The United States Food and Drug Administration Federal Trade Commission

The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the... more +
The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the passage of the 1906 Pure Food and Drugs Act. The agency is charged with protecting the integrity of the nation's food supply and cosmetic products, as well as monitoring the safety and efficacy of drugs, medical devices, and biological products.  less -
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Food and Beverage Law Update: August 2016

When food and beverage companies think of their largest risks, data breaches have not historically come to mind, but this is changing because of reports in the past few months of major breaches by companies such as Noodles &...more

Health Update - July 2016

The Vulnerability of Healthcare Information - According to a report the Brookings Institute issued in May 2016, 23% of all data breaches occur in the healthcare industry. Nearly 90% of healthcare organizations had some...more

Lowered Risk for Inventors Who Use Contract Product Development or Manufacturing

On July 11, in The Medicines Company v. Hospira, Inc., the Federal Circuit held that a contract manufacturer's sale of manufacturing services to an inventor did not constitute a commercial sale of the patented invention for...more

Senate Judiciary Introduces CREATES Act To Expedite Access To Affordable Drugs

Following months of public outcry and Congressional probes into significant drug price increases, the Senate Judiciary Committee introduced legislation targeting “behavior that blocks competition and delays the creation of...more

Recent Court Cases Interpreting “Reverse Payments” Post-Actavis

Patent settlement agreements were traditionally deemed outside the purview of antitrust scrutiny unless the patent holder’s conduct fell outside the legitimate scope of the patent’s exclusionary power. This all changed when...more

Can Plaintiffs Sue a “Celebrity Spokesperson”?

We’ve thought a lot about the various secondary entities that plaintiffs sometimes sue in prescription medical product liability litigation – such as sales reps, physicians, hospitals, pharmacies, distributors, and a number...more

FTC Maintains Aggressive Stance Against Pay-for-Delay Deals

A recent complaint filed by the Federal Trade Commission (FTC) indicates that the agency is continuing its aggressive pursuit of agreements between drug manufacturers that delay the entry of generic pharmaceuticals into the...more

What You Need to Know About U.S. Law: Product Regulations and Importing into the United States - What You Don't Know CAN Hurt You...

What do the Federal Trade Commission (FTC), Consumer Product Safety Commission (CPSC), Federal Drug Administration (FDA), Department of Agriculture (USDA), and Environmental Protection Agency (EPA) have in common? Each is, of...more

Food and Beverage News and Trends Series - May 2016

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. FDA finalizes rule to combat antimicrobial resistance. The FDA this week...more

FTC Targets “All Natural” and “100% Natural” Claims on Personal Care Products

As we have previously reported, FDA is currently seeking public comments on the use of the term “natural” on food labeling. The announcement came as a surprise since FDA had previously declined requests from consumers, the...more

When Customer Supply Contracts Lead to Trouble: Exclusive Dealing Provisions Result in FTC Monopolization Action against Invibio

The Federal Trade Commission (FTC) continues to aggressively enforce the antitrust laws. On April 27, 2016, the FTC took action against Victrex, plc and its wholly owned subsidiaries, Invibio, Inc. and Invibio Limited...more

Update on Recent FTC Enforcement Actions Against Cosmetic Companies

On April 12th, the FTC announced proposed settlements and orders with four companies: Trans-India Products, Erickson Marketing Group, ABS Consumer Products and Beyond Coastal. The FTC issued an administrative complaint...more

Wave of the Future: Government Releases New Tool to Aid Medical App Developers Comply with HIPAA

This month, the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), the Office of the National Coordinator for Health Information Technology (ONC), and the Federal Trade Commission (FTC)...more

Mobile App Compliance for Dummies: New Tool Helps Developers Understand Their Legal Compliance Requirements

In a joint effort by the Federal Trade Commission (FTC), Office for Civil Rights (OCR), HHS Office of National Coordinator for Health Information Technology (ONC), and Food and Drug Administration (FDA), a new web-based tool...more

AGG Food and Drug Newsletter - April 2016

Arnall Golden Gregory LLP's (AGG) 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...more

Product Regulations: What You Don't Know Can Hurt You - and Could Destroy Your Business

What do the Federal Trade Commission (FTC), Consumer Product Safety Commission (CPSC), Federal Drug Administration (FDA), Department of Agriculture (USDA), and Environmental Protection Agency (EPA) have in common? Each is, of...more

When Is Natural Unnatural? When It’s Not: The Federal Trade Commission Takes Exception to “All Natural” Claims

In the 1975 song, “Natural Mystic,” legend Bob Marley sang “There’s a natural mystic blowing through the air – I won’t tell no lie.” Channeling Marley, the Federal Trade Commission recently took enforcement action against...more

FTC Creates Web-Based Tool for Mobile Health App Developers

The new interactive tool highlights the relevant federal regulatory schemes, but the high-level analysis may limit its value to mobile health app developers....more

Federal Agencies Provide User-Friendly Guidance on Compliance with Data Privacy Laws

How federal privacy laws apply to mobile health applications has been an area of significant ambiguity. Recently, the Federal Trade Commission’s (FTC), the U.S. Department of Health and Human Services (HHS) Office of Civil...more

Federal Trade Commission Releases New Mobile Health Apps Interactive Tool

The Federal Trade Commission (FTC) in conjunction with the Office for Civil Rights (OCR), the HHS Office of National Coordinator for Health Information Technology, and the Food and Drug Administration, have developed a new...more

FTC’s “All Natural” Cases Are More About “All” Than “Natural”

The Federal Trade Commission announced last week filing of four consent decrees and an administrative complaint relating to companies selling various personal care products – shampoos, sunscreens, moisturizers – featuring...more

FTC Releases Tool And Best Practices For Mobile Health App Developers

On April 5, the Federal Trade Commission (“FTC”) announced that it had created a web-based tool designed to assist developers of health-related mobile apps identify and understand what federal laws and regulations might apply...more

A New Tool for Health App Developers to Navigate a Crowded Regulatory Field

As regulators seek to define their authority and the scope of their enforcement power, more health apps will continue to flood the marketplace and transform how patients are treated. As mobile health applications...more

FTC Releases Mobile Health Apps Interactive Tool

Consider this: A 42-year-old man arrives at the emergency room showing signs of a heart attack. The ER doctors, using the patient’s activity tracker—in this case, a Fitbit® —are able to pinpoint when the patient’s normal...more

“Multi-Agency Interactive Tool” Available for Developers of Health Apps

It seems as though 2016 may become the year that industry receives a plethora of helpful interactive portals from Federal Agencies. My colleague Matt Cohen recently reported on the existence of a new CPSC tool called The...more

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