedy by any criterion.

I.  From Timothy Inklebarger at FoodNavigator-USA: Trump purge at FDA and USDA triggers food safety ‘brain drain’: Government data shows deep staff cuts as food safety leaders warn of fewer inspectors, loss of institutional knowledge and delays in lab and outbreak work… Read more

The US Office of Personnel Management’s Federal Workforce Data tool shows the Department of Agriculture and Department of Health and Human Services are among the hardest hit, losing 22,253 and 17,406 jobs, respectively, since the beginning of 2025.

II.  ͏ From Gary Schwitzer’s Health News Review:FDA staff “rife with mistrust and paranoia”: Concern about staff “trampled on…perpetual uncertainty…chaos…no stability.”

It didn’t take Dr. Richard Pazdur long to see that he wanted out of Marty Makary’s FDA. The 26-year FDA veteran was hired in November to be director of the Center for Drug Evaluation and Research. He resigned in December. Why?  …Pazdur, looking distraught, spoke of an agency crumbling, with leaders making up rules as they went and longtime, experienced staff members leaving after layoffs and perpetual uncertainty left them unable to do their jobs. At different points, he described “chaos” at the agency with staff having gone through “a lot of trauma,” and said “you do not have stability.

Comment

If your purpose is to dismantle government, this is how you do it.  As I said, a national tragedy.

HHS issued a press release last week: FDA takes New Approach to “No Artificial Colors” Claims

Companies will now have flexibility to claim products contain ‘no artificial colors’ when the products do not contain petroleum-based colors. In the past, companies were generally only able to make such claims when their products had no added color whatsoever — whether derived from natural sources or otherwise. The agency sent a letter to industry providing notice of the FDA’s intent to exercise enforcement discretion related to these voluntary labeling claims.

..Additionally, the agency today also approved beetroot red, a new color option, and approved the expanded use of spirulina extract, an existing color additive derived from a natural source…This brings the total number of new food color options approved under the current administration to six.

…Ongoing progress in removing petroleum-based colors from the food supply is being publicly tracked by the FDA at Tracking Food Industry Pledges to Remove Petroleum Based Food Dyes.

Natural colors are generally extracted from vegetables, spices, or insects.  They go through industrial processing to extract the pigments and stabilize them.  (A series of videos explains the processes)

Are natural colors healthier?  They might be.  They are not associated with behavioral problems in children.

Are they safer?  Possibly, but they are not as well studied or regulated.  According to Time,

…their natural sources of color do not necessarily mean that they are safer or free of potentially harmful compounds. Natural sources may be treated with pesticides and herbicides, and are also prone to contamination with bacteria and other pathogens…To strip natural products of these contaminants, manufacturers process them with various solvents—some of which could remain in the final coloring and contribute to negative health effects…[and] it generally takes more natural color than synthetic color to make the same shade in a final food.

One additional point: color additives—regardless of source—are an indicator of ultra-processing.

Candy and cereals made with colors extracted from natural sources will still be ultra-processed.

The purpose of food colors—no matter their source—is entirely cosmetic.  They make foods look more appealing and appear to taste better. That’s why the food industry loves added colors.

Removing the more vibrant and more stable petroleum-based colors may reduce sales.

Will doing so Make America Healthy Again?  We shall see.

If I counted right, the FDA oversaw 17 recalls of pet food and animal feed in 2025.

The causes included Salmonella, Listeria, aflatoxin, bird flu, plastics, and “presence of particulate matter”

Not yet on that list is an even more serious case involving Darwin’s raw pet food (thanks to  Phyllis Entis for writing and sending) : Darwin’s raw pet food linked to human case of E. coli O157:H7 in four-year-old child.

The contamination came to light after food-safety attorney, William Marler, initiated third-party testing of an previously unopened package of BioLogics All-Natural and Grain Free, Beef Recipe for Dogs found E. coli O157:H7 in the raw, frozen product. Whole genome sequencing (WGS) confirmed that the strain found in the pet food was a match for the strain recovered from the child.

In addition to the E. coli O157:H7-positive sample, the third-party lab recovered Salmonella Infantis and Salmonella Hadar from previously sealed packages of Darwin’s chicken dog food and duck dog food, respectively.

This example is notable for two reasons.  The company refused to recall the products (recalls are voluntary) and continued to sell contaminated food:

Darwin’s pet food tests positive for Listeria and Salmonella: The FDA has again found bacterial contamination in Darwin’s Natural Pet Products dog food and the producing company, Arrow Reliance, is again refusing to recall its products.Read more 

As I keep insisting, pet food is not a separate entity; it is part and parcel of the food supply for humans.  Contaminated pet food can and does infect pet owners and their children.   It is made from the same foods that go into the human food supply and is an early warning of problems to come (hence my book, Pet Food Politics: The Chihuahua in the Coal Mine)

That is why safety and other pet food issues are well worth tracking.

SAFETY

• APHA reveals Salmonella findings in animals and pet food: Reports of Salmonella in raw meat-based pet food in the United Kingdom have declined again from the record levels seen in 2022.The Animal and Plant Health Agency (APHA) collected data on Salmonella from animals, feeding stuff and animal by-products (ABP) in England, Wales and Scotland.Read
• Dog food, treats linked to Salmonella outbreak in Canada: The Canadian government reports 27 confirmed cases across four provinces connected to handling various dog food products. Read more
• Dog Food Recalled Nationwide Due to Bacterial Contamination: FDA: North Carolina-based Viva Raw said the recalled dog and cat foods were contaminated with Salmonella and Listeria monocytogenes.

INGREDIENTS

• Report: China dominates critical vitamin, amino acid supplies: New IFEEDER research reveals U.S. dependence on Chinese-produced feed additives essential for animal nutrition and food security. Read more
• Shark-based pet snacks rising in popularity, include regulated species: DNA barcoding of shark-based pet treats in Thailand identified eight species of shark. Biologists have classified many of those species as near threatened, while also under international trade regulations. Read more
• Good fatty acids boosted by BSFL insect protein in dog food: Nevermind humans, dogs didn’t need to be convinced of insect-based pet foods’ value. In preference testing, dogs showed no significant difference in consumption between traditional and insect-based diets. Read more
• Tesco issues urgent recall over contaminated dog food fears: The retailer has issued an urgent recall notice after a foreign body contamination was detected in Lily’s Kitchen branded dog food cans…. Read more

I thought this post on X was well worth a follow up.  I went right to the site: Human Foods Program 2026 Priority Deliverables.

Its vision: “to ensure that food serves as a vehicle for wellness.”

Its mission: “to protect and promote the health and wellness of the American public through science-based approaches to prevent foodborne illness, reduce diet-related chronic disease, and ensure chemicals in food are safe.”

Its 2026 Priority Deliverables: these are listed in three categories: food chemical safety, nutrition, and microbiological food safety.

I.  Food Chemical Safety (my selection and summary)

• Reform GRAS; regulate
• Review safety of food chemcials
• Conduct research on microplastics
• Establish action levels for cadmium and inorganic arsenic in baby foods
• Research consumer exposure to PFAS and other chemicals
• Regulate new dietary ingredients
• Modernize oversight of supplements
• Collect opinions on allergens; develop regulations

II.  Reducing chronic disease through better nutrition

• Research ultra-processed foods; develop definition
• Research infant formula nutrient requirements
• Recruit experts to develop a UPF policy agenda
• Work toward issuing a front-of-package label to encourage healthier consumer choice and reformulation
• Implement the “healthy” front-of-package label
• Develop strategy to reduce added sugars
• Evaluate phase I targets for sodium reduction
• Issue guidance on food labeling for online shopping

III.  Microbiological food safety

• Get states to take action
• Increase oversight of imported food
• Increase oversight of imported shrimp
• Train growers to prevent produce contamination
• Improve recall communication

Comment

I haven’t listed everything but this should give you the idea.  Lots of this involves “research,” “develop,” and “evaluate.”  Hardly any involves real regulation (except for chemical food additives).  Still, this is, or could be, an impressive list.

The most pressing area is microbial food safety, because we are still seeing so many people made ill by contaminated food, especially infant formula.

The big question: Where is the FDA going to get the resources needed to carry out this agenda?  The FDA, already working for decades on an increasingly bare-bones budget for all it is required to do, eliminated a fifth of its workforce last year.

And this administration prefers personal responsibility as the primary approach to dietary health.

It would be great if the FDA could do all this in 2026.  We are already in February.  It has best get busy.

If you are wondering what’s going on at the FDA, and why everyone seems to be worried about its current leadership, take a look at this instructive post on X: “Nearly 90% of senior leaders who were at the FDA a year ago are no longer there.”

The FDA is cutting down its safety inspections of foreign food imports, even though nearly all seafood, about 60% of fresh fruit and about 40% of vegetables are imported, and we increasingly rely on food imports.

As ProPublica explains, Foreign Food Safety Inspections Hit Historic Low After Trump Cuts.

These crucial foreign inspections are neither easy nor cheap. They typically last longer than domestic ones and cost nearly $40,000 a visit, and they can require months of logistical planning, special visas and diplomatic approval from the host country…Then Congress passed the Food Safety Modernization Act of 2011, which set firm targets for the agency: It needed to conduct more than 19,000 foreign food inspections annually by 2016 and increase the number of food field staff to no fewer than 5,000 workers.

The FDA has never fulfilled this congressional mandate…ProPublica’s Annie Waldman and Brandon Roberts crunched the numbers and found that the U.S. is on track to have the fewest foreign food inspections since 2011 (excluding pandemic years).

This does not bode well for food safety.

It’s not as if we don’t already have plenty of food safety problems.

• The FDA’s list of current recalls and warnings
• The USDA’s list of current recalls and warnings

To review the status of food safety regulation:

• We have plenty of laws requiring all food producers to follow rigorous procedures to greatly reduce the risk of pathogenic contaminants.
• But these laws work much, much better when they are enforced through inspection.
• It’s not that food producers want to make customers sick; it’s that it’s all too easy to cut corners on safety.
• No food producer wants to test for pathogens; if they find any, they have to recall products.
• The system only works with firm oversight.

Fewer inspections gives producers license to be sloppier.

Not a good idea.

The FDA is starting the regulatory process to close the GRAS Loophole.

This proposed rule, if finalized, would amend the Generally Recognized as Safe (GRAS) regulations in 21 CFR [Code of Federal Regulations] parts 170 and 570 to require the mandatory submission of GRAS notices for the use of human and animal food substances that are purported to be GRAS.

What?  You mean manufacturers are not already required to tell the FDA when they are putting new additives into foods?

No, they are not.  Hence, the “GRAS Loophole.”  Food manufacturers have been allowed to decide for themselves whether a new additive is safe and also to decide whether to inform the FDA about it.

Closing the loophole is a long-standing goal of food advocates.  Even I got into this one.

In 2013, I wrote a short editorial about the history and significance of GRAS determinations: Nestle M. Conflict of interest in the regulation of food safety: a threat to scientific integrity. JAMA Internal Medicine. 2013;173(22):2036-8. 

Here’s the FDA’s version of this history.

And Food Dive explains: FDA takes first step toward closing GRAS ingredient ‘loophole’

Dive Brief:

• The FDA proposed a rule that companies provide health data and other documentation when declaring a new food ingredient or additive is safe, a step toward eliminating a voluntary approval process decried by Health Secretary Robert F. Kennedy Jr.
• The rule would require companies to submit mandatory notices when declaring an ingredient is Generally Recognized as Safe, or GRAS. Currently, notices are voluntary, though strongly encouraged by the FDA.
• The proposal is included among a list of upcoming regulatory priorities by the Trump administration. In March, Kennedy directed the FDA to explore rulemaking to eliminate companies’ ability to self-affirm that an ingredient is safe.

If the FDA can pull this off, it will indeed be a MAHA Win.

I hope it can, given how many FDA employees are no longer with the agency (~3,500 according to reports).