Food and Drug Administration (FDA)

On July 22, 2020, the U.S. Food and Drug Administration (FDA) submitted draft enforcement guidance for cannabidiol (CBD) industry for review by the White House’s Office of Management and Budget (OMB). The draft guidance is not yet available.  No date or proposed deadline for producing a final policy, but this submission indicates that the FDA

Yesterday, the FDA belatedly released a report in its progress towards CBD enforcement, as required by Congress.

Although the report repeats the FDA’s concerns regarding CBD safety, and fails to offer a useful timeline for a reasonable regulatory pathway for the CBD market, it also affirms a desire for a nuanced “risk-based” approach to CBD

Perkins Coie’s Food Litigation 2019 Year in Review assessed key legal issues facing the food and beverage industry. Among these topics was cannabis, and especially hemp-derived CBD, in food and beverage products. The 2018 Farm Bill ushered in a new era for cannabis and cannabidiol (CBD). Following the law’s passage, products containing CBD have continued

On the heels of the U.S. Food and Drug Administration’s (FDA) recent declarations regarding the safety of products containing cannabidiol (CBD), several companies have been hit with class action lawsuits alleging that that the company’s CBD-containing products are mislabeled and falsely advertised in violation of state law. Further class action litigation is expected given the

On July 31, Dr. Scott Gottlieb, the outgoing FDA commissioner, published an editorial in which he proposed how the FDA could expedite approval of food and beverage products that contain cannabidiol (CBD).

In the full article on PerkinsCoie.com, we review Dr. Gottlieb’s proposal which highlights areas of concern for business involved in the CBD

On March 28, 2019, the Federal Trade Commission (FTC) joined the Food and Drug Administration (FDA) in sending warning letters to three companies that market products that contain cannabidiol (CBD), which the companies claim can treat a variety of serious physical and mental disorders.

CBD can be added to foods and beverages, and can be synthesized, or derived from either hemp (which is legal at the federal level under the 2018 Farm Bill) or marijuana (which is illegal as a Schedule I controlled substance under the Controlled Substances Act). The FDA has not yet approved CBD as a food additive, and products containing CBD are currently deemed unsafe under the federal Food, Drug, and Cosmetic Act. The FDA has cited deceptive marketing practices as its main concern with respect to products that contain CBD, and has taken the position that selling products that contain CBD through unapproved therapeutic claims is illegal. Between 2015 and 2018, the FDA issued 18 warning letters regarding products containing CBD.  Each of the letters was triggered by drug claims. Ten of the warning letters also challenged adding CBD to dietary supplements, and one warning letter also challenged adding CBD to food. Despite the warning letters, the FDA has not yet undertaken a single enforcement action against a CBD product.
Continue Reading FTC Joins FDA in Sending Warning Letters to Companies Advertising and Selling Products Containing Cannabidiol (CBD) Claiming to Treat Alzheimer’s, Cancer, and Other Diseases