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Hemp CBD: Legal without approval

Hemp CBD: Legal without approval

The statement in the article “CBD 101” [April/May 2020] that hemp CBD products need Food and Drug Administration approval to be legal is false.

Many products are legal without FDA approval. Such products include animal supplements, medical feed and compounded drugs [https://bit.ly/34XNuYS]. This means that animal supplements like Denamarin, glucosamine tablets, fish oil and hemp CBD that veterinarians carry in their practices do not require FDA approval to be legal.

The FDA’s statement that there are no FDA-approved cannabis animal products does not mean that hemp CBD animal supplements are illegal. It means that no product that actually requires FDA approval, such as drugs and food that also has cannabis in it, has been approved for animals. If a product does not require FDA approval, like a hemp CBD animal supplement, then no FDA approval is needed for the product to be legal.

The California Veterinary Medical Board updated its “Guidelines for Veterinarian Discussion of Cannabis Within the Veterinarian-Client-Patient Relationship” [https://bit.ly/2XV1hOy] to reflect this. The guidelines no longer say that veterinarians should not recommend or use unapproved hemp CBD products. Instead, the guidelines allow veterinarians to use, recommend and sell hemp CBD products that are not drugs.

The Food Drug and Cosmetic Act has a broad definition of what an animal drug is. While the definition says that products intended to treat a disease or affect the structure of an animal’s body is a drug, the definition is not literal as “CBD 101” suggests. If the definition were literal, then you could not use, recommend or sell animal supplements like Denamarin, fish oil, hemp CBD or glucosamine, which are intended to affect the structure of an animal’s body. The reason you can use, recommend and sell such products is because the FDA does not regulate animal supplements as drugs.

The hemp CBD manufacturers that received FDA warning letters for selling unapproved animal drugs explicitly claimed that their products treated or cured cancer and other diseases. The claims make the products drugs because the companies intended for their products to treat or prevent a disease. While those particular products from the manufacturers are drugs, hemp CBD animal products that manufacturers do not intend to be used to treat a disease are not drugs.

Failing to understand this and telling veterinarians that hemp CBD products are illegal unless they are FDA approved harms animals and veterinary businesses. It causes clients to use hemp CBD that they bought from a gas station on their pet instead getting a legal and safe hemp CBD animal supplement from their veterinarian.

It also hurts veterinary businesses by needlessly scaring veterinarians so that they do not buy legal and safe hemp CBD animal supplements. Unfortunately, this causes veterinarians to miss an opportunity to support patient health and earn revenue by selling hemp CBD animal supplements.

Stacey Evans is the VP general counsel at ElleVet Sciences LLC. Her expertise is drug, hemp and veterinary law. She is a former member of the U.S.  Department of Agriculture Secretary Advisory Committee on Animal Health and former chair of the Animal Law Committee of the American Bar Association.

A rebuttal

Editor’s note: Dr. Gail Golab, chief veterinary officer at the American Veterinary Medical Association, was interviewed in the article “CBD 101.” She responds.

I appreciate the opportunity to respond to Ms. Evans. It appears she either has misinterpreted my comments or has a different reading of federal law than the AVMA on this topic.

First, it is important to clarify that nowhere within the article is there a statement that “hemp CBD products need Food and Drug Administration approval to be legal”. Instead, the questions posed in the article, and my statements in response, pertained to CBD’s use as a therapeutic agent. I pointed out that it is important to consider the intended use of a product, as well as how it is labeled and marketed. As acknowledged by Ms. Evans in her comments, the Food, Drug and Cosmetic Act (FDCA), 21 U.S.C. § 321(g)(1), defines a “drug” in part as “articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals[.]”  The FDA describes “intended use” [https://bit.ly/2WgSaVV] as “the objective intent of the persons legally responsible for the labeling of drugs” and indicates that “the intent is determined by such persons’ expressions or may be shown by the circumstances surrounding the distribution of the article.”

One could logically ask for what purpose, other than a therapeutic one, would CBD be marketed to veterinarians by manufacturers for use in their patients? Ms. Evans, herself, references support of “patient health” as a basis for the sale of CBD products by veterinarians.

Second, Ms. Evans posits that CBD products are animal supplements and, therefore, do not require FDA approval. She points to a consumer webpage [https://bit.ly/34XNuYS] as support for her claim. On this webpage there is no mention of “animal supplements” or several of the other products mentioned by Ms. Evans, so we do not read this consumer webpage to say that certain products do not require FDA approval. At most, the webpage shows that some products may not have FDA approval, but that is not the same as FDA approval not being required for those products.

Specifically, with respect to CBD products as dietary supplements, warning letters sent by FDA to multiple companies marketing CBD products [https://bit.ly/2WfwdGF] show that the FDA appears to have concluded that CBD products cannot be dietary supplements because they do not meet the definition of a dietary supplement under the FDCA. In addition, FDA long ago concluded [https://bit.ly/2yhn2h1] that the federal Dietary Supplement Health and Education Act does not apply to products marketed as dietary supplements for animals, stating, “There is no ‘dietary supplement’ regulatory classification for animal food substances and products” and “They are considered either ‘foods’ or ‘new animal drugs’ depending on the intended use.” I have already commented on CBD for use in veterinary medicine as “drug” above. Furthermore, FDA has concluded that it is a prohibited act under § 301(ll) of the FDCA to introduce or deliver for introduction into interstate commerce any animal food to which CBD has been added [https://bit.ly/35keFgS].

Finally, with respect to the California Veterinary Medical Board’s “Guidelines for Veterinarian Discussion of Cannabis Within the

Veterinarian-Client-Patient Relationship” [https://bit.ly/2XV1hOy], the board expressly clarifies that even industrial hemp-derived products are “drugs” if they are “intended for use in the diagnosis, cure, mitigation, treatment or prevention of a disease or intended to affect the structure or function of the body of an animal[.]” The guidance further states that there “are no FDA-approved drugs containing industrial hemp for use in animals” and that a veterinarian who “markets or sells drugs not approved by FDA is in violation of federal law.”

In closing, it is important to note that the AVMA is not commenting on the legal or regulatory status of specific products or the business practices of a particular company. The AVMA fully recognizes the evolving legal and regulatory landscape of cannabis and CBD at both the state and federal levels, particularly when those products are marketed for use in animals.