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Category Archives: Food and Drug

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Ingredient Supplier Settles FTC Charges Related to Sponsored Trial

Posted in Advertising, Federal Trade Commission, Food and Drug
Earlier this week, the FTC announced a settlement with a company that supplies functional ingredients to food and dietary supplement sellers. According to the FTC, the company sponsored “a seriously flawed human clinical trial” on a green coffee ingredient, advertised the results of the study, and through its advertising, provided its customers with the “the means and … Continue Reading

The FTC Has Announced a Weight Loss Settlement … But Wait, Keep Reading

Posted in Advertising, Federal Trade Commission, Food and Drug
That the FTC has announced another weight loss settlement is no news at all.  The FTC averages about six new weight loss orders per year.  The new settlement, nevertheless, is notable as a reminder of the following points. The FTC has the power to impose bans.  The Order against the marketers of Double Shot diet … Continue Reading

FTC Releases a Second Order Requiring Preservation of Records from Clinical Trials

Posted in Advertising, Federal Trade Commission, Food and Drug
The FTC recently announced a settlement with the makers of Nopalea, a fruit drink derived from Nopal or “prickly-pear” cactus. The FTC alleges that the company and two individuals disseminated unsubstantiated claims that Nopalea improves respiration, treats skin conditions, and reduces inflammation and pain, including pain associated with arthritis, fibromyalgia, and other conditions. The company … Continue Reading

FTC’s i-Health Settlement Features Evolving Substantiation and Fencing-In Standards

Posted in Advertising, Federal Trade Commission, Food and Drug
Earlier this week, the FTC announced that supplement marketers i-Health, Inc. and Martek Biosciences Corporation (the Companies) have agreed to settle charges of deceptive advertising for claiming that their BrainStrong Adult dietary supplement will improve adult memory and prevent cognitive decline.  BrainStrong Adult, which is sold at drug stores nationally and advertised online and on … Continue Reading

Is that Flexibility We See in an FTC Order on Disease Claims?

Posted in Advertising, Federal Trade Commission, Food and Drug
On May 28, 2014, the FTC announced a settlement with the company that sells Lice Shield shampoos, leave-in sprays, and products to be applied to head gear.  In the FTC’s view, the company did not possess adequate substantiation for claims that the products will prevent or reduce the risk of head lice.  Without admitting any … Continue Reading

POM Wonderful LLC Raises the Stakes at the D.C. Circuit

Posted in Advertising, Federal Trade Commission, Food and Drug
On May 2, 2014, POM Wonderful LLC (“POM”) argued before the U.S. Court of Appeals for the D.C. Circuit, urging it to overturn a Federal Trade Commission (“FTC”) decision prohibiting POM from making disease-related claims without first having at least two randomized and controlled human clinical trials (“RCTs”) to back them up.  POM argued that … Continue Reading

Why Marketers Should Care about FDA’s OTC Drug Review

Posted in Advertising, FDA
We’re all familiar with the phrase “speak now or forever hold your peace.”  If you develop products that are in commerce pursuant to an OTC drug monograph — such as fluoride toothpastes, facial washes that also treat acne, antiperspirants, cough/cold medicines, or thousands of other products that contain a “drug” — now is the time to speak or, … Continue Reading

Fit To Be Tied? Lessons from the Fitbit Recall

Posted in Advertising, Advertising Litigation, Class Action Litigation, Consumer Product Safety, FDA
The Consumer Product Safety Commission recently announced a recall of the Fitbit Force, a wireless activity-tracking wristband, because of consumer reports of rashes, skin irritation and blistering.  Consumers are directed to stop using the product and it is now illegal to sell or resell the product.  As is increasingly common, announcement of the recall was … Continue Reading

FTC Judgment Adds to Growing Number of Medical Food Regulatory Actions

Posted in Advertising, FDA, Federal Trade Commission
The Federal Trade Commission announced recently that it obtained a $2.2 million judgment against Wellness Support Network, Inc., and its two principals.  The company claimed that its products, Diabetes Pack and Insulin Resistance Pack, could treat diabetes, insulin resistance, and various metabolic disorders.  The FTC alleged that although Wellness Support Network touted their products as … Continue Reading

The Hits Keep on Coming: New “Natural” Settlements and Filings

Posted in Advertising Litigation, Class Action Litigation, Food and Drug
Two more food companies have reached settlements over “natural” claims. In a class action suit against Popchips, Inc., plaintiffs alleged that the maker of Popchips snacks misled consumers by labeling and promoting its product as “natural” when it contained artificial and synthetic ingredients. Popchips denies the allegations, but agreed to establish a $2.4 million fund to … Continue Reading

A Win for Keeps for Lance Armstrong?

Posted in Advertising Litigation, Class Action Litigation, Food and Drug
Shortly after Lance Armstrong admitted to doping during his seven Tour de France wins, a group of plaintiffs filed a class action against both Armstrong and FRS, the maker of over-the-counter energy products. The plaintiffs alleged that FRS and Armstrong, a former FRS endorser, had engaged in false advertising and breach of warranty when they promoted FRS products as Armstrong’s … Continue Reading

Ravioli Trees and Tortellini Bushes: What is Considered a “Natural” Food?

Posted in Advertising Litigation, Food and Drug
A new article published by the Food and Drug Policy Forum “Ravioli Trees and Tortellini Bushes: What Should Courts Expect from the Reasonable Consumer When it Comes to “Natural” Claims?’” discusses how in recent years there have been many consumer class action cases alleging that advertisers are deceptively labeling their products as natural when the … Continue Reading

Audio Conference Event: Tips for Reducing Class Action Litigation Risk following Regulatory Enforcement

Posted in Advertising, Advertising Litigation, Class Action Litigation, Federal Trade Commission, Food and Drug, NAD
The number of consumer class actions filed following regulatory enforcement by the FTC, FDA, or NAD have skyrocketed in recent years.  Consumer products companies – particularly food, dietary supplement, and cosmetic manufacturers – now must consider not just how to respond to a federal or state regulator who is seeking information about their marketing campaign, … Continue Reading

​Drink Maker Settles Over Misleading Ads​

Posted in Advertising, Advertising Litigation, Food and Drug
​Last week, the New York Attorney General announced a settlement with Abbott Laboratories ​over an advertising ​campaign for its Pediasure SideKicks ​drinks. The AG determined that ​the campaign conveyed the misleading impression that children who ​drink SideKicks are more energetic and perform better in sports than children who don’​t ​drink SideKicks. In the ad, a … Continue Reading

Handy Health Tracking Mobile App…Or Regulated Medical Device?

Posted in Federal Trade Commission, Food and Drug, Mobile Marketing, Privacy and Information Security
The use of mobile apps for health purposes has created new questions for users, developers, and regulators regarding the balance between convenience, expanded health care, and public safety. The line between apps that are useful tools for accessing health information and those that are considered medical devices can be unclear but is very important for … Continue Reading

Alabama Supreme Court Holds Brand-Name Drug Manufacturer Liable for Ad Representations Made by Generic Drug Manufacturer

Posted in Advertising, Advertising Litigation, Food and Drug
The Alabama Supreme Court recently held in Wyeth, Inc. v. Weeks, – So.3d –, No. 1101397, 2013 WL 135753 (Ala. Jan. 11, 2013) that a drug company may be held liable for fraud or misrepresentation (by affirmative misrepresentation or omission), based on statements it made in connection with the manufacture and distribution of a brand-name … Continue Reading

Commission Issues Decision In the matter of POM Wonderful LLC

Posted in Advertising, Advertising Litigation, Federal Trade Commission, Food and Drug
On January 16, 2013, the Federal Trade Commission (“Commission”) issued an Opinion In the matter of POM Wonderful LLC upholding in part and overruling in part Chief Administrative Law Judge D. Michael Chappell’s May 2012 initial decision regarding advertising claims for POM Wonderful (“POM”) products. In pertinent part the Commission opinion, issued by Commissioner Maureen … Continue Reading

Federal Court Awards Summary Judgment to Nestlé in False Advertising Class Action Involving Probiotic Supplement

Posted in Advertising, Advertising Litigation, Food and Drug
On July 16, 2012, the United States District Court for the District of New Jersey granted summary judgment in favor of Nestlé Healthcare Nutrition, Inc. in Scheuerman, et al. v. Nestlé Healthcare Nutrition, Inc., No. 2:10-cv-03684 (D.N.J.), a putative nationwide class action challenging Nestlé’s advertising and marketing campaign for its BOOST® Kid Essentials Drink (“BKE”) … Continue Reading

All Sides Appeal Initial Decision in FTC’s POM Wonderful Action

Posted in Advertising, Advertising Litigation, Federal Trade Commission, Food and Drug
We reported on May 23 on Chief Administrative Law Judge Chappell’s initial decision in the FTC’s action against POM Wonderful. On June 4, all parties filed notices of appeal. The FTC staff’s notice states that it is appealing "(1) The failure to find that certain of the challenged advertisements made the claims alleged in the … Continue Reading

Administrative Judge in FTC versus POM Wonderful Lowers the Bar, but POM Still Can’t Clear It

Posted in Advertising, Advertising Litigation, Federal Trade Commission, Food and Drug
On May 17, Chief Administrative Law Judge Michael Chappell issued his Initial Decision in the FTC’s case against POM Wonderful, accusing POM of making unsubstantiated claims that its pomegranate juice and pomegranate extract supplement pills can prevent, treat, cure or mitigate heart disease, prostate cancer, erectile dysfunction, and other medical conditions. The decision found POM, … Continue Reading

Ninth Circuit Pulps POM Wonderful’s Lanham Act Claims Against Coca-Cola, Affirming FDA Preclusion of Challenge to Regulated Food Labeling

Posted in Advertising, Advertising Litigation, Food and Drug
A panel of the Ninth Circuit Court of Appeals ruled May 17 on an appeal from summary judgment in a case filed by pomegranate juice maker POM Wonderful against the Coca-Cola Company’s Minute Maid division. The dispute was over a Minute Maid pomegranate-blueberry juice blend that POM alleged misrepresented itself on its label as containing … Continue Reading

Recent Decision Applies Prior Substantiation Doctrine to Bar False Advertising Claims Based on Lack of Substantiation

Posted in Advertising, Advertising Litigation, Food and Drug
Continuing with the recent trend of dismissing false advertising complaints premised on a "prior substantiation" theory or granting summary judgment to defendants in such cases where the plaintiff fails to demonstrate affirmatively that a challenged advertising statement is false, in Stanley v. Bayer Healthcare, LLC, No. 3:11-cv-00862, 2012 WL 1132920 (S.D. Cal. Apr. 3, 2012), … Continue Reading

Foreign Territory: Dietary Supplement Clinical Trials Conducted Abroad

Posted in Advertising, Federal Trade Commission, Food and Drug
The Federal Trade Commission ("FTC"), in the last couple of years, has made clear that it expects advertisers making strong cause-and-effect claims (e.g., “Lose weight,” “Helps prevent irregularity”) to possess, at a minimum, at least one well-designed and reliable clinical study. Yet, at the same time, FTC staff—those who conduct FTC investigations—have made statements that … Continue Reading

Introducing the Food and Drug Law Access Blog

Posted in Food and Drug
We are proud to announce a new blog from Kelley Drye & Warren LLP:  Food and Drug Law Access. This sister blog to Ad Law Access provides news and commentary concerning food and drug law and public policy developments, including legislative, regulatory, enforcement, and case law developments relating to the federal laws administered by the FDA, … Continue Reading