The CBD regulatory map is more confusing than ever, as FDA continues to delay its ruling on the legality of CBD as a food and dietary supplement additive. On the flip side, the Hemp Access and Consumer Safety Act was introduced in Congress in May to make CBD products exempt from provisions of the Food, Drug & Cosmetic Act.
This impasse was heightened in June when FDA released a list of guidance documents that it intends to issue within the next year. There is no commitment to publish anything about CBD.
The CBD Controversy
It all began in December 2018, with the passage of the Farm Bill, permitting the commercial cultivation, processing, marketing, and sale of industrial hemp products in the U.S. Hemp and derivatives of cannabis with concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC) were removed from the definition of marijuana in the Controlled Substances Act.
Since hemp seed does not contain CBD or THC, FDA approved hemp seed products—hulled hemp seed, hemp seed protein powder, and hemp seed oil—to be used in the U.S. food supply.
Products containing CBD and THC are a more complicated issue. The FD&C Act prohibits the addition of an active ingredient in an approved drug product to a food or dietary supplement. Epidiolex, a drug used for treatment of seizures in pediatric disease, was approved in June 2018 and its active ingredient is CBD. FDA can make an exception for CBD but the process usually takes three to five years.
In the meantime, farmers aggressively planted hemp, which could bring more than ten times the revenue of traditional crops. Food, beverage, dietary supplement, and health and beauty aid manufacturers embraced the supposed “health” properties of CBD and started adding it to products. As many have said, the CBD craze is like the Wild Wild West or the California Gold Rush.
In May 2019, FDA held its first (and last) public hearing on CBD. More than 500 attended in person and scores of advocates testified, ranging from state department of agriculture officials to farmers to manufacturers to doctors to consumers concerned about drug addiction.
FDA has expressed many concerns, including but not limited to:
• CBD has the potential to cause liver damage and slow brain activity which could lead to injuries.
• CBD can cause side effects such as changes in alertness, gastrointestinal distress, and mood.
FDA questions include:
• What happens if you take CBD daily for sustained periods of time?
• What level of intake triggers the known risks associated with CBD?
• How do different methods of consumption affect intake (e.g., oral consumption, topical, smoking or vaping)?
• How much CBD is safe to consume in a day? How does it vary depending on the form in which it’s taken?
• Are there drug interactions that need to be monitored?
• What are the impacts to children, the elderly, and pregnant or lactating women?
• What are the risks of long-term exposure?
As FDA studies these issues, CBD products have flooded the market. CBD is in sodas, coffee, cookies, barbecue sauce, tinctures, and so on. Statista reports that 2020 CBD product sales in the U.S. were approximately $5 billion. Yet FDA enforcement has been light, only issuing 13 warning letters since January 2020; most of which have been for ridiculous health claims, including that CBD can cure or mitigate COVID-19.
Supermarkets and specialty food retailers continue to grapple with the legality of selling these products, despite the fact that many states permit CBD products to be sold.
The issue: When CBD products cross a state line, they are illegal.
A Patchwork of State Regulations
The legality of CBD for non-medical purposes varies by state and is constantly changing. As of July, CBD in some form was legal in 40 states. It was legal with restrictions in seven states—Georgia, Idaho, Mississippi, Missouri, New Hampshire, South Carolina, and South Dakota. It continued to be illegal in Idaho, Iowa, and South Dakota.
And it gets even more complicated. For instance:
Maryland: CBD oil is legal but CBD food or beverage products are not.
Michigan: CBD is legal but not in food or drinks.
New York: CBD is legal but it is illegal to process it in food or beverages.
North Carolina: CBD oil is legal but edibles, drink, and food infusions are not.
Ohio: CDB edibles and drinks are banned.
And so on. More than 30 states are currently considering cannabis or CBD legislation.
The Hemp Access and Consumer Safety Act
An unlikely trio--Democrats Ron Wyden and Jeff Merkley from Oregon, and Republican Rand Paul from Kentucky—introduced the Hemp Access and Consumer Safety Act in May. Simply stated, the legislation exempts hemp and hemp-derived products from the condition of the FD&C Act that “prohibits any new dietary ingredient, food, or beverage from entering the market if it has been studied or approved as a drug.”
The Hemp Access and Consumer Safety Act:
Gives hemp-derived CBD products an opportunity to lawfully be used in dietary supplements, foods, and beverages under the FD&C Act.
Prioritizes consumer safety, requiring manufacturers to comply with all existing federal regulations for products that contain CBD.
Ensures that these products are properly labeled.
Senator Merkley wrote, “Every day that the FDA drags its feet to update its CBD regulations, hemp farmers are left guessing about how their products will be regulated, and real economic gains for workers and business owners in Oregon and across the country are left on the table. Hemp-derived CBD products are already widely available, and we all need the FDA to issue clear regulations for them just like they do for other foods, drinks, and dietary supplements.”
The Consumer Brands Association (CBA, formerly the Grocery Manufacturers of America) has rallied to support the legislation. In letters sent to FDA Acting Commissioner Janet Woodcock and Senator Wyden, CBA said that action “is needed to protect consumers; ensure product safety and transparency; establish guardrails for legal product innovation and distribution in interstate commerce; and provide the clarity needed for manufacturers of these products.”
CBA added that FDA’s “inaction is resulting in a marketplace full of CBD-containing products produced in establishments that escape FDA regulations.”
The bill has been read twice and referred to the Committee on Health, Education, Labor & Pensions, chaired by Senator Patty Murray, Democrat of Washington.
With all of the pending legislation facing Congress, it may be awhile before this bill is considered. And the food industry and consumers will continue to be confused by the conflicting regulations on CBD in food and beverage products.
Related: RTD Coffee With CBD Experiences High; Canopy Growth, Martha Stewart Launch CBD Line.