News & Analysis as of

Manufacturers Federal Food Drug and Cosmetic Act (FFDCA) Dietary Supplements

Davis Wright Tremaine LLP

Six Key Takeaways on Dietary Supplement Regulation, 30 Years Post-DSHEA

Dietary supplement industry leaders and regulators gathered in Salt Lake City in June to examine the current status of the Dietary Supplement Health and Education Act of 1994 (DSHEA), 30 years after that legal building block...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

Harris Beach PLLC

New York Medical and Life Sciences: Year in Review 2021

Harris Beach PLLC on

From pharmaceuticals to dietary supplements, preemption to public health, New York state and federal courts issued decisions in 2021, which further shaped the landscape in the medical and life sciences legal world. To prepare...more

Alston & Bird

Bringing Dietary Supplements to Market: Key Requirements and Best Practices

Alston & Bird on

Whether you are looking to enter the market or grow your footprint in the industry, you need to know what regulations are relevant and how to prepare to bring a dietary supplement to market. ...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

Epstein Becker & Green

Federal Courts Say They Will Decide Cases Against CBD Product Manufacturers When the Smoke Clears

Epstein Becker & Green on

The cannabidiol (“CBD”) consumer product marketplace is booming. And, while FDA has maintained its position that CBD, even hemp-derived CBD, may not be included as an ingredient in conventional foods or dietary supplements,...more

Seyfarth Shaw LLP

Seyfarth on CBD – February 2020 Update

Seyfarth Shaw LLP on

CBD continues to flourish in the markets despite lack of federal regulations, and we’ve identified some significant events that indicate there’s no sign it’s stopping. ...more

Wilson Sonsini Goodrich & Rosati

FDA Announces Unprecedented Recall of Dietary Supplements

Recently, a New York-based dietary supplement manufacturer (and its subsidiaries) issued a nationwide recall of all lots of dietary supplement products manufactured and sold between January 2013-November 2019. Because the...more

Robinson+Cole Health Law Diagnosis

Bipartisan Bill for Federal Regulation of CBD in Foods and Dietary Supplements

A bipartisan bill was introduced in the U.S. House of Representatives on January 13, 2020, that (1) would allow hemp-derived cannabidiol (CBD) to be regulated as a dietary supplement, if all of the other applicable...more

Mintz - Health Care Viewpoints

Consumer Product Regulatory Priorities in 2019: An Ever-Shifting Landscape for FDA

This is our third year-end post for 2019 related to the Food and Drug Administration (FDA), focusing on the agency’s activities in the widely divergent area of “consumer products.” In taking a wide-lens view of the past year,...more

Bradley Arant Boult Cummings LLP

The Beginning of the End or the End of the Beginning? The FDA Issues 15 New Warning Letters to CBD Companies - Cannabis Industry...

The U.S. Food and Drug Administration (FDA) sent a shot across the bow of the cannabidiol (CBD) industry on November 25. The FDA disclosed that it issued warning letters to 15 companies “for illegally selling products...more

Wilson Sonsini Goodrich & Rosati

Microbes and Medical Foods: A Growing Area of Commercial Importance

The 2nd Annual Microbiome Movement conference, recently held in San Diego, California, highlighted the growing importance of microbes as the basis for various commercial products. Microbe-containing products regulated by the...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 | 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

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - October 2017

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

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