Tag Archives: CBD

Proposed Class Action Alleges Company’s CBD Products Violate Federal Law (subscription to Law360 required)

As our readers may recall, on November 25, FDA issued warning letters to 15 companies for illegally selling FDA-regulated products containing cannabidiol (CBD) in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA alleged that CBD lacks an appropriate regulatory status in the products and, in some cases along with product claims, … Continue Reading

11th Circuit Rules for Plaintiffs in Class Action Lawsuit Based on Economic Loss From Purchase of ‘Worthless’ Supplements Containing DMBA – an Impermissible NDI

  We previously reported on a flurry of FDA enforcement actions in 2015 based on adulteration per se, which followed years of relative inaction in the dietary supplement marketing arena outside of enforcement against products with specific health or safety concerns.  FDA’s enforcement actions included warning letters to 14 companies regarding the marketing of products … Continue Reading

CBD Update: FDA Takes More Aggressive Enforcement Action in Warning Letters to Companies

On November 25, 2019, FDA issued warning letters to 15 companies for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). The products cited in the warning letters cover a wide range of forms including oils, drops, dietary supplements, conventional food (including gummies, peanut butter, … Continue Reading

Trade Group Petitions FDA to Allow CBD Supplements

In the wake of rapidly increasing sales, FDA has continued to maintain that dietary supplements containing hemp-derived cannabidiol (CBD) are illegal under the Federal Food, Drug & Cosmetic Act. FDA officials have previously stated that the agency is exploring additional regulatory pathways available to hemp products containing CBD, but predicted that completing a potential rulemaking … Continue Reading

FDA and FTC Send Warning Letter for Marketing Unapproved Drugs and Dietary Supplements Containing CBD

On October 10, the FDA and FTC sent a joint warning letter to Rooted Apothecary LLC for illegally selling unapproved drug products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat teething pain and ear aches in infants, autism, attention-deficit/hyperactivity disorder (ADHD), Parkinson’s and Alzheimer’s disease, among other conditions. As described in the … Continue Reading

Trade Associations Send Letter to All Members of Congress Urging Action on CBD in Dietary Supplements

On October 8, the American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition, and the United Natural Products Alliance – a group of trade associations representing the dietary supplement and natural products industries, sent a letter to all 535 members of Congress urging them to pass legislation that would make … Continue Reading

Congress Continues to Seek Regulatory Clarity on CBD from FDA

A bipartisan group of members of Congress sent a letter to FDA on September 19 urging the Agency to quickly provide legal clarity and establish a regulatory pathway for food products containing hemp-derived cannabidiol (CBD). “We appreciate FDA’s proactive approach towards pursuing a legal pathway for the production of hemp-derived products containing CBD … However, FDA’s … Continue Reading

Mitch McConnell Introduces Bill Amendment That Would Compel FDA to Issue CBD Enforcement Discretion Policy

Senate Majority Leader Mitch McConnell (R-KY) has introduced language into a Senate appropriations bill that would require FDA to issue temporary guidance on enforcement related to products containing cannabidiol (CBD).  The amendment, which was shared with the U.S. Hemp Roundtable, would require FDA to provide Congress with a report on how it will develop its … Continue Reading

FTC Steps Up Enforcement Against CBD Health Claims

CBD-infused products continue to flood the market as the U.S. Food and Drug Administration (FDA) explores additional regulatory pathways for hemp products containing cannabidiol (CBD). Currently, under the Federal Food, Drug and Cosmetic Act, CBD cannot lawfully be added to a food or marketed as a dietary supplement. On September 10, 2019, the Federal Trade … Continue Reading

Update on the Regulation of CBD-Infused Products

As previously reported on this blog, state regulators want a role in the regulation of CBD-infused food, beverages, and supplements. And while industry has been pressuring FDA to create a pathway for the lawful use of CBD in food and dietary supplements, currently, under the Federal Food, Drug and Cosmetic Act (FD&C Act), CBD (or … Continue Reading

FDA Exploring Additional Regulatory Pathways for CBD Products

In testimony before the U.S. Senate Committee on Agriculture, Nutrition, and Forestry on July 25, FDA’s Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., reiterated that FDA “is committed to advancing hemp products through the Agency’s existing regulatory pathways.” She added that the Agency is “further exploring whether it would be appropriate to make additional regulatory … Continue Reading

State AGs Want Role in Regulation of CBD-Containing Products

Many, including state regulators, are closely watching the U.S. Food and Drug Administration (FDA) as it works through the challenges associated with regulating cannabidiol (CBD) products.  Under the Federal Food, Drug and Cosmetic Act (FD&C Act), CBD cannot lawfully be added to a food or marketed as a dietary supplement; however, industry has been pressuring … Continue Reading

Bill Introduced to Protect State Cannabis Programs from Federal Interference

As previously reported on this blog, while the 2018 Farm Bill removed hemp from the Controlled Substances Act, its passage did not affect FDA’s authority to regulate cannabidiol (CBD) or other hemp products in FDA-regulated products. In December 2018, FDA released a statement clarifying that it is illegal to sell a food or dietary supplement that … Continue Reading

FDA Reiterates That Scientific Data and Safety Information are Required to Support a Regulation or Formal Enforcement Discretion Policy on the Use of CBD in Foods

  Many businesses are already capitalizing on a surge in the popularity of cannabidiol (CBD) products and are pressuring the Food and Drug Administration (FDA) for a regulatory path to enable the lawful use of CBD in foods and dietary supplements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).  Industry wants FDA to … Continue Reading

FDA Announces New Steps to Advance Regulatory Framework for CBD Products

Interest in products derived from cannabis (Cannabis sativa L.) and its components, including cannabidiol (CBD) has been high for the past couple of years and only increased when Congress passed the 2018 Farm Bill in December 2018.  Among other things, the law established a category for “hemp,” defined as cannabis (Cannabis sativa L.), and derivatives of cannabis (e.g., … Continue Reading

New York City, Ohio, and Maine Crackdown on Food Products with CBD

City and state officials in New York, Ohio, and Maine have placed embargoes on food products containing cannabidiol (CBD).  The embargoes, which appear to have all begun in January, require restaurants and retailers to remove all CBD-containing food products from their shelves and prohibit their sale.  In all three jurisdictions, however, restaurants and retailers were … Continue Reading

Senators Ask FDA to Update Federal Regulations Governing Use of CBD in Food, Beverages, and Dietary Supplements

As previously reported on this blog, the Agriculture Improvement Act (also known as “the 2018 Farm Bill”) removed hemp from the Controlled Substances Act, which means it is no longer an illegal substance under federal law.  However, the 2018 Farm Bill does not affect FDA’s authority to regulate derivatives of cannabis (e.g., CBD) or other … Continue Reading

In Light of 2018 Farm Bill, FDA Issues Statement on Use of CBD in Food; Completes Evaluation of 3 Hemp-Related GRASNs

The Agriculture Improvement Act (also known as “the 2018 Farm Bill”) was signed into law on December 20, 2018.  Among other things, the law changes certain federal authorities relating to the production and marketing of hemp, defined as cannabis (Cannabis sativa L.), and derivatives of cannabis (e.g., CBD) with extremely low (less than 0.3% on … Continue Reading

Contrary to Popular Reports, Farm Bill Will Not Affect FDA Status of CBD

Media outlets are reporting that a Farm Bill provision removing industrial hemp (Cannabis sativa L.) from Schedule I of the Controlled Substances Act will change the FDA status of cannabidiol (CBD) in foods.  However, the relevant provisions under Subtitle G (“Hemp Production”) affect only the Drug Enforcement Administration’s (DEA’s) authority over hemp farming and allow states to … Continue Reading
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