Tag Archives: Food and Drug

Eggs-aggeration: Goop Settles With California District Attorneys Over Misleading Health Claims

The California Food, Drug, and Medical Device Task Force announced a settlement this week with Goop, the lifestyle brand founded by Gwyneth Paltrow, which we’ve written about here and here. The complaint alleges that Goop made false and misleading representations regarding the effects or attributes of three products—the Jade Egg, Rose Quartz Egg, and Inner … Continue Reading

FTC Cries Foul On Breathometer Accuracy Claims

The FTC recently announced a settlement with Breathometer, Inc., a company that marketed a smartphone accessory that it claimed could detect blood alcohol levels.  Users could simply plug the accessory into the headphone jack, open the Breathometer app, blow, and receive a reading of their blood alcohol content within five seconds.  Breathometer marketed the products … Continue Reading

FTC Settles with Health App Marketers for Unsubstantiated Melanoma Detection Claims

The Federal Trade Commission announced this week that it has reached settlements with two marketers for “deceptively claiming their mobile apps could detect melanoma, even in its early stages.” MelApp and Mole Detective claim to have the ability to accurately screen for a mole’s analyzed melanoma risk despite the absence of clinical testing. The FTC … Continue Reading

Handy Health Tracking Mobile App…Or Regulated Medical Device?

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

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

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

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

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

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

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

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

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

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

A Look Back at FDA’s Scrutiny of Personal Care Products in 2011

Our new sister blog, Food and Drug Law Access, posted an informative article, "FDA’s Scrutiny of Personal Care Products in 2011," from HAPPI — the Household and Personal Products Industry magazine. It is often said that “beauty lies in the eye of the beholder.” A review of Food & Drug Administration (FDA) enforcement activity in … Continue Reading

USDA Issues Draft Guidance Regarding the National Organic Program

On February 3, 2012, the U.S. Department of Agriculture’s (“USDA”) Agriculture Marketing Service (“AMS”) published draft guidance clarifying how exemptions and exclusions from certification as a producer or handler of organic food products apply to handling operations. Under USDA regulations governing the production and handling of products labeled as “100 percent organic,” “organic,” or “made … Continue Reading

US, Canada Reach Agreement on Organic Ruminant Stocking Rates

The Agriculture Marketing Service of the United States Department of Agriculture announced an agreement reached with Canada’s Food Inspection Agency that will provide U.S. organic dairy, beef, sheep, goat and bison producers with more streamlined access to the Canadian market. Canada now considers U.S. organic requirements for access to pasture and living conditions to be … Continue Reading

New USDA Final Rule Raises Nutrition Quality Standards for Meals Served at School

On January 25, 2012, the Food Nutrition Service of the U.S. Department of Agriculture (“USDA”) issued a final rule that substantially modifies the menu planning and nutrition requirements for the National School Lunch Program and the School Breakfast Program. The rule, which is intended to improve the dietary habits of school children in grades K-12 … Continue Reading

Fourth Circuit Clarifies Scope of Federal Preemption for Requirements Governing Medical Devices

The United States Court of Appeals for the Fourth Circuit recently affirmed a West Virginia federal district court’s holding that a plaintiff’s common law tort claim was preempted by the 1976 Medical Device Amendments (“MDA”) to the Food, Drug, and Cosmetic Act (“FDCA”). Under the MDA, certain medical devices, known as Class III devices, are … Continue Reading

Supreme Court Unanimously Holds California Law Prohibiting Sale, Processing or Holding of Nonambulatory Pigs Expressly Preempted under the Federal Meat Inspection Act

In a unanimous opinion published on January 23, 2012, the Supreme Court reversed the Ninth Circuit Court of Appeals and held that a California law prohibiting the sale, processing or holding of a nonambulatory animal was expressly preempted by the Federal Meat Inspection Act (FMIA). The case, National Meat Association v. Harris, dealt with Section … Continue Reading

USDA Publishes Two Proposed Rules Regarding Ingredients in Organic Food Products

Today the United States Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS) published two proposed regulations that will affect companies that produce and market organic food products. One proposed rule would clarify which vitamins and minerals are permitted for use in organic food and infant formula, while the other proposed rule would renew the status … Continue Reading

The “Prior Substantiation” Doctrine: An Important Check On the Piggyback Class Action

A disturbing trend has emerged in false advertising litigation: plaintiffs are filing class action complaints that are virtually identical to or rely heavily on FTC complaints or FDA warning letters. Those complaints allege that certain advertising claims are false, deceptive, and/or misleading because the defendants do not possess “prior substantiation” for the claims, i.e., the … Continue Reading