Labeling

News & Analysis as of

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FDA Issues Draft Guidance on Labeling For Biosimilar Products

The federal Food and Drug Administration (“FDA”) recently published a draft guidance on labeling for biosimilar products that is intended to assist applicants in developing draft labeling for proposed biosimilar products....more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The FDA recently released draft guidance concerning the labeling of biosimilar products (analogous in the biologic context to generic drugs).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

J Brand Hit with California Putative Class Action Suit Alleging False Origin Claim

A proposed class action suit against J Brand, an industry leader in the fashion world that sells its jeans and apparel to countless retailers, was recently filed in California over alleged false origin claims. At the center...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

Pecking A Blow For Chicken Preemption

It may have been our limited caffeine intake to that point in the day, but, when Bexis asked us to do a post on a case about representations about chicken, our initial thought was of some of the songs sung a la chicken. When...more

Children's Products: An Analysis of Small Parts Regulation and Choking Hazards

The Consumer Product Safety Commission (CPSC), through the Consumer Product Safety Improvement Act (CPSIA) and other federal regulations, has established specific requirements for the manufacture and sale of all children's...more

Generators of Regulated Medical Waste in New Jersey Must Meet Federal Standards After Preemptions

Generators of regulated medical waste (RMW) in New Jersey may need to revise their handling, marking and storage practices and procedures to meet federal hazardous materials requirements (49 CFR parts 171-180) (the federal...more

EPA Codifies New Changes to FIFRA Minimum Risk Pesticide Requirements

On December 28, 2015, the U.S. Environmental Protection Agency (EPA) finalized important changes to the “minimum risk” pesticide exemption under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)....more

EPA Revises Minimum Risk Pesticide Exemption Regulations

The final rule revising the U.S. Environmental Protection Agency (EPA) regulations governing the minimum risk pesticide exemption from pesticide registration requirements was published in the Federal Register on December 28,...more

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