The U.S. Food and Drug Administration (FDA) has asserted its authority to regulate products derived from cannabis, including hemp, and is therefore playing a major role in the development of markets for hemp derived food, cosmetics and drugs in the United States. This series explores the function and jurisdiction of the FDA in those sectors, how FDA decisions may affect the hemp business, and how stakeholders and consumers can participate in the process of getting products approved for public use.
By Sanford Stein | First in a Series
There is a way to go before the wholesale use of CBD and other hemp derived compounds are going to be widely available in the United States without limitations and disclaimers on their legality and use in food, cosmetics and drugs.
Just like any other legal product in the U.S., before a product can be used in food, beverages or other consumables, it must receive approval from the Food and Drug Administration (FDA). The FDA is governed by the Food, Drug and Cosmetics Act and regulates those products. In order to receive FDA approval, the products undergo stringent tests for safety, proper dosing and general use.
The FDA is considered highly thorough in its mission but also exceedingly conservative and slow. For example, drugs used to treat various ailments, including cancer, are often quicker to market and public use in other countries than they are in the U.S., due to FDA’s approach.
That said, the FDA is highly regarded and takes its mission of food and drug safety seriously. If a product is approved by the FDA there is good reason to believe it is safe to use. For that reason, it would be unfair to assume that the slow walk that the FDA is taking in regard to approvals for new hemp derived ingestibles, is more acute because the product in question is hemp or hemp derived. That said, there is already an active hemp products market in the U.S., which the FDA acknowledges.
Background: The Farm Bills
The 2018 U.S. Farm Bill (the Agricultural Improvement Act of 2018, Public Law 115-534), removed industrial hemp (Cannabis Sativa L) from the list of prohibited substances under the U.S. Controlled Substances Act, Schedule 1 – the strictest drug category. Industrial hemp is defined as Cannabis Sativa L containing less than 0.3% delta 9 THC on a dry weight basis. If it has more than that or has THC that is not delta 9, then the material is considered to be marijuana, which remains a Schedule 1 prohibited substance and is not legal to own, possess, sell or use under federal law.
So it’s important to know if a hemp derived product meets the threshold definition of industrial hemp. The use of the term “industrial hemp” in the Farm Bill is unfortunate since all hemp containing 0.3% delta 9 THC or less is legal under that Act, whether or not used for “industrial” purposes (think textiles, building materials, plastics etc.).
Comment on proposed FDA rules
Prior to the Farm Bill of 2018, the Farm Bill of 2014 allowed the legal growing of industrial hemp, also at the 0.3% THC standard. Hemp was legal to grow pursuant to state approved authorization for research at a university with a four-year agriculture program, or for “commercial” studies. It turned out that almost anything could be considered commercial research and a lot of hemp was grown at 0.3% THC or less under the 2014 bill in the various U.S. states that allowed it. So when the 2018 Farm Bill removed any remaining legal impediments to growing industrial hemp at 0.3% THC, there was already considerable experience growing at that level.
When the 2018 Bill passed there was a great deal of excitement that hemp was now legal in the U.S. without restriction on interstate commerce. A lot of the interest in growing hemp in the U.S. was for CBD extraction and that compound’s use in all sorts of products including oils, salves, drops, food and beverages. Hemp infused beer would soon be available. Well, yes, but not exactly.
The FDA is keenly aware of the burgeoning CBD market, having stated: “There is a significant interest in the development of therapies and other consumer products derived from cannabis and its components, including cannabidiol (CBD). FDA recognizes the potential opportunities that cannabis or cannabis-derived compounds may offer and acknowledges the significant interest in these possibilities.”
But the agency’s conservative, cautionary approach is rather typical: “However, FDA is aware that some companies are marketing products containing cannabis and cannabis-derived compounds in ways that violates the Federal Food, Drug and Cosmetics (FD&C) Act and may put the health and safety of consumers at risk. The agency is committed to protecting the public health while also taking steps to improve the efficiency of regulatory pathways for the lawful marketing of appropriate cannabis and cannabis-derived products.”
The FDA refers to cannabis, not distinguishing hemp in this statement, but we assume it is referring to industrial hemp since any other form of cannabis is still listed under Schedule 1 and therefore beyond the FDA’s jurisdiction to study.
‘Concerns’ are raised
Hemp derived products are in active use and have been for a long time; there is a plethora of CBD products available in the market and online. Typically, these products include the standard disclaimers that they have not been approved by the FDA and are not intended to treat, prevent or cure any disease. Even then, caution should be observed and raised in the sale and distribution of these products, and anyone thinking about it should consult with an attorney. Some have strayed from that stated limitation and have encountered FDA enforcement actions to cease and desist from further sales. They may also be fined and their products can be confiscated.
Of those that are being marketed properly, the FDA has said: “[Our] efforts have yielded useful information and raised concerns about the characteristics of currently marketed CBD products, including whether the actual CBD content in these products has matched the content described in these products’ labeling and whether these products have contained other cannabinoids (such as delta-9 tetrahydrocannabinol ((THC)) or contaminants (such as heavy metals and pesticides)).”
FDA believes that understanding the characteristics of marketed CBD products is critical to making informed decisions about how best to protect public health in the marketplace. As such, FDA has undertaken its own CBD product testing to better understand the contents and characteristics of currently marketed CBD products.
Role in drug approval
The FDA’s role in the regulation of drugs, including cannabis and cannabis-derived products, also includes review of applications to market drugs to determine whether they are safe and effective for their intended indications. The FDA’s drug approval process requires that clinical trials be designed and conducted in a way that provides the agency with the necessary scientific data upon which the FDA can make its approval decisions.
Without this review, the FDA cannot determine whether a drug product is safe and effective. It also cannot ensure that a drug product meets appropriate quality standards. For certain drugs that have not been approved by the FDA, the lack of FDA approval and oversight means the safety, effectiveness, and quality of the drug – including how potent it is, how pure it is, and whether the labeling is accurate or false – may vary considerably.
Under the Food, Drug and Cosmetics Act, products intended to treat a disease, or those which have a medical use, are considered drugs. Only one drug with CBD, Epidiolex, has been approved by the FDA for human use, and that is only for the treatment of rare, severe forms of epilepsy. According to the FDA “There is very limited information for other marketed CBD products, which likely differ in composition from the FDA-approved product and have not been evaluated for potential adverse effects on the body.”
The FDA is also concerned about CBD products marketed for infants and children –and notes that they 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.
Of note, the FDA has stated:
• Some of the products are foods to which CBD has been added. Under the FD&C Act, it is illegal to introduce into interstate commerce any human or animal food to which certain ingredients, such as CBD, have been added.
• 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.
• 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.
Time for authorization is now
With the passage of the 2018 Farm Bill, industrial hemp is legal. Still, it’s the FDA that determines how it may be used, how much, how often and in what forms. This process can take some time; but so far, hemp derived compounds are on a typical path through the FDA.
To advance the market, the FDA might be advised to relax its approach to years of research for product approval. It’s possible. For example, the FDA has approved a plethora of new products and devices for use to combat, test and prevent COVID 19, with its Emergency Use Authorizations for medical devices, masks, and test kits. It is time for the FDA to authorize the early use of CBD and other hemp derived products, even if only on an interim basis and subject to further study.
• More on FDA’s guidance and how to comment
• Hemp as an industrial product under the 2018 Farm Bill
American lawyer Sanford Stein is a leading authority in the regulated cannabis industry with emphasis in government regulations, legislation and business opportunities. He has legislative experience at every level of government, and has appeared as lead counsel before at the United States Supreme Court. He is the founder of Cannabis Law LLC.
Disclaimer: This article and its contents are not intended to be used as legal advice. Please consult with a lawyer before taking any actions with respect to any of the information contained in this article for any use or sale of hemp or hemp-derived products or compounds.