Cannabidiol (CBD) in Dietary Supplements: Perspectives on Science, Safety, and Potential Regulatory Approaches

Walker, Larry; Koturbash, Igor; Kingston, Rick; ElSohly, Mahmoud A.; Yates, Charles R.; Gurley, Bill J.; Khan, Ikhlas A.

doi:10.1080/19390211.2020.1777244

Cited by 31 publications

(26 citation statements)

References 21 publications

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“…It is important to note that the large variability in CBD formulations, the inaccuracy in their content of active ingredients, and their quality or potential contaminants make the consumption of these products very risky even for healthy individuals who use them as dietary or health supplements. 31 The number of Warning Letters for illicitly marketing CBD experienced a marked increase in 2019 compared with previous years. There are multiple reasons that could explain this sharp increase, including the surge of new CBD products that came to the market as a result of the Farm Bill, 3 as well as new cannabis legal programs that were enacted in multiple states since 2015.…”

Section: Analysis Of Fda Warning Letters For Cbd Claims 3 Discussionmentioning

confidence: 99%

Health Claims About Cannabidiol Products: A Retrospective Analysis of U.S. Food and Drug Administration Warning Letters from 2015 to 2019

Wagoner

Lazard

Romero‐Sandoval

et al. 2021

Cannabis and Cannabinoid Research

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Background: Cannabidiol (CBD) products are increasingly available to consumers in the United States and are subject to regulation by the U.S. Food and Drug Administration (FDA). CBD products cannot be marketed as unapproved new drugs with claims of therapeutic benefit. In addition, because CBD is the active ingredient in a FDA-approved CBD product, Epidiolex, CBD cannot be marketed as, or in, food products or dietary supplements. The FDA has issued Warning Letters to promote voluntary regulatory compliance. These letters provide insights as to the types of violations for CBD products detected in the U.S. market. Objective: The goal of this retrospective study was to content analyze Warning Letters issued by the FDA to identify illicit marketing of CBD products. Design: Warning Letters issued by the FDA between 2015 and 2019 were content analyzed using a deductive approach. We extracted year of issuance, issuing office, and claim types that are currently prohibited by the FDA, including (i) unapproved new drug, (ii) misbranded drug, (iii) false and/or misleading, (iv) FDA-approved/ endorsed, (v) dietary supplement, and (vi) adulterated food product. In addition, we documented the disease or conditions the product claimed to affect, pharmacological effects, and location of violation. Results: Of the 39 Warning Letters issued, 97% were for violations made on company websites and 56% were for social media accounts. Almost all letters (97%) cited violations of marketing CBD as an unapproved new drug. These illicit therapeutic claims were made for > 125 unique health problems, including cancer (87.2%), diabetes (71.8%), inflammation (66.7%), pain (66.7%), and arthritis (66.7%). The majority of letters (79.5%) also cited illicit marketing of CBD as a dietary supplement or food product. CBD was promoted as having 16 unique pharmacological effects, including anti-inflammatory (53.8%), anticancer (43.6%), and antipsychotic (30.8%). Conclusions: CBD products have been unlawfully advertised online as unauthorized drugs with health claims that promote therapeutic benefits and as dietary supplements. Efforts are needed to regulate and monitor illicit advertising so consumers are not misled about the risks and benefits of CBD use.

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Section: Analysis Of Fda Warning Letters For Cbd Claims 3 Discussionmentioning

confidence: 99%

Health Claims About Cannabidiol Products: A Retrospective Analysis of U.S. Food and Drug Administration Warning Letters from 2015 to 2019

Wagoner

Lazard

Romero‐Sandoval

et al. 2021

Cannabis and Cannabinoid Research

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“…In the opening article for this Special Issue, Walker and colleagues provide their opinion on the perspectives on science, safety, and potential regulatory approaches for CBD in the United States (Walker et al 2020). The authors note that the observed rapid expansion of marketed consumer CBD products, paralleled by the wide-ranging disease treatment claims, and the prevalence of substandard or even adulterated products, pose a serious public health and regulatory dilemma.…”

Section: Regulatory Aspectsmentioning

confidence: 99%

“…The goals of this program will be the identification of competent manufacturers and aiding with bringing their quality products to the market; ensuring there is a robust safety surveillance system; collaborative efforts with U.S. FDA in implementation of a regulatory reporting framework that shares the findings related to the program experience. This approach would consider establishing collaboration with trade organizations, manufacturers, academia, and nonprofit standards organizations (Walker et al 2020).…”

Section: Regulatory Aspectsmentioning

confidence: 99%

Cannabidiol and Other Cannabinoids: From Toxicology and Pharmacology to the Development of a Regulatory Pathway

Koturbash

Mackay

2020

Journal of Dietary Supplements

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Cannabidiol (CBD) is a non-psychotropic constituent of Cannabis sativa that has grown in popularity during the last decade. CBD is the active component of EPIDIOLEXV R , a U.S. Food and Drug Administration (FDA)-approved drug designed for the treatment of drug-resistant pediatric epileptic seizures associated with several rare syndromes. Furthermore, CBD has been proposed as a treatment for a number of other diseases for which clinical trials are now ongoing. Accumulating evidence indicates that the number of "CBD-containing" products, available mostly online, is growing exponentially. However, the U.S. FDA currently prohibits sales of CBD as a dietary supplement (DS) or ingredient in conventional food. Further, clear federal regulatory and quality oversight does not exist, which has led to an uncontrolled CBD market that, in turn, threatens to result in negative health effects experienced by a trusting public. Thus, there are open questions demanding answers in the very near future: For which medical purposes is CBD provably effective? Can it be used safely as a non-prescription product? At what level? Is a hemp extract that contains CBD a different ingredient than isolated CBD? Is CBD safe for everyone? What is a future path for hemp products with CBD as well as for other cannabinoids? Should CBD be allowed as a drug only, or is there a way for hemp extracts to be listed as a dietary supplement and food ingredient? This Special Issue, the first of its kind on CBD and other phytocannabinoids, is devoted to answering those and other questions by publishing articles in the fields of pharmacology, toxicology, and regulation.

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“…We have included this information into a new version (version 3; v3 13 ) of our article 2 to strengthen our arguments. Besides the mentioned human evidence, experimental research in vivo and in vitro resulted in concerns about hepatotoxicity 14 , teratogenicity 15 , and gut inflammation 16 .…”

Section: Side Effects Of Cbd Productsmentioning

confidence: 99%

Evidence for side effects of cannabidiol (CBD) products and their non-conformity on the European food market – response to the European Industrial Hemp Association

Lachenmeier

Walch

2020

F1000Res

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An interesting and valuable discussion has arisen from our recent article (Lachenmeier et al., 2020) and we are pleased to have the opportunity to expand on the various points we made. Equally important, we wish to correct several important misunderstandings that were made by Kruse and Beitzke (2020) on behalf of the European Industrial Hemp Association (EIHA) that possibly contributed to their concerns about the validity of our data, toxicological assessment and conclusions regarding regulatory status of cannabidiol (CBD) products. First and foremost, our study did only assess the risk of psychotropic Δ9-tetrahydrocannabinol (THC) without inclusion of non-psychotropic Δ9-tetrahydrocannabinolic acid (THCA). Secondly, as this article will discuss in more detail, there is ample evidence for side effects of CBD products, not only in paediatric patients, but also in adult users of over-the-counter CBD products (including inadvertent “high” effects). Thirdly, the exposure and risk assessment was conducted using up-to-date guidelines according to the European Food Safety Authority (EFSA) and the German Federal Institute for Risk Assessment (BfR). And finally, the current legal situation in the European Union, without approval of any hemp extract-containing product according to the Novel Food regulation, actually allows blanket statements that all such products are illegal on the market, and this indeed would imply a general ban on the use and marketing of such products as food or food ingredients until such an approval has been granted. We hope that this reassures the F1000Research readership regarding the validity of our results and conclusions. We are pleased, though, that the EIHA has acknowledged the fact that there are non-compliant CBD products available, but according to our data these are a substantial fraction of the market.

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Cannabidiol (CBD) in Dietary Supplements: Perspectives on Science, Safety, and Potential Regulatory Approaches

Cited by 31 publications

References 21 publications

Health Claims About Cannabidiol Products: A Retrospective Analysis of U.S. Food and Drug Administration Warning Letters from 2015 to 2019

Health Claims About Cannabidiol Products: A Retrospective Analysis of U.S. Food and Drug Administration Warning Letters from 2015 to 2019

Cannabidiol and Other Cannabinoids: From Toxicology and Pharmacology to the Development of a Regulatory Pathway

Evidence for side effects of cannabidiol (CBD) products and their non-conformity on the European food market – response to the European Industrial Hemp Association

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