Tag Archive for: CBD

The Hazy Relationship between the FDA and CBD

By: Jon Avidor, Sarah Siegel and Liam McKillop

Walking around New York City, it could be easy to be under the impression that the sale of certain CBD products is legal. You can walk into your local convenience store and buy CBD-based chocolate candies over the counter, or you may have walked by one of the various CBD dedicated stores operating in Manhattan. However, in most instances, that is not the case. The legality of the CBD industry is not clearly defined, especially when it comes to CBD-based products such as foods, drinks, cosmetics, and pet goods and how the Food and Drug Administration (“FDA”) regulates the manner in which these products are sold and marketed.

The FDA, which operates as a science-based regulatory agency committed to protecting and promoting public health, has worked to balance the significant public interest and demand for CBD products while continuing to maintain their rigorous public health standards as it relates to drug approval. However, as the popularity of CBD and the industry in general continues to grow—evidenced by estimates that U.S. consumers spent $300 million on CBD foods and drinks throughout 2018—the FDA has continued to come under public pressure to regulate and stay up to date on the legal status of CBD products. 

There are two types of CBD: (1) hemp-based CBD, and (2) THC-based CBD. While both types come from the same plant—Cannabis sativa L.—there are major differences between the chemical makeup of the two after post-harvest, leading to a difference in how the two products are regulated by the FDA. As both types of CBD are common, the legal status of the two individual products has created confusion throughout the CBD industry. 

When the 2018 Farm Bill was signed into law in December 2018, the definition of “hemp” was amended to now be defined as “all parts of the plant Cannabis sativa L. with a delta-9 tetrahydrocannabinol concentration (the component of the plant which is responsible for the “high” attributed to cannabis) of not more than 0.3%.” Further, hemp was removed from the Controlled Substances Act, allowing for hemp-based CBD products to be put into interstate commerce. The result of this is that a majority of CBD products that are sold commercially are hemp-based. However, the Farm Bill ensured that the FDA would continue to have the authority to regulate products that contain cannabis or cannabis-derived compounds under the Federal Food, Drug & Cosmetics Act (“FDC Act”). The FDA has continued to maintain its position that it is currently illegal for THC-based CBD products like foods and drinks to be placed into interstate commerce and/or marketed as a dietary supplement.

Under the FDC Act, any product (excluding foods and drinks) which intends to provide either a therapeutic or medical effect on the body of humans or animals, is a drug. To date, Epidiolex—which is used as a treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome—is the only drug containing CBD which has been approved by the FDA. Further, the FDA has different regulatory standards when it comes to products like foods and drinks and even further differing standards for cosmetic products, with the latter being generally considered to be much less rigorous. For example, with cosmetic products (products which are considered to be “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the body”), there are no pre-approval requirements when it comes to the addition of CBD into these products. 

Meeting the definition “hemp” is only the first step to legally sell a specific type CBD product. The legal status of the product will also depend on its intended use, how the product is labeled and how the product is marketed. For instance, the FDA has concluded that no THC-based CBD product can be marketed or advertised as a dietary supplement, as the FDA has yet to discover scientific evidence which backs up the proposition. The FDA is currently unaware of any evidence which supports CBD products being used as a dietary supplement, and will therefore enforce against companies that market products as such.  it looks to enforce against products which market themselves as such. The FDA worries that such deceptive marketing claims can put the public at risk as individuals may be inclined to attempt to use such products instead of approved treatment methods for their conditions.  

Due to the rapid rise in popularity of CBD and the recent law changes related to hemp and cannabis (which continue to vary at the state and local level), it seems that the goalposts for FDA regulation of CBD products continue to be moved. While the FDA continues to consider public health above and beyond public demand, the FDA also understands that companies are begging for clearer guidelines related to the marketing and sale of their products and that the public wants to know more about the prospective therapeutic and medical benefits of CBD. However, as an agency, the FDA needs to be comfortable with the scientific evidence which supports the purported benefits, and due to the current status of tests and clinical trials, the FDA is not yet there.


CBD Between the Lines

By: Steve Masur and Kristen Kennedy

Cannabidiol, or CBD, has been making headlines the past few years for its potential to deliver many health benefits. Proponents claim that CBD can, among other things, relieve pain, ease anxiety and depression, and even benefit pets. This summer, the FDA approved the first CBD-based drug, and sales of CBD in forms like edibles and oils are expected to pass 1 billion dollars in 2020. Understandably, many people are interested in doing business in the CBD space, but one question stands in the way: is CBD legal? It depends on two things: the state(s) it’s being bought and/or marketed in, and the source of the CBD.

CBD, State-by-State

Every state has its own rules regarding CBD, found naturally in the cannabis plant, and THC, CBD’s psychoactive cousin found in marijuana. At the more permissive end of the continuum, states like California and Nevada have given the green light to adult use of cannabis for either medical or recreational use. In the middle of the spectrum are many states that have medical cannabis laws, which may also include the use of CBD. The least-permissive states provide no protection whatsoever for CBD sellers or purchasers. However, CBD continues to be widely sold and purchased in many states which do not permit it, and enforcement on the whole is sporadic. Therefore, the crucial first step in establishing a CBD business is to become well acquainted with the law in your state and any state you plan to do business in.

Know the Source

A big part of operating within the law is determining the source of the CBD being offered for sale. Ensuring the CBD is either sourced from industrial hemp or portions of the cannabis plant exempt from the definition of “marijuana” in the Controlled Substances Act (CSA) is crucial to staying within the law. Sellers of industrial hemp, defined as any cannabis plant containing less than 0.3 percent THC, must confirm that the cultivator is operating within a state that has an agricultural pilot program, complying with Section 7606 of the 2014 Farm Bill. (Industrial hemp is widely expected to be removed from the CSA and thus become fully legal with the passage of the 2018 Farm Bill, so this pilot program requirement will no longer exist in the future.) Sellers of CBD derived from exempt plant material must verify that the CBD was derived from mature stalks or seeds incapable of germination, as exempted from the CSA. These distinctions should be laid out in a carefully-worded purchase and sales agreement between you and your supplier, with representations and warranties to this effect to protect your business.

Find a Reliable Supplier

The importance of using a reputable supplier can’t be overstated. In a study carried out last year, researchers found that less than one-third of CBD products purchased online contained the amount of CBD they claimed to have. It may be in your best interest to source CBD from a state where marijuana is regulated, as CBD companies in states like Washington are required to test their products and accurately label them. Some things to look for in a wholesaler include a certificate of analysis that provides information on the levels of CBD, THC, and other compounds in a CBD product, what sorts of claims they make on their web site, and what type of extraction method they use.

Don’t Overstate the Claims

Once you set up your CBD business, be sure not to make unfounded claims about what it can do. The FDA has warned companies that have made dubious claims, such as that CBD could combat and prevent the spread of cancer and inhibit cancer cell growth. References to legitimate medical studies, however, are a safe way to highlight CBD’s potential benefits, as are third-party testimonials that don’t stray into the realm of unfounded medical claims. And be sure to include an FDA disclaimer on your web site, which is required by law.

Draft Clear Legal Policies

As you build your CBD business, be sure to stay within the bounds of the law in other ways. Draft legal policies that let your users know how you collect and use their data, and create clear, user-friendly terms and conditions that are easy to find on your web site. It’s also not a bad idea to include a basic and up-to-date statement of CBD laws, which may put customers who are uncertain of the legality of CBD at ease.


We would like to thank our intern Kristen Kennedy for her contribution to this article.