Communications & Media Consumer Protection Products Liability

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Retail and Consumer Products Law Roundup - January 2016

Eye on the Courts: IP Cases for Retailers to Note - Why it matters - Retail companies have closely monitored a series of cases from the U.S. Supreme Court on down, which have focused on IP matters covering induced...more

FDA Extends Comment Period on “Natural” Food Labeling by 90 Days

In November we reported that the federal Food and Drug Administration (FDA) announced that it was seeking public comments on the use of the term “natural” on food labeling, including foods that are genetically engineered or...more

Off-Label Promotion and Product Liability: Are Industry’s Recent Court Wins in One Space a Win in the Other?

The pharmaceutical industry has recently felt empowered and emboldened by recent litigation that would seemingly allow companies to distribute, proactively, information about unapproved uses, i.e., off-label, so long as the...more

California Recognizes State Claim for Foods Mislabeled as “Organic”

On December 3, 2015, the California Supreme Court held that a claim for intentionally mislabeling produce as “organic” is not preempted by the federal regulatory regime for certifying organic growers. Quesada v. Herb Thyme...more

Breaking News - FDA Generic Drug Anti-Preemption Proposal Again

We just read on 360 this morning that the FDA has again postponed its schedule for finalizing the generic drug labeling changes (the so-called "Supplemental Applications Proposing Labeling Changes for Approved Drugs and...more

New Draft Prop. 65 Warning Regulations: What Manufacturers and Suppliers Need to Know

On November 24, 2015, the Office of Environmental Health Hazard Assessment (“OEHHA”) issued proposed revisions to its January 15, 2015 draft Prop. 65 warning regulations. 27 CCR §§25600 et seq. The full text of the new draft...more

Avoiding the risks associated with ambiguous marketing claims

Your business likely has a designated team responsible for developing memorable and informative marketing materials. But does that team include someone who can objectively review your materials to identify the risks...more

Tommie Copper Hurts While the FTC Finds Relief

Tommie Copper advertised its copper-infused compression garments with the slogan: “Life Hurts. Find Relief.” Now, the company is itself hurting, after the FTC announced a settlement that requires it to pay over $1 million in...more

Keeping it Legal: Managing FDA Compliance for Consumer-Generated Content

Social technology platforms allow manufacturers to leverage consumer-generated content about their products (“CGC”) more easily than ever before. Such CGC generally takes the form of written testimonials and product reviews...more

FDA Proposes Gluten-Free Labeling Standards for Fermented and Hydrolyzed Foods

On November 18, 2015, the FDA issued a proposed rule to set standards for making a “gluten-free” claim for foods that are fermented, hydrolyzed, or distilled, or that otherwise contain fermented or hydrolyzed ingredients....more

New FDA Guidance Doubles-Down on 1980 Fortification Policy and Potential Misbranding Risks of “Inappropriate Fortification”

FDA recently released its Guidance for Industry: Questions and Answers on FDA’s Fortification Policy (Guidance) to “clarify the existing policy” in response to questions FDA has received from the food industry, other federal...more

FDA Issues Final Food Biotechnology Labeling Guidelines for Plant Foods; Discourages “GMO Free” Claims

On November 19, 2015, FDA issued its final guidance for industry concerning the requirements for voluntarily indicating whether food products have or have not been derived from genetically engineered plants. The final...more

FDA Seeks Comments on the Meaning of “Natural”

On November 12, 2015, the U.S. Food and Drug Administration (FDA) requested comment on the use of the term "natural" in the labeling of human food products. The notice states that it is establishing "a docket to receive...more

Weight-Loss Claims: How Many Studies Does the FTC Really Think It Takes?

On Tuesday, the FTC announced that it has sent warning letters to 20 marketers of weight-loss dietary supplements. The letters question whether the companies possess adequate support for claims and describe the scientific...more

The FDA Gets Pulled Into the "Natural" Labeling Fray: Surprise Move May Change the Food Fight

In a surprising change of tack, the U.S. Food and Drug Administration (FDA) announced Tuesday that it will accept public comments on the use of "natural" claims on food labels. The move, which may signal FDA's intention to...more

FDA’s Comment Period for “Natural” Food Labels Is Now Open

FDA took long-awaited and much-anticipated steps this week to address the requests of both consumers and food manufacturers and producers for guidance and regulation on use of the term “natural.” For years now, consumer...more

FDA Requests Public Comment on "Natural" Food Labels

The U.S. Food and Drug Administration this week issued a request for public comment on the use of the term "natural" in the labeling of food products. This represents the first time in 22 years that the FDA has indicated an...more

South Korean companies: progress with risk in the United States - South Korea: Building for the future

South Korean companies have made great strides in the US consumer product market, yet they must be more proactive in preventing US class action lawsuits. South Korean companies have progressively exposed themselves to...more

FDA Requests Public Comment on How “Natural” Claims Should be Regulated; Opening 90-Day Comment Period

FDA is requesting public comment on how “natural” claims should be regulated. The 90-day public comment period will open on November 12, 2015, when the FDA notice is published in the Federal Register. In particular, FDA...more

FDA Requests Comments on Use of Term "Natural" on Food Labeling

After years of litigation and controversy around use of the term "natural" on food labels, the U.S. Food and Drug Administration (FDA) is now seeking comments on the issue. This action has important implications for companies...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

VW Group – A Storm in a Teacup?

We've all seen a lot of media coverage about the 1.2 million Volkswagen/Audi/Seat/Skoda vehicles sold in the United Kingdom that are fitted with "defeat" software and the storm clouds are brewing. But the reality is that...more

California Federal Court Is Unpersuaded By A Recent Fourth Circuit False Advertising Decision In Reconsidering Its Ruling On A...

The Honorable John A. Kronstadt for United States Federal District for the Central District of California, denied a Defendant’s motion to reconsider his previous ruling on a motion to dismiss based upon a subsequent Fourth...more

Lands’ End Requests Dismissal of “Made in U.S.A.” Class Action After Reimbursing Plaintiff

Last week, Lands’ End tried a second time to dismiss a “Made in U.S.A.” class action with the novel argument that, because the company had already reimbursed the plaintiff for the necktie she purchased, she is not injured and...more

Another Major Earthquake: California Creates Big Fissures in Proposition 65 Regulations – Proposals Could Shatter Defenses

In the midst of making Proposition 65’s longstanding warning regulations far more onerous, and vexatious litigation far more likely, California’s Office of Environmental Health Hazard Assessment (OEHHA) has unveiled still...more

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