HAMPTON, VA. — Food plant inspections by the US Food and Drug Administration might be reduced as the result of deep staffing cuts under the Trump administration and Robert F. Kennedy Jr., secretary of Health and Human Services.
Food manufacturers should anticipate significant changes in frequency of plant inspections, self-affirmed GRAS (generally recognized as safe) guidelines, ingredient traceability regulations and more, according to David Lennarz, president, Registrar Corp., an organization that assists food and beverage, drug, medical device and cosmetics companies with FDA regulatory compliance.
Food Business News spoke with Lennarz about how current staff reductions at the FDA are impacting the industry now, and what to expect from the FDA in the next few years.
FBN: How much change were you anticipating at the FDA with the new administration and the appointment of Robert F. Kennedy Jr. as secretary of Health and Human Services? Has anything surprised you?
Lennarz: What surprised everyone, frankly, was the breadth and depth of the cuts at the agency. In my communications with contacts I have at FDA, they were even surprised by the speed and randomness of it … the whole dysfunction of how it came down and how people were notified and everything else that went with it.
FBN: Because of the staffing cuts, what immediate changes have you noticed in working with your food company clients?
Lennarz: We (Registrar Corp.) serve as the US agent for foreign food facilities under the Bioterrorism Act. We are the point of contact between FDA and the foreign company, so we’re notified when our clients will be inspected. There has been a definite reduction in notices of inspections, which we would attribute to the reduction in workforce at FDA.
FBN: What about food safety inspections at US-based plants?
Lennarz: As you probably know, FDA outsources a lot of that to state agencies, and those are done through federally awarded contracts for inspections. For example, here in Virginia, our state agency is the Department of Agriculture, and they have a cadre of FDA-trained inspectors who are essentially under contract with FDA and will go out and perform those inspections on a local basis.
I suspect the thing to watch for is, are those contracts being cut or reduced? That would obviously impact the actual physical inspections that are taking place. As consumers, we all have interest in knowing that factories producing our food are doing so in a safe way and meeting the regulatory requirements. It’s in everyone’s interest to make sure that these inspections continue either directly by FDA or through a state agency.
We haven’t seen a decrease in US-related inspections, but I think that’s something to watch for. Clearly, there are lots of folks in the industry who are close with FDA and concerned about that as a potential fallout, and what the impact will be on food safety.
It might be three months or six months before we can start to really get some data around what FDA is doing on inspections, both here in the US and also overseas. What will that look like post-reduction in workforce and attempts to cut budgets?
“There’s nothing better to drive a company to reinforce the safe production of food than an FDA inspection that turns up issues.” -- David Lennarz, president, Registrar Corp.
| Photo: ©LITTLEWOLF1989 – STOCK.ADOBE.COMFBN: How should food companies approach inspections in the meantime?
Lennarz: No food manufacturer likes to have an inspection. But they are in many cases valuable. I wouldn’t go so far as to call it help, but insight comes out of these (inspections). There’s nothing better to drive a company to reinforce the safe production of food than an FDA inspection that turns up issues.
As you can imagine, all it typically takes is a couple food safety scares to refocus attention around this.
FBN: Ingredients generally recognized as safe (GRAS) also have come under scrutiny from the FDA recently. What are you hearing about changes to GRAS regulations?
Lennarz: The whole system around self-affirmation is likely to come under attack and probably under reform, which is kind of interesting because if you think about it – the general concept of a deregulatory environment – a change around GRAS is actually the opposite, right?
That will certainly impact the industry. It will impact the companies that are producing raw ingredients and having those ingredients sold into further processing. We’ll see if Kennedy pushes the agency to make those changes to how GRAS has usually been done.
FBN: One FDA change we’re not hearing as much about is the food traceability rule that was scheduled to go into effect January 20, 2026, but now has been pushed back 30 months by the new administration.
Lennarz: The traceability piece of the Food Safety Modernization Act was plowing forward, companies were starting to choose software vendors, and there was a lot of movement in getting suppliers on board in using those software tools. Then of course we saw pretty much right after Trump came into office that FMI was able to essentially say, “Yeah, not so fast. This is too expensive and too difficult for our members. They all need time.” So, it got pushed 30 months, which is a significant amount of time.
We as a company have been watching and following it carefully, and our impression of where the industry was in meeting (the January 2026 deadline) is that there was no way, particularly with foreign suppliers, that (food companies) were going to be anywhere near ready to meet that date.
We have a massive, multinational client. They had no plan as of two months ago to implement a (traceability) solution and they have several thousand suppliers and dozens of factories around the world. They did not have a plan. They had no software ready. I think what we’ll probably find 24 months from now is companies will be in the same boat they are today. I think what companies have done now is say, “OK, we’ve got 30 months, we have other fires to put out. We’ll deal with this a year from now.”
FBN: What advice would you have for food manufacturers about how to navigate the current and future FDA regulatory landscape?
Lennarz: There are always efforts at making examples of companies. It’s important to remain vigilant and to be following what’s out there and what’s required. Just because FDA isn’t perhaps enforcing or getting out as much today doesn’t mean that couldn’t change tomorrow or the next day. I think companies need to remain vigilant around food safety and around what they’re doing in their regulatory work.
I’ve spoken to some of my contacts at FDA, and I was going to meet with one this month, and he said, “Give me a couple weeks and we’ll get together for dinner. I have so many retirement parties coming up.” It’s interesting times, that’s for sure.
