The FDA is planning to regulate the CBD industry in the very near future, and this regulatory action will likely represent the groundwork for national cannabis law.
Between federal legalization of industrial hemp, accomplished through the 2018 Farm Bill, coupled with the number of states that either have, or are in the process of, legalizing medical and/or recreational marijuana, the FDA is facing a monumental task – to create an effective regulatory system for safe products to enter and remain in the market. There are a number of reasons why this is significant, including the fact that the federal government has never before tried to regulate a plant and its products that have such wide-ranging pharmaceutical & wellness applications. Obviously, the FDA’s decisions will have substantial effects on cannabinoid regulation in general.
The FDA has been skeptical of the rapidly growing cannabis industry, but it is under increasing pressure from Congress to ease the path to market for cannabis-derived products. These products are different from medical marijuana, which a growing number of states allow for treating severe pain, nausea and other ailments. Conservative estimates predict that sales of CBD in the United States could be $16 billion by 2025.
Much of the current concern is the result of the unregulated nature of the market. As with supplements and food, the FDA has established standards that all companies are supposed to follow. Those who violate the rules can be fined or even sued. This approach gives businesses and their employees the flexibility to produce high-quality products without burdensome red tape, but the FDA has made statements suggesting that they could completely end the CBD supplement industry.
CBD is a non-toxic, non-intoxicating, non-habit-forming, neuroprotective antioxidant. Removing CBD-rich hemp extract and hemp-derived products from the retail supplement market would be devastating for people (like me!) who are currently benefitting from daily CBD supplementation. Most people agree that, given CBD’s intrinsic safety & numerous potential health benefits, it should be legally available without a prescription.
In the United States, health agencies have called for more research into potential therapeutic uses, as well as into health risks. The FDA has taken a harder line, pointing out the lack of quality control in the field and stressing the absence of data proving that CBD products are safe, whether they work, and what the proper dosages should be if they do work.
Oversight of cannabis is complex and crosses three federal agencies. The Department of Agriculture is developing a plan to regulate hemp, though the states may also do so if they meet certain criteria. The federal Drug Enforcement Administration (DEA) issues registrations for growing and processing marijuana for medical research. The FDA regulates drugs, including those derived from marijuana.
Congressional hearings held on Friday, May 31, 2019 were the first step in what is likely to be a long process to define a legal path to market for CBD products that the FDA considers safe. During the course of the hearings and information-gathering process, the FDA panel’s questions focused on several key issues that highlight primary areas of concern for the FDA’s CBD Working Group.
Health risks associated with CBD and other cannabis-derived products. The panel repeatedly questioned speakers regarding the safety and efficacy of CBD and requested data to back up claims from some speakers that CBD has been “proven” to be safe. The panel also called upon stakeholders to provide information regarding the presence of heavy metals, pesticides and other potential contaminants in CBD products.
- Proper dosing and delivery methods of CBD products. Testimony from speakers regarding the theoretical establishment of dosing requirements, in general and as affiliated with varying delivery methods (i.e. edible producing, vaping, topical application) was inconsistent. FDA requested more data from stakeholders on this issue.
- Proper labeling. Associated with the dosing issue is the proper labeling of CBD products and the lack of any clear rules.
- The creation of a balanced regulatory scheme that takes into consideration both dietary supplements and prescription drug development. FDA is aware that it must somehow address the growing demand for safe dietary supplements containing CBD with concerns that the supplement market may negatively impact the development of prescription-level CBD-derived drugs.
- Safety issues for “vulnerable” groups. Among the many unknowns, FDA is concerned with the effects of CBD exposure on vulnerable populations such as children, pregnant women, and the elderly
The FDA updated its website (www.fda.gov) on June 19, 2019 to include the following statements regarding CBD and regulation:
When dealing with complex questions like those posed by CBD, the FDA’s top priority is always our mission of protecting and promoting public health. The Agency is committed to science-based decision making when it comes to CBD, while also taking steps to consider if there are appropriate regulatory pathways for the lawful marketing of CBD, outside of the drug setting.
While we recognize the potential benefits of CBD, questions remain regarding its safety. During our review of the marketing application for Epidiolex, we identified certain safety risks, including the potential for liver injury. Furthermore, unsubstantiated therapeutic claims — such as claims that CBD products can treat serious diseases — can lead consumers to put off getting important medical care. Over the past several years, the Agency has issued several warning letters to firms that were marketing unapproved new drugs claiming to contain CBD, including for uses such as treating cancer or Alzheimer’s disease. These products were not approved by the FDA for the diagnosis, cure, mitigation, treatment, or prevention of any disease. Consumers should beware of purchasing and using any such products. The FDA also tested the chemical content of cannabinoid compounds in some of the products, and many were found not to contain the levels of CBD they claimed to contain.
The Agency understands the importance of communicating clearly with the public about our approach to CBD and is taking an Agency-wide, integrated, and collaborative approach to addressing the regulation of products made from CBD that fall under our jurisdiction. Through this work, the FDA is exploring potential pathways for various types of CBD products to be lawfully marketed. An important component of this work is obtaining and evaluating information to address outstanding questions related to the safety of CBD products that will inform the Agency’s consideration of potential regulatory frameworks for CBD while maintaining the FDA’s rigorous public health standards.
Reaction from the industry was positive. "We look forward to the FDA being more open to considering the medical benefits of cannabinoids and examining the research on the subject," said Morgan Fox, director of media relations for the National Cannabis Industry Association.
Erica McBride Stark, executive director for the National Hemp Association, said, "we encourage the FDA to move as quickly as possible to protect the interests of all and welcome the opportunity to bring this important industry out of the shadows. Creating this legal framework will protect both consumers and the industry.