News & Analysis as of

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

FTC Green Guides: FTC Sends Warning Letters Concerning Environmental Certification Seals

The Federal Trade Commission (FTC) announced in a September 14, 2015, press release, "FTC Sends Warning Letters about Green Certification Seals," that it sent warning letters to five providers of environmental certification...more

Arizona Supreme Court Poised to Consider “Learned Intermediary” Doctrine

The Arizona Supreme Court will soon decide whether to grant or deny review of the Court of Appeals’ January 2015 decision regarding the longstanding “learned intermediary” doctrine. In January, the lower court held that the...more

Senators to Receive Update on Biosimilar Implementation from CDER’s Woodcock

On September 17, 2015, members of the Senate Health, Education, Labor & Pensions (HELP) Committee will have an opportunity to hear from and question Dr. Janet Woodock, the director of FDA’s Center for Drug Evaluation and...more

Advertising Law - September 2015

Third Circuit Affirms FTC's Power to Regulate Data Security Practices - Affirming the power of the Federal Trade Commission to regulate corporate cybersecurity, the Third Circuit Court of Appeals held that the agency may...more

ACA Menu Labeling Requirements: Draft FDA Guidance

The FDA’s 105-page final rule on chain restaurant nutrition labeling of menu items now has an associated, 53-page, draft guidance document, supplementing the FDA’s 132-page Food Labeling Guide, we learned from the September...more

Mandatory GMO Labeling Quashed Under House Bill

In late July, the U.S. House of Representatives passed the Safe and Accurate Food Labeling Act. The controversial legislation, as passed by the House, creates a national voluntary standard for the labeling of foods with GMO...more

Governor Brown signs bill returning California to mainstream on “Made in USA” labeling and providing a potential avenue to end...

A bill signed last week by California Governor Jerry Brown gives manufacturers and retailers a good argument that pending litigation over “Made in USA” labeling should be dead in its tracks. That is the key takeaway from the...more

California Relaxes Its “Made in the U.S.A.” Law

To the consternation of many, California law has long imposed a “Made in the U.S.A.” standard that has been more stringent than the federal standard, requiring manufacturers of all types who wanted to make a country of origin...more

California Joins rest of Country in “Made in USA” Rules

California, the beacon of individualism and often marching to its own set of rules, has joined the rest of the country as Gov. Jerry Brown has signed SB 633 which revises California’s take on what constitutes “Made in USA”....more

Eli Lilly and Company v. Teva Parenteral Medicines, Inc. (S.D. Ind. 2015) - District Court Finds Lilly Patent Infringed Based on...

Last week, in Eli Lilly and Company v. Teva Parenteral Medicines, Inc., Judge Tanya Walton Pratt of the U.S. District Court for the Southern District of Indiana determined that Eli Lilly and Company had shown by a...more

District Court Grants Summary Judgment of No Damages for Failure to Mark

Plaintiff Juno Manufacturing, LLC ("Plaintiff" or "Juno") filed a patent infringement complaint against Defendant Nora Lighting, Inc. ("Defendant" or "Nora"). The complaint alleged that Defendant infringed Plaintiff's patent,...more

The Name Game Continues: AbbVie Files Supplemental Citizen Petition Raising Additional Concerns Regarding Biosimilar Labeling

AbbVie previously filed a citizen petition to the FDA arguing against its interim labeling requirements for biosimilars under the Biologics Price Competition and Innovation Act (“BPCIA”). In its supplemental petition, AbbVie...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

Summary of California Appellate Decisions -August 2015

Insurance; Duty To Defend; Insurance Coverage; Intentional Acts; Sexual Misconduct - Gonzalez v. Fire Insurance Exchange (2015) 234 Cal.App.4th 1220, 184 Cal.Rptr.3d 394 (WL 960927) - Facts: This is an...more

Arsenic In Calif. Wine, But Is There A Problem?

A class action was filed in California Superior Court on March 19, 2015, Doris Charles et al. v. The Wine Group Inc. et al., case no. BC576061, that has raised a number of questions about the extent to which arsenic should be...more

D.C. Circuit Reaffirms Previous Conflict Minerals Decision: Disclosure Requirement Violates First Amendment

In a 2-1 decision, a three-judge panel from the U.S. Court of Appeals for the D.C. Circuit reaffirmed its previous decision striking down a narrow portion of the U.S. Securities and Exchange Commission’s (“SEC”) conflict...more

Animal supplements still in limbo, facing increased FDA scrutiny

The thousands of food, agriculture and life sciences companies regulated by the federal government already face a barrage of complicated regulations. Add in significant regulatory uncertainty and a major reorganization of the...more

Guest Post - Impossibility Preemption for Innovator Drug Manufacturers: Where Are We Now?

Today we have a guest post (her second - she's a glutton for punishment) from fellow Reed Smith associate Danielle Devens. This one brings together recent precedent recognizing post-Levine preemption in cases involving...more

Putting A Lotion Claim In The Primary Jurisdiction Basket

When Jame Gumb urged his captive to put lotion on her skin, he was not concerned with improving its firmness. While Buffalo Bill from "Silence of the Lambs" may not be who most would think about when reading Franz v....more

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