News & Analysis as of

Warning Letters

Sheppard Mullin Richter & Hampton LLP

What to Watch: Potential Increase in Enforcement of “RUO” Diagnostics

Last spring, we wrote about a warning letter the United States Food & Drug Administration (“FDA” or the “Agency”) issued to Agena Bioscience Inc. (the “Agena Warning Letter”) for allegedly promoting its diagnostic product...more

Sheppard Mullin Richter & Hampton LLP

FDA Ratchets Enforcement on Social Media Promotion in New Warning Letter

The U.S. Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) recently posted a warning letter (the “Letter”, issued on May 29, 2025, to Sprout Pharmaceuticals, Inc. (“Sprout”) and its CEO,...more

Arnall Golden Gregory LLP

Not a Second Time: FDA’s Office of Prescription Drug Promotion Issues a Warning Letter to a Company for Unlawful Promotion

The authors were thinking of the Beatles’ 1963 song, “Not a Second Time,” when we read the latest Warning Letter from the Food and Drug Administration’s Office of Prescription Drug Promotion. The company received a Warning...more

Troutman Pepper Locke

Unpacking the Illicit E-Cigarette Crackdown by State AGs

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In mid-January, a bipartisan coalition of nine state attorneys general, as well as the Washington, D.C., attorney general, announced a coordinated effort to curb illicit electronic cigarette sales. The attorneys general of...more

Wiley Rein LLP

FTC Sends Warning Letters to 37 Eyeglass and Contact Lens Prescribers Over Possible Rule Violations

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On June 3, 2025, the Federal Trade Commission (FTC) announced its staff had sent warning letters to 37 contact lens prescribers that, according to the FTC, were the subject of consumer complaints concerning possible...more

Axinn, Veltrop & Harkrider LLP

FTC Peeling Back the Layers of the Orange Book

The Federal Trade Commission (FTC) is continuing to pursue pharmaceutical manufacturers for allegedly improperly listing patents in the “Orange Book,” delaying the entry of generic drug competitors. On May 21, the FTC...more

Arnall Golden Gregory LLP

OPDP is Still Standing: FDA’s Office of Prescription Drug Promotion Issues Two Enforcement Actions Since Recent Layoffs

Taking a note from Sir Elton John’s 1983 hit, “I’m Still Standing,” the Food and Drug Administration’s Office of Prescription Drug Promotion issued two enforcement actions (one Notice of Violation and one Warning Letter)...more

Polsinelli

Orange Book Listings: Republican Led FTC Picks Up Where Democrat Led FTC Left Off

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Key Takeaways - The Federal Trade Commission (FTC), now under Republican leadership, has continued its scrutiny of Orange Book listings for device patents, signaling bipartisan concern over potential anti-competitive...more

Cozen O'Connor

FTC Preemptively Throws Flag on StubHub Ahead of Football Season

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The FTC sent a warning letter to StubHub Holdings, Inc. regarding practices that may violate the Commission’s new Rule on Unfair or Deceptive Fees. In the letter, the FTC warned the company that it may have misrepresented...more

Hogan Lovells

AI Health Law & Policy: Complying with FDA GMP rules for AI-enabled diagnostic devices

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The U.S. Food and Drug Administration (FDA) recently issued a Warning Letter citing a failure to obtain marketing authorization via a premarket approval (PMA) or 510(k) clearance as well as Good Manufacturing Practice (GMP)...more

Cozen O'Connor

Bipartisan AG Task Force Wants to Hang Up on Illegal Robocalls

Cozen O'Connor on

The bipartisan Anti-Robocall Multistate Litigation Task Force—consisting of 51 AGs—issued warning letters to nine Voice over Internet Protocol (VoIP) providers that they may be transmitting illegal robocall traffic in...more

Arnall Golden Gregory LLP

Step by Step: FDA Cracks Down on Unauthorized Medical Device Modifications

The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical device (i.e., 510(k)). ...more

Cooley LLP

Complete Response Letter, Warning Letter and Shareholder Lawsuit Follow FDA Data Integrity Findings

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Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 Warning Letter from the US Food and Drug Administration (FDA) on the heels of a routine...more

Hinch Newman LLP

Did Your Company Receive an FTC Warning Letter or Notice of Penalty Offense?

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Has your company received an FTC warning letter or a penalty offense notice? If so, such correspondence should not be ignored because there is a high likelihood that the FTC is in the process of actively and quickly seeking...more

Arnall Golden Gregory LLP

I Don’t Want Your Photograph: Actually, FDA Might Want to Take Photographs During an Inspection

While the authors are not huge fans of the rock band Def Leppard, its 1983 “Photograph” hit came to mind recently, when we read a recent Warning Letter issued, in part, because of a company’s refusal to allow photographs...more

Arnall Golden Gregory LLP

It Cuts You Up: OPDP Issues an NOV to a Dermatologic Drug Company

Peter Murphy’s 1989 single, “Cuts You Up,” came to mind when we read FDA’s Office of Prescription Drug Promotion’s (“OPDP”) latest Notice of Violation....more

Health Care Compliance Association (HCCA)

In This Month’s E-News: November 2024

On the heels of a $7.6 million payment by Cleveland Clinic to settle allegations of False Claims Act (FCA) violations and unallowable sharing of passwords, Michael Lauer, NIH deputy director for extramural research, penned a...more

Gardner Law

Navigating Government Investigations: A Guide for FDA-Regulated Companies

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Government investigations are an ever-present reality for companies operating in FDA-regulated industries. Whether you're in pharmaceuticals, medical devices, biologics, laboratories, food, cosmetics, veterinary, or cannabis,...more

Gardner Law

Responding to Letters from FDA

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There are several forms of communications FDA may send to signify an issue. FDA may send a company a notice of a violation in the form of a Warning Letter, an Untitled Letter, or an “It Has Come to Our Attention” Letter. Any...more

Husch Blackwell LLP

FDA Issues Stern Reminder for Retailers on Recalls

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Since the fall 2023, the United States has been facing a massive recall of apple cinnamon fruit purees (like apple sauce) due to the presence of elevated levels of lead which caused the product to be considered adulterated...more

Wiley Rein LLP

Wiley Consumer Protection Download (September 17, 2024)

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Welcome to Wiley’s update on recent developments and what’s next in consumer protection at the Consumer Financial Protection Bureau (CFPB) and Federal Trade Commission (FTC). In this newsletter, we analyze recent regulatory...more

Holland & Knight LLP

FDA Warning Letter Marks Significant Shift in Enforcement of Laboratory Developed Tests

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The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more

Kelley Drye & Warren LLP

Attorneys General Support Social Media Warning Labels

42 state attorneys general joined forces in a bipartisan National Association of Attorneys General (NAAG) letter to Congress, backing the United States Surgeon General’s recent call for Congress to require a surgeon general’s...more

DLA Piper

Food and Beverage News and Trends - August 2024

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This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape. FDA rolls out Phase II of long-term sodium reduction plan. FDA has released new,...more

Napoli Shkolnik

The Risks of Unregulated Regenerative Medicine

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A recent New York Times article reported that dozens of spine surgery patients at NewYork-Presbyterian/Weill Cornell Medical Center were treated with a product that was not approved for use in such procedures. Burst...more

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