The Food Drug and Cosmetic Act (FDAC) gives the Food and Drug Administration (FDA) broad regulatory powers over legal drugs and more limited power over the regulation of food. For drug makers, the FDA is the fearsome elephant in the room because of the immense amount of time and huge levels of money it takes to get a legal drug to market. Though the FDA has cracked down on “CBD” and anyone making medical claims about it, it hasn’t taken up the torch in going after the thousands of people and businesses making medical claims about cannabis in their respective states. That though may soon change as the FDA is taking an increased interest in the medical claims and allegations surrounding cannabis on the state level.
Under the FDCA, the FDA categorizes a substance as either a food or a drug, depending on how it is labeled or advertised. If labeling even suggests the substance is “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or is an ‘article’ (other than food) intended to affect the structure or any function of the body of man or other animals,” the FDA will regulate it as a drug with very few exceptions.
The hope for most businesses active in the state-legal cannabis space is that cannabis will stay out of the realm of the FDA since “drugs” are subject to a comprehensive regulatory scheme that controls every part of the process, including formulation, testing for safety and efficacy, pre-clearance, manufacturing, labeling, sales, and recalls. However, with the advent of medical cannabis in multiple states, and given the long list of ailments it can allegedly treat as codified by multiple state laws, it’s no wonder the FDA is finally getting around to analyzing what’s being said and done in the state-legal medical cannabis industry.
For those who don’t want to end up tangling with the FDA, cannabis edibles may be a safer bet since the FDA is more hands-off when it comes to regulating food. The FDA basically categorizes food as anything people ingest that is not a drug. Though the FDA has promulgated hundreds of pages of food regulations, it mostly relies on food makers to self-enforce these regulations. However, when the FDA learns of regulatory violations, whether they regard food or drugs, it can and usually does take serious action.
Importantly, the food/drug distinction is not always clear. In the Dietary Supplement Health and Education Act (DSHEA), Congress permitted some labeling claims for food (including dietary supplements) formerly limited to drugs. Under DSHEA, the FDA has issued regulations allowing certain specific health claims to be made about foods, e.g., “Three grams of soluble fiber from oatmeal daily in a diet low in saturated fat and cholesterol may reduce the risk of heart disease.” Food makers can also ask the FDA to permit other health claims if supported by scientific evidence. And other claims may be made regarding the role of an ingredient intended to affect a structure or function of the human body, under certain limited circumstances.
What does all of this mean for cannabis businesses and specifically for edibles makers? If your cannabis label or advertising does not make claims that bring your product within the FDA’s drug definition, the FDA should not treat your edible as a drug under the FDCA. Of course, this doesn’t make your edibles lawful under federal law; it just means you won’t have to spend time dealing with the FDA if the FDA ever takes it upon itself to start enforcing drug and food laws against state-legal cannabis businesses.
And what would likely go down in the event your medical cannabis products are ever viewed as drugs by the FDA? The FDA’s efforts to pursue and shut down interstate CBD sellers tells us that it would likely be a short and swift ending for most state-legal medical cannabis businesses unless they have buckets of cash and time to get through formal, comprehensive drug trials. See here, here, and here for more on that.
As of now, the FDA has kept its nose out of state-legal medical cannabis and it remains a sleeping giant, but change may be on the horizon given the FDA’s recent spike in feeling a “responsibility” to answer whether cannabis has medical benefits in certain contexts. As a result, all state-legal medical cannabis businesses should be aware that FDA intervention may be imminent.