Topic: Food & Drug Administration

Subscribe to Food & Drug Administration RSS feed

Class actions against CBD companies proliferate under federal and state law

On the heels of FDA sending out a tranche of warning letters to sellers of cannabidiol (CBD) products, enterprising plaintiffs lawyers have filed a spate of consumer class actions over these types of products. The complaints put forth a number of different theories tied to the current illegality of these products due to FDA regulation. These include allegations that companies:

misled consumers by marketing their products as dietary supplements,
inaccurately listed CBD dosages or product content; and
made unsubstantiated claims about CBD’s ability to treat, prevent, or cure human disease.

Is it worth the risk?

Hemp-derived CBD was legalized in … Continue Reading

FDA clarifies position on CBD, cracks down on 15 online stores

By Mark Faccenda (US), Will Troutman (US) and Katie Fragoso (US) on December 11, 2019 Posted in Consumer class actions, Food & Drug Administration

The U.S. Food and Drug Administration issued a revised consumer alert on Cannabidiol (CBD), warning that the agency is aware that some companies are marketing CBD products in ways that violate the federal Food, Drug and Cosmetic Act (FD&C Act), and that may put the health and safety of consumers at risk. The FDA also sent a new round of warning letters to 15 companies in an effort to crack down on illegal selling practices.

The CBD industry is one of the fastest growing markets in the US. CBD-infused ointments, gummy bears, beauty creams, baby oil, dog treats—you name it, … Continue Reading

Trump FDA relaxes FSMA enforcement

By Will Troutman (US) on January 10, 2018 Posted in Food & Drug Administration

On Januay 5, 2018, the FDA announced that it will relax enforcement of the Food Safety Modernization Act in specified areas. Our colleagues at the Norton Rose Fulbright Health Law Pulse have put together a brief summary and analysis explaining the announcement, which is likely to have impacts on retailers and their food contact substance suppliers.

FDA says evaporated cane juice labels are false and misleading

By on May 27, 2016 Posted in Consumer class actions, Food & Drug Administration

On Wednesday, the FDA issued guidance on the use of the phrase “evaporated cane juice” in order to “enhance consumers’ ability to make informed choices among sweeteners by promoting accurate and consistent labeling.” In an opinion that will have far-reaching implications in the food industry, the FDA concluded that “the term ‘evaporated cane juice’ is false or misleading because it suggests that the sweetener is a ‘juice’ or is made from ‘juice’ and does not reveal that its basic nature and characterizing properties are those of a sugar.”

In recent years, food manufacturers have used the phrase “evaporated cane juice” … Continue Reading

Ninth Circuit says “not so fast” for Hain Celestial dismissal

By on April 16, 2015 Posted in Consumer class actions, Food & Drug Administration, Recent consumer products case law

Last Friday, the Ninth Circuit reversed a holding by the District Court for Southern District of California dismissing “All Natural” false advertising claims against Hain Celestial cosmetics because they were barred by the primary jurisdiction doctrine. The Court stated that dismissal of the claims was the improper result, even if the FDA did have primary jurisdiction to handle the all natural claims. Along the way, the Ninth Circuit also managed to make plaintiff-friendly rulings regarding FDA preemption and unjust enrichment claims.

All Natural Cosmetics?

Hain Celestial markets and sells cosmetics advertised as “All Natural,” “Pure Natural,” or “Pure, Natural & … Continue Reading

Ninth Circuit says no preemption for Benecol’s “No Trans Fat” label claims

By on March 22, 2015 Posted in Consumer class actions, Food & Drug Administration, Recent consumer products case law

Reversing an order from the Southern District of California, the Ninth Circuit has held that state law false advertising claims based on “No Trans Fat” statements on the butter/margarine substitute Benecol are not preempted by federal law.

Robert Reid filed class claims for violations of California’s Consumer Legal Remedies Act, Unfair Competition Law and False Advertising Law, arguing that representations on the labeling of Benecol – among them “No Trans Fat”, “No Trans Fatty Acids” and “Proven To Reduce Cholesterol” – were misleading to consumers because the product did contain trans fat (albeit a very small amount) and that … Continue Reading

FDA calorie and nutrition labels foreshadow possible global standards

By Stephen Giles (AU) on December 29, 2014 Posted in Food & Drug Administration, Recent legislation and regulations

The US Food and Drug Administration finalized its rules requiring the listing of calorie information on menus and menu boards of certain food sellers. The rules apply to chains with at least 20 units operating under the same name (irrespective of the ownership structure) and vending machines with at least 20 locations.

The new rules implement requirements in Obamacare (the Patient Protection and Affordable Care Act of 2010), and are part of the government’s effort to fight obesity. They will pre-empt existing state laws covering the same types of foods and establishments, unless the state laws areidentical to … Continue Reading

One plaintiff not enough to prove advertising likely to deceive reasonable consumers

By on November 12, 2014 Posted in Consumer class actions, Food & Drug Administration, Recent consumer products case law

It seems that lately, all it takes to bring a false advertising class action regarding “all natural” or “no sugar added” representations on product packaging is the say-so of one consumer who claims the representations are misleading (even though they might not be technically “false”).

Indeed, at the motion to dismiss stage, courts tend to be quite consumer friendly, many times finding that bare allegations of deception are enough to move the case into discovery.

While this may be frustrating for many defendants who believe they have done nothing wrong, there is light at the end of the tunnel. Despite … Continue Reading

Formula for Disaster: FTC sues Gerber for falsely advertising baby formula as “FDA Approved”

By on November 7, 2014 Posted in Food & Drug Administration

Last week the FTC sued Gerber Products Co., alleging that it has no basis for asserting that its Good Start Gentle baby formula reduces the risk of infant allergy development and that these health claims were falsely advertised as “FDA Approved.”

Whether to identify products as “FDA Approved” raises important questions for companies considering using qualified health claims. Many companies choose not to make such claims, given the often confusing nature of FDA-required language identifying limited evidence supporting the claims.

FDA requires that a health claim characterize the relationship between a substance (food or food component) and a reduction in … Continue Reading

E-cigarette flavor found to contain chemical associated with lung disease

By on October 23, 2014 Posted in Food & Drug Administration, Recent legislation and regulations

A recent investigation conducted by the BBC has concluded that an e-cigarette flavoring purchased in Northeast England contained a potentially harmful chemical that has been associated with the lung condition known as “popcorn worker’s lung.”

The British television program, Inside Out, purchased four liquid refills for the e-cigarettes and sent them for laboratory testing. While three of the refills came back without indication of harmful chemicals, the fourth (a butterscotch flavoring) contained a chemical called diacetyl.

Diacetyl is a yellow/green liquid with an intense butter flavor. The chemical occurs naturally in alcoholic beverages, but is also used as a … Continue Reading

Pom Wonderful ditches appeal of state law preemption ruling

By on September 26, 2014 Posted in Consumer class actions, Food & Drug Administration

On September 22, 2014, the Ninth Circuit approved Pom Wonderful’s request to drop its appeal of U.S. District Judge S. James Otero’s February 2013 order holding that Pom’s UCL and FAL false advertising claims are preempted by the federal Food Drug and Cosmetics Act. The Ninth Circuit dismissed the appeal with prejudice. Norton Rose Fulbright Consumer Products Law Blog

By way of background, Pom sued Coca-Cola for false advertising under both § 43(a) of the Lanham Act and California state false advertising laws because Coca-Cola markets a drink advertised as “Pomegranate Blueberry Flavored Blend of 5 Juices.” The juice blend, sold under Coca-Cola’s Minute Maid brand, … Continue Reading

Breadth of primary jurisdiction expanded in class actions

By on September 22, 2014 Posted in Consumer class actions, Food & Drug Administration, Recent consumer products case law

The doctrine of primary jurisdiction gained ground in false advertising litigation, as Judge Sammartino of the Southern District of California dismissed a putative class action against Kashi Company because FDA signaled that it was reevaluating draft guidance that served as a partial basis for the plaintiffs’ complaint.

In Saubers v. Kashi Co., 2014 WL 3908595 (S.D. Cal. Aug. 11, 2014), Judge Sammartino held that because the FDA is in the process of evaluating the alleged deceptive and misleading representation, “evaporated cane juice,” the doctrine of primary jurisdiction warranted dismissing the claims. The Court held that the FDA’s draft guidance … Continue Reading

All natural: FDA silence continues to create problems for false advertising defendants

By on August 3, 2014 Posted in Consumer class actions, Food & Drug Administration

In recent years, a rash of consumer class actions have been filed alleging false or misleading advertising where a product is marketed as “natural,” “all-natural,” “made from 100% natural ingredients,” or other similar representations when the product allegedly contains some synthetic product or was processed in some way that does not occur in nature. These claims are thorny for defendants because the Food and Drug Administration has yet to provide a definition of what a “natural” ingredient is, thereby offering no standard governing this marketing claim that companies can look to for a safe harbor.

Identifying this ambiguity in current … Continue Reading