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FDA Advances Work Related to Cannabidiol Products with Focus on Protecting Public Health, Providing Market Clarity

Over the past year, the U.S. Food and Drug Administration has embarked on a comprehensive evaluation of cannabidiol (CBD) products, with a focus on educating the public about the risks and unknowns of these products, gathering the science needed to better understand both these safety concerns and potential benefits to inform our regulatory approach, as well as taking steps when necessary to address products that violate the law in ways that raise a variety of public health concerns.

Today, we are providing updates on our efforts in this area, including several new steps in areas of education, research and enforcement with the ultimate goal of continuing to protect the public health and working to provide market clarity.

Educating the Public About Potential Risks of Using CBD

We’re seeing CBD being marketed in a number of different products, such as oil drops, capsules, syrups, food products, such as chocolate bars and teas, cosmetics and other topical lotions and creams, as well as products marketed for pets and other animals – and we understand consumers are seeking out these novel products for a variety of perceived health-related or other reasons.

But as the agency has stated before, we are concerned that some people wrongly think that the myriad of CBD products on the market have been evaluated by the FDA and determined to be safe, or that using CBD ‘can’t hurt.’ Aside from one prescription drug approved to treat two rare, severe pediatric epilepsy disorders, no other CBD products have been evaluated or approved by the FDA.

We remain focused on educating the public about the number of questions that remain regarding CBD’s safety. There may be risks that need to be considered before using CBD products outside of the monitored setting of a prescription from your health care provider.

In particular, the agency recently updated the public on concerns about potential harm from CBD products, including potential liver injury, interactions with other drugs and male reproductive toxicity, as well as side effects such as drowsiness. In addition, there is still much we do not know about other potential risks. For example, other than the approved prescription drug, we know little about the potential effects of sustained and/or cumulative use of CBD, co-administration with other medicines, or the risks to vulnerable populations like children, pregnant and lactating women, the elderly, unborn children and certain animal populations. This does not mean that we know CBD is unsafe to these populations or under these circumstances, but given the gaps in our current knowledge, and the known risks that have been identified, we also are not at a point where we can conclude that unapproved CBD products are safe for use. We encourage Americans to consult with their health care providers before using CBD products.

We will continue to expand our educational efforts on this front. This includes consumers broadly, specific populations where there are additional, important health considerations, as well as health care professionals who must understand these risks when talking to their patients. We will also continue to update our online resources for consumers, researchers and industry, as well as sustain multiple lines of communication with Congress, industry, researchers and our regulatory partners at the federal, state, local, territorial, tribal and international levels to share and collect needed information and hear a variety of perspectives.

Closing Knowledge Gaps in Both Safety and Potential Benefits

The marketplace for CBD-containing products is quickly evolving and it is critical that we work together with stakeholders and industry to develop high-quality data to close the knowledge gaps about the science, safety and quality of many of these products, as well as further evaluate any potential benefits outside of the one FDA-approved drug product to treat two rare, severe pediatric epilepsy disorders.

To address the questions and concerns we’ve already raised, we’re seeking reliable and high-quality data. This includes data on, among other things: the sedative effects of CBD; the impacts of long-term sustained or cumulative exposure to CBD; transdermal penetration and pharmacokinetics of CBD; the effect of different routes of CBD administration (e.g., oral, topical, inhaled) on its safety profile; the safety of CBD for use in pets and food-producing animals; and the processes by which “full spectrum” and “broad spectrum” hemp extracts are derived, what the content of such extracts is, and how these products may compare to CBD isolate products.

Given the importance of answering these questions, we’re exploring a number of ways to address the data gaps as quickly as possible. This includes encouraging, facilitating and initiating more research on CBD, providing venues for industry and researchers to share new data with the agency and identifying opportunities to further collaborate with our federal partners at Centers for Disease Control and Prevention, Substance Abuse and Mental Health Services Administration and National Institute on Drug Abuse on this important issue.

Importantly, the Agriculture Improvement Act of 2018 – which, among other things, changed federal law so that cannabis and cannabis derivatives with very low levels of the psychoactive intoxicating component of cannabis, delta-9 tetrahydrocannabinol (THC) are no longer controlled substances – has opened significant new opportunities for research, and as that body of research develops and grows, there will be considerably more information available. In particular, there’s been an increased interest in drug development from CBD and other compounds found in cannabis and we are working to support drug development as much as possible.

First, given all the research and activity in this space, we are taking new steps to provide a public and transparent way for stakeholders to provide new and emerging information to us in real time as it becomes available. To this end, in the coming days we are re-opening the public docket we established for our May 2019 public hearing. The docket provides a valuable conduit for submission of scientific data on CBD to the agency, so we have decided to extend the comment period indefinitely to allow the public to comment and to share relevant data with the agency. As the agency continues to move forward to explore viable pathways for CBD products outside the drug context, this extension will allow stakeholders to continue to provide relevant data as research in this area evolves.

This docket also includes a mechanism for a stakeholder to submit data or information that the stakeholder believes to be confidential. We hope that this will enable responsible industry participants, academic researchers, and other stakeholders to share relevant information with the FDA – including information about specific products, which could help inform appropriate regulatory steps.

We also are working to generate data to help inform our work in this area. For example, the FDA’s Office of the Chief Scientist recently awarded a grant to the FDA’s National Center for Toxicological Research to conduct a study to better understand the effects of CBD exposure during pregnancy. Additionally, we’ve initiated a research study in partnership with the University of Mississippi to evaluate the levels of CBD and THC in a sample of cosmetic products to assess sensitization of THC and CBD topically, and dermal penetration.

As data become available that are high-quality, reliable and relevant to our evaluation of CBD products that fall under the FDA’s purview, we will be able to refine – and, perhaps in some cases, revise – our thinking and approaches.

Monitoring the Marketplace with a Focus on Greatest Risk to Public Harm

As we work to educate the public and close the knowledge gaps to further guide our approach to CBD products, we will continue to monitor the marketplace and take appropriate action against unlawful CBD products that pose a risk of harm to the public.

We have seen many CBD products being marketed with claims of therapeutic benefit, such as treating or curing serious diseases such as cancer and Alzheimer’s disease, or other drug claims, without having gone through the drug approval process. The proliferation of such products may deter consumers from seeking proven, safe medical therapies for serious illnesses – potentially endangering their health or life.

We also have serious concerns about products that put the public at risk in other ways. For example, we are aware of the risks posed by product contaminants such as heavy metals, THC or other potentially harmful substances. We also have significant concerns about products marketed with false claims or statements such as omitted ingredients, incorrect statements about the amount of CBD, products marketed for use by vulnerable populations like children or infants, and products that otherwise put the public health at risk.

As we move forward, we are currently evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors the agency intends to take into account in prioritizing enforcement decisions. Any enforcement policy would need to further the goals of protecting the public and providing more clarity to industry and the public regarding the FDA’s enforcement priorities while we take potential steps to establish a clear regulatory pathway.

Conclusion

Our ongoing efforts related to CBD, including the steps we’re announcing today, are in line with our mission to protect the public, foster innovation and promote consumer confidence. We recognize the significant public interest in CBD and we must work together with stakeholders and industry to develop high-quality data to close the substantial knowledge gaps about the science, safety and quality of many of these products. We are committed to working efficiently to further clarify our regulatory approach to these products – as always, using science as our guide and upholding our rigorous public health standards.

FDA Says Most CBD Products May Not Be Safe, and Warns 15 Companies to Stop Selling Them

CBD may pose unknown health risks and cannot be marketed as a dietary supplement, food or therapeutic cure-all.

CBD products may be trendy, but health officials are worried that these products — which are often marketed illegally — may not be safe.

Yesterday (Nov. 26), the U.S. Food and Drug Administration (FDA) issued warning letters to 15 companies that sell CBD products because the products violate federal law. The agency also issued an update to consumers about the popular products, and stressed that there is limited evidence for their safety.

CBD, short for cannabidiol, is a chemical found in cannabis that does not induce a mind-bending high. Although drug developers have long sought to uncover the potential health benefits of CBD, to date, only one CBD product has survived the FDA approval process — a prescription drug to treat rare forms of childhood epilepsy. Nonetheless, consumers can now purchase any number of unapproved CBD products, from oils to chocolate bars to pet foods, from companies that claim their goods deliver therapeutic benefits or help treat disease.

These companies have broken federal law by marketing the unproven health benefits of their CBD products, mixing the drug into food, or advertising CBD as a dietary supplement, the FDA announced yesterday. What’s more, these companies may have placed their customers at unknown risk, the FDA said.

“We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD ‘can’t hurt,'” Dr. Amy Abernethy, the FDA’s principal deputy commissioner, said in a statement. In reality, the FDA does not have enough data to say whether CBD can be “generally recognized as safe,” and several reports raise questions about the unintended health consequences of consuming the compound.

For instance, when scientists first tested the safety of the approved CBD epilepsy drug, they noted that CBD could inflict damage to the liver. If taken without medical supervision, the damage could prove more extensive, the FDA said in a consumer update on cannabis-derived compounds. Several studies indicate that CBD may alter how the body breaks down other drugs, either increasing or decreasing their potency. In addition, studies in animals suggest the compound may impede the function of testes and sperm, deplete testosterone levels and impair male sexual behavior.

Some reports have uncovered contaminants “such as pesticides and heavy metals” in CBD products, the FDA said. Other studies highlight the potential side effects of taking the compound, including sleep disruption, diarrhea, abdominal pain and mood changes. And questions still linger about how repeated CBD exposure might affect someone over time.

Moreover, the compound may trigger unknown effects in vulnerable populations, including pregnant people and children. Some of the companies called out today specifically market products “for infants and children,” who may not metabolize and excrete the drug as adults do, the agency noted.

“As we work quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD, we’ll continue to monitor the marketplace and take action as needed against companies that violate the law in ways that raise a variety of public health concerns,” Abernethy said.

The FDA defines a “drug” as any non-food product intended to treat a disease, have a therapeutic use, or affect the structure or function of the body. By this definition, many CBD products count as drugs and should be subject to the same scrutiny as other pharmaceuticals, Abernethy said. In addition, the FDA will continue to evaluate the safety and regulation of CBD products intended for “non-drug uses,” according to the consumer update.

“This overarching approach regarding CBD is the same as the FDA would take for any other substance that we regulate,” Abernethy said. The agency encouraged consumers to speak with health care professionals about how to treat diseases and conditions with existing drugs, and to be wary of “unsubstantiated claims” associated with CBD products.

The FDA requested that the companies issued letters respond within 15 working days and report how they plan to correct the violations.

The FDA Just Approved a Marijuana-Based CBD Drug for Epilepsy

It’s the first time the FDA has greenlighted a marijuana-derived drug.

The Food and Drug Administration (FDA) made history on Monday: For the first time, it approved the use of a marijuana-derived drug.

The drug, Epidiolex, treats two rare and severe forms of epilepsy in patients ages 2 and older using a purified form of cannabidiol oil (CBD oil), a derivative of cannabis that doesn’t result in a high. GW Pharmaceuticals is producing the drug. In clinical trials, it reduced seizures in people with Dravet syndrome and Lennox-Gastaut syndrome without the harsh side effects of typical epilepsy drugs, which can include nausea, blurred vision and liver problems.

In a press release, FDA Commissioner Scott Gottlieb, MD, makes clear this is not a sweeping legalization of marijuana in general, or any of its other 80 active chemicals:

Proponents of CBD oil say it brings benefits including better sleep, pain management, and depression relief. But the number of people who swear by it aside, CBD oil is classified as a Schedule I drug by the Drug Enforcement Administration (DEA), which means it has no medicinal value. Before GW Pharmaceuticals can market it, the DEA will need to change its classification. (That said, by state law, CBD oil is legal in the 30 US and territories where medicinal or recreational marijuana is legal.)

It also remains to be seen how FDA approval will affect insurance coverage for epileptic patients seeking CBD treatment. For example, at a new (legal) Texas dispensary that made headlines for treating a 2-year-old boy with epilepsy, a 7.5-milliliter bottle costs $105, and is not up for coverage.

The good news? Dr. Gottlieb emphasizes that as long as medical marijuana product developers play by the rules and submit to government drug development programs, this is only the first of many advances for treatments like CBD.

“Drugs derived from marijuana also are eligible for several programs that are intended to facilitate and expedite development and review of new drugs that address unmet medical needs in the treatment of serious or life-threatening conditions,” he says. “The FDA will continue to support rigorous scientific research on potential medical treatments using marijuana and its components that seek to be developed through the appropriate scientific channels.”