Category Archives: FDA

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A New Challenge for FDA?

Two Executive Orders Continue Trump Administration Efforts to Restrain Agency Policymaking Last week, President Trump signed two executive orders designed to limit the ability of federal agencies to make and enforce policy through the use of guidance documents. While this may seem like a mere technical issue, the ramifications could be significant. A federal agency … Continue Reading

Alzheimer’s and Cancer? FTC Announcement Shows That FDA Is Not the Only Agency That Is “Serious”

Last week, the Federal Trade Commission issued a press release announcing that it had issued warning letters to three unnamed sellers of cannabidiol (CBD) products who marketed everything from gummies to creams with bold claims that the products could treat a wide variety of the most serious diseases known to man. This follows an earlier … Continue Reading

Ninth Circuit Affirms FDA Preemption in Tossing Vitamin E Supplement Case

There is no denying that, at times, the express claims made on dietary supplement labels may seem to convey a broader implied claim to the consumer regarding the supplement’s performance benefits. While that may be true, last month the Ninth Circuit confirmed that plaintiffs cannot successfully allege that a lawful “structure/function” claim misleadingly implies that … Continue Reading

FTC and FDA Issue Warning Letters to Supplements Companies

Earlier this week, the FTC and the FDA announced a joint effort to combat unsubstantiated health claims in the supplement space. In three warning letters—to Gold Crown Natural Products, TEK Naturals, and Pure Nootropics, LLC (collectively, the “Companies”)—the agencies explain that certain efficacy claims may lack competent and reliable scientific evidence for support. Specifically, the … Continue Reading

CBD Update: The FDA Commissioner Cannot Ignore the Buzz – But Is Further Deregulation on the Horizon?

With the ink on the president’s signature barely dry, the commissioner of the U.S. Food and Drug Administration (FDA) – Dr. Scott Gottlieb – issued a statement letting everyone know that the agency is aware of the implications of the Agriculture Improvement Act of 2018 (a/k/a the Farm Bill). As we reported last month, CBD … Continue Reading

New Farm Bill Cracks Open Door to Processing for Legalized Hemp and CBD Oil

Signed into law on December 20, 2018, the 2018 Farm Bill may present a tremendous opportunity for banks and payments companies to provide banking, processing, and other services to the hemp industry. We expect a variety of companies to move swiftly in developing, marketing, and selling products (including CBD oil) that, until yesterday, were controlled … Continue Reading

Cell Cultured Food—FDA and USDA Reach Agreement on Splitting Up Oversight

Previously on the blog, we noted that federal government agencies don’t always play well together. So, when these agencies synchronize their efforts, the industry would do well to take notice. One such coordination effort is well underway. The FDA and the USDA just announced that they will jointly oversee cell‑cultured food production derived from livestock … Continue Reading

FDA, CPSC & the Need for Speed: Recent Actions Highlight Importance of Promptly Reporting Product Safety Issues

On consecutive days last month, both the Consumer Product Safety Commission (CPSC) and the U.S. Food and Drug Administration (FDA) made clear that delays in reporting potential product hazards or defects could significantly damage a company’s reputation and bottom line. The message from these agencies is clear—manufacturers and distributors of products regulated by CPSC and/or … Continue Reading

Will FDA Be Forced To Eat Menu Labeling?

The Affordable Care Act (ACA) gave our nation “Obamacare.” The ACA also gave the FDA the obligation to adopt regulations requiring “a restaurant or similar retail food establishment that is part of a chain with 20 or more locations doing business under the same name” to disclose the calories contained in “standard menu” items. This … Continue Reading

9th Circuit Delivers Sweet Victory to Soft Drink Advertisers

San Francisco found itself in a sticky situation after the Ninth Circuit struck down a city ordinance that would have required soda companies and other makers of sugar-sweetened beverages to place the following warning on their ads: WARNING: Drinking beverages with added sugar(s) contributes to obesity, diabetes, and tooth decay. This is a message from … Continue Reading

Springtime for Food Marketers? Two Big Wins in California in Recent Days

The coming of spring has been accompanied by good news for two food marketers—ConAgra and Bumble Bee Foods—in their respective court fights in California. In the Northern District of California, a federal judge dismissed a putative class action against ConAgra alleging that the marketer’s Crunch N’ Munch product violated California’s unfair competition law since it … Continue Reading

FTC, New York AG File Complaint Against Marketers of Dietary Supplement Prevagen

Have you seen an ad like this (we have, more times than we can remember): “Ever walk into a room and forget why? Spend extra time looking for your car keys or purse? Have trouble remembering names or faces?” If the answer is yes, the dietary supplement Prevagen may be just what the doctor ordered. … Continue Reading

Slack-Fill Consumer Class Action Challenge Not Enough Muscle to Survive

Last week, the Southern District of New York dismissed with prejudice a putative consumer class action alleging that containers for Muscle Milk protein powder violated New York consumer protection laws because they were approximately one-third empty at the time of purchase. More specifically, the plaintiff’s Amended Complaint contended that “Defendant CytoSport, Inc. intentionally packaged its … Continue Reading

The FTC Weighs in Further on All Natural Claims

At last year’s Kennedy Center Honors, Aretha Franklin brought down the house and brought President Obama to tears with her rendition of Natural Woman. Marketers relying on “all natural” claims also may feel like crying these days. We’ve blogged frequently about natural claims; see this recent post. Much of the misery in this area results … Continue Reading

Ninth Circuit Decides Not To Stay Natural Case, But Read the Fine Print

When courts decide to stay actions to await FDA guidance in an area, it’s only natural that our ears perk up. Which has been going on a lot, with cases such as Kane v. Chobani and Swearingen v. Santa Cruz Natural, Inc. Last week, however, the Ninth Circuit Court of Appeals, which had previously opted … Continue Reading

Class Action Labeling Claims Partially Evaporated, But What’s Left May Signal a Revival of “Evaporated Cane Juice” Claims

Earlier this year, we discussed the Ninth Circuit’s decision staying a consumer class action against Chobani challenging its listing of “evaporated cane juice” as an ingredient on its yogurt labels. According to the plaintiffs in that case, “evaporated cane juice” was simply code for sugar, and Chobani therefore allegedly misled them about the healthiness of … Continue Reading

Major Changes Coming to Nutrition Facts and Supplement Facts Labels Near You

FDA finalizes rule to revise Nutrition Facts panels for foods and Supplement Facts panels for Dietary Supplements On May 20, 2016, the U.S. Food and Drug Administration (FDA or the Agency) issued a final rule (Rule) that overhauls the design and content of nutrition labeling for foods and dietary supplements (known as the Nutrition Facts … Continue Reading

FDA Reverses Stance on Kind Snack Bar Labels and Re-Evaluates Its “Healthy” Standard

The U.S. Food and Drug Administration announced this week that Kind LLC may label its snack bars as “healthy,” sort of. In 2015, the FDA warned Kind that several of its products were misbranded as “healthy,” and that such labeling falsely claimed that the snacks were low-fat or rich in anti-oxidants, among other things. The … Continue Reading

It’s Not Nice to Fool Mother Nature: FTC Takes Aim at “All Natural” Claims

While the Food and Drug Administration (FDA) is still considering whether to issue guidance over the use of the term “natural” in food products, the Federal Trade Commission (FTC) is steamrolling ahead this week with a flurry of settlements and a complaint over deceptive use of the terms “all natural” and “100% natural” in the … Continue Reading

Ninth Circuit Stays Class Action Food Labeling Lawsuit Until the FDA Completes Review

The pitter patter of class action footsteps that food companies hear may have gotten a bit quieter, at least for now, based upon a Ninth Circuit decision in Kane v. Chobani this week.  The lawsuit centers on Chobani’s use of the terms “evaporated cane juice” and “only natural ingredients” on its yogurt labels.  According to … Continue Reading

FTC Considers Advertising of Homeopathic Drugs

On Monday, September 21st the Federal Trade Commission (“FTC”) held a workshop entitled Homeopathic Medicine & Advertising (“workshop”). The workshop consisted of three panels: one discussing the homeopathic industry parameters generally, one discussing the science of homeopathic medicine, and the last discussing the legal and regulatory issues surrounding the marketing of homeopathic medicines. … Continue Reading
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