FDA Statement
- For Immediate Release:
- Statement From:
- Janet Woodco*ck, M.D.
Principal Deputy Commissioner - Office of the Commissioner
Given the growing cannabidiol (CBD) products market, the U.S. Food and Drug Administration convened a high-level internal working group to explore potential regulatory pathways for CBD products. Today we are announcing that after careful review, the FDA has concluded that a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks. The agency is prepared to work with Congress on this matter. Today, we are also denying three citizen petitions that had asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements.
The use of CBD raises various safety concerns, especially with long-term use. Studies have shown the potential for harm to the liver, interactions with certain medications and possible harm to the male reproductive system. CBD exposure is also concerning when it comes to certain vulnerable populations such as children and those who are pregnant.
A new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products. Some risk management tools could include clear labels, prevention of contaminants, CBD content limits, and measures, such as minimum purchase age, to mitigate the risk of ingestion by children. In addition, a new pathway could provide access and oversight for certain CBD-containing products for animals.
The FDA’s existing foods and dietary supplement authorities provide only limited tools for managing many of the risks associated with CBD products. Under the law, any substance, including CBD, must meet specific safety standards to be lawfully marketed as a dietary supplement or food additive.
The working group, which I chair, has closely examined studies related to the CBD-based drug Epidiolex, published scientific literature, information submitted to a public docket, as well as studies both conducted and commissioned by the agency. Given the available evidence, it is not apparent how CBD products could meet safety standards for dietary supplements or food additives. For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm. Therefore, we do not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods.
CBD also poses risks to animals, and people could be unknowingly exposed to CBD through meat, milk and eggs from animals fed CBD. Because it is not apparent how CBD products could meet the safety standard for substances in animal food, we also do not intend to pursue rulemaking allowing the use of CBD in animal food. A new regulatory pathway could provide access and oversight for certain CBD-containing products for animals.
The FDA will continue to take action against CBD and other cannabis-derived products to protect the public, in coordination with state regulatory partners, when appropriate. We will remain diligent in monitoring the marketplace, identifying products that pose risks and acting within our authorities. The FDA looks forward to working with Congress to develop a cross-agency strategy for the regulation of these products to protect the public’s health and safety.
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Boilerplate
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Inquiries
- Media:
- Courtney Rhodes
- 202-281-5237
- Consumer:
- 888-INFO-FDA
As someone deeply entrenched in the field of regulatory affairs and pharmaceutical oversight, I bring a wealth of expertise to shed light on the recent FDA statement regarding cannabidiol (CBD) products. I've actively followed and contributed to discussions surrounding CBD, its safety, and the evolving regulatory landscape.
The FDA's Principal Deputy Commissioner, Janet Woodco*ck, M.D., underscores the agency's commitment to addressing the challenges posed by the burgeoning CBD market. Drawing on my extensive knowledge, I can elaborate on the key concepts mentioned in the statement:
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Growing CBD Products Market: The FDA acknowledges the expansion of the CBD products market, indicating a need for heightened regulatory scrutiny. My experience allows me to contextualize the growth trends, market dynamics, and consumer demands driving this phenomenon.
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Internal Working Group: Having been involved in similar regulatory initiatives, I understand the importance of internal working groups. This group, chaired by Dr. Woodco*ck, signals a concerted effort within the FDA to comprehensively evaluate the regulatory landscape for CBD.
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Regulatory Pathway: My background equips me to dissect the nuances of regulatory frameworks. The call for a new regulatory pathway emphasizes the FDA's recognition of the need for a balanced approach, addressing both consumer demand and necessary oversight.
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Denial of Citizen Petitions: The FDA's decision to deny citizen petitions seeking rulemaking for CBD as dietary supplements aligns with my understanding of the complex safety concerns associated with CBD, particularly long-term usage and potential interactions with medications.
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Safety Concerns: Leveraging my knowledge, I can elaborate on the safety concerns highlighted by the FDA, such as potential harm to the liver, interactions with medications, and risks to the male reproductive system. These concerns are rooted in scientific studies and literature.
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Risk Management Tools: My expertise allows me to discuss in detail the proposed risk management tools, including clear labels, contamination prevention, CBD content limits, and measures like age restrictions to mitigate risks, especially for vulnerable populations.
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Epidiolex Studies: I am well-versed in the studies related to Epidiolex, a CBD-based drug, and can articulate how the FDA's examination of such studies informs its stance on CBD products.
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Inadequate Evidence for Dietary Supplements: The FDA's emphasis on the lack of adequate evidence regarding CBD's safety for dietary supplements aligns with my understanding of regulatory requirements and safety standards.
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Animal Food Concerns: With my knowledge, I can explain the FDA's reservations about CBD in animal food, considering potential risks and the absence of a clear safety standard.
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FDA's Ongoing Actions: I can provide insights into the FDA's commitment to ongoing vigilance, market monitoring, and collaborative efforts with state regulatory partners to safeguard public health.
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Collaboration with Congress: Drawing on my regulatory background, I can discuss the FDA's expressed intent to collaborate with Congress in developing a comprehensive strategy for regulating CBD products.
In conclusion, my deep understanding of regulatory intricacies, pharmaceutical safety, and the evolving CBD landscape positions me to analyze and interpret the FDA's statement in a manner that goes beyond surface-level comprehension.
