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

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On May 26, 2022, the U.S. Food and Drug Administration (FDA) issued Warning Letters to four companies[1] concerning the illegal sale of unapproved animal drugs containing cannabidiol (CBD) intended for use in food-producing animals. These Warning Letters demonstrate the first time the FDA chose to focus on marketing CBD-containing products for use in food-producing animals, as opposed to pets, and the specific concerns related to such use. Food-producing animals, as defined by the FDA, include cattle (veal calves, beef cattle, and dairy cattle), swine, chickens, turkeys, and others (such as lambs).

Dosing food-producing animals with CBD is especially scrutinized because the FDA is not concerned solely with the well-being of the animals, but also with contamination of the food products they produce, such as the milk, eggs, and meat. Like antibiotics and other drugs used in animals, the potentially CBD-contaminated animal-based foods could pose unique risks when ingested by humans.

The FDA additionally expressed concern because the animals’ owners may incorporate CBD treatments as opposed to obtaining veterinary care for their animals. By relying on the claims that CBD producers make about their products, owners of food-producing animals may delay or forego seeking professional treatment in hopes that the CBD will cure the underlying ailment. In reality, by hoping to defeat the animals’ short-term symptoms (such as anxiety) with CBD, animal owners may actually be dampening important signals of serious medical conditions, making a proper diagnosis and treatment more difficult in the long-term.

Background

For a product to be an animal drug, the product must (i) be used to treat disease, (ii) have a therapeutic or medical use, or (iii) affect the structure or function of the animal. To legally market a new animal drug, the drug itself must obtain pre-market approval from FDA through either (a) an approved new animal drug application (NADA), (b) a conditionally approved NADA, or (c) an FDA index listing. Other than Epidiolex, which has received FDA approval as a human drug, all CBD-containing products intended for use as a drug are illegal, and such illegal drugs cannot be sold on the open market. Additionally, the FDA has issued several statements that the agency cannot conclude that CBD is generally recognized as safe (GRAS) among experts, is not listed in the Association of Animal Feed Control Official (AAFCO) Official Publication, or subject to a food additive petition. Therefore, CBD also cannot be marketed as a part of animal feed.

Many unanswered questions and data gaps about CBD toxicity exist, and some of the available data raise serious concerns about potential harm from CBD when used in food-producing animals. For example, the FDA has not yet been able to evaluate CBD for its:

  • Effectiveness for intended use,
  • Proper dosage,
  • Interactions with FDA-approved drugs in the animals
  • Interactions with FDA-approved drugs in humans who eat the food products, and
  • Side effects/safety concerns it may cause.

After a food-producing animal is treated with a drug, residues of that drug may remain in the animal or the food it produces until the drug leaves the animal’s system. When approving a new animal drug, the FDA establishes “withdrawal periods” before slaughter, egg collection, or milking to ensure that an animal-based food is safe for consumption. However, the FDA lacks data on the minimum time required between a dose of CBD and when food products from the animal can safely be produced, so the FDA cannot set standards for when foods from CBD-treated animals are safe.

The FDA’s concerns expressed in these Warning Letters arose not because it was aware of any actual use of CBD products with food-producing animals, but rather because the companies’ marketing was directed toward use as a drug without the appropriate pre-market approvals. These companies had marketed their products for the mitigation, treatment, or prevention of disease in animals. Specifically, the companies included claims that the products would help “farm animals with stress, anxiety, pain, inflammation, injuries…” and provide “support to help manage normal stress, promote a calming effect, maintain a healthy gut, maintain a normal and balanced behavior, maintain healthy joints, maintain a normal inflammatory response….” These, along with other marketing claims, showed that the products were intended for use as new animal drugs.

The Warning Letters were issued to companies operating in North Carolina, Kansas, Texas, and Nevada, indicating that despite differing state laws surrounding animal consumption of CBD, the risks of contaminating human food products alarms the FDA across the board.

These Warning Letters, while only imposing a 15-day window upon the companies to show how they will address the violation and prevent further violations, may result in further consequences later on. While the FD&C Act does not provide a private right of action, consumers and the Plaintiff’s bar have used a Warning Letter as a basis to object to the legality of the products through consumer protection laws.

[1] Haniel Concepts dba Free State Oils, Hope Botanicals, Plantacea LLC dba Kahm CBD, and Kingdom Harvest.

Written with the assistance of Braden O’Brien, a summer associate in the Husch Blackwell LLP Denver, Colorado office.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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