The FDA is slowly clearing the fog of confusion surrounding consumer products under its jurisdiction containing cannabis or cannabis derivatives, including drugs, dietary supplements, foods, and cosmetics. As one of his final acts before leaving the FDA on April 5, Commissioner Scott Gottlieb, M.D., announced new steps
to advance [the] agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products
with a particular focus on cannabidiol (CBD).
CBD is one of more than 100 biologically active chemical compounds in the cannabis plant and one of the most commonly known. Unlike THC, another well-known compound found in cannabis, CBD is not intoxicating. It is marketed in a variety of forms, such as oil, drops, capsules, syrups, teas, and topical lotions, often sold online, not necessarily legally.
Some confusion surrounding CBD’s legal status was generated by the Agricultural Improvement Act of 2018, which legalized hemp, basically defined as cannabis plants and derivatives containing no more than 0.3 percent THC (dry weight). Although legal hemp may contain CBD, that does not mean that CBD in any form, from any source, is also legal, contrary to popular misconception. Hemp-derived CBD is legal, according to this Brookings Institution publication,
if and only if that hemp is produced in a manner consistent with the [Agricultural Improvement Act], associated federal regulations, associated state regulations, and by a licensed grower. All other cannabinoids [including CBD] produced in any other setting, remain a Schedule I substance under federal law and are thus illegal.
“Associated federal regulations” include the Food, Drug & Cosmetics (FD&C) Act and the rules enacted by the FDA under the authority conferred on the agency by the FD&C Act, a subject we explore in more detail below.
(In this post, we’ll look at federal law only. State laws on CBD are all over the map. Over the past few decades, many states have legalized cannabis for medical purposes and some for adult recreational use. All of those uses remain illegal under federal law.)
Like other cannabis products, CBD is being promoted for near-miracle health benefits, which remain unproven. (SBM’s own Dr. David Gorski has done a good job of evaluating such claims in a series of posts, finding them wanting.) Right now, in Florida, where I live, yet another sad case of parents vying with the state to choose “natural” remedies over chemotherapy for their child is proceeding through the courts. A three-year-old boy who was diagnosed last month with acute lymphoblastic leukemia has been temporarily removed from the custody of his parents by the state, which is seeking permission from the court to re-start his chemotherapy, offering a cure rate of over 90% after a full 2 ½ year-regimen. His parents’ attorney told reporters that they want to start the child on medical marijuana (legalized by the Florida legislature) which “is a far superior treatment to chemotherapy” and that he will present studies to the court that “show cannabis causes ‘cell death of cancer’ without harmful side effects.” These are exactly the type of claims that are getting companies who make them in trouble with the FDA.
When (if ever) are CBD products legal?
While hinting that there may be an avenue forward for CBD-containing dietary supplements and foods, the FDA is making clear it will not tolerate companies illegally selling CBD products that claim to prevent, diagnose, treat, or cure disease, claims that can legally be made only by FDA-approved drugs (sometimes referred to as “drug claims”). To bring home the point, the FDA, in conjunction with the FTC, recently issued warning letters to three companies – Advanced Spine and Pain (headed by an M.D.), Nutra Pure, and PotNetwork Holdings – making what Dr. Gottlieb said were “unfounded, egregious claims” that their products containing CBD could treat cancer, neurodegenerative conditions, autoimmune diseases, opioid use disorder, and other serious diseases, putting consumers at risk. As he pointed out, when products make unproven claims to treat serious or life-threatening diseases
patients may be misled to forgo otherwise effective, available therapy and opt instead for a product that has no proven value or may cause them serious harm.
CBD successfully stopped cancer cells in multiple different cervical cancer varieties.
CBD also decreased human glioma cell growth and invasion, thus suggesting a possible role of CBD as an antitumor agent.
For Alzheimer’s patients, CBD is one treatment option that is slowing the progression of that disease.
CBD has demonstrated the ability to block spinal, peripheral and gastrointestinal mechanisms responsible for the pain associated with migraines, fibromyalgia, IBS and other related disorders.
Cannabidiol May Be Effective for Treating Substance Use Disorders.
Obviously, making claims that are legally limited to FDA-approved drugs will put you in the crosshairs of the agency as well as the FTC, and rightly so. How, then, might a company legally sell CBD-containing products, in the FDA’s view? For the answer to that question, we turn to a new agency webpage: “FDA Regulation of Cannabis and Cannabis-Derived Products,” and other recent FDA statements on the subject.*
Can I sell CBD at all?
According to the FDA,
It depends, among other things, on the intended use of the product and how it is labeled and marketed.
As noted, the Agriculture Improvement Act legalized hemp, which may contain CBD. However, as the FDA has taken pains to point out, Congress explicitly preserved the agency’s authority to regulate products containing cannabis or cannabis-derived compounds, including CBD. Thus, the fact that hemp is legal doesn’t automatically mean you can use it in an FDA-regulated product (e.g., dietary supplements), as we shall see below. And, whether it’s legal hemp-derived CBD or not, it’s important to remember that a seller can never legally (under federal law) market a CBD product for the prevention, cure or mitigation of a disease.
Can CBD be used in dietary supplements?
No, regardless of whether the CBD is hemp-derived or not. Under the Dietary Supplement Health and Education Act (DSHEA), dietary supplements can’t contain substances that are active ingredients in an FDA-approved drug or authorized for investigation as a new drug. In June, 2018, the FDA approved a new drug, Epidiolex, which contains cannabis-derived CBD, for the treatment of seizures associated with two rare and severe forms of epilepsy. (Prior to approval, the FDA had taken the position that supplements couldn’t contain CBD because Epidiolex was the subject of a new drug investigation [NDI]).
There would be an exception to this rule if CBD had been marketed as a dietary supplement prior to the NDI or FDA approval of Epidiolex, but the FDA says there’s no evidence this is the case. It is, however, willing to revisit this conclusion based on new evidence, a possible path forward for CBD-containing supplements. (There are two other possible exceptions to the ban on CBD in supplements and foods, although much harder to come by, which we’ll get to in a minute.)
Can CBD be added to foods, including animal foods?
No again, if the food is introduced, or delivered for introduction, into interstate commerce, for the same reason that CBD cannot be an ingredient in dietary supplements – because it’s an active ingredient in an FDA-approved drug. However, since the FDA’s authority over foods in this case is based on Congress’s constitutional authority to regulate interstate commerce, the FDA apparently does not claim jurisdiction over your locally-made, locally-sold CBD-laced brownies, cookies, gummies, and the like, as long as the sellers aren’t shipping them out-of-state. They may still be illegal under federal law, however, depending on the CBD’s source
Can CBD be an ingredient in cosmetics?
Currently, there is no FDA regulation prohibiting the use of CBD in cosmetics, which do not require pre-market approval (except for color additives), as long as the cosmetic otherwise complies with the law, including refraining from making drug claims or false advertising. The FDA can take action if any ingredient, including CBD, proves unsafe to consumers. Again, no matter the FDA’s position, the CBD in cosmetics may still be illegal under federal law.
Can CBD be used in drug compounding?
This is one question the FDA does not address: Whether and under what circumstances pharmaceutical-grade CBD can be used in traditionally compounded drugs. While components of FDA-approved drugs can legally be used in compounding, other restrictions may prevent CBD’s use in compounded drugs. (It’s complicated.) If that is not the case, we should worry about doctors, including naturopaths with prescription privileges, prescribing compounded CBD for unproven uses.
Prohibitions aside, Dr. Gottlieb’s recent FDA Statement also announced
a number of important new steps and actions to advance our consideration of a framework for the lawful marketing of appropriate cannabis and cannabis-derived products under our existing authorities.
Toward this end, the FDA will
- hold a public hearing on May 31, giving “stakeholders” the opportunity to provide the FDA with information relevant to the its current regulation of cannabis products and possible “lawful pathways” for marketing these products. Presumably this will include an opportunity to argue with the FDA about whether CBD was already being marketed as a dietary supplement ingredient prior to Epidiolex’s approval.
- take written public comments “to share . . . experiences and challenges with these products, including information and views related to product safety.”
- form a “high-level agency working group to explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed.”
There are apparently two potential “lawful pathways” in the FDA’s thinking. One, obviously, would be for Congress to change the law (as it did with hemp), allowing dietary supplements and foods to contain CBD within a framework, in Dr. Gottlieb’s view, that defines permitted concentration levels.
The other is the FDA’s enacting a regulation, through notice-and-comment rulemaking, which can take years, permitting CBD in supplements and food. However, the FDA thinks it is critical to answer “open questions . . . regarding the safety conditions raised by their widespread use.” For example, during its review of Epidiolex, the FDA identified safety risks, including potential liver injury. As Dr. Gottlieb points out, these risks can be managed with medical supervision, but it is not clear how to address them when CBD is used with no medical oversight and without the labeling requirements for prescription drugs. He says there are also questions regarding cumulative exposure if consumers access CBD across a broad range of consumer products as well as questions of CBD’s “intended functionality” in these products.
Either way, it is clear to Dr. Gottlieb that Congress wants action on CBD:
Every meeting I go into on Capitol Hill, almost every meeting, I get asked about this.
Given the current disarray in Congress and the FDA’s lack of resources, it’s likely that we’ll continue to muddle along with conflicting federal and state laws, outlandish claims of health benefits, and confused sellers and consumers for the time being.