The U.S. Food and Drug Administration doesn’t wait for a public health crisis to act. When a manufacturer crosses the line-whether by selling unsafe food, mislabeling drugs, or pushing unapproved vaping products-the FDA has a clear, step-by-step system to shut it down. And in 2025, that system is more active than ever.
Warning Letters Are the First Big Step
Most enforcement actions start with a FDA warning letter. It’s not a gentle reminder. It’s a formal notice that says: You’re breaking the law, and we’re watching. These letters are issued under the Federal Food, Drug, and Cosmetic Act (FDCA), and they list every violation found during inspections or reviews. Common issues include poor manufacturing practices, false claims on labels, or selling products without approval.Manufacturers get just 15 business days to respond. That’s not a suggestion-it’s a deadline. The letter demands a detailed plan: what went wrong, how it’s being fixed, and how it won’t happen again. If the response is vague, delayed, or incomplete, the FDA doesn’t wait. It moves to the next level.
Since early 2023, under Commissioner Robert Califf, the FDA has returned to a 1990s-style enforcement model: issuing hundreds of warning letters per year. In 2024 alone, the agency sent 149 warning letters to human food facilities and 37 to animal food producers for failing to meet Current Good Manufacturing Practices (cGMP). In pharmaceuticals, 58 letters targeted compounding pharmacies and telehealth firms misbranding GLP-1 weight-loss drugs like semaglutide. That’s not random-it’s targeted.
What Happens If You Ignore It?
Ignoring a warning letter is like ignoring a court summons. The FDA doesn’t bluff. After the response deadline passes, inspectors return. If the fixes aren’t real, the agency escalates.One major next step: Civil Monetary Penalties. These fines can hit $10,000 to $1 million per violation under 21 U.S.C. § 333(f). For a company selling thousands of units of a contaminated product, that adds up fast.
Worse, the FDA can issue a Recall Notice-voluntary at first, but mandatory if the company refuses. A mandatory recall means the product is pulled from shelves, warehouses, and even consumers’ homes. The cost? Not just money. It’s trust, reputation, and sometimes, the business itself.
The most severe action? Withdrawal of Approval. If a drugmaker repeatedly fails to meet quality standards, the FDA can permanently revoke its right to sell that product. This isn’t theoretical. In 2024, the FDA withdrew approval for multiple compounded drugs that were being marketed as safe alternatives to FDA-approved medications-but weren’t tested or regulated properly.
Import Alerts and Border Enforcement
You don’t have to be based in the U.S. to get caught. The FDA watches every shipment entering the country. If a foreign manufacturer has a history of violations, the agency puts them on an Import Alert. That means: Detention Without Physical Examination (DWPE).When the product arrives at a U.S. port, it’s blocked. No inspection needed. No second chance. The importer gets a notice explaining why it was held and has 30 days to prove it’s safe. If they can’t? The product is destroyed or returned. In 2024, over 12,000 shipments from China, India, and other countries were detained under these alerts-mostly for unapproved drugs, contaminated supplements, and unsafe food additives.
Unannounced Inspections Are the New Normal
For years, foreign factories could expect advance notice before an FDA inspection. That’s over. Since May 2025, the agency has ramped up unannounced inspections by 300%. These aren’t routine checks. They’re raids.Inspectors show up without warning, demand access to records, and take samples on the spot. If a company delays, denies, or redacts documents-especially if it’s done to hide violations-that’s a federal crime under Section 303(f) of the FDCA. Criminal charges can follow, including jail time for executives.
McGuireWoods attorneys call this the FDA’s most powerful-and underused-tool. Companies that thought they could hide behind distance or bureaucracy are now finding out the FDA has teeth, and it’s coming directly to their door.
Why Tobacco and Compounding Drugs Are Top Targets
Not all violations are treated the same. The FDA has clear priorities.Tobacco is the biggest enforcement area right now. Since 2021, the agency has issued over 700 warning letters to companies selling unauthorized vaping products-especially those with flavors and packaging aimed at teens. Even if the product is technically legal, if it hasn’t gone through the FDA’s premarket review, it’s illegal. The agency is focused on youth access, and it’s not backing down.
Compounding drugs are another hot zone. Companies that mix medications like semaglutide and tirzepatide in labs are being hit hard. Many claim these are “custom” formulations for patients-but they’re being sold in bulk, marketed like brand-name drugs, and sold online. The FDA says that’s misbranding. In the first half of 2025 alone, 58 warning letters went out to these operators. Some were shut down. Others are now facing criminal investigations.
How Companies Are Changing Their Approach
The tone of warning letters has changed too. Older letters used phrases like “OPDP requests you cease…” Now, they say: “FDA requests you take immediate action.” That’s not just wording. It’s a power shift.Today, warning letters are signed by the directors of CDER (Center for Drug Evaluation and Research) or CBER (Center for Biologics Evaluation and Research)-not mid-level reviewers. That means the letter carries the full weight of the agency. Legal teams now treat these as emergencies. Companies are forming cross-functional response teams within hours of receiving a letter: quality control, legal, regulatory affairs, and even PR.
One pharmaceutical company in New Jersey spent $2.3 million in 2024 fixing cGMP issues after a warning letter. They didn’t just patch the problem-they rebuilt their entire quality system. Their CEO said: “We didn’t want to be the next headline.”
What’s Next for FDA Enforcement?
The FDA’s 2026 budget includes $50 million to expand inspections, hire more investigators, and improve digital monitoring. That means more unannounced visits, more data checks on websites and social media, and more letters targeting online marketing.Telehealth companies are already seeing the shift. In 2025, the FDA issued warning letters to clinics promoting compounded GLP-1 drugs on Instagram and TikTok. Those posts? Now considered illegal advertising. The agency says if you’re selling a drug online, you’re subject to the same rules as a pharmacy.
For manufacturers, the message is clear: compliance isn’t optional. It’s not a checklist. It’s a daily commitment. The FDA isn’t waiting for you to fix things. It’s watching-and it’s ready to act.
What happens if I don’t respond to an FDA warning letter within 15 days?
If you don’t respond-or if your response is inadequate-the FDA will escalate. This could mean a follow-up inspection, a civil penalty of up to $1 million per violation, a product recall, or even withdrawal of approval for your product. Ignoring the letter guarantees a stronger enforcement action.
Can the FDA shut down a foreign manufacturer?
Yes. The FDA doesn’t need to enter the country to stop a foreign company. It can block shipments with an Import Alert, refuse entry at U.S. ports, and publicly list the company as non-compliant. Many foreign manufacturers lose U.S. market access permanently after one serious violation.
Are FDA warning letters public?
Yes. All FDA warning letters are posted on the agency’s website. They’re searchable by company name, product, or date. Investors, customers, and competitors check them regularly. A single warning letter can damage a company’s reputation and stock value.
What’s the difference between a Warning Letter and an Untitled Letter?
An Untitled Letter is for minor or technical violations, often related to advertising language. It’s less formal and doesn’t require a formal response. A Warning Letter is for serious, regulatory-significance violations-like safety risks or unapproved products-and demands a detailed corrective plan. Warning Letters carry far more legal weight.
Can FDA inspections happen without notice?
Yes. Since May 2025, the FDA has significantly increased unannounced inspections, especially for foreign facilities. These inspections can lead to FDA Form 483 observations, warning letters, or even criminal charges if records are withheld or access is denied.
How can a company avoid a warning letter?
Stay ahead of regulations. Regular internal audits, staff training on cGMP and FSMA rules, and proactive communication with regulators reduce risk. Don’t wait for an inspection to fix problems. If you see a gap, fix it before the FDA does. Companies that treat compliance as part of daily operations rarely get warning letters.
Nancy Kou
December 19, 2025 AT 16:07The FDA’s been quiet for too long and now they’re swinging like a bull in a china shop. I get the need for safety, but this feels like overkill. Every small compounding pharmacy is being treated like a pharmaceutical cartel. Where’s the nuance? Where’s the grace? We’re not talking about tainted baby formula here-we’re talking about doctors trying to help patients with personalized meds in a broken system.
Ryan van Leent
December 20, 2025 AT 00:37so the fda just decides whats legal now like its the supreme court or something