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Dietary Supplements FDA Warning Letters

Epstein Becker & Green

Litigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast

Epstein Becker & Green on

When it comes to dietary supplement class actions, there’s a little less class and a lot more action. In this episode of Speaking of Litigation, Epstein Becker Green litigators Teddy McCormick, Jack Wenik, and Robert Lufrano...more

K&L Gates LLP

Litigation Minute: Beauty From Within and the Confusing Claims Landscape

K&L Gates LLP on

What You Need To Know In A Minute Or Less - The current industry trend “beauty from within” refers to a focus on wellness—namely physical, mental, and lifestyle—and its impact on beauty. Oral supplements that consumers can...more

Jackson Walker

Mid-Year FDA Update: What’s New for Dietary Supplements?

Jackson Walker on

The U.S. Food and Drug Administration (“FDA”) regulates both finished dietary supplements (e.g., the “multi-vitamin” tablets that you might buy at the grocery store) and dietary ingredients (e.g., the B vitamins contained in...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

MarkIt to Market® - March 2021: Watching the Pot™

Naughty With Nature - Last week, the FDA issued two warning letters to companies selling drugs where CBD is listed as an ingredient on the label. The FDA’s “naughty list” of companies manufacturing CBD-ingredient drugs is...more

Kelley Drye & Warren LLP

FDA Enforcement: There’s Nothing Inactive About CBD and “FDA Registered” Is Misleading

On Monday, FDA announced two warning letters issued to makers of topical CBD products labeled as OTC drugs. Amidst a backdrop of facility inspections that revealed significant good manufacturing compliance concerns, the most...more

Hogan Lovells

FDA signals uptick in enforcement with market sweep on depression claims

Hogan Lovells on

On 19 February, 2021 the U.S. Food and Drug Administration (FDA) announced warning letters to ten companies for selling dietary supplements that claim to cure, treat, mitigate, or prevent depression and other mental health...more

Husch Blackwell LLP

CBD Companies Now Facing Monetary Penalties For Deceptive Marketing, Will Civil Liability Follow?

Husch Blackwell LLP on

The Federal Trade Commission (“FTC”) has joined the U.S. Food and Drug Administration (“the “FDA”) in enforcing laws related to marketing CBD products. The FDA has historically issued warning letters and pursued companies...more

Arnall Golden Gregory LLP

With One Warning Letter, FDA Demonstrates Many of the Ways It Can Establish the Intended Use of a Product Labeled as a Dietary...

On March 31, 2020, the Food and Drug Administration issued a Warning Letter to a dietary supplement firm for making claims about its products that establish the products are unapproved new drugs, in violation of Federal Food,...more

BCLP

FDA and FTC Warn Against Making Unapproved Disease Claims Regarding COVID-19

BCLP on

In response to the outbreak of COVID-19, the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) have issued several new warning letters to companies claiming their products prevent, treat or cure the novel...more

BCLP

FDA and FTC Warn Against Making Unapproved COVID-19 Claims

BCLP on

In response to the outbreak of COVID-19, the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) have issued several new warning letters to companies claiming their products prevent, treat or cure the novel...more

The Rodman Law Group, LLC

FDA Recognizes the Need for CBD Regulation

On February 26, 2020 the Food and Drug Administration’s (“FDA”) new commissioner, Dr. Stephen Hahn, acknowledged the growing consumer demand for CBD products. “People are using these [CBD] products,” Hahn said in his first...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

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

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

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

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l December 2019

LEGISLATION, REGULATIONS & STANDARDS - FDA Issues Warning Letters, Consumer Update On CBD, Sparking Litigation Against CBD Cos. - The U.S. Food and Drug Administration (FDA) has issued a consumer update on cannabidiol...more

McDermott Will & Emery

What to Know About FDA’s Recent Statements on CBD

McDermott Will & Emery on

Last week FDA issued a public release on CBD titled, “What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis derived Compounds, Including CBD.” The FDA document does not...more

Seyfarth Shaw LLP

FDA Stresses CBD Safety Concerns in 15 Warning Letters and Revised Consumer Update

Seyfarth Shaw LLP on

In its largest mass enforcement action involving cannabidiol (CBD) yet, the U.S. Food & Drug Administration (FDA) announced on November 25 the issuance of 15 warning letters to various companies for illegally selling products...more

Akin Gump Strauss Hauer & Feld LLP

FDA Explains Current Thinking on CBD and Issues Targeted Warning Letters

On November 25, the Food and Drug Administration (FDA) issued 15 warning letters to companies selling products containing hemp-derived cannabidiol (CBD) and released a summary of its approach to the regulation of CBD...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

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

FDA Declares CBD Is Not GRAS and Signals That It Will Maintain Its Deliberate Approach

With its recent issuance of additional warning letters and the release of a consumer update, the Food and Drug Administration (FDA) appears to be signaling that it will continue its deliberate approach in determining an...more

McDermott Will & Emery

FDA Regulatory Check-Up: CBD and Dietary Supplements

McDermott Will & Emery on

The Food and Drug Administration (FDA) has communicated a commitment to ensuring that firms marketing dietary supplements are not misleading particularly vulnerable consumers (e.g., elderly, cancer patients, or children) with...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Cannabidiol Marketing Warning as Congressional Pressure for Action Continues

Following through with its promise to take enforcement actions against companies marketing cannabis-derived products that could put consumers at risk, the Food and Drug Administration (FDA) recently issued a warning letter to...more

Faegre Drinker Biddle & Reath LLP

2 Lessons for CBD Industry in Recent FDA Warning Letter

With a pointed warning letter to a seller of cannabidiol (CBD) products, the Food and Drug Administration (FDA) last week sent a reminder to the industry: follow FDA labeling guidelines when marketing CBD and hemp products....more

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