Hemp : Is it a supplement, drug, or plant? None of the above if you ask the FDA.

Updated: May 14

1. Many products (suggested by Veterinarians) are legal without FDA approval. Such products include animal supplements, medical feed, compounded drugs and associated products such as shampoo.

2. Vitamin, minerals, and plant-based supplements do not require FDA approval. The FDA only regulates drugs, not vitamins, minerals or supplements.

3. 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 are considered a drug, the definition is not literal. If the definition were literal, then veterinarians could not discuss, sell, or recommend products such as glucosamine, probiotics, or omega fish oil and they are discussing, selling, and recommending these items without risk of license revocation.

4. The FDA long ago concluded 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.”

5. Hemp CBD manufacturers can not market their products implying that these products will or may treat medical conditions or diseases (as they are not drugs) yet other non-FDA-approved pet supplements such as Omega Fish Oil can. Hemp CBD manufacturers should have the same legal right to market the same way other non-FDA-approved products.


6. Per the FDA :

'The FDA’s approach to cannabis and cannabis-derived compounds has been consistent. We treat substances derived from cannabis just like we do any other substances, and they are subject to the same authorities as any other substance. Under the statutory authorities, the FDA has the responsibility to administer, the relevant legal requirements vary depending on which type of product we’re talking about. For example, if a product is being marketed as a drug - meaning, for example, that it’s intended to have a therapeutic effect such as treating a disease - then it’s regulated as a drug, and it generally cannot be sold without FDA approval (or, in the case of an over-the-counter drug, an FDA monograph). Drugs have important therapeutic value, and it is critical that we continue to do what we can to support the science needed to develop new drugs from cannabis. Food, including dietary supplements, is regulated differently, but with the same goal of protecting consumers. The relevant statutory provisions prohibit the use of CBD because CBD was the subject of substantial clinical investigations into its potential medical uses before it was added to foods because CBD is the active ingredient in Epidiolex, an FDA-approved prescription drug product to treat rare, severe forms of epilepsy.

7- CBD-containing products labeled as dietary supplements have proliferated in the U.S., despite repeated assertions for years by FDA that CBD cannot be lawfully marketed as a dietary supplement because the cannabis-derived compound was first studied as a drug.

H.R. 841 would expressly allow CBD and other hemp-derived compounds to be marketed in dietary supplements, subjecting the products to FDA oversight and the same provisions of law that apply to all other supplements. Critics of the bill said it would circumvent FDA’s ongoing efforts to assess conditions under which CBD could be safely consumed in a dietary supplement.


https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd


Reference: https://todaysveterinarybusiness.com/hemp-cbd-legal-evans-golab/

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