Dietary Supplements

News & Analysis as of

Washington Healthcare Update

This Week: Congress tries to put together a tax extender package, which may provide an opportunity for some Affordable Care Act changes... HHS releases final rule on bundled payment for Joint Replacement Comprehensive Care...more

The DOJ Press Conference on Dietary Supplements: Heavy on Hype, Short on Facts

On Tuesday, a nimiety of federal agencies converged at a press conference at the Department of Justice to announce new and ongoing cases against dietary supplement marketers. Federal agencies included FDA, the FTC, the U.S....more

DOJ continues crack down on dietary supplement industry

In October, Life Sciences Decoded described the increased state and federal scrutiny against the dietary supplement industry, including a lawsuit that the Oregon Attorney General filed against GNC. This scrutiny and...more

The FTC Pressures Press Interactions, Defies Commercial Speech Doctrine

On Tuesday, the FTC joined the Department of Justice and several other federal agencies in announcing numerous recent and ongoing actions against dietary supplement marketers. The FTC, in its discussions, highlighted a case...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

Preemption Should Have Taken Down Performance Enhancement Class Action

Is it a food or is it a drug? The answer makes a difference because different laws apply. And then there are dietary supplements, which come under the “food” umbrella, but have some unique rules of their own. It can get...more

FDA Partially Stays Controversial Policy of Requiring INDs for Clinical Studies Evaluating Food, Dietary Supplements and Cosmetics

On Friday, October 30, 2015, FDA issued a Federal Register notice announcing a partial stay of the agency’s controversial Final IND Guidance entitled, “Investigational New Drug Applications—Determining Whether Human Research...more

FDA Stays Final Guidance on INDs for Foods and Dietary Supplement Studies

On October 30, 2015, the U.S. Food and Drug Administration announced that it was staying portions of its controversial Final Guidance relating to the types of studies that require compliance with Investigational New Drug...more

GNC lawsuit reflects FDA’s crackdown on dietary supplement industry

The Oregon Attorney General’s Office hit General Nutrition Centers (GNC) with a lawsuit last week alleging that the company knowingly sold supplements that contained FDA-banned ingredients. The action should serve as a...more

Advertising Law - October 2015 #3

With EU Safe Harbor Invalidated, Companies Ask: What Now? - What happens now?: That is the question that businesses across the country are asking after the Court of Justice of the European Union (CJEU) threw out the...more

Going on Offense against State Deceptive Trade Practices AG Actions

We have posted many times about cases where a manufacturer of a regulated product is sued over alleged violations of a state consumer protection or deceptive trade practices act because of something allegedly amiss in the...more

Advertising Law - October 2015 #2

"Flying Rabbi" Suit Crash Lands in NY Appellate Court - A New York man was unsuccessful in his lawsuit accusing Jimmy Kimmel of misappropriating his image during a skit on the late night TV show, Jimmy Kimmel...more

Food and Beverage Alert (US) - October 2015

FSMA will have major impact on dietary ingredient suppliers, expert says. The biggest change in food regulation in the US in the past 75 years will have a major effect on the suppliers of dietary ingredients, a food-quality...more

US v Bayer: Randomized Clinical Trials not Required for Dietary Supplement Structure Function Claims – Key Takeaways

In a much anticipated opinion for the dietary supplement industry and for products making health benefit statements, the District of New Jersey in US v. Bayer has found in favor of Bayer in holding that the government failed...more

Hi-Tech Accuses Dynamic of Trademark Infringement and False Claims of Steroid Powered Products

On September 28, 2015, Hi-Tech Pharmaceuticals, Inc. (“Hi-Tech”), a Georgia corporation, brought a trademark infringement action against Dynamic Sports Nutrition, LLC d/b/a Anabolic Research (“Dynamic”), and Brian Clapp...more

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...more

Advertising Law - August 2015 #4

In Case You Missed It: Possible Jail Time for TCPA Violations, Microsoft Gets Slammed With Solicitation Scam Class Action, and 'Do Not Disturb' Technology Gets Pushed on FCC - The world of the Telephone Consumer...more

Animal supplements still in limbo, facing increased FDA scrutiny

The thousands of food, agriculture and life sciences companies regulated by the federal government already face a barrage of complicated regulations. Add in significant regulatory uncertainty and a major reorganization of the...more

7th Circuit Rejects “Heightened” Ascertainability Requirement for Class Actions

Creating a clear circuit split on a class action issue of increasing importance, the Seventh Circuit has rejected the notion that in order to certify a class, a trial court must be able to identify class members in a reliable...more

Procera AVH Marketers Can Forget About Claiming to Reverse Memory Loss

It turns out that there is not a magic pill capable of reversing the effects of aging on the human brain, including memory loss, or at least not one we can remember right now. The FTC recently reminded the marketers of...more

Does CPSC or FDA Have Jurisdiction Over Your Consumer Product?

As our readers know, we write about legal developments that affect companies involved in manufacturing, importing, distributing, and/or selling “consumer products.” In many cases, these products fall squarely within the...more

The Meaning of Falsity in Misrepresentation Cases

When a consumer sues a product manufacturer over an allegedly false advertisement, what must the consumer allege to state a claim that the advertisement is false?...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

Certification Unhealthy: Ninth Circuit Vacates Order Certifying Class of Dietary Supplement Purchasers

The Ninth Circuit vacated a class certification order issued by the Central District of California, finding that common issues did not predominate because plaintiff had failed to demonstrate that the alleged misrepresentation...more

Ninth Circuit Reverses Class Certification In Joint Supplement Case Because Not All Class Members Saw Misrepresentation

The Ninth Circuit has held that a district court abused its discretion in certifying a class based on allegedly false health claims because not all class members saw the advertising. The Ninth Circuit said that the trial...more

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