News & Analysis as of

Federal Food Drug and Cosmetic Act (FFDCA) Health Claims

Husch Blackwell LLP

Revitalize and Recharge: The Emergent Trend of Adaptogens and Nootropics in Functional Beverages

Husch Blackwell LLP on

In an industry full of buzzwords, “adaptogens” and “nootropics” are current stand outs within the beverage industry. The beverage industry experienced a significant shift in consumer preference following the COVID-19...more

Epstein Becker & Green

FDA Releases Updated Directory on Select Dietary Supplement Ingredients

Epstein Becker & Green on

Whether a consumer is taking calcium carbonate for strong bones, magnesium to fall asleep, or high-dose caffeine to stay awake, the U.S. Food and Drug Administration (FDA) does not approve dietary supplements for safety and...more

Husch Blackwell LLP

A Cannabis Pivot to Smokable Herbs

Husch Blackwell LLP on

As the cannabis industry continues to navigate choppy economic and legal waters into 2024, some cannabis companies are pivoting to the smokable herbs market. And I do not mean to those hemp-derived intoxicating cannabinoids...more

Husch Blackwell LLP

The Future of Functional Foods

Husch Blackwell LLP on

Following the social isolation and public health concerns associated with the COVID-19 pandemic, many Americans reevaluated their health and wellness priorities, creating new opportunities for food systems companies to...more

Vicente LLP

CBD Products Liability Lawsuits Could Be Revived After FDA Declines to Regulate Cannabidiol

Vicente LLP on

In recent years, several CBD companies faced product liability lawsuits brought by consumers. Many of these cases were dismissed without prejudice or stayed until the FDA takes action to regulate CBD products, meaning that as...more

Troutman Pepper

FDA Remains Vigilant Against CBD-Related Health Claims

Troutman Pepper on

Why It Matters - In March 2021, the FDA issued four warning letters to CBD companies around the country. The administration takes a strong stance on product labelling and marketing efforts containing health claims about...more

Faegre Drinker Biddle & Reath LLP

Preemption of Structure/Function Claims

Seen frequently on grocery items, and especially on dietary supplements, structure/function claims describe the role of a nutrient or ingredient in the structure or function of the human body. Examples include “Calcium builds...more

Womble Bond Dickinson

Insight into Medical Foods and the Scope of FDA Regulation

Womble Bond Dickinson on

The FDA has issued warning letters to manufacturers of products marketed as medical foods to treat a range of medical conditions, including fibromyalgia, autoimmune disorders, irritable bowel syndrome, arthritis, asthma,...more

Brownstein Hyatt Farber Schreck

State and Federal Agencies Crack Down on Claims for Touted COVID-19 Preventatives, Treatments and Cures

The market for consumer products is likely contracting overall, but judging by empty drugstore shelves, anxious consumers remain keenly interested in purchasing over-the-counter medications, supplements and various herbs,...more

Burns & Levinson LLP

CBD as a Dietary Supplement – A Potential Regulatory Avenue for Retail Hemp Operators Selling THC Extracts

Burns & Levinson LLP on

On January 13, 2020, Representative Collin Peterson, the Chairman of the House Agricultural Committee, introduced a new bipartisan bill, H.R.5587 (Bill 5587), in the U.S. House of Representatives that would potentially...more

Dorsey & Whitney LLP

The FDA Takes Aim at CBD Labeling

Dorsey & Whitney LLP on

Despite the legalization of cannabis sales in many states and Congress’s removal of hemp and hemp-derived cannabidiol (CBD) from the list of scheduled drugs under the Controlled Substances Act, recent events serve as a...more

Brownstein Hyatt Farber Schreck

FDA Cracks Down on Companies Selling CBD Products

The past year has seen a veritable tidal wave of consumer product marketing claiming that cannabidiol (CBD) infused or derived products cure or treat cancer, epilepsy, anxiety, inflammation, diabetes, Alzheimer’s disease,...more

Perkins Coie

FDA Declines to Conclude CBD is Safe and Sends Flurry of Warning Letters

Perkins Coie on

On November 25, 2019, the U.S. Federal Drug Administration (FDA) took several significant actions regarding sellers of products containing cannabidiol (CBD). The FDA announced that it cannot conclude that CBD is “generally...more

Faegre Drinker Biddle & Reath LLP

Biotin Supplement Suit Dismissed on Preemption Grounds

A California federal judge tossed a proposed class action against allegedly “worthless” biotin dietary supplements on preemption grounds earlier this week, citing the Ninth Circuit’s recent decision in Dachauer v. NBTY, Inc.,...more

Carlton Fields

CBD Health Claims Spur FDA Warning & Product Seizure Threats

Carlton Fields on

The 2018 Farm Bill gave cannabis businesses around the country a legal path to market and sell hemp and hemp-derived products. Despite the groundbreaking law, several regulatory uncertainties remain. The FDA has been a source...more

Bradley Arant Boult Cummings LLP

Labeling and Advertising Risks for CBD Companies - Cannabis Industry News Alert

Cannabidiol (CBD) – a non-psychoactive component of cannabis with numerous claimed health benefits – has steadily grown in popularity in recent years. This upward trajectory went into overdrive with the passage of the...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin l November 2018

LEGISLATION, REGULATIONS & STANDARDS - Personal Care Products Legislation Introduced in Congress - Rep. Janice Schakowsky (D-Ill.) has introduced the Safe Cosmetics and Personal Care Products Act of 2018, which would...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update | August 2018 #3

LEGISLATION, REGULATIONS & STANDARDS - ASA Upholds Complaints Against Ads Targeting Children - The U.K. Advertising Standards Authority (ASA) has upheld the Obesity Health Alliance’s complaints against advertisements...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin | June 2018

LEGISLATION, REGULATIONS & STANDARDS - Hawaii Bans Two Sunscreen Ingredients - The Hawaii legislature has passed a law that will prohibit the sale or distribution of sunscreen containing oxybenzone and octinoxate after...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin | April 2018

FDA Issues Guidance on Concentrated Caffeine - The U.S. Food and Drug Administration (FDA) has released guidance clarifying that "dietary supplements containing pure or highly concentrated caffeine in powder or liquid...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin | February 2018

FDA Issues Draft Guidance for Homeopathic Drug Products - The U.S. Food and Drug Administration (FDA) has issued draft guidance, "Drug Products Labeled as Homeopathic," that would prioritize enforcement and regulatory...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin | December 2017

Sen. Hatch Introduces New Bill Regulating Cosmetic Safety - Sen. Orrin Hatch (R-Utah) has introduced legislation aiming to modernize cosmetics regulation, proposing amendments to the Federal Food, Drug and Cosmetic Act...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin | October 2017

The use of beauty products is “an understudied source of environmental chemical exposures” with a disparate effect on women of color, George Washington University and Occidental College researchers argue. Ami R. Zota, et al.,...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin | May 2017

Senators Call For Removal of Dioxane from Cosmetic Products - U.S. Sens. Chuck Schumer (DN. Y.) and Kirsten Gillibrand (DN. Y.) have petitioned the Food and Drug Administration to prohibit detectable levels of 1,4dioxane...more

Cozen O'Connor

Words Matter: Product Claims Can Trigger Regulatory Application And Corrective Action

Cozen O'Connor on

Most of us understand that the facts that give rise to the legal issues we face are sometimes sewn far in advance. This is certainly true in the area of product claims or statements. ...more

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