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 appropriate regulatory scheme for foods containing cannabidiol (CBD). Included in the announcement on the warning letters was a declaration by the FDA that it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food.

The agency's action is occurring during a time when CBD-infused food products continue to permeate the market, including holiday season-inspired turkey gravy. The FDA also continues to face intense political pressure to provide industry guidance with members of Congress urging the agency to act quickly in providing some certainty for the industry, especially hemp farmers.

New Warning Letters

On November 25, 2019, the FDA issued warning letters to 15 companies for illegally selling products containing CBD. The letters outlined how the companies are using online stores and social media to market CBD products in interstate commerce in ways that violate the Food, Drug, and Cosmetic (FD&C) Act, including marketing CBD products to treat diseases or for other therapeutic uses. Other violations outlined in the letters include marketing CBD products as dietary supplements and adding CBD to human and animal food.

As part of its announcement, the FDA also highlighted that some of the products involved in the warning letters raise other legal and public health concerns, including:

• Some of the products are marketed for infants and children—a vulnerable population that may be at greater risk for adverse reactions due to differences in the ability to absorb, metabolize, distribute, or excrete a substance such as CBD.
• Some of the products are foods to which CBD has been added. The FDA provided a reminder that it is illegal to introduce into interstate commerce any human or animal food to which certain drug ingredients, such as CBD, have been added. In addition, the FDA is not aware of any basis to conclude that CBD is GRAS among qualified experts for its use in human or animal food. There also is no food additive regulation which authorizes the use of CBD as an ingredient in human food or animal food, and the agency is not aware of any other exemption from the food additive definition that would apply to CBD. CBD is therefore an unapproved food additive, and its use in human or animal food violates the FD&C Act for reasons that are independent of its status as a drug ingredient.
• Some of the products are marketed as dietary supplements. However, CBD products cannot be dietary supplements because they do not meet the definition of a dietary supplement under the FD&C Act.
• One product outlined in a warning letter is intended for food-producing animals. The agency remains concerned about the safety of human food products (e.g., meat, milk, and eggs) from animals that consume CBD, as there is a lack of data establishing safe CBD residue levels.

The announcement on the warning letters also included the notable declaration on GRAS. "Based on the lack of scientific information supporting the safety of CBD in food, the FDA is also indicating today that it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food."

Consumer Update

On the same day it issued the warning letters, the FDA also published a revised Consumer Update that details the safety concerns about CBD products. The update reminded consumers that the FDA has seen only limited data about CBD safety and "these data point to real risks that need to be considered before taking CBD for any reason."

To emphasize this point, the FDA warned consumers that CBD has the potential to cause harm such as that it can: cause liver damage; affect the metabolism of other drugs, causing serious side effects; and increase the risk of sedation and drowsiness when mixed with alcohol.

"There are many important aspects about CBD that we just don't know"

The FDA also seemed to provide a clear signal that it intends to take a cautious approach toward developing a regulatory approach for these products, acknowledging that there are many aspects about CBD that they are not aware of, such as:

• What happens if you take CBD daily for sustained periods of time?
• What is the effect of CBD on the developing brain (such as children who take CBD)?
• What are the effects of CBD on the developing fetus or breastfed newborn?
• How does CBD interact with herbs and botanicals?
• Does CBD cause male reproductive toxicity in humans, as has been reported in studies of animals?

USDA Interim Hemp Rule Not Immune to Congressional Pressure

Although the U.S. Department of Agriculture (USDA) released the long-awaited interim final rule on hemp production, that has not alleviated congressional pressure on the department. Responding to several concerns expressed by the hemp industry over the interim final rule, Oregon Senators Ron Wyden (D) and Jeff Merkley (D) sent a letter to USDA Secretary Sonny Perdue requesting several changes.

The letter highlighted five concerns that should be addressed before the final rule is issued.

1. The proposed requirement for hemp to be tested within 15 days before harvest was described as an impossible obstacle for growers to overcome. The letter urged the USDA to follow the Oregon model and extend the timeline for testing before harvest to a more realistic timeframe of 28 days;
2. The interim rule requires testing labs to be registered with the Drug Enforcement Administration (DEA). Sens. Wyden and Merkley argued that this requirement would cause unnecessary delays;
3. Allow testing for delta-9 THC using methods that do not involve the application of heat or decarboxylation, and to remove all requirements for converting THCA into THC, as the 2018 Farm Bill allows for flexibility in testing methods by allowing "other similarly reliable methods."
4. Rather than requiring a sample from the flower or bud located at the top one-third of the plant, the letter urges the USDA to follow Oregon's pre-harvest sampling protocol that a "sample shall be obtained from flowering tops when flowering tops are present and shall be approximately 8 inches in length."
5. The interim rule's threshold of 0.5 percent for THC content was described in the letter as being arbitrary and far too low. Sens. Wyden and Merkley suggested that the USDA set a negligence threshold greater than 1 percent for THC content, arguing that a reasonably prudent hemp producer could take the necessary steps and precautions to produce hemp—such as using certified seed, using seed that has reliable grown complaint plants in other parts of the country, and engaging in other best practices—yet still produce hemp plants that exceed this 0.5 percent THC concentration.