Warning Letters

News & Analysis as of

FDA Is Cold As Ice As It Steps Up Foreign Inspection Enforcement

So far, in 2017, the Food and Drug Administration’s Office of Manufacturing Quality in the Center for Drug Evaluation and Research has released fourteen Warning Letters. Of these, 100% involved manufacturing facilities...more

“Final warning” on Air pollution from the European Commission

On 15 February 2017, the European Commission (the Commission) sent final warnings (a Reasoned Opinion) to France, Germany, Italy, Spain and the United Kingdom for failing to comply with the air pollution limits for nitrogen...more

FDA Enforcement Activities Update for FY 2016: CDRH Warning Letters Fall to 8-Year Low

The Food and Drug Administration (FDA) recently released statitistics regarding its enforcement actvities for FY 2016. Of note, the number of warning letters issued by the Center for Devices and Radiological Health (CDRH),...more

Anyone Can Enter Into a Quality Agreement, It's the Hold: FDA Issues a Warning Letter Referencing Lack of Quality Oversight

Many of us remember the classic comedy bit on the Seinfeld television show where Jerry was unable to secure the rental car for which he had made a reservation. He tells the agent: See, you know how to ‘take’ the...more

Happy Holidays from FDA: The Agency Issues Four Enforcement Letters for Unlawful Promotion

The Food and Drug Administration recently issued holiday gifts, in the form of enforcement letters, to four pharmaceutical companies. The letters are reminders that FDA is not in a partying mood when it comes to unlawful...more

Words Matter: Product Claims Can Trigger Regulatory Application And Corrective Action

Most of us understand that the facts that give rise to the legal issues we face are sometimes sewn far in advance. This is certainly true in the area of product claims or statements. ...more

Mortgage Lenders Receive Wake Up Call from CFPB

Last week, the CFPB issued a warning letter to 44 mortgage lenders and brokers concerning possible violations related to their collection and reporting of mortgage data under the Home Mortgage Disclosure Act (HMDA) and...more

What’s in a Name? Looming Food Identity Issues…

Chase Purdy at Quartz recently published an article with the following headline: “To lure people put off by the freakiness of lab-made meat, this is what the industry wants to call it.” It got me thinking about the importance...more

AGG Food and Drug Newsletter - October 2016

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

What a Difference a Claim Can Make: FDA Issues a Warning Letter for Unlawful Medical Device Promotion

Much has been written, including by us, about the Food and Drug Administration’s enforcement approach (or lack thereof) concerning off-label promotion. However, FDA has not curled itself up into a ball, abdicating its...more

Don’t Come Around Here No More: A Drug Company Receives a Warning Letter for Limiting Inspection

In the “what were they thinking department,” a drug company located outside of the United States recently received a Warning Letter for limiting and refusing an FDA inspection. In addition, the agency placed the company on an...more

The Digital Download - Alston & Bird’s Privacy & Data Security Newsletter – August 2016

General Data Protection Regulation (GDPR) Published, Commencing Two-Year Countdown to Application. One of the most important EU legislative initiatives in recent years, and a landmark in privacy regulation worldwide, the GDPR...more

You Wear It Well (or Do You?): FDA Objects To These Skincare Companies’ Unapproved New Drug Claims

In the 1972 hit, “You Wear it Well,” Rod Stewart sang about a woman and offered the classic line, “Madame Onassis got nothing on you.” The tune came to mind when reading four Warning Letters issued by the Food and Drug...more

FTC Sends Warning Letters to Companies Making Zika Virus-Protection Claims

Last Friday, the Federal Trade Commission (“FTC”) sent warning letters to ten online marketers that were making Zika virus-protection claims. The Center for Disease Control believes that the Zika virus is spread primarily...more

Avoiding the Road to Ruin in Your Road To Rio Marketing Blitz

Late last month, the United States Olympic Committee (the “USOC”) sent a few not so nice warning letters to brands that sponsor athletes, but chose not to pay the “golden” price of becoming an “official” sponsor of the games....more

FTC Issues Warning Letters to 28 Companies Claiming Participation in the APEC CBPR System

On July 14, 2016, the Federal Trade Commission (FTC) announced that it had issued warning letters to 28 companies regarding their claim of participation in the Asia Pacific Economic Cooperation Cross Border Privacy Rule (APEC...more

The First Cut is the Deepest: FDA Issues a Warning Letter to a Skincare Company for Marketing Unapproved New Drugs

The Food and Drug Administration recently issued a Warning Letter to a skincare company for promoting and selling unapproved new drugs. While the letter itself is not unusual in content, the enforcement action continues a...more

Advertising Law - June 2016

First Circuit Affirms Ruling Against Jerk.com - In a victory for the Federal Trade Commission, the First Circuit Court of Appeals affirmed a Commission ruling that website Jerk.com, a self-described reputation management...more

Pharmaceutical Company Reaches Preliminary Agreement in Principle to Resolve DOJ and SEC Investigations

So On May 12, 2016, Aegerion Pharmaceuticals, Inc., announced that it has reached “preliminary agreements in principle” with the Department of Justice (DOJ) and the Securities and Exchange Commission (SEC) to resolve the...more

CMA warns UK estate agents against colluding in online portal selection

On 21 April 2016, the Competition and Markets Authority (“CMA”) published an open letter to estate agents in the UK stressing the importance of making independent commercial decisions and warning them against unlawful...more

FDA Revisits Nutty Definition of “Healthy” Food

On May 10, the Food and Drug Administration announced it will be reevaluating how it defines “healthy” food. The move constitutes a reversal of an FDA warning letter issued in March 2015 to Kind, LLC, accusing the snack bar...more

Move over GNC: Crackdown on dietary supplement makers continues

In the fourth quarter of 2015, the dietary supplement industry was reminded that the Department of Justice (DOJ) and the federal Food and Drug Administration (FDA) were watching. This reminder came on the heels of the DOJ...more

FDA to Chew Over Meaning of “Healthy”

Although “healthy” might sound like a subjective term, FDA has long-defined “healthy” under nutrient content claim regulations. For example, to be “healthy” an item must be low in fat and saturated fat. Many stakeholders and...more

The Writing's on the Wall: Wise Pharma Companies Will Heed FDA Warning in New Draft Guidance on Data Integrity cGMPs

FDA is again shining a spotlight on data integrity violations, announcing in a new draft Guidance for Industry: Data Integrity and Compliance with CGMP that it was “troubl[ed]” by the growing number of such violations that...more

Seeing Double . . . or More: FTC Sends over 50 Warning Letters to Contact Lens Prescribers and Sellers

The FTC recently sent over 50 warning letters to contact lens prescribers and sellers warning them that they may be in violation of the Fairness to Contact Lens Consumer Act, 15 U.S.C. § 7601 et seq., and the Contact Lens...more

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