Food Safety Warnings Stop Going Out After FDA Laid Off Staffers

The FDA’s public posting of warning letters from its food division stalled after the agency temporarily fired staff to review them, making the center overdue on notices that flag compliance violations in seafood, produce, and other foods.

At least a dozen letters warning companies on significant violations of federal requirements have been piling up at the agency’s Human Foods Program before they can be publicly posted on the Food and Drug Administration’s website, according to two sources at the FDA familiar with the matter.

Letters are first issued to companies, but the task to review and redact them before they’re posted to a public database was halted in April after the US Department of Health and Human Services laid off—then rehired—staff that handled the agency’s public records. Other FDA centers continued to push out warning letters after the reduction-in-force, but the last letter from the foods program over an on-site inspection was posted Jan. 21, one day after President Donald Trump was sworn into office.

The FDA’s delay to post the letters creates a gap in communication between the agency and members of the industry, attorneys say. Aside from the specific recipient of the letters, the notices also serve as guidance for other companies or manufacturers regulated by the FDA, giving a heads-up to those that may be committing a similar violation.

“It’s important that people get a whole range of information from the government, not only notices about recalls or pending rules, but also warning letters,” said Sandra Eskin, CEO of Stop Foodborne Illness and a food safety official at the US Department of Agriculture during the Biden administration. “That really is an integral part of their enforcement power.”

Warning letters often identify concerns with poor manufacturing practices, claims or intended use, and incorrect directions for use. The notices aren’t formal legal actions, but rather an advisory message from the agency. The FDA provides an opportunity for companies and manufacturers to address the agency’s concerns and requests within a certain time frame.

“Warning letters are the first tool in FDA’s arsenal to say, ‘hey, we noticed this,’” said Claudia Lewis, co-chair of Venable LLP’s FDA group. “It’s a recitation of ‘here’s what the rule is, this is how we’re interpreting it currently, here’s why we’re concerned about the activity that we see.’”

Enforcement Tool

The FDA is tasked with regulating foods, drugs, tobacco, and other products under the Federal Food, Drug and Cosmetic Act, relying on various enforcement vehicles to ensure safe and effective products are on the market.

Warning letters are usually the first notice in an FDA investigation when a company doesn’t work with the agency to comply with federal law. The information in those letters not only serves as an advisory for the recipient but also for the rest of the industry to understand how the agency views enforcement.

The letters are also valued as another form of communication from the agency, attorneys say.

“Warning letters are the easiest way for us to keep an eye on enforcement trends and understand what the agency is thinking and what they’re focused on,” said Natalie Rainer, a partner at K&L Gates LLP’s San Francisco office. “That level of detail can be really helpful to illustrate, for example, how FDA interprets certain regulations.”

Various notices from the foods program and center for food safety often confront companies about product claims related to dietary needs, weight loss, and other labeling issues that might make a claim about intended use. Warning letters also give notice of manufacturing violations, cross contamination concerns, or the use of unsafe ingredients.

Attorneys say that counsel seeking to pursue class actions often use the letters to help build a case against a manufacturer that may have harmed the public health by failing to comply with good manufacturing practices.

Such letters are also used to help companies create a risk analysis for their products.

“It’s sort of a litmus test of where the agency is concerned about a particular claim or group of ingredients or a particular classification,” Lewis said. “It gives the industry more direction as to where the line is on claims because FDA ultimately regulates products based on their intended use.”

Recalls Continue

Despite some concerns about the delay in posting food warning letters, the FDA continues to issue recalls—another major enforcement area that allows the FDA to remove products from the market that are in violation of regulation and spur safety concerns.

The agency issued at least 15 food and beverage recalls in April and at least 10 in May, according to the agency’s recall database. Some of the recalls were due to presence of undeclared products, contamination of salmonella, or contaminants of ingredients that were not declared on labels.

While recall information is seen as one of the most significant communications from the FDA, industry watchers still value warning letters as the first form of awareness for products at risk.

“Among the most important information is information about product recalls, information about outbreaks and outbreak investigations,” Eskin said. “A warning letter is not actionable in the same way a recall is, but yet the warning letters tell you, uh oh.”