Food Safety
search
cart
facebook twitter linkedin
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Food Safety
  • NEWS
    • Latest News
    • White Papers
  • PRODUCTS
  • TOPICS
    • Contamination Control
    • Food Types
    • Management
    • Process Control
    • Regulatory
    • Sanitation
    • Supply Chain
    • Testing and Analysis
  • PODCAST
  • EXCLUSIVES
    • Food Safety Five Newsreel
    • eBooks
    • FSM Distinguished Service Award
    • Interactive Product Spotlights
    • Videos
  • BUYER'S GUIDE
  • MORE
    • ENEWSLETTER >
      • Archive Issues
      • Subscribe to eNews
    • Store
    • Sponsor Insights
  • WEBINARS
  • FOOD SAFETY SUMMIT
  • EMAG
    • eMagazine
    • Archive Issues
    • Editorial Advisory Board
    • Contact
    • Advertise
  • SIGN UP!
Food TypeRegulatoryIngredientsFDAGuidelines

Adding Cannabidiol to the Menu

February 19, 2019

Projected to near $22 billion in market revenue by 2022—up from an estimated $500 million in 2018—the hemp-derived cannabidiol (CBD) market presents a substantial growth opportunity for food, beverage, and dietary supplement companies. Already, CBD has exploded into mainstream wellness products—from oils and dietary supplements to various foods and infused beverages. Even household brands like Coca-Cola are exploring the possibility of rolling out CBD-infused functional wellness drinks.

The 2018 Farm Bill’s legalization of hemp has catapulted CBD, a key hemp derivative, into the regulatory spotlight.[1] Now that hemp is legal, a key question is whether and to what extent CBD may be added to food, beverage and dietary supplement products for distribution nationwide. Misconceptions abound with some incorrectly believing that the enactment of the 2018 Farm Bill permits the unrestricted use of hemp and its derivatives. 

States primed to cash in on hemp production are urging federal regulators to provide clarity. For example, U.S. senators Ron Wyden (D-OR) and Jeff Merkely (D-OR) recently called for updated federal regulations in a January 15, 2019 letter to Commissioner Scott Gottlieb of the U.S. Food and Drug Administration (FDA). The senators contend that the current “regulations limit producers from taking full advantage of the industrial hemp market by, for example, prohibiting food products containing CBD from being sold across state lines.”

Forging an efficient and predictable regulatory pathway will be essential to commercializing CBD-infused foods, beverages, and dietary supplements for nationwide distribution. This article addresses the current regulatory state of affairs for hemp-derived CBD and looks ahead to a recently announced public meeting that could take us one step closer to adding CBD-infused products to the menu across the U.S.

What is CBD?
CBD or cannabidiol is a nonpsychoactive chemical compound. CBD may be derived from hemp or marijuana. Hemp and marijuana themselves are distinct species of Cannabis, a genus of plants with two primary species—indica and sativa. Hemp and marijuana both derive from the C. sativa family. Hemp and marijuana therefore share certain similarities. Importantly, however, there are key biological differences. For example, whereas hemp contains just 0.3 percent or less of tetrahydrocannabinol (THC), a psychoactive chemical compound, marijuana contains THC concentrations between 15–40 percent.

The distinction between hemp and marijuana is critical because the Agriculture Improvement Act of 2018 (i.e., the 2018 Farm Bill) legalizes hemp and tasks the U.S. Department of Agriculture (USDA) with the responsibility to develop federal regulations to monitor hemp cultivation and production (though no timeline has been set). Marijuana continues to be classified as a Schedule I drug pursuant to the Controlled Substances Act.

Whereas USDA is set to oversee hemp cultivation and production, FDA exercises oversight regarding the use of hemp and its derivatives (like CBD) in foods, beverages, and dietary supplements.

Current FDA Regulation and Enforcement of CBD
Current federal law prohibits the addition of CBD to foods and dietary supplements regardless of whether the CBD is derived from hemp or marijuana. More specifically, FDA interprets the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Dietary Supplement Health and Education Act of 1994 (DSHEA), respectively, to prohibit the interstate marketing of food and dietary supplements containing added CBD. Subject to limited exceptions, neither food nor dietary supplements are permitted to contain an investigational or approved drug as a component. CBD was approved as a drug in 2018.

DSHEA defines “dietary supplement” to exclude products that contain an FDA-approved drug or a substance that has been “authorized for investigation as a new drug” [see §3(a)(ff)(3)(B)(ii)]. Likewise, the FD&C Act generally prohibits the sale of any food to which an approved or investigational drug has been added.[2]  

Notable statutory carve-outs include: (1) evidence that the substance of interest has been marketed in a dietary supplement or a conventional food prior to new drug approval or investigation and (2) the issuance of a new rule approving the use of the substance in food or dietary supplements. To date, no evidence has been presented to FDA indicating that CBD was used in food or dietary supplements prior to CBD’s drug approval or investigation. But the jury is out on whether FDA will ultimately issue a rule authorizing the use of hemp-derived CBD in food or dietary supplements. FDA stakeholder engagement anticipated for 2019 may push FDA down the road of regulation that will open up a whole new world of CBD-infused foods, beverages, and dietary supplements. In the meantime, it continues to be unlawful under federal law to add CBD to food or dietary supplements. But what is your regulatory risk if you currently market CBD-infused foods and dietary supplements? 

To date, FDA regulatory activity in the CBD sphere has focused on unsubstantiated disease claims. In 2017, for example, FDA issued warning letters to four companies—Greenroads Health, Natural Alchemist, That’s Natural! Marketing and Consulting, and Stanley Brothers Social Enterprises LLC—citing unsubstantiated claims in connection with over 25 different dietary supplement products. These claims cited by the FDA ranged from “[CBD] has antipsychotic properties, which makes it very useful for treating bipolar disorder” to “Adding CBD oil as part of your daily Alzheimer’s medicine routine has a good chance at delaying the progression of the disease.”

Under the FD&C Act, a product becomes a “drug”—and hence subject to stringent oversight—if it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body. Outside of unsubstantiated disease claims, FDA has not otherwise targeted CBD foods, beverages, and dietary supplements. It remains to be seen whether the enactment of the 2018 Farm Bill will have any bearing on FDA’s enforcement in this area.

FDA to Hold Public Meeting
In a December 20, 2018 statement, FDA Commissioner Scott Gottlieb indicated that FDA is gearing up to hold a public meeting (date to be determined) to gather stakeholder input relevant to the lawful pathways by which products containing Cannabis or Cannabis-derived compounds may be marketed in foods and dietary supplements, and how FDA might consider making these regulatory pathways “more predictable and efficient.” No agenda has been announced as of this writing. But several key questions for discussion as it pertains to CBD might include:

• What aspects of existing regulatory pathways can be leveraged to facilitate an efficient and predictable FDA review of CBD-infused foods and dietary supplements?

• Given the current approval of CBD as a drug and the absence of an applicable exemption for its use in foods or dietary supplements, will enforcement discretion and industry guidance alone be sufficient to overcome this hurdle? If not, what should a rulemaking include? Should Congress step in?

• Biotech companies are also looking to enter this market. Should CBD produced from genetically modified microbes (outside of the plant) be subject to a distinct premarket review process from plant-derived CBD? Would the regulatory status of CBD be the same or different if the regulatory sequences used to modify the microbes stem from pathways similar to those of hemp as opposed to marijuana?

• From an enforcement perspective, how will the FDA and the U.S. Drug and Enforcement Administration (DEA) interpret their statutory mandates? Since CBD can also be derived from marijuana, a schedule I drug subject to DEA oversight, will FDA and DEA exercise joint oversight to confirm the source of CBD in food and dietary supplement products?

FDA is poised to take action that could lead to the commercialization of CBD-infused foods and dietary supplements. In December 2018, FDA gave the nod to hulled hemp seeds, hemp seed protein, and hemp seed oil for use in food. More specifically, on December 20, 2018, FDA announced that it completed its evaluation of three Generally Recognized as Safe (GRAS) notices related to hulled hemp seeds, hemp seed protein, and hemp seed oil and that the agency had no questions regarding the company’s conclusion that the use of such products as described in the notices is safe. In responding to the GRAS notices, FDA noted that the hemp seed-derived ingredients contain only trace amounts of THC and CBD, which the seeds may pick up during harvesting and processing when in contact with other parts of the plant. FDA wrote, “consumption of these hemp seed-derived ingredients is not capable of making consumers ‘high’.”

CBD is understood to be nonpsychoactive. So to the extent that companies can demonstrate to FDA that CBD does not pose any human health risks when used as intended and is otherwise compliant with the FD&C Act and DSHEA, and the laws are updated to accommodate hemp-derived CBD in foods and dietary supplements, CBD-infused products could very well hit the marketplace—nationwide—sooner rather than later. Further, while FDA has already taken a position on CBD as a drug, other cannabinoid derivatives with similar safety profiles which are not the subject of drug approvals may present a lower regulatory hurdle for commercialization, providing claims are carefully structured to avoid classification as a drug.

Looking Ahead
It is quite conceivable that FDA will choose to undertake rulemaking to authorize the use of CBD in foods and dietary supplements. As an interim action—to facilitate the immediate commercialization of CBD-added products nationwide—FDA could choose to issue a formal policy statement indicating that it will not enforce the prohibition on foods and dietary supplements containing CBD.

Biotech companies are also looking to enter this market by using microbes to synthetically create CBD. Poised to scale up, biotech CBD production interests will need to be represented in updated federal policy and/or regulations concerning the use of CBD in foods and dietary supplements. For example, a targeted exemption could be designed to address plant and nonplant CBD-sources and specify the allowable uses of hemp derived-CBD outside of the prescription drug zone.

Rising consumer appetite for CBD-infused foods and dietary supplements coupled with the recent legalization of hemp in the U.S. has set the stage for high expectations.

Brian P. Sylvester, Esq., special counsel with Wiley Rein LLP, provides emerging and established companies in the food, beverage and agricultural biotechnology sectors with practical solutions to complex regulatory challenges. He draws on his combined public-and private-sector industry experience, including his former role as a regulatory attorney with U.S. Department of Agriculture, to help clients achieve business objectives for a range of commodities regulated by the USDA and FDA.

References
1. The Farm Bill defines hemp as any part or derivative of the Cannabis sativa L. plant with a tetrahydrocannabibol level below 0.3 percent on a dry-weight basis.
2. uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section331&num=0&edition=prelim.


Author(s): Brian P. Sylvester, Esq.

Share This Story

Looking for a reprint of this article?
From high-res PDFs to custom plaques, order your copy today!

Recommended Content

JOIN TODAY
to unlock your recommendations.

Already have an account? Sign In

  • people holding baby chicks

    Serovar Differences Matter: Utility of Deep Serotyping in Broiler Production and Processing

    This article discusses the significance of Salmonella in...
    Contamination Control
    By: Nikki Shariat Ph.D.
  • woman washing hands

    Building a Culture of Hygiene in the Food Processing Plant

    Everyone entering a food processing facility needs to...
    Facilities
    By: Richard F. Stier, M.S.
  • graphical representation of earth over dirt

    Climate Change and Emerging Risks to Food Safety: Building Climate Resilience

    This article examines the multifaceted threats to food...
    Best Practices
    By: Maria Cristina Tirado Ph.D., D.V.M. and Shamini Albert Raj M.A.
Subscribe For Free!
  • eMagazine Subscription
  • Subscribe to eNewsletter
  • Manage My Preferences
  • Website Registration
  • Subscription Customer Service

More Videos

Sponsored Content

Sponsored Content is a special paid section where industry companies provide high quality, objective, non-commercial content around topics of interest to the Food Safety Magazine audience. All Sponsored Content is supplied by the advertising company and any opinions expressed in this article are those of the author and not necessarily reflect the views of Food Safety Magazine or its parent company, BNP Media. Interested in participating in our Sponsored Content section? Contact your local rep!

close
  • Deli Salads
    Sponsored byCorbion

    How Food Safety is Becoming the Ultimate Differentiator in Refrigerated and Prepared Foods

Popular Stories

recalled sysco and lyons imperial nutritional shakes

Listeria Outbreak Linked to Nutritional Shakes Served at Healthcare Facilities Causes 14 Deaths

Scientist inspecting food substance with microscope

FDA Announces ‘Proactive’ Post-Market Chemical Review Program to Keep Food Supply Safe

Image of fish on ice

Common Fish Food Poisoning Types and Prevention Methods

Events

June 12, 2025

Additive Bans Ahead: Your Guide to Avoiding Risk and Maintaining Agility

Live: June 12, 2025 at 12:00 pm EDT: From this webinar, attendees will learn how ingredient bans will impact product development, labeling, and sourcing.

View All

Products

Global Food Safety Microbial Interventions and Molecular Advancements

Global Food Safety Microbial Interventions and Molecular Advancements

See More Products
Environmental Monitoring Excellence eBook

Related Articles

  • Color Coding: Adding Discipline to a Food Processor’s Preventive Control Program

    See More
  • FSS news generic image

    FDA announces effective date for final rule adding soy leghemoglobin to list of color additives exempt from certification

    See More
  • free range chickens eating from bucket

    Researchers Achieve 80 Percent Reduction in Campylobacter in Chickens by Adding Biochar to Feed

    See More

Events

View AllSubmit An Event
  • December 12, 2024

    Cooking Instructions Validation: How to Ensure the Safety of Not-Ready-to-Eat Products

    On Demand: From this webinar, attendees will be able to identify the different requirements for ready-to-eat and not-ready-to-eat products.
  • September 24, 2024

    Avoid the Recalls: How to Maintain Brand Reputation and Drive Company-Wide Compliance

    On Demand: This webinar will cover how to reduce the risk of costly product recalls that can jeopardize brand and customer loyalty.
View AllSubmit An Event

Related Directories

  • D.L. Newslow & Associates Inc.

    D. L. Newslow & Associates, Inc. offers superior consulting, auditing and training services in Food Safety and Quality Management Systems. Anyone in the food and beverage, chemical, environmental or related industries will benefit from our Consulting and Training. The Newslow team of highly skilled subject matter experts focus on providing “Excellence based on Experience”. This has been our motto since inception. Our total team averages 50 plus years of actual plant experience in the areas of management, QA, QC, Food Safety, PRPs, Management System development, and other key positions in various industry sectors.
  • Williams Recruiting Co.

    Drawing on over 25 years of national and international leadership experience, David founded the Williams Recruiting Company in order to meet the specific sales, marketing and executive recruiting needs of the food and beverage industries. Current clients include start-ups and Fortune 100 companies seeking to fill roles ranging from regional sales manager to CEO.
  • Kerry

    Kerry is the world’s leading taste and nutrition partner for the food and beverage industry. We innovate with our customers to create delicious products with improved nutrition, functionality and sustainability. Our consumer insights, RD&A team and extensive global footprint enable us to solve food safety challenges with differentiated solutions.
×

Never miss the latest news and trends driving the food safety industry

eNewsletter | Website | eMagazine

JOIN TODAY!
  • RESOURCES
    • Advertise
    • Contact Us
    • Directories
    • Store
    • Want More
  • SIGN UP TODAY
    • Create Account
    • eMagazine
    • eNewsletter
    • Customer Service
    • Manage Preferences
  • SERVICES
    • Marketing Services
    • Reprints
    • Market Research
    • List Rental
    • Survey/Respondent Access
  • STAY CONNECTED
    • LinkedIn
    • Facebook
    • Instagram
    • X (Twitter)
  • PRIVACY
    • PRIVACY POLICY
    • TERMS & CONDITIONS
    • DO NOT SELL MY PERSONAL INFORMATION
    • PRIVACY REQUEST
    • ACCESSIBILITY

Copyright ©2025. All Rights Reserved BNP Media.

Design, CMS, Hosting & Web Development :: ePublishing