Since the Farm Bill of 2018 changed the definition and regulatory status of hemp from an agricultural perspective, confusion and misinformation has been rife on the U.S. Food and Drug Administration (FDA) regulatory status of hemp and its products—including cannabidiol (CBD), a non-psychoactive cannabinoid.  Despite there not being a clear basis for concluding that CBD has an appropriate FDA regulatory status for use in food, CBD has gained mass popularity, and it is not uncommon to see CBD sold in chocolate, oils, and even pet treats in your local stores.  In this article we have summarized the current status of CBD in food and dietary supplements and the hurdles that lie in the path of supporting a suitable FDA status for such uses.

Impact of 2018 Farm Bill

When Congress passed the 2018 Farm Bill (formally known as the Agriculture Improvement Act of 2018), there was widespread misunderstanding that the law legalized substances derived from the Cannabis sativa L. plant, including CBD, for use in food and dietary supplements.  In fact, the relevant provisions of the Farm Bill merely removed hemp from the Controlled Substances Act definition of marijuana.  The 2018 Farm Bill defined “hemp” as Cannabis sativa L. with less than 0.3% tetrahydrocannabinol (THC, a psychoactive component of cannabis) on a dry weight basis[1] and affected the Drug Enforcement Administration’s authority over hemp farming.  The change granted more authority to states to regulate the growth, production, and distribution of hemp products.

The 2018 Farm Bill had no effect on FDA’s authority to regulate CBD or other hemp products; it also did not change the regulatory definitions of “food additive” and “dietary ingredient” to facilitate the use of ingredients like CBD in food and dietary supplements.[2]  FDA continues to have authority to regulate products containing cannabis and cannabis-derived compounds, including those classified as hemp.[3]  Therefore, CBD is subject to the same regulatory requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA) as other food additives and new dietary ingredients.

Current FDA Position on CBD

FDA has consistently taken the position that it is unlawful to sell a food or dietary supplement containing CBD in interstate commerce because CBD is not eligible for use in those products under the FFDCA, as CBD had been studied for possible “drug” uses before it was marketed in foods or dietary supplements.  These clinical studies led to FDA’s 2018 approval of Epidiolex, which contains a purified form of CBD, as a drug for use in the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome.  Pursuant to Section 301(ll) of the FFDCA, FDA is taking the position that it is unlawful to market foods that contain an added “drug” that has been approved by FDA or “for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public.”   (While there are exceptions for substances that were in foods before they were approved or studied as drugs, such as caffeine or baking soda, FDA has determined that CBD does not fall under such exceptions.[4])  Likewise, FDA has cited Section 201(ff)(3)(B)(i) of the FFDCA, which explicitly excludes approved drugs or those substances that are the subject of publicly-disclosed clinical studies, from the definition of “dietary ingredients,” as being the basis for CBD not being permitted for use in dietary supplements.  Thus, FDA’s current position is that marketing foods or supplements containing CBD violates the FFDCA and, because of this, that such products are adulterated.

That said, FDA thus far has taken enforcement action only against foods and supplements containing CBD when such products make drug claims concerning the prevention, diagnosis, mitigation, treatment, or cure of disease.  Specifically, FDA has sent warning letters to a number of companies making claims that CBD can treat conditions such as cancer, Alzheimer’s disease, opioid withdrawal, pain, pet anxiety, arthritis, and other conditions.[5]

In early March 2020, FDA released a Congressionally requested report[6] on the agency’s progress toward developing a regulatory framework to allow CBD in conventional foods and dietary supplements.  To the frustration of many, however, it appears that little actual progress has been made.  The most significant revelation from the report is that FDA is considering developing a risk-based enforcement policy that could clarify FDA’s enforcement priorities.  Given the widespread availability of such products, however, an informal policy of enforcement discretion has essentially been in place for some time.

Congress Tries to Intervene

FDA has received considerable pressure from Congress, particularly members like Senate Majority Leader Mitch McConnell of Kentucky whose states have invested in hemp agriculture,[7] to permit CBD to be legally sold in foods and supplements.  In September 2019, bipartisan Congress members sent a letter to FDA urging the Agency to provide legal clarity and establish a regulatory pathway for food products containing hemp-derived CBD.[8]  They expressed concern with FDA’s estimate that rulemaking on this topic could take between 3 to 5 years and asked for more expeditious measures, like announcing a policy of enforcement discretion and using an interim rule to establish a regulatory framework.  Several bills have been introduced to create a legislative fix for this issue.  One proposed solution, outlined in a H.R. 5587 introduced by Representative Collin Peterson of Minnesota, would amend Section 201(ff)(3)(B)(i) of the FFDCA (discussed above) to exempt “cannabidiol or a hemp-derived cannabidiol containing substance” from the prohibition on marketing approved drugs as dietary supplements.

Lack of Safety Data

As of yet, there have been no proposed Congressional fixes that address the second hurdle to an appropriate FDA status for CBD:  the definitions of “food additive,” “new dietary ingredient,” and related definitions of adulteration in the FFDCA.  These aspects of the law require FDA to evaluate CBD based on a robust safety data set and do not provide FDA with the authority to authorize CBD for use in food and dietary supplements in the absence of such information.

“Food additive” is defined under Section 201(s) of the FFDCA as substances that are intended, or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food.  While food additives require FDA premarket clearance so as not to be found to adulterate food, there is an exemption from the definition of “food additive” for substances that are “generally recognized as safe” (GRAS) for their intended use.  GRAS status can be supported by either common use in food prior to 1958 (which is not relevant to CBD) or general recognition of safety through scientific procedures—generally requiring the availability of published safety studies in peer-reviewed journals.  Similarly, supplements containing new dietary ingredients are considered adulterated unless they contain only ingredients “present in the food supply as an article used for food in a form in which the food has not been chemically altered” or if, 75 days before marketing, the company submits to FDA evidence to show the dietary ingredient “will reasonably be expected to be safe” for human consumption under labeled conditions of use.  In any case (i.e., to obtain premarket clearance or to support a GRAS position), there must be a robust data set supporting the safety of CBD for use in food.  While FDA has had no questions concerning the use of hulled hemp seeds, hemp seed protein, and hemp seed oil as ingredients for use in human food based on existing safety data,[9] to FDA’s knowledge, there are not adequate safety data for CBD.[10]

Setting aside the lack of safety data, FDA is aware of potentially adverse safety data regarding CBD.  FDA has noted that taking CBD may increase or decrease the effects of other medications, as well as the risk of liver injury (a side effect observed in its review of Epidiolex).[11]  Studies performed on laboratory animals found potential male reproductive toxicity concerns (e.g., a decrease in testicular size, inhibition of sperm development, and decreased testosterone).[12]  Any safety data developed to support CBD’s safety would also need to adequately address these adverse data to satisfy FDA’s requirements for the safety of food additives and new dietary ingredients.

The current regulatory framework under the FFDCA does not allow FDA to affirmatively evaluate the safety of CBD for use in foods and supplements, nor does FDA have funding to sponsor the necessary studies to support the safety of CBD.  Rather, FDA is waiting for the necessary safety data to be developed to evaluate CBD’s safety.  While FDA held a public hearing on cannabis in May 2019 and opened a public docket to gather comments and data for FDA review (through which the Agency received approximately 4,500 comments), FDA has yet to receive the necessary safety information to allow it to agree that CBD has a suitable status for use in food and dietary supplements.[13]

What about the States?

For the foreseeable future, it does not appear that CBD will have a suitable FDA status for use in food and supplements, and cannabis containing more than 0.3% THC remains an illegal narcotic under the Controlled Substances Act.[14]  But how are states handling this issue?

The legality of cannabis state regulation is varied.  Some states, like California and Colorado, have completely legalized recreational cannabis, which includes CBD products.  Other jurisdictions, such as Vermont and Washington, DC, have legalized marijuana but do not allow sales.  Others have decriminalized it or only allow medical use.[15]  A number of states, like Texas and Wisconsin, continue to regulate marijuana as an illegal drug.  Individual states handle issues such as age restrictions, dosage, labelling, testing, and licensing of marijuana differently.  Further complicating matters, individual cities and counties can impose different rules, with some completely banning the growing, manufacturing, and selling of cannabis.  As a result, in many jurisdictions, there is a conflict between the federal government and states that permit the marketing of CBD products.

*                             *                             *

Regulations concerning CBD remain in flux.  It remains to be seen how Congress and FDA will address the legality of CBD in food and dietary supplements under the FFDCA.  However, the CBD industry should be aware that robust safety data will most likely be required to ultimately convince FDA to permit CBD in food and dietary supplements.  This endeavor will take a considerable amount of time and financial resources and will need to overcome existing data on adverse health effects.    Despite these issues, we expect to continue to see CBD readily available in food and dietary supplements, provided that such products do not bear drug claims.

This article was first published in the April-June 2020  issue of West Coast Industrial Solutions’ magazine and is republished here with permission.

 


[1]  What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD; FDA (March 5, 2020), available at: https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis

[2] Contrary to Popular Reports, Farm Bill Will Not Affect FDA Status of CBD; Daily Intake, Keller and Heckman (December 13, 2018), available at: https://www.dailyintakeblog.com/2018/12/contrary-to-popular-reports-farm-bill-will-not-affect-fda-status-of-cbd/

[3] Remarks at the National Industrial Hemp Council 2019 Hemp Business Summit; FDA (August 12, 2019), available at:  https://www.fda.gov/news-events/speeches-fda-officials/remarks-national-industrial-hemp-council-2019-hemp-business-summit-08132019

[4] FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns; FDA (November 25, 2019), available at:  https://www.fda.gov/news-events/press-announcements/fda-warns-15-companies-illegally-selling-various-products-containing-cannabidiol-agency-details

[5] Id.  See also FDA warns company marketing unapproved cannabidiol products with unsubstantiated claims to treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety (July 23, 2019), available at:  https://www.fda.gov/news-events/press-announcements/fda-warns-company-marketing-unapproved-cannabidiol-products-unsubstantiated-claims-treat-cancer.

[6] Report to the U.S. House Committee On Appropriations and the U.S. Senate Committee on Appropriations – Cannabidiol (CBD) – Report in Response to Further Consolidated Appropriations Act, 2020 – U.S. Food and Drug Administration (undated) (public existence disclosed on March 5, 2020), available at: https://hempsupporter.com/assets/uploads/FDA-CBD-Report.pdf.

[7] Senator Mitch McConnell, Leader McConnell Discusses Tobacco 21 Legislation, Hemp and CBD with FDA Commissioner Nominee (November 20, 2019), available at:  https://www.republicanleader.senate.gov/newsroom/press-releases/leader-mcconnell-discusses-tobacco-21-legislation-hemp-and-cbd-with-fda-commissioner-nominee.

[8] Congress Continues to Seek Regulatory Clarity on CBD from FDA; Daily Intake, Keller and Heckman (September 24, 2019), available at: https://www.dailyintakeblog.com/2019/09/congress-continues-to-seek-regulatory-clarity-on-cbd-from-fda/

[9] Remarks at the National Industrial Hemp Council 2019 Hemp Business Summit; FDA (August 12, 2019), available at:   https://www.fda.gov/news-events/speeches-fda-officials/remarks-national-industrial-hemp-council-2019-hemp-business-summit-08132019

[10] FDA, FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD) (March 11, 2020), at https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd.

[11] What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD; FDA (March 5, 2020), available at:https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis

[12] Id.

[13] Id.

[14] Cannabis remains a Schedule 1 drug under the Controlled Substances Act. This means that it cannot be used on federal lands within the states as it remains unlawful under federal law.  Let’s Talk Cannabis; California Department of Public Health (November 17, 2017), available at: https://www.cdph.ca.gov/Programs/DO/letstalkcannabis/Pages/legal.aspx.  This is because of the Cole memorandum that was issued in 2013. The memorandum was sent to all United States Attorneys that the Justice Department would not enforce the federal marijuana prohibition on states that legalized marijuana in some form and implemented effective enforcement systems.  Cole Memorandum; U.S. Department of Justice (August 29, 2013), available at: https://www.justice.gov/iso/opa/resources/3052013829132756857467.pdf.  After a brief rescission of the Cole Memorandum by Attorney General Jeff Sessions in 2018, current U.S Attorney General William Barr made a pledge not to go after companies growing or manufacturing marijuana that was in compliance with state laws and with the Cole Memorandum. Cannabis Quick Hits; Daily Intake, Keller and Heckman (February 1, 2019), available at: https://www.dailyintakeblog.com/2019/02/cannabis-quick-hits/.

[15] About Marijuana; NORML (last accessed March 11, 2020), available at:  https://norml.org/marijuana

 

Reposted from Keller and Heckman’s Blog, The Daily Intake

 

  • As previously reported in this blog, the 2018 Farm Bill removed hemp – defined as Cannabis sativa L. with less than 0.3% THC on a dry weight basis – from the definition of “marijuana.” As a result, while marijuana remains a Schedule I drug, hemp is no longer a controlled substance under Federal law. However, since CBD has been approved for use in the drug Epidiolex, the Federal Food, Drug, and Cosmetic Act (FD&C Act) has prohibited adding it to a food or a dietary supplement.  Epidiolex is a liquid formulation of pure plant-derived CBD.
  • GW Pharmaceuticals PLC, the manufacturer of Epidiolex, recently submitted a supplemental New Drug Application (sNDA) to expand the label of its Epidiolex cannabidiol oral solution, CV, to include the treatment of seizures associated with Tuberous Sclerosis Complex (TSC). Epidiolex is currently approved in the U.S. for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome. The submission is supported by data from a favorable Phase 3 safety and efficacy study conducted in 2019, which showed that Epidiolex reduced TSC-associated seizures by roughly 48% from baseline. The Phase 3 study also demonstrated that the observed safety profile was consistent with data from prior studies.
  • TSC is a rare genetic disorder that causes predominantly benign tumors to grow in various vital body organs such as the brain, heart, kidneys, and lungs. Affecting more than 40,000 people in the U.S. and nearly one million people around the world, TSC is a leading cause of genetic epilepsy today. More than 60% of individuals with TSC are not able to achieve seizure control via standard methods and treatments. The disorder typically manifests in the first year of life and is linked to an increased risk of autism and intellectual disability in children.
  • Epidiolex has been granted Orphan Drug Designation from FDA for the treatment of TSC. According to GW Pharmaceuticals, FDA approval of the sNDA is expected later this year. Epidiolex is GW’s lead cannabinoid product candidate and the first FDA-approved drug that contains a purified drug substance derived from marijuana.

Reposted from Keller and Heckman’s Blog, The Daily Intake

  • Many businesses are already capitalizing on a surge in the popularity of cannabidiol (CBD) products and are pressuring the Food and Drug Administration (FDA) for a regulatory path to enable the lawful use of CBD in foods and dietary supplements under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Industry wants FDA to create an exception by regulation to the FD&C Act prohibition that currently makes it illegal to add CBD to a food or market CBD as a dietary supplement. Some would alternatively be satisfied with a formal nonenforcement policy from FDA on the statutory prohibition.
  • At a May 31, 2019 meeting, discussed in this blog, FDA pointed out that it has never issued a regulation to create an exception to the statutory prohibition against the use in food of a substance that has been approved as a drug. Confirming there is no policy of enforcement discretion with respect to the use of CBD, FDA also remarked on a lack of research to support the safety of CBD for use in food and dietary supplements. The docket, FDA-2019-N-1482, solicits information on safety (including whether there is a threshold level that could appropriately be considered safe for), manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.
  • A June 14, 2019 statement by Dr. Amy Abernethy, FDA’s Principal Associate Commissioner for Policy, reiterates that outstanding questions related to the safety of CBD products must be addressed before a regulatory framework can be established for lawfully marketing foods and dietary supplements containing CBD. Dr. Abernathy indicated that upon review of the docket (which she indicated may remain open past the current July 2, 2019 deadline for comments), FDA will identify gaps and examine “how additional research can be performed quickly and efficiently to address critical questions about the safety and effectiveness of CBD.”

Reposted from Keller and Heckman’s Blog, The Daily Intake

  • Interest in products derived from cannabis (Cannabis sativa L.) and its components, including cannabidiol (CBD) has been high for the past couple of years and only increased when Congress passed the 2018 Farm Bill in December 2018.  Among other things, the law established a category for “hemp,” defined as cannabis (Cannabis sativa L.), and derivatives of cannabis (e.g., CBD) with extremely low (less than 0.3% on a dry weight basis) concentrations of THC. The changes included removing “hemp” from the Controlled Substances Act, which means it will no longer be an illegal substance under federal law.
  • However, FDA’s authority to regulate CBD or other hemp products did not change with the passage of the 2018 Farm Bill and significant public interest in this area has pushed the Agency to explain its current approach to these products and its intended next steps.  FDA issued a statement in December 2018 repeating its long-held position that it is illegal to use CBD in food and supplement products because CBD is an active ingredient in an approved drug product (Epidiolex) and has been the subject of publicly-disclosed clinical investigations.  Further confusing matters, however, outgoing FDA Commissioner Scott Gottlieb announced during testimony to the Senate Appropriations Committee on March 28, 2019 that FDA was exercising “enforcement discretion” and not taking action against CBD-containing products unless they make “over-the-line claims” (as reported here and here).
  • On April 2, 2019, FDA released a statement from Commissioner Gottlieb that announces several next steps:
    • public hearing will be held on May 31, as well as a broader opportunity for written public comment, for stakeholders to share their experiences and challenges with these products, including information and views related to product safety.
    • The Agency will create a high-level internal agency working group to explore potential pathways for dietary supplements and/or conventional foods containing CBD and other cannabis-derived ingredients to be lawfully marketed, including a consideration of what statutory or regulatory changes might be needed and what the impact of such marketing would be on the public health.
    • The Agency will update its webpage with answers to frequently asked questions on this topic to help members of the public understand how the FDA’s requirements apply to these products.
  • In addition to the above, FDA announced that it has issued warning letters to three companies in response to their making unsubstantiated claims about their products’ ability to limit, treat or cure cancer, neurodegenerative conditions, autoimmune diseases, opioid use disorder, and other serious diseases, without sufficient evidence and the legally required FDA approval.