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Food and Drug Administration (FDA) Federal Food Drug and Cosmetic Act (FFDCA) Cannabidiol (CBD) oil

Foley Hoag LLP - Cannabis and the Law

Senate Wades Into the Muddy Waters of Intoxicating Hemp

With the persisting uncertainty surrounding the next iteration of the Farm Bill and its treatment of hemp-derived consumable products, perhaps it should come as no surprise that legislators on Capitol Hill have proposed...more

Knobbe Martens

FDA and FTC Crack Down on Delta-8 THC Copycat Products

Knobbe Martens on

In a concerted effort to combat the illegal sale of delta-8 THC edibles packaged to look like popular snacks, the US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have recently begun issuing...more

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

Mintz - Health Care Viewpoints

2023: Another Year Chock Full of Challenges for FDA

At the start of 2022, we reflected on what the Food and Drug Administration (FDA) had accomplished during the preceding 12 months and the challenges that could be ahead for the agency during the impending year, especially...more

Holland & Knight LLP

Congressional Leaders Seek Stakeholder Input Regarding CBD Regulation

Holland & Knight LLP on

The bipartisan leadership of the House Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor and Pensions released a formal Request for Information (RFI) to the public on July 27, 2023, to...more

Mintz - Health Care Viewpoints

Those Aren’t Doritos: FTC and FDA Send Warning Letters to Companies Marketing Delta-8 Infused Munchies

The Federal Trade Commission’s (FTC) recent press release marks a continuation in government action against manufacturers of products infused with delta-8 tetrahydrocannabinol (delta-8).  In May 2022, the U.S. Food and Drug...more

Perkins Coie

FDA Releases Public Inventory of Unapproved Food Additives

Perkins Coie on

The U.S. Food and Drug Administration (FDA) released a public inventory on July 12, 2023, of certain food ingredients that the agency has determined are unsafe because they are unapproved food additives that are not Generally...more

Troutman Pepper

New Congressional Bills Seek to Advance FDA CBD Product Regulation

Troutman Pepper on

Under the sponsorship of Representatives Morgan Griffith (R-VA) and Angie Craig (D-MN), congressional lawmakers recently renewed their effort to force the Food and Drug Administration’s (FDA) hand in regulating cannabidiol...more

Lippes Mathias LLP

FDA Regulation of CBD is TBD

Lippes Mathias LLP on

After rounding out 2022 with a series of warning letters to companies selling products containing cannabidiol (“CBD”) the U.S. Food and Drug Administration (“FDA”) began 2023 by issuing a press release announcing its...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

Latham & Watkins LLP

FDA Finalizes Quality Recommendations for Cannabis in Clinical Investigations

Latham & Watkins LLP on

FDA provides recommendations on sources of cannabis in clinical research, resources for information on quality, and control status considerations under the Controlled Substances Act. Key Points: ..The Food and Drug...more

Eversheds Sutherland (US) LLP

FDA says “no” to CBD: Now what?

The FDA’s recent decision not to regulate CBD like a food or dietary supplement leaves a multi-billion-dollar industry in a lurch. What’s next, and what should companies do now?...more

Vicente LLP

Recent FDA Enforcement Letters Signal Increased FDA Scrutiny of Hemp Products

Vicente LLP on

On November 21, 2022, the FDA issued five warning letters to companies selling CBD, Delta-8, and other hemp products for humans and pets. These letters are notable for the following five reasons (see additional details...more

Hogan Lovells

FDA issues notable new round of warning letters involving foods with added CBD

Hogan Lovells on

On November 16, 2022, the United States Food and Drug Administration (FDA) issued Warning Letters to five companies that market food and beverage products containing cannabidiol (CBD). FDA takes the position that the...more

Ward and Smith, P.A.

New Day, Same Story: FDA Issues Additional Warning Letters for Sale and Marketing of Hemp-Infused Human and Animal Products

Ward and Smith, P.A. on

This week, the U.S. Food & Drug Administration (FDA) posted warning letters to five hemp companies for, in the words of the FDA, "illegally selling products containing cannabidiol (CBD)."  The warning letters and additional...more

Husch Blackwell LLP

FDA Issues Warning Letters to Companies Whose Products Are Intended for Use with Food-Producing Animals

Husch Blackwell LLP on

On May 26, 2022, the U.S. Food and Drug Administration (FDA) issued Warning Letters to four companies concerning the illegal sale of unapproved animal drugs containing cannabidiol (CBD) intended for use in food-producing...more

Hogan Lovells

FDA Cites Five Companies for Illegally Selling Delta-8 THC and CBD Products

Hogan Lovells on

The U.S. Food & Drug Administration (FDA) recently issued Warning Letters to five companies selling products containing delta-8 tetrahydrocannabinol (delta-8 THC) and cannabidiol (CBD). In addition to the various violations...more

Mintz - Health Care Viewpoints

FDA Expresses Displeasure with Consumer Products Containing Trendy Cannabis Ingredient Delta-8 THC

On May 4, 2022, the U.S. Food and Drug Administration (FDA) for the first time issued warning letters related to products containing delta-8 tetrahydrocannabinol (delta-8 THC). FDA has previously sent warning letters to...more

Clark Hill PLC

FDA Warns Companies Allegedly Illegally Selling CBD and Delta-8 THC Products to Label and Brand More Carefully

Clark Hill PLC on

For the first time, the U.S. Federal Food and Drug Administration (“FDA”) this week issued consumer warnings and sent letters to five companies, alleging that they are selling products in a way that violates Food, Drug and...more

Vicente LLP

FDA Enforcement Action Targeted at Hemp-Derived Delta-8 Products

Vicente LLP on

On May 4, 2022, the FDA issued five warning letters to companies for selling products containing hemp-derived Delta-8 THC. Notably, this is the first time the FDA has issued warning letters specifically for Delta-8 products....more

Vicente LLP

Federal Hemp Legislation Outlook: What’s on the Horizon for 2022?

Vicente LLP on

Hemp was federally legalized nearly four years ago. Since then, the industry has dealt with constantly changing rules, despite being in regulatory purgatory due to snail-paced progress from the U.S. Food & Drug Administration...more

Ward and Smith, P.A.

Delta-8 THC: More Risk than Reward

Ward and Smith, P.A. on

Hemp product producers and sellers must consider a large number of legal and regulatory compliance risks each day.  Are their inputs and plant material coming from legally compliant sources?  Are their products,...more

King & Spalding

FDA Rejects Bids To Market CBD-Based Dietary Supplements

King & Spalding on

On July 23, 2021, the U.S. Food and Drug Administration (“FDA” or “Agency”) rejected two New Dietary Ingredient (“NDI”) notifications to market full-spectrum cannabidiol (“CBD”) as part of dietary supplements. This move...more

King & Spalding

Selling CBD-Infused Products Might Be Riskier Than You Think

King & Spalding on

The global cannabidiol (CBD) market size is expected to reach USD 13.4 billion by 2028. And yet a large part of that market—CBD-infused food, beverages, and dietary supplements—consists of unlawful sales. This article...more

Vicente LLP

What Is The FDA Saying About Full Spectrum Hemp? Key Takeaways From Rejections Of NDINs

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Almost three years since the legalization of hemp production in the United States, the U.S. Food and Drug Administration (FDA) is still in the process of determining the regulatory framework for CBD and other hemp...more

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