Food Safety Warnings Stop Going Out After FDA Laid Off Staffers

Bloomberg Law: “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.’”