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 -
News & Analysis as of

United States v. Bayer: Preventing or Treating Disease Claims

In recent years, the FTC and the Center for Science in the Public Interest (“CSPI”) seem to have seen disease claims everywhere, regardless of whether the FDA has deemed the same claims appropriate, non-disease...more

Be Careful About What you Claim – Or Fail to Claim – FTC Sends Green Guides Warning Letters

Last week the Federal Trade Commission (FTC) sent warning letters to providers of environmental certification seals, and to businesses using those seals, alerting them to the Commission’s concerns that the seals “could be...more

First Amendment Right to Off-Label Promotion – Has Pandora’s Box Been Opened for FDA?

A handful of recent court decisions, including one issued just last month, seems to have potentially cracked open the door for pharmaceutical manufacturers to have more leeway to promote off-label uses of their products....more

Alert: Key Regulatory Considerations for Digital Health Companies

Digital health is a growing field that promises improved patient education, wellness, engagement, access to care, and outcomes, among other things. However, with these new technologies come unique regulatory concerns that...more

[Webinar] The Digital Health Update: Recent Developments in the Regulation of Medical Devices and Health Apps - Sept. 22nd, 1:00...

Tuesday, September 22, 2015, 1:00 P.M. CST -- Both the FDA and the FTC have been busy this summer. Just this month, both agencies took their strongest actions to date relating to cybersecurity and the regulation of medical...more

Federal Judge in Ohio Accepts Future Competition Theory: Parties Should Proceed with Caution in Deals to Acquire Potential...

The court’s decision in FTC v. Steris demonstrates the importance of conducting a thorough antitrust analysis of all aspects of a merger or acquisition from every possible angle, including likely future competition. On...more

What’s in a Name? When You’re Selling a Food with an Established Federal Standard of Identity, a Whole Lot!

A bluntly labeled section of the Code of Federal Regulations – “Mayonnaise” – provides a description of this particular food dressing, the food’s required ingredients, optional ingredients, and how to declare those...more

FTC Staff Comment Encourages FDA to Reevaluate its Current Approach to Regulating Homeopathic Products

On Friday, staff of the Federal Trade Commission’s Bureau of Consumer Protection, Office of Policy Planning, and Bureau of Economics submitted a written comment to FDA recommending that FDA reconsider its current regulatory...more

FTC Urges FDA to Reconsider Homeopathic Regulatory Framework

In a comment filed last Friday, the Federal Trade Commission (FTC) responded to its sister-agency’s request for comments by urging the Food and Drug Administration (FDA) to reconsider how homeopathic drugs are regulated. As...more

Six Ways for Data-Driven Medical Device Companies to Implement Effective Privacy and Security Measures

The increasing amounts of health information being generated, stored and collected have heightened the special risks medical device manufacturers have long faced. In addition to the nexus to patient health and safety, if a...more

FDA Recalls Kim Kardashian’s Post

Last month, Kim Kardashian praised Diclegis, a drug for morning sickness, on her social media accounts. Since Kim doesn’t follow us on social media, we don’t always keep tabs on her. But when her posts raise regulatory...more

Advertising Law - August 2015 #2

FDA Wants to Pour Some Sugar on the Nutrition Label - Adding to the proposed changes to the Nutrition Facts label—the first tweaks in 20 years—the Food and Drug Administration has suggested yet another: adding the...more

Food Litigation Newsletter - July 2015

THIS NEWSLETTER AIMS to keep those in the food industry up to speed on developments in food labeling and nutritional content litigation. RECENT SIGNIFICANT RULINGS - District Court Dismisses and Stays False...more

First Federal Appellate Court Holds a NonCash Reverse Payment Subject to Antitrust Scrutiny: Is the Third Circuit's Decision in...

Recently, the Third Circuit issued the first federal appellate decision interpreting the Supreme Court's landmark decision in FTC v. Actavis, Inc.[1], potentially greatly expanding the scope of settling parties in reverse...more

Focus on Tax Controversy and Litigation - Supreme Court Decides Maryland v. Wynne and Rules that Maryland Tax Scheme Is...

In This Issue: - Maryland’s Tax Scheme Ruled Unconstitutional - “FTC Generator” Case Update - FSA Rules that Equitable Disgorgement May be Deductible Expense - District Court Upholds Attorney Client...more

All Eyes on Homeopathics: FTC Workshop Signals Targeted Regulatory Scrutiny of Homeopathic Products

On Tuesday, the Federal Trade Commission “FTC” announced it will be hosting a workshop in September to evaluate advertising for over-the-counter homeopathic products. Homeopathy is an alternative medicine practice dating back...more

REMS and Antitrust: Latest Litigation Lessons

Brand name pharmaceutical companies have long stood in the way of generic pharmaceuticals entering the market. To keep generics at bay, brands have used a variety tactics, including ultimately unlawful ones like fraudulently...more

Advertising Law - May 2015 #2

Data Breach Notification, Cyber Sharing Bills Move Forward - As multiple privacy and data security bills wend their way through the legislative process, three proposals have made significant steps forward. ...more

Healthcare Legal News Volume 5 Number 2

According to a recent study by Accenture, by 2017 approximately 18 percent of the American public will purchase insurance through exchanges versus relying on traditional employer healthcare coverage or foregoing insurance...more

Increased FTC Enforcement as FDA Deregulates Low-Risk Health IT Devices

The FTC steps up enforcement of misleading software and mobile app promotional claims as FDA deregulates low-risk health IT devices. In recent weeks, the Federal Trade Commission (FTC) has taken several enforcement...more

While FDA’s Proposed e-Cigarette Rule is Pending, FTC Mulls Enforcement Action

Ahead of finalizing FDA’s tobacco products “deeming” rule, the FTC considers taking enforcement action against e-cigarette firms for violative advertising, marketing, and sales practices....more

Alert: Federal Policy Developments Impacting Medical Technology Companies

Health care is always a major issue in Washington, DC but recently how to promote innovation in medtech has become a priority within that conversation. Thus far, 2015 has produced a major legislative initiative in the form of...more

Long-tail Risk on the Horizon for the Tanning Bed Industry

As the United States continues through a winter that included a historic blizzard in the Northeast, many of us may be longing for summer days spent on the beach, soaking up the sun and working on a tan. A number of people,...more

FDA Draft Guidances on General Wellness Products and Device Accessories Continue Risk-Based Approach to Health IT

On January 20, 2015, the United States Food and Drug Administration (FDA) issued two new draft guidance documents, announcing the agency’s plans not to regulate “general wellness products” (including certain software...more

Product labeling requirements aren't all black and white

Your company has created and developed a new, innovative product. You’ve tested your product, you’ve adopted a new trademark, and you’re ready to begin manufacturing. The remaining steps of preparing your product for sale,...more

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