As the FDA fiddles, California has enacted legislation to regulate the manufacturing and marketing of CBD products.
California is cracking down on the rapidly growing hemp industry with a new law that ensures CBD-infused products are safe and contain the amount of the cannabinoid their packages claim they do.
Products containing CBD extracts have become increasingly popular since the passage of the 2018 Farm Bill, but the Food and Drug Administration (FDA) hasn’t regulated it even though it’s being used in food, supplements and other health and beauty products in thousands of retail outlets across the country.
Although the Farm Bill was key to decriminalizing hemp and jumpstarting the CBD industry, it did not establish any regulatory guidance for CBD, which is still considered illegal under the Federal Food Drug and Cosmetic Act.
But with California Governor Gavin Newsom signing AB-45 into law on October 6, the Golden State now has a framework for the manufacture and sale of hemp-derived products businesses operating in the state must adhere to.
Without clear regulatory policy at the federal level, responsible CBD companies have been forced to comply with a patchwork of state regulations that are costly and cumbersome. With AB-45 in place, regulations are being drafted to help responsible CBD companies bring more safe CBD products to market.
Among the big changes in California is that CBD is now permitted to be infused into food and beverages, a provision that CV Sciences Vice President of Business Development Stuart Tomc calls “a bit of a stunner.” “We didn’t think CBD would be allowed in food and beverages,” Tomc says. “I’ve been on the phone with retailers since this happened.”
San Diego-based CV Sciences is a supplier and manufacturer of hemp cannabidiol (CBD) products that operates two distinct business segments: a consumer product division focused on manufacturing, marketing and selling plant-based dietary supplements and CBD products to a range of market sectors and a drug development division focused on developing and commercializing CBD-based novel therapeutics.
The new law also requires labels on CBD-infused products to contain a warning stating that the product has not been tested for safety or efficacy — a stronger message than the Food and Drug Administration’s (FDA) mandate that labels must indicate that the federal agency has not evaluated the product.
The new, required messaging on the labels actually could have a positive impact on the CBD industry, Tomc says. “If you saw a product that sold as much as CBD has been selling and you saw a warning label that says it wasn’t safe or effective, it might spur more conversation and may actually be helpful,” he explains.
Manufacturers of CBD products also are prohibited from making any claims about CBD, a provision that already exists on the federal level. “They’re trying to create a market that people can operate in if there’s demand for the product,” Tomc says. “As soon as the feds step in and regulate CBD like every other ingredient, California will follow suit.”
A key compromise that helped get AB-45 through the California legislature was the removal of language in the bill that would ban smokable hemp products in California. Hemp farmers are advocates of smokable hemp because it brings in the highest revenue per acre. But such products won’t be available until the Legislature enacts a new tax on them — a measure that’s likely to be taken up next year.
The bill includes a phase-in approach that will permit the sale of smokable hemp products to adults and the manufacturing of smokable hemp products to be sold in other states.
While AB-45 has opened the market for a wider variety of CBD products, they’re not likely to hit store shelves any time soon because the California Department of Public Health still must hammer out specific rules and may impose additional regulations on the manufacture and sale of hemp products. The department has the authority to determine the maximum serving sizes for hemp-derived CBD, hemp extract and derivative products; active cannabinoid concentration per serving size; the number of servings per container; and other requirements for food and beverages. It also may set an age requirement for the sale of certain hemp products.
Because the industry lacks federal standards for the manufacturing, testing and labeling of CBD products, those available today vary widely in safety and quality. After evaluating nearly 3,000 CBD products, Leafreport found that only 42 percent of the companies published potency results and only 13 percent published test results for microbals, heavy metals and pesticides. Of the products Leafreport tested for CBD potency, more than 84 percent were outside the limits of acceptable variance (plus or minus 10 percent of label value).
“There’s a lot of enthusiasm around cannabis and hemp,” Tomc says. “We hope AB-45 creates an environment where people can abandon any of the stereotypes they’ve had and learn about cannabinoids and the endocannabinoid system.”