CBD's Future Totally Dependent on FDA

Cannabis research firm Brightfield Group released its CBD: FDA Impact and the Path Forward/ 2022 Mid-Year US CBD Report, which found that growth in the CBD industry is “heavily dependent” on Food and Drug Administration (FDA) regulation, though there has been little progress on federal regulation for cannabidiol (CBD) since provisions removing hemp and hemp derivatives from prohibition were passed in the Farm Act of 2018. 

“If federal regulation were to be implemented by 2024, sales are expected to reach $11.0 billion by 2027, driven by accelerated growth of ingestible products like capsules and gummies as well as increased acceptance by mainstream retailers,” the Brightside report said. “Without such guidance, the CBD market is expected to remain decidedly lower.”

CBD Needs FDA

Currently, the U.S. CBD market is expected to reach $5 billion by 2022, according to Brightside. The report then offered two scenarios – projections with FDA guidance in place by 2024, or without. Their analysis predicted more than $4 billion in growth for the CBD industry by 2027, to $11 billion with the implementation of a regulatory scheme. However, without regulation, the report predicted relatively stagnant growth over the same time period to just over $6 billion. 

Lack of FDA guidance, Brightside pointed out, presented challenges for CBD industry businesses by allowing a market environment with “a shifting product mix and competition from other hemp-derived cannabinoids, though price compression has begun to subside, and the industry is increasingly attracting attention from large firms.”

“While waiting for increased oversight, companies have been seeking to define CBD’s place in the wider wellness landscape and using tactics like creating non-CBD products that can be sold through mainstream outlets and partnering with retailers who do not sell CBD to increase distribution and reach a novel base of consumers,” the report surmised.

Charlotte’s Web CBD Gummies

Brightside said CBD product companies Charlotte’s Web (OTC: CWBHF) and Your CBD Store (SunMed) were the two top leaders in company shares for the second year in a row. Charlotte’s Web saw the largest portion of industry online sales and was third in brick-and-mortar sales behind Your CBD Store (SunMed) and American Shaman. Companies that saw significant gains in Q1 2022 included High Tide and Heavenly Rx/Simply Better Brands. 

Grocery store sales of CBD products grew 18 percent since 2021, with $131 million in sales predicted for 2022. Brightside called grocery companies “risk averse” in regards to CBD products, resulting in marketing challenges for ingestible CBD products. Topicals will account for more than 41 percent of grocery store CBD product sales in 2022, with tinctures a distant second place at just over 19 percent. With FDA guidance, the report said, the ingestible CBD product market was set to boom.

Hope Fades

Pundits and industry experts are not hopeful for any federal regulations to come from the agency any time soon. Though four years have passed since the hemp provisions were approved in the Farm Bill, only one CBD-based pharmaceutical application has been approved by the FDA; Epidiolex, which was developed to treat seizures associated with a severe form of pediatric epilepsy. 

The FDA has said there is not enough data or research on CBD (or other cannabinoids) to allow comprehensive guidance for the industry. The COVID-19 pandemic also apparently slowed progress for the agency, as it prioritized vaccine approval over the last two years. 

An open day-long meeting in mid-June was held by the Science Board to the FDA to discuss the challenges to evaluating cannabinoids as dietary supplements or food ingredients, as well as safety reviews and concerns regarding toxicity possibly associated with consistent consumption of large amounts of CBD. The agency claims concerns are based on data gathered during the approval of Epidiolex. CBD industry leaders said the meeting provided only more delaying tactics from the FDA. 

In February, the appointment of new FDA Commissioner Robert M. Califf, M.D., gave attorney Blair Gue of Rogoway Law, a glimmer of hope for progress. Comments from Califf, though, were nonspecific regarding when FDA guidance on CBD may be forthcoming. Gue pointed out that continued pressure on the agency was needed from CBD industry companies. 

“Though Commissioner Califf could not provide a plan or timeline for the adoption of hemp or CBD regulations, he did express a strong desire to work with Congress on the subject moving forward.  Given Commissioner Califf’s comments about his willingness and desire to make real progress on the FDA’s industrial hemp product and derivative regulations, now is the time for the industrial hemp community to apply pressure to ensure that he actually does so,” she said. 

Joanne Cachapero


FundCanna

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