Just a few months ago, the CBD and hemp industry was given added legitimacy when President Trump signed off on the Hemp Farming Act, as part of the 2018 Farm Bill. With the signing of this bill, low-THC cannabis products have been removed completely from direct review or regulation under the Controlled Substances Act. While previous legislation had already carved out exceptions for low-THC products that were under 0.3% THC-content, this new law served to clarify that hemp was legal to grow and transport across state lines. In addition, the law is also providing hemp farmers with rights and federal agricultural grants previously denied to them. They now also have access to the national banking system as well as the right to marketing, agronomy research and crop insurances, all important advantages to grow and expand the hemp industry into a legitimate agricultural commodity.
In short, the hemp industry has been formally legalized on a federal level, but problems and roadblocks still exist. Additionally, much remains murky about how products are tested, how to prove THC content below 0.3% level, what claims can be made by hemp foods and nutritional supplements, and what oversight is still held by which federal agencies. For the hemp industry to truly flourish, these products must be allowed to succeed in the market, not be restricted by inaccurate and outdated federal bureaucracy and red-tape.
ENTER THE FDA
Even though the bipartisan support for hemp resulting in the signing of the Farm Bill was a big win in the eyes of the hemp industry, the Federal Drug Agency (FDA) rained on the parade when they came out with an official FDA statement regarding cannabis shortly after. The gist of it is that:
- Under section 351 of the Public Health Service Act, they stated that they still hold the authority to regulate and control cannabis derived products and compounds because, as defined under this section, they consider cannabis to be a medicine. As such, cannabis and cannabis derived compounds will be subject to the same requirements as do any other FDA-regulated products (i.e. medicines), regardless of if it is being marketed or sold as a food or dietary supplement.
- The FDA “…continue(s) to be concerned at the number of drug claims being made…” about cannabis and cannabis derived products, and that any products making therapeutic claims need to be approved by them before they may be sold. Any cannabis and cannabis derived products that make any therapeutic claims are considered by the FDA as being a new drug, requiring registration and approval. This means that they have to go through the FDA drug approval process and clinical trials.
- Most critically for the hemp industry, the FDA finds it “…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.” The FDA also considers CBD products that claim to be supplements as being in violation of the FD&C Act because they were marketed as dietary supplements or involved the addition of CBD.
Basically, to boil it all down to this: the statement by the FDA makes it clear that they see CBD as a drug, or if not exactly a drug, something that they still have authority over. While the FDA has always had authority over drug-related health claims, this statement appeared to indicate that the FDA believes their authority extends even further, allowing them to pre-emptively ban CBD products or even arbitrarily reclassify them as medications.
Nice for them, but many would argue that the FDA is somewhat overreaching and that, in the greater scheme of things, they are not only wrong about CBD, but also wrong about what they are really capable of and permitted to do about CBD. While removing the DEA from having oversight under drug laws certainly freed the hemp industry from one source of regulatory risk, the FDA still remains a dangerous threat to the hemp industry if they are allowed the power to restrict the booming hemp and CBD market. The FDA’s public proclamations that they have the authority to arbitrate whether cannabidiol can be marketed as a dietary supplement or added to food for health benefits, are cause for concern. This is particularly concerning when the FDA has already been ruled against by the Supreme Court numerous times for overstepping their authority when it comes to these products, and their protection under the Dietary Supplement Health and Education Act of 1994.
Prior to 1994, a patchwork of different laws and rules governed how vitamins and supplements could be sold, and how they were treated differently than prescription medications In the late 1980’s and early 1990’s the fear was real when the Nutrition Advertising Coordination Act of 1991 was suggested. In this bill the FDA would have gained a considerable amount of power in regulating nutritional supplements – including making it illegal to advertise nutritional or therapeutic claims as well as increasing the FDA’s enforcement powers and penalties. Included in these powers would have been making common vitamin and mineral supplement go through the same approval process and federal registration as pharmaceutical drugs, with the associated cost increases being passed on to the consumer.
In response, health-food industry banded together to lobby government and Congress to vote down the laws and to “preserve the consumer’s freedom to choose dietary supplements.”
The result was the Dietary Supplement Health and Education Act of 1994 (DSHEA), a landmark piece of legislation which defined what dietary supplements are, their labelling requirements, and most importantly, that supplement manufacturers do not need to receive FDA approval before producing and selling dietary supplements that were marketed in the United States before 1994. If you have ever bought vitamins or supplements at your local grocery or health food store, and didn’t have to show a prescription or speak publicly to a doctor before you were allowed to purchase them, then you have DSHEA to thank for that freedom.
Simply put, DSHEA not only protects the rights of consumers to make their own decisions about dietary supplements like Vitamin C, melatonin or a daily multivitamin, but to a large extent, it also protects the ability of responsible CBD brands to bring their products to market. Despite the FDA’s public statements to the contrary, there is no question that hemp-based products were promoted as supplements and food products long before 1994 (media references are made to hemp farming by our founding fathers in their writings leading up to the Declaration of Independence!). There are numerous examples of hemp being used in supplements and food products prior to 1994, and for that reason alone, the FDA’s position is suspect when it comes to any outright prohibition of CBD products as dietary supplements.
On the one hand the FDA is categorizing cannabis as well as cannabis derived products such as CBD oils, lotions and gummies as drugs. That in their eyes makes CBD products subject to all the research, testing and clinical trialing that all drugs are subjected to. On the other hand, CBD manufacturers, companies and brands are labelling, distributing and marketing CBD products as a dietary supplement, and freely marketing products that contain less than 0.3% THC nationwide.
And in doing so, they are well within their rights.
According to the DSHEA, a dietary supplement may only describe the role of a nutrient or ingredient if “it affects the normal structure of function of the human body; it characterizes the means by which it acts to maintain such structure or function; the manufacturer has proof that the claim is truthful; and that the statement includes a disclaimer”. You have likely seen this disclaimer on every bottle of vitamins or supplements you have ever used, and it lays out the language that, unlike a drug or medication, the product is not intended to diagnose, treat, or cure any disease. Any dietary supplement that does not use that disclaimer, or make claims how their product can “cure cancer” or any other impermissible claim not backed by science, is and should be regulated by the FDA. These are called structure/function claims, and dietary supplements lose the protections of DSHEA when they make impermissible health claims. There is no dispute that the FDA should and does have the authority to regulate medicinal claims. In this role, the FDA can fulfill its duty to protect consumers from bad actors, while still not extending its authority over legitimate products beyond what Congress intended.
In the end it seems that the issue is partly one of semantics – is CBD a drug or a dietary supplement in the eyes of the FDA, and what actions if any will they take? If a CBD product is going to rely on the protections and freedom associated with classification as a dietary supplement, then the product cannot also make health claims reserved for drugs. Likewise, if a CBD supplement complies with all labeling requirements and the state laws in which it is sold, the FDA should maintain a “hands-off’ approach and not overreach their constitutional authority in the face of product compliance with the existing laws.
No one disputes the FDA’s passion for wanting to protect the American public’s health and safety. In many instances the hemp and CBD industry shares the same concerns of the FDA. All legitimate CBD sellers agree that there are some bad actors out there that need to be stopped, and that drug claims or promises of “cures” for serious disease have no place in the CBD supplement industry. Nor have the cannabis and hemp industries ever disputed the need for regulation in order to ensure the health and safety of the public where dangerous or mislabeled products enter the commercial market. However, the concerning issue comes in with the FDA trying to overreach, not only in their control over the industry and its products, but also in its right and ability to enforce that control. For now, the FDA seems to have adopted a wait and see approach when it comes to actual enforcement, and to their credit, have reached out to Congress for clarification on hemp and its future. While the recent sudden resignation of the FDA Commissioner will likely delay resolution of the outstanding questions, the hope remains that the FDA will retract some of their zealous positions in favor of achieving an end result that protects people’s ability to acquire the hemp products they want for their health.
The FDA is wrong about CBD, and the sooner they realize this, the better for consumers. Isn’t it maybe time they moved away from what seems more like an attempt at keeping their stranglehold over their pharmaceutical fiefdom, than a real concern for the health and safety of the American people?