As many of us are aware, the Agriculture Improvement Act of 2018 — better known as the Farm Bill — was signed into law yesterday. Among other things, this new law changes certain federal authorities relating to the production and marketing of hemp, defined as cannabis (Cannabis sativa L.), and derivatives of cannabis with extremely low (less than 0.3 percent on a dry weight basis) concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC). These changes include removing hemp from the Controlled Substances Act, which means that it will no longer be an illegal substance under federal law.
The FDA released a public statement explaining their regulatory authority over the product. Just as important for the FDA and our commitment to protect and promote the public health is what the law didn’t change: Congress explicitly preserved the agency’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act. This allows the FDA to continue enforcing the law to protect patients and the public, while also providing potential regulatory pathways for products containing cannabis and cannabis-derived compounds.
In particular, we continue to be concerned at the number of drug claims being made about products not approved by the FDA that claim to contain CBD or other cannabis-derived compounds. Among other things, the FDA requires a cannabis product (hemp-derived or otherwise) that is marketed with a claim of therapeutic benefit, or with any other disease claim, to be approved by the FDA for its intended use before it may be introduced into interstate commerce. This is the same standard to which we hold any product marketed as a drug for human or animal use.
Cannabis and cannabis-derived products claiming in their marketing and promotional materials that they’re intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases (such as cancer, Alzheimer’s disease, psychiatric disorders and diabetes) are considered new drugs or new animal drugs and must go through the FDA drug approval process for human or animal use before they are marketed in the U.S.
Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk, as these products have not been proven to be safe or effective. This deceptive marketing of unproven treatments raises significant public health concerns, as it may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases. We’ll also continue to closely scrutinize products that could pose risks to consumers.
Additionally, it’s unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived. This is a requirement that we apply across the board to food products that contain substances that are active ingredients in any drug.
They also announced that the agency has completed the evaluation of three Generally Recognized as Safe (GRAS) notices related to hulled hemp seeds, hemp seed protein, and hemp seed oil and that the agency had no questions regarding the company’s conclusion that the use of such products as described in the notices is safe.
To help members of the public understand how the FDA’s requirements apply to these products, the FDA has maintained a webpage with answers to frequently asked questions. The FDA recognizes the public’s interest and plans on gathering additional input relevant to the lawful pathways by conducting a public meeting.
While the FDA was worried about regulatory agendas, others in the hemp industry were very pleased with the new law.
Vote Hemp, the nation’s leading grassroots hemp advocacy organization working to change state and federal laws to allow commercial hemp farming, is thrilled to announce the federal legalization of hemp farming in the U.S. The new bill allows state departments of agriculture to file hemp programs plans and regulate hemp cultivation per their State specific programs.
In addition to defining hemp as cannabis that contains no more than 0.3% THC by dry weight, the bill asserts a ‘whole plant’ definition of hemp, including plant extracts; and removes roadblocks to the rapidly growing hemp industry in the U.S., notably by authorizing and encouraging access to federal research funding for hemp, and removing restrictions on banking, water rights, and other regulatory roadblocks the hemp industry currently faces. The bill also explicitly authorizes crop insurance for hemp.
Vote Hemp consulted with State agriculture officials and calculated that approximately 77,731 acres of hemp crops were planted across 23 states during 2018 in the U.S., 40 universities conducted research on hemp cultivation, and 3,544 State hemp licenses were issued across the country. Data from market research by Hemp Business Journal supports an estimate of total retail sales of hemp food, supplements, and body care products in the United States at $553 million.
U.S. Sen., D-Va, Mark Warner, said in a statement, “Industrial hemp is very different than marijuana. Industrial hemp has been the subject of extensive research at James Madison University, Virginia Tech and a number of other Virginia institutions. There is enormous interest from Virginia farmers because this crop can be used in a variety of ways, including for medicinal products, clothing products, furniture, and a wide variety of other potential uses. Industrial hemp will be a great addition to the Commonwealth’s agricultural industry, and I believe Virginia can become one of the top hemp-producing states in the country.”