Category Archives: Food and Drug

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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 evidence required to support such claims. The Commission is asking the companies to review all product claims, including endorsements and testimonials, to … Continue Reading

United States v. Bayer: Preventing or Treating Disease Claims

In recent years, the FTC and the Center for Science in the Public Interest (“CSPI”) seem to have seen disease claims everywhere, regardless of whether the FDA has deemed the same claims appropriate, non-disease structure/function claims.  In the United States v. Bayer Corp., for the second time in recent months, a court called them on … Continue Reading

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 we discussed here, both agencies recently signaled interest in the homeopathic area with the FDA hosting a two-day public hearing last … Continue Reading

FTC Resolves Case Against “Melanoma Detective” App Marketer

The FTC announced late last week that it resolved its case against the final defendant, Avrom Lasarow, in the “Melanoma Detective” app matters.  The FTC alleged that claims that the apps could detect and diagnose melanoma in its early stages were not supported by competent and reliable scientific evidence.  As we discussed here, the FTC … Continue Reading

The Pleading Bar In False Advertising Cases Has Been Raised

The Fourth Circuit recently issued a decision affirming a district court’s order dismissing a false advertising claim against GNC and Rite Aid relating to several supplement products containing glucosamine and chondroitin, as well as other ingredients.  This case raises the bar for plaintiffs at the pleading stage because they now must allege that “all reasonable … Continue Reading

All Eyes on Homeopathics: FTC Workshop Signals Targeted Regulatory Scrutiny of Homeopathic Products

On Tuesday, the Federal Trade Commission “FTC” announced it will be hosting a workshop in September to evaluate advertising for over-the-counter homeopathic products. Homeopathy is an alternative medicine practice dating back centuries that incorporates the principle of “like cures like,” which holds that a given disease’s symptoms are “healing responses” that can be replicated by … Continue Reading

Decision Highlights Questions Over Substantiation for Weight Loss Claims

The Eleventh Circuit recently issued a decision in an contempt proceeding against Hi-Tech Pharmaceuticals and several individuals. The case highlights the ongoing debate over whether clinical trials are required for weight loss claims and, if so, whether the clinical trials must be on the full product formulation rather than active ingredients. In 2008, a federal district … Continue Reading

One-A-Day Keeps the Plaintiff’s Lawyers Away: FDA Determinations on Disease Claims Preempt Class Action Allegations

A California court recently dismissed, in part, a consumer class action against labeling and advertising claims for twenty different Bayer One-A-Day multivitamins. The plaintiffs had alleged that the claims, “supports heart health” and “supports immunity” – which Bayer used for many of the products – were impermissible disease claims. The court rejected these allegations. It found, first, … Continue Reading

FDA Avoids Legality in Warning Letters Regarding Cannabis-Based Dietary Supplements

FDA recently made public a batch of warning letters issued in February.  Among these were several letters issued to dietary supplement companies regarding their use of express disease reduction claims, such as inhibiting malignant tumor growth, reducing symptoms of rheumatoid arthritis, and treating chronic depression. But wait, there’s more. Four letters were issued to companies … 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

FTC v. Bayer: The Good News

The Department of Justice recently filed a motion in federal court against Bayer Corporation over advertising for its probiotic supplement, Phillips’ Colon Health.  The DOJ alleges that Bayer lacks the “competent and reliable scientific evidence” that a prior 2007 order requires the company to possess for any efficacy or benefit claim for a dietary supplement. According to … Continue Reading

Ingredient Supplier Settles FTC Charges Related to Sponsored Trial

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

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

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

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?

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

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

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

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

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

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?

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?

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