CBD MarketWatch 2023: FDA Claims New Regulatory Pathway Needed for CBD

After a review of scientific evidence and three citizen petitions, FDA said in January that it still has “considerable safety concerns” about cannabidiol (CBD), and the existing regulatory frameworks for foods and dietary supplements are “not appropriate” for CBD. The agency also said it wants to work with Congress to establish “a new way forward.”

FDA denied petitions from the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), and the Natural Products Association (NPA) to issue a regulation that would allow companies to legally market dietary supplements containing CBD derived from hemp.

Safety First. In a statement, FDA Principal Deputy Commissioner Janet Woodcock, MD, said the use of CBD raises “various safety concerns, especially with long-term use.”

Woodcock chairs the FDA’s working group that examined CBD studies in light of an expanding market amid growing consumer demand that followed passage of the 2018 Farm Bill.

FDA has noted that while the 2018 Farm Bill changed how “hemp” is regulated under the Controlled Substances Act, the legislation did not change how “hemp” is regulated under the Federal Food, Drug, and Cosmetic Act.

FDA’s statement said CBD 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.”

As such, it’s not clear how CBD products could meet applicable safety standards, according to the agency.

In its response letter to the petitions from CHPA and CRN, FDA said: “Accumulating evidence about CBD suggests that there are considerable safety concerns with its potential use as a dietary supplement, and it is not apparent from your Petition or the available evidence how a CBD product would be able to meet the applicable safety standard that the law provides for dietary supplements.”

The agency later said, “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.”

A New Path Through Congress

Instead, a new regulatory pathway could provide safeguards and oversight to manage and minimize risks, FDA said in its statement.

“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.”

According to FDA, the agency’s existing authorities over foods and supplements “provide only limited tools for managing many of the risks associated with CBD products.”

The drug approval process, meanwhile, allows FDA “to evaluate dosage and potential adverse effects, among other things, as well as when the product is taken under medical supervision. However, dietary supplements are not subject to the same approval process as drugs and are generally not prescribed by, nor is their use generally overseen by, a physician.”

In its response to CHPA and CRN, FDA also said it doesn’t have the resources “to take enforcement action against every violative product in this exploding market.”

As a result, FDA wants to work with Congress “to develop a new pathway that balances consumers’ desire to access CBD products with the regulatory oversight necessary to better manage the risks these products present.”

In the meantime, FDA said it would remain vigilant and continue to act “against CBD and other cannabis-derived products to protect the public, in coordination with state regulatory partners, when appropriate.”

NDIs Aren’t Enough. In its response letters, FDA said the New Dietary Ingredient Notification (NDIN) process “is not sufficiently robust to protect the public health from potentially unsafe dietary supplements.”

“Under current law, FDA has no systematic way to know when new dietary supplements are introduced to the marketplace and whether they have complied with the NDIN requirement. Further, even when an NDIN has been submitted and evaluated by FDA, the NDIN authorities do not always prevent unsafe products from being marketed. For example, if an FDA response letter raises identity or safety concerns with a particular NDI, but the notifier nonetheless proceeds to market, FDA’s only recourse (once it becomes aware of such marketing) is to attempt to remove the product from the market by undertaking a resource-intensive enforcement action in which we would bear the burden of proof to demonstrate that the product is adulterated. In the meantime, the unsafe dietary supplement could remain on the market. The new regulation proposed by the Petition would not change this outcome.”

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House Reps Try Again to Regulate CBD and Other Hemp Derivatives as Dietary Ingredients

On Mar. 17, hoping to create a legal pathway for regulation of CBD products, Congressman Morgan Griffith (R-VA) and Congresswoman Angie Craig (D-MN) reintroduced two pieces of legislation that had previously stalled in Congress.

The Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2023 would make hemp, CBD derived from hemp, and other hemp-derived products lawful for use in dietary supplements under the Federal Food, Drug, and Cosmetic Act.

The CBD Product Safety and Standardization Act would direct the FDA to regulate CBD as the agency would for other food ingredients, setting requirements for quality and labeling, among other areas.

The bills follow FDA’s announcement in January when it asked Congress to work with the agency to develop a “new regulatory framework” for CBD. 

Griffith, a member of the House Energy and Commerce Committee, introduced identical legislation in 2020 and 2021 with “Blue Dog” Democrat Kurt Schrader (D-OR) who lost his party’s renomination bid in 2022. That seat eventually turned red as the Republicans took control of the House following the November 2022 midterm election. 

“The Food and Drug Administration has dragged its feet in properly regulating CBD and hemp-derived products on the market, creating confusion about its legal uses,” Griffith said in a press release. “Americans need better guidance and that is why I have introduced these two pieces of legislation, which will create a pathway for regulation in both the food and dietary supplement spaces.”

Craig also serves on the House Energy and Commerce Committee, along with the House Agriculture Committee and Small Business Committee.

“In Minnesota we’ve seen firsthand that our local governments and small businesses need more guidance when it comes to CBD and hemp-derived products,” Craig said in the press release announcing the introduction. “That’s why I’ve partnered with Rep. Griffith on these bipartisan bills to better regulate CBD products, keep consumers safe and ensure our hemp farmers and businesses have the support they need.”

These bills were endorsed by the U.S. Hemp Roundtable, the American Herbal Products Association (AHPA), Council for Responsible Nutrition (CRN), National Cannabis Industry Association, Indigenous Cannabis Industry Association, Spartan Sword, Association of Western Hemp Professionals, and Alliance for Natural Health USA.

“The FDA has made it clear that legislative action by Congress is needed to solve its CBD regulatory problem and these two bi-partisan bills re-introduced by Reps. Griffith and Craig serve as the solution,” said Jonathan Miller, U.S. Hemp Roundtable General Counsel in a statement. “The FDA’s inaction over the past four years has had a devastating impact on U.S. hemp growers and has left thousands of unregulated products on the marketplace, raising health and safety concerns for consumers. The U.S. Hemp Roundtable is grateful to Rep. Griffith for his steadfast leadership on behalf of the hemp industry, and we are proud to work closely with him, Rep. Craig and other original co-sponsors on this critical legislation that is integral for hemp farmers, CBD producers and consumers.”

Michael McGuffin, president of the American Herbal Products Association (AHPA), added: “In the two and half years since this legislation was first introduced and following FDA’s recent passing of the buck to Congress on CBD dietary supplements, no substantive progress on establishing a lawful pathway for CBD dietary supplements has been made.”

This legislation, however, would provide FDA “the statutory authority the agency believes it requires to regulate CBD products as dietary supplements,” he continued. “It would also ensure that consumers have access to CBD dietary supplements that are clearly subject to FDA’s enforcement of the robust regulations that apply to all other herbal dietary supplements. The bill would codify the position AHPA adopted years ago recommending that manufacturers and marketers of CBD dietary supplements comply with all of the federal regulations that apply to such operations under the Dietary Supplement Health and Education Act (DSHEA) and other relevant amendments to the Federal Food, Drug, and Cosmetic Act.”

CRN applauded the introduction of the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2023 and said it remains committed to creating a legal pathway to market safe, non-psychoactive hemp-derived cannabinoids as dietary supplements.

“Over four years ago, Congress purposefully removed hemp-derived CBD from the Controlled Substances List to jumpstart a market, yet FDA refuses to recognize that directive,” said CRN President Steve Mister. “While FDA delays, a sizable market has grown for CBD—legal or otherwise. Americans know these products are safe because they have been taking them for years. Consumers don’t need a new regulatory scheme that will potentially limit consumer choice. They want access to the safe, innovative products to help them lead healthier lives that the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act will provide.”

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FSA Validates Novel Foods Applications from Association for the Cannabinoid Industry

The Association for the Cannabinoid Industry’s (ACI) novel foods applications (RP126 and RP127) have been validated in the UK by the Food Standards Agency (FSA).

The ACI received formal notification from the FSA that both its applications for the authorization of CBD isolate and distillate “fall within the scope of the novel foods regime” as set out in Regulation (EU) 2015/2283 (as retained) and fulfill the requirements set out in Article 10(2) of that Regulation.

These applications are now regarded as valid, and will now move on to the risk assessment stage to be assessed further.

“This is a key milestone for the sector and the ACI,” said Steve Moore, ACI co-founder and strategic counsel. “The new consumer cannabinoid sector has been set as an important regulatory challenge. Today’s outcome suggests that by collaborating, they are both progressing towards market authorization for thousands of products but also delivering the safety data the authorities have been crying out for.”

ACI member applications account for 30% of the products currently permitted to remain on the market under the novel foods authorization process. These applications relate to 320 brands sold in Britain. 

In 2022, the ACI submitted a toxicological package and related bioavailability data to the FSA to support the consortium of member applications.

This included the dose range finding study and the OECD408 rodent toxicity study to determine a No Observable Adverse Effect Level (NOAEL), to cover the safety implications of not only CBD, but also the minor cannabinoids and other plant matrices present in these plant-derived products.

Two years from the novel food application submission deadline, FSA’s update comes a year after the food safety body published its first public list of ingestible CBD products deemed temporarily compliant, pending the submission of toxicology data, its risk assessment, and acceptance to progress to the
validation stage.

“This outcome was only achievable due to the expertise of our regulatory and scientific team led by Dr. Parveen Bhatarah and Dr. Paul Duffy, who have provided exemplary insight and advice throughout this process,” said Paul Birch, ACI co-founder.

In 2019, the FSA assigned ingestible CBD products with novel food classification under the Novel Food Directive. For a product to be legally available for sale, it must be present on the FSA’s public register, which is updated when the status of an application changes.   

Ingestible CBD products include CBD oil drops, tinctures, and any infused food or beverage. The directive does not apply to CBD vape products, cosmetics, or topicals.

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Legal Cannabis Sales Could Nearly Double in 5 Years: BDSA

Global legal cannabis spending grew 4.8% to $32 billion in 2022, according to BDSA (Louisville, CO), which provides market intelligence for the cannabis industry. The company updated its 5-year global market forecast in February, predicting a compound annual growth rate (CAGR) of 13.2% from 2022 to 2027, resulting in a market size of $59.6 billion by 2027. 

Despite economic uncertainty and rising inflation, BDSA said it expects legal U.S. cannabis sales to grow 14% by the end of 2023.

“Legal cannabis spending slowed significantly in 2022 due to rapid price declines across all markets,” said Roy Bingham, co-founder and CEO of BDSA. “Despite this, our updated forecast predicts strong growth in the U.S. driven by developing markets, particularly the adult-use markets of Missouri, New Jersey, and New York. Additionally, four of the top five U.S. markets—Florida, Illinois, Massachusetts and Michigan—will increase by a combined 9.5% in 2023, adding nearly $770 million in new spending.” 

While legal cannabis sales saw rapid growth during the height of the pandemic, 2022 marked the first overall spending contractions in many mature markets throughout the U.S., with the mature adult-use markets of California, Colorado, Nevada, and Oregon suffering a combined spending decline of 16.5%.

BDSA said it expects to see a return to growth for most mature markets in 2024, though mature markets in the U.S. are expected to grow slower during the forecast period.

Several newer markets saw a strong expansion in 2022, and growth in new and emerging markets is expected to ramp up in the coming years, BDSA noted. New Jersey and Montana, which launched adult-use sales in 2022, saw approximately 140% growth last year, while Missouri grew by 84% in its second full year of medical-only sales.

By 2027, BDSA predicted adult-use sales will contribute 78% of the total global legal cannabis spend, up from 64% in 2022. U.S. legal cannabis spending is expected to grow at a CAGR of 11.3%, from $26.1 billion in 2022 to $44.5 billion in 2027, driven primarily by the New York, Florida, New Jersey, and California markets.

BDSA also predicted the launch of several new adult-use markets by 2027, including Maryland and Oklahoma in 2024 and Florida and Ohio in 2025. New adult-use markets in Hawaii and Minnesota are also possible. Although BDSA does not expect any comprehensive U.S. federal regulations on cannabis in this timeframe, there is a possibility of partial reform, such as cannabis banking, within the next few years.

Globally, cannabis markets beyond the U.S. and Canada are expected to grow at a CAGR of 40% to $9.5 billion in 2027, up from $1.8 billion in 2022. BDSA forecasts the Canadian market will see 12% overall growth this year, becoming a $5.7 billion market by 2027 at a CAGR of 6.3%.

New adult-use markets and Germany and Mexico are the primary drivers of global growth, and current limited medical cannabis programs are expected to expand, primarily within the European Union and Latin America.

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Best-Selling Author and Family Physician Publishing New ‘Courage in Cannabis’ Anthology

Dr. Bridget Cole Williams, MD, an established board-certified family physician with nearly 20 years of experience in family medicine from the Cleveland Clinic, is the best-selling author of Courage in Cannabis—An Anthology of Inspiring Stories Written By Heroes. This collection of 18 diverse authors who share how cannabis has changed their lives, was published in 2021.

Williams is expanding the book series this spring with Courage in Cannabis, Volume 2—The Triumphant Stories, a new compilation of stories written by doctors, lawyers, patients, caregivers, participants in the legacy market, entrepreneurs, advocates, and others that offers unique perspectives into the power and potential of the cannabis plant in business and medicine, and in creating more resilient economies and communities.


“Courage in Cannabis is a compilation in which each story is unique and written with the hope of inspiring others,” said Williams. “I was so moved by the heartfelt, challenging, and motivating stories that my patients shared, I knew others needed to be inspired as well. In these times, anyone that chooses cannabis or enters the industry has a story of courage. This is true simply because a very short time ago, cannabis was illegal everywhere in North America.”

“However, that is changing rapidly,” she noted, “now that in 2023 the medical use of cannabis is legal in 37 states, and recreational or adult-use cannabis has been approved in 19 states and Washington, D.C.

Williams is also the CEO of Green Harvest Health, medical cannabis, CBD and integrative clinics located in Ohio, and Embody, a premium CBD lifestyle brand. She was named a Top Female Business and Top Minority Business with the Ohio MBE Awards 2021 and a Women in Medicine Top Doctor for 2021.

Through its nonprofit organization, GHH Community Foundation, Courage in Cannabis, Volume 2—The Triumphant Stories is seeking Sponsor Partners to help support the book’s development, expand its reach, and help educate, inspire, and end the stigma of cannabis.

“For our Sponsor Partners, this is not just an opportunity to support the book and its contributing writers; it also is an experience. The authors get to know one another, do book signings, network, appear on podcasts and in conferences and educational events, and support one another, while also serving as role models for the responsible use of cannabis. The book has made it into the hands of politicians, celebrities, churchgoers, and naysayers. It has inspired and encouraged so many,” Williams added.

Williams noted that the goal of Courage in Cannabis is to develop a series of educational workshops, workbooks, podcasts, future book editions, and more.