Communications & Media Consumer Protection Products Liability

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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

Circuit Court Grants Writ of Mandamus Requiring EPA to Act on Petition to Ban Chlorpyrifos

In an opinion issued on August 10, 2015, the U.S. Court of Appeals for the Ninth Circuit granted a writ of mandamus requested by Pesticide Action Network North America and the Natural Resources Defense Council (Petitioners)...more

A Handmade Dismissal for Maker’s Mark

A recent decision from the Southern District of California demonstrates the uphill battle consumer lawsuits face when challenging “handmade” or “handcrafted” labels on alcoholic beverages. On July 27, 2015, in Nowrouzi et...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

District Court Holds That FDCA Does Not Prohibit and Criminalize Truthful Off-Label Promotion of FDA-Approved Prescription Drugs

On August 7, 2015, the U.S. District Court for the Southern District of New York released its Amarin opinion addressing whether truthful, non-misleading off-label promotion of U.S. Food and Drug Administration (FDA)-approved...more

New NAD Decision Addresses Crowdsourced Reviews

The NAD recently determined that Euro-Pro could not support a claim that its Shark vacuum receives “more 5-star online reviews than any other vacuum brand.” To support the claim, Euro-Pro had looked at over 4,000 verified...more

International Food Law Gazette - July 2015

King & Spalding is pleased to provide this first edition of the International Food Law Gazette, a publication of our Food & Beverage Group. For decades, King & Spalding has closely advised leading food, beverage and dietary...more

A Couple of Law Review Articles We Actually Like

The last couple of times we’ve commented on new law review articles, we haven’t liked what we’ve seen very much. We’re gluttons for punishment, however, and this time we were rewarded. We found a couple of recent law review...more

Who’s Watching Dietary Supplement Advertising?  Everybody!

For several years now, dietary supplement advertising has been squarely on the radar of the FTC, state regulators, self-regulators, and last but never least, plaintiff’s lawyers. A recent FTC settlement with the makers of the...more

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