FDA official: CDER warning letters up 50% in FY 2025

WASHINGTON – The US Food and Drug Administration's (FDA) Jill Furman, director of the Center for Drug Evaluation and Research's (CDER) Office of Compliance (OC), reported that there has been a 50% increase in warning letters issued by CDER in FY 2025. She noted that a significant portion of this increase is due to letters sent to telehealth platforms that are making false claims about compounded drug products.

Furman offered her thoughts on recent enforcement efforts undertaken by the OC, as well as emerging trends at the Food and Drug Law Institute’s 2025 Enforcement, Litigation, and Compliance Conference. Her remarks addressed noncompliance issues in CDER’s domain, which includes manufacturing, unapproved drugs, compounding, and clinical trials oversight.

She called the 50% bump in warning letters a “very significant increase” and added that “this shows that our teams are continuing to do the critical work to protect the public.”

One of the factors contributing to the increase has been the uptick in warning letters to telehealth platforms that make false and misleading claims about compounded products. These letters accounted for 22% of the warning letters issued in FY 2025. This includes companies illegally marketing and advertising of glucagon-like peptide-1 (GLP) agonist drugs for diabetes and weight loss. “This was a significant effort we took in FY 2025,” Furman said.

The remaining warning letters issued in FY 2025 cited drug manufacturing facilities for good manufacturing practice (GMP) violations (35%), unapproved drug and misbranding violations accounted (18%), or clinical research and Institutional Review Board (IRB) violations (5%).

Furman said FY 2025 was a “year of change” for her office. The former Office of Regulatory Affairs was converted to the Office of Inspections and Investigations (OII) at the start of the fiscal year. This change meant that there was “a great deal of coordination within the suboffices. We take a coordinated approach to our actions, this will be stronger as we get into 2025,” she said.

In FY 2025, FDA issued 126 import alerts, which Furman said was a significant increase compared to the previous year. Additionally, there were 317 drug recall events, the majority of which fell under the Class II category.

In other areas, Furman said that FDA has established a Green List of import alerts to prevent active pharmaceutical ingredient (APIs) from unverified foreign sources from getting into the US. “This [list] works to protect consumers against poor quality APIs,” she said.

Other priorities, Furman said, include targeting the distribution of potentially dangerous ophthalmic products and addressing fraudulent Botox products. In fiscal year 2025, CDER issued 18 warning letters to companies for marketing fraudulent Botox products. Furman said that these products are especially concerning because they are unapproved and can pose serious health risks. Some may be counterfeit, fake, or falsified, while others might contain incorrect ingredients.

Another area of focus is the evaluation of clinical trials and clinical trial data, specifically in cases of bioresearch violations. In fiscal year 2025, CDER assessed clinical data for over 150 marketing applications and investigated more than 900 complaints related to bioresearch violations. Following these investigations, the office issued 21 official action indicated (OAI) or Form 483 reports. Some of these violations included a failure to submit investigational new drug applications.

Furman stated that moving forward, supply chain accountability “will continue to be an important focus for us leading into 2026.”

FDA official: CDER warning letters up 50% in FY 2025

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