Labeling

News & Analysis as of

Stick a Fork in It – FDA Anti-Generic Drug Preemption Proposal Postponed Until After the Presidential Election

On May 18, the FDA extended the comment period for its proposed generic drug labeling rule until April 2017 – that is, until after the next presidential election. We believe that, for all practical purposes, this means that...more

No Common Sense – Today’s Cost of Doing Business

What is a retailer to do? The world today is filled with people assuming they are being disrespected and believing they are being defrauded. It’s not just that some customers can be surly and demanding when they are in your...more

FDA Issues Interim Response to UAW’s Citizen Petition on Biosimilar Labeling

As we previously reported, UAW Retiree Medical Benefits Trust and affiliated funds filed a Citizen Petition on November 2, 2015 asking FDA to adopt a “same labeling” approach for biosimilar labeling. On May 19, 2016, FDA...more

FDA Releases (an Updated) Guidance on Medical Foods: What They Are, And What They Are Not

The Food and Drug Administration recently released its Second Edition of its “Guidance for Industry: Frequently Asked Questions About Medical Foods.” The newer version updates previous guidance and provides responses to...more

Labeling and Pedigree Requirements of the Drug Supply Chain Security Act

Counterfeit and adulterated prescription drugs in the supply distribution chain pose a significant risk to patient safety. On November 27, 2013, President Obama enacted the Drug Supply Chain Security Act (DSCSA), which amends...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

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

Advertising with Environmental Certifications and "Green" Seals of Approval

As consumer demand for eco-friendly, non-toxic, and sustainably-sourced products continues to rise, so does the use of environmental certifications on packaging and advertisements for virtually every kind of consumer product,...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 Asks – Are Your “All Natural” Claims All Accurate?

Companies that make “all natural” claims for their products may come under FTC scrutiny and enforcement. The Federal Trade Commission announced five cases this week with companies that market their products as “all...more

FDA Issues Draft Guidance on Labeling For Biosimilar Products

The federal Food and Drug Administration (“FDA”) recently published a draft guidance on labeling for biosimilar products that is intended to assist applicants in developing draft labeling for proposed biosimilar products....more

FDA Biosimilars Guidance Not Conducive To Preemption

The FDA recently released draft guidance concerning the labeling of biosimilar products (analogous in the biologic context to generic drugs). It’s called, not surprisingly “Labeling for Biosimilar Products Guidance for...more

FCC Releases Open Internet Transparency/Disclosure Rule Safe Harbor in the Form of Broadband Service “Labels” for End User...

The FCC has released its safe harbor disclosure framework under the Open Internet transparency requirements for end user customer disclosures, which take the form of a broadband “label” –not unlike the form of labels used by...more

California District Court Unplugs Duracell False Advertising Suit

Recently, Judge Lucy H. Koh of the Northern District of California dismissed a putative class action claiming that Procter & Gamble and Gillette deceptively advertised Duracell Coppertop AA and AAA batteries. Defendants...more

FDA Differentiates Biosimilar Labeling from Generic Drug Labeling

In another highly anticipated regulatory move, FDA has released draft guidance on “Labeling for Biosimilar Products.” Made public on March 31st, the draft guidance sets forth FDA’s recommendations on the labeling of...more

Federal Preemption Claims: Clear Evidence and an Unclear Standard

Last week, a federal court in Utah granted Aventis Inc.’s motion for summary judgment based on federal preemption of failure-to-warn claims. Cerveny v. Aventis, Inc., 2016 U.S. Dist. LEXIS 34182 (D. Utah Mar. 16, 2016). The...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On March 29, 2016, Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, “Medicaid and Children’s Health Insurance Programs: Mental Health Parity and...more

FDA and Amarin Pharma Reach Milestone Settlement Allowing Off-Label Drug Promotion

A milestone Settlement Agreement was reached March 8, 2016 between the Food and Drug Administration and Amarin Pharma, Inc. that expressly allows Amarin to promote its drug product, Vascepa®, for unapproved – i.e.,...more

New Labeling Requirements and Production Standards Apply to All Alcoholic Beverages Imported, Manufactured, and Sold in Mexico

Executive Summary - In response to the growing issue of alcohol abuse in Mexico and the related health problems associated with alcohol abuse, the Mexican government implemented revised labeling requirements and...more

Schumer Alleges False “Made in America” Representations on GSA Website: False Claims Act Inquiry to Follow?

Sen. Charles Schumer recently alleged, in a letter to the General Services Administration (GSA), and in an associated press release, that the U.S.Government’s policy of purchasing American-made products is being thwarted by...more

An Honest Struggle to Advertise "Natural" Products

On February 12, 2016, two consumers brought a proposed New York state class action lawsuit against The Honest Company, Inc., a personal care products company co-founded by actress Jessica Alba. The lawsuit alleges that The...more

FDA outrages critics over sneaky rule change on drugs, medical devices

It’s a short paragraph, fine-print tucked in a 10,000-word document on tobacco product regulations. But these 245 words (see Intended Use Regulations, ? 201.128) have lit up critics of the U.S. Food and Drug Administration....more

FDA Unveils Action Plan to Combat Opioid Abuse

The U.S. Food and Drug Administration (“FDA”) recently announced a “far-reaching action plan” to evaluate and improve the agency’s prescription opioid policies. The announcement came amidst public criticism and mounting...more

China's “RoHS 2” Regulation: What Manufacturers Must Know

After years of deliberation and industry anticipation, China’s Ministry of Industry and Information Technology (“MIIT”) promulgated the “RoHS 2” regulation on January 21, 2016, with the formal (translated) title “Management...more

226 Results
|
View per page
Page: of 10
JD Supra Readers' Choice 2016 Awards

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×