Labeling

News & Analysis as of

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

The Name Game: Institutional Investors Submit Citizen Petition Regarding Biosimilar Labeling

On November 23, 2015, a group of fifteen institutional investors submitted a citizen petition to the FDA regarding biosimilar labeling (“Investors’ Citizen Petition”). The group includes investors from the public sector and...more

Negotiators Reach Deals on Government Funding, Tax Extenders Legislation

After several long weeks of negotiations on end-of-year obligations, congressional negotiators reached agreements on both a government funding bill that pays for the federal government through the remainder of FY16 as well as...more

Ninth Circuit Does an About-Face in Military Watch Trademark Dispute - Multi Time Machine, Inc. v. Amazon.com, Inc.

The U.S. Court of Appeals for the Ninth Circuit previously found that a jury could potentially find that online retailer Amazon.com created a likelihood of consumer confusion with the format of its product search returns when...more

When Are Jeans Made In The U.S.A.?

A little over 30 years ago, Bruce Springsteen unleashed “Born in the USA”–the rock anthem about disaffected Vietnam veterans struggling as they returned home. Today, clothing manufacturers and their resellers riffing on that...more

WTO COOL Decision puts Congress on the Clock

The World Trade Organization (WTO) issued an arbitration decision in the longstanding Country-of-Origin Labelling (COOL) dispute between Canada, Mexico, and the United States on December 7. The arbitrator determined that...more

Stakeholders Say Biosimilars Names Should Be Meaningful and Memorable

FDA has received comments from more than 170 groups on its proposal for naming biosimilars. Biosimilar makers, insurers and pharmacies largely oppose distinct nonproprietary names (also known as proper names) for...more

EWG Begins Certification Program for Consumer Products

The Environmental Working Group (EWG) announced on October 27, 2015, EWG VERIFIED™, a verification program intended “to give consumers peace of mind at point of sale as they try to avoid toxic and potentially harmful...more

DOJ continues crack down on dietary supplement industry

In October, Life Sciences Decoded described the increased state and federal scrutiny against the dietary supplement industry, including a lawsuit that the Oregon Attorney General filed against GNC. This scrutiny and...more

Warnings Causation Sinks "Failure to Update" Claim

This post is not from the Dechert side of the blog. “Failure to update” claims have multiple problems. You probably already know what we are referring to. Federal law requires that generic drug manufacturers...more

FDA Regulatory and Compliance Monthly Recap — October 2015

FDA releases draft ICH guidance with aim to improve pharmaceutical benefit-risk assessments - The agency released ICH guidance to regulate how pharmaceutical makers should present benefit-risk information in regulatory...more

ANDA Update - October 2015

Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

You Can Check Out Anytime You Want, But You Can Never Leave: FDA Import Detentions and Recommendations to Minimize Delays

In The Eagles’ song, “Hotel California,” Don Henley sings, “You can check out anytime you want, but you can never leave.” Life science companies can try to import all they want, but that doesn’t mean the products will make it...more

FTC Strikes Again—Company Found to Make False and Misleading Biodegradable Claims

On October 20, 2015, the United States Federal Trade Commission (FTC) released a Final Order with a corresponding Opinion against ECM BioFilms, Inc. (ECM) stating that ECM made false and unsubstantiated environmental claims...more

FTC Announces Red Light on Unqualified “Green Approved” Seals

Updated to clarify that this post is not about Green Seal, Inc. but the environmental seals or certifications warned against in a recent FTC update. Manufacturers of consumer products labeled with unspecified environmental...more

US v Bayer: Randomized Clinical Trials not Required for Dietary Supplement Structure Function Claims – Key Takeaways

In a much anticipated opinion for the dietary supplement industry and for products making health benefit statements, the District of New Jersey in US v. Bayer has found in favor of Bayer in holding that the government failed...more

FDA Regulatory and Compliance Monthly Recap — September 2015

Pacira sues FDA, alleging it illegally attempted to restrict truthful and non-misleading speech about its post-surgery pain drug Exparel - The drugmaker filed a First Amendment suit seeking an injunction to prevent the...more

Children's Products and the Consumer Product Safety Improvement Act of 2008: A Synopsis of the Rules and Regulations Governing Toy...

Children's products, including toys, are regulated by the Consumer Product Safety Commission (CPSC) through the Consumer Product Safety Improvement Act of 2008 (CPSIA). Certain sections of CPSIA focus on children's toys....more

Ruling Allows Gerber False Advertising Suit to Crawl Onward

For plaintiffs concerned that the Fourth Circuit Court of Appeals’ June 19, 2015 decision in Brown v. GNC Corp. signaled the muscling in of a stricter new pleading standard for false advertising class actions nationwide, a...more

"The Future of Government Regulation, Enforcement of Off-Label Promotion"

Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...more

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