In recent years, CBD (cannabidiol) has rapidly gained popularity in the health and wellness industry, positioned as a versatile treatment for a multitude of conditions including pain, anxiety, stress, sleep disorders, diabetes, acne, depression, and even cancer, according to some bold claims.
However, limited research does not support most of these claims about its therapeutic properties. The growing interest in CBD, which began in 2019 on the wave of herbal supplements' popularity and the spread of marijuana legalization, has increased significantly during the coronavirus pandemic as people look for ways to cope with the new stress. In 2022, sales of CBD products in the U.S. totaled $4.17 billion, and it is predicted that the market could quadruple by 2026.
Today, CBD can be purchased in a variety of forms, including oils, vapes, tinctures, and edibles — all available in stores, gas stations, and tobacco stores across the country. Products such as CBD bath bombs and dog treats are also available online; CBD-infused beverages and sweets have become an integral part of everyday life. Things like nail polish or toothpicks with CBD are also available on the market, and some manufacturers even offer pillows and bedding with this component to improve sleep. No wonder there is a «Wild West» spirit in this fast-growing segment.
However, the legal status of CBD in the country remains unclear, as it is in a gray area of federal law. All substances advertised as supplements or food products must meet safety standards set by the Food and Drug Administration (FDA).In this context, manufacturers and marketers of CBD face a difficult task, as products containing it have never received FDA approval.
However, the legal status of CBD in the country remains unclear, as it is in a gray area of federal law. All substances advertised as supplements or food products must meet safety standards set by the Food and Drug Administration (FDA).In this context, manufacturers and marketers of CBD face a difficult task, as products containing it have never received FDA approval.
The FDA has for years failed to provide clear guidance on the regulation and labeling of CBD in supplements and foods, resulting in semi-legal tinctures and gummy candies on store shelves that use the unclear status for marketing. The agency has warned companies and consumers against unproven claims of health benefits, reiterating that CBD does not meet the definition of a food additive. This position was criticized by marketers and consumers as demand for CBD only grew. In the absence of regulation, consumers cannot be sure of the composition of products purchased at gas stations, for example.
The FDA recently issued a ruling on CBD that could have a major impact on the industry. It rejected three petitions for guidance, arguing that existing safety standards are insufficient to regulate CBD. The FDA has expressed doubts about the safety of products containing CBD, especially with long-term use, and said the problem requires congressional attention.
The FDA recently issued a ruling on CBD that could have a major impact on the industry. It rejected three petitions for guidance, arguing that existing safety standards are insufficient to regulate CBD. The FDA has expressed doubts about the safety of products containing CBD, especially with long-term use, and said the problem requires congressional attention.
«We have not established sufficient evidence to determine a safe dose or duration of consumption of CBD before it can cause harm» — said Janet Woodcock, FDA deputy commissioner. She noted that a new pathway is needed to balance the regulation of CBD to ensure access to the products while maintaining the necessary precautions. The agency intends to work with Congress to create a new regulatory framework for CBD.
Recent years have been a time of innovation for the CBD industry, although government regulation has not kept pace with growing demand. Now the question remains: will the FDA's announcement change the way manufacturers view the market or lead to a dip in clandestine operations while federal regulation is pending?
Why have there been problems with the regulation of CBD?
Cannabidiol (CBD) is a bioactive component found in the cannabis plant and is the second most common cannabinoid after tetrahydrocannabinol (THC). Unlike THC, CBD does not produce the euphoric effects associated with marijuana, which has made it particularly popular in recent years. This factor allows consumers to derive potential medical benefits from cannabis without the perceived psychoactive effects.
It is worth noting that all varieties of hemp are cannabis, but not all hemp is considered marijuana. With the passage of the 2018 Farm Bill legalizing hemp (defined as cannabis with THC content below 0.3%) and its derivatives, including CBD, new business opportunities have arisen, as legalization and THC-related restrictions were not in place.
Cannabidiol (CBD) is a bioactive component found in the cannabis plant and is the second most common cannabinoid after tetrahydrocannabinol (THC). Unlike THC, CBD does not produce the euphoric effects associated with marijuana, which has made it particularly popular in recent years. This factor allows consumers to derive potential medical benefits from cannabis without the perceived psychoactive effects.
It is worth noting that all varieties of hemp are cannabis, but not all hemp is considered marijuana. With the passage of the 2018 Farm Bill legalizing hemp (defined as cannabis with THC content below 0.3%) and its derivatives, including CBD, new business opportunities have arisen, as legalization and THC-related restrictions were not in place.
However, regulation of CBD faces the same challenges as THC: active cannabinoid research in the U.S. is virtually non-existent due to the ongoing federal prohibition of marijuana. The Drug Enforcement Agency restricts marijuana cultivation for scientific purposes, and the slow process of legalization prevents scientists from studying the medical benefits and risks associated with cannabinoids, leaving agencies such as the FDA without sufficient information to make informed regulatory decisions.
CBD has been linked to efficacy in seizure prevention, enabling the FDA to approve Epidiolex, a drug containing CBD as the active ingredient. This is why the FDA avoids regulating other products with CBD. Under the regulations, if a substance such as THC or CBD is used in a clinical drug, other products containing that ingredient cannot be considered dietary supplements. This has led to the rule that CBD cannot be used in food and beverages, including dog treats.
Last August, two sides of Congress expressed frustration over the FDA's lack of response to the CBD regulatory initiative. With the transfer of oversight from the FDA to Congress, the CBD industry is hoping for a change on this issue. US Hemp Roundtable's chief counsel, Jonathan Miller, said the bill will be re-proposed in the House and Senate in the coming weeks, and disagreed with the FDA, assuring that Congress must act.
Miller also believes that the FDA's attachment to CBD as a pharmaceutical drug is misguided. He pointed out that the FDA emphasizes the side effects of high doses of CBD, while studies show that lower doses consumed by store-bought products usually have no side effects.
According to Olivia Alexander, founder and CEO of leading health brand Kush Queen, over-the-counter access to CBD products is essential for those who use them in their health regimen, especially in states with limited access to legal cannabis. Alexander emphasizes the importance of her company's lab testing and points out the need for regulation within the industry.
In 2019, the National Cannabis Industry Association (NCIA) submitted a paper outlining the need for a clear regulatory structure for CBD, including proper labeling and criteria for health benefit claims. NCIA Communications Director Bethany Moore emphasizes that regulation is necessary to protect public health, but does not pose a significant safety risk.
Hemp producers have experienced significant impacts due to federal inaction. Some experts argue that the FDA's lack of regulation has caused hemp prices to plummet, which in turn has jeopardized farmers' profitability. Miller notes that since the passage of the 2018 Farm Bill, which legalized hemp production, cannabis and CBD biomass prices have dropped by more than 95%. He hopes a bipartisan initiative to help farmers will find support in Congress.
Grey market confusion
The FDA often declines reporters' requests for interviews when the topic concerns the fate of existing products, such as whether they will be taken off the shelves and whether the agency will continue to send warnings to CBD companies promoting its health benefits. Given the slowness of federal regulators, the CBD market is likely to remain active in the near future despite the lack of responses from the FDA.
Hemp producers have experienced significant impacts due to federal inaction. Some experts argue that the FDA's lack of regulation has caused hemp prices to plummet, which in turn has jeopardized farmers' profitability. Miller notes that since the passage of the 2018 Farm Bill, which legalized hemp production, cannabis and CBD biomass prices have dropped by more than 95%. He hopes a bipartisan initiative to help farmers will find support in Congress.
Grey market confusion
The FDA often declines reporters' requests for interviews when the topic concerns the fate of existing products, such as whether they will be taken off the shelves and whether the agency will continue to send warnings to CBD companies promoting its health benefits. Given the slowness of federal regulators, the CBD market is likely to remain active in the near future despite the lack of responses from the FDA.
While the industry waits for Congress to begin drafting new regulations, stores and online retailers that sell CBD report that they continue to operate unchanged. Employees at such stores in Rhode Island, Massachusetts, New York, Kentucky and Missouri, were often not even aware of the FDA's announcement. For example, an employee at a CBD Kratom store in New York said he hadn't noticed any changes. And a representative at CBD World in Warwick, Rhode Island, also confirmed that he hasn't seen any changes in his work so far.
An employee at SunMed CBD in Worcester, Massachusetts, said this was the first time he'd heard about the issue, adding that most customers don't realize that CBD is not subject to regulation by the FDA. He noted that if customers inquire about the safety of CBD, they are advised to consult a physician, especially if they are taking prescription drugs. In addition, lab results are available for all products, including data on cannabinoids, terpenes, and the presence of pesticides, herbicides, and heavy metals.
Alex Valle, owner of SunMed CBD, expressed surprise at the FDA's announcement, adding that regulation is long overdue.He expressed hope for progress, arguing that cannabis use has a long history.
Hemp and cannabis advocates hope the FDA's decision will push Congress to reasonably regulate CBD and other cannabis products. For most suppliers, however, the situation remains business as usual. As Alexander of Kush Queen pointed out, the FDA's announcement has had no impact on their business.
For now, consumers are left with the choice of using CBD products or waiting for further data and clear regulation.