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FDA's pledge to regulate CBD welcome, but much more needed

The lack of regulatory oversight in the hemp-derived product market gives brands leeway to commit food fraud, this food safety expert argues—and he urges the Food & Drug Administration to act.

Tyler Williams

March 4, 2023

5 Min Read
Tyler Williams, CEO at ASI Food Safety as of January 2023, former CTO of CSQ Cannabis Safety & Quality

As a longtime food safety professional, I find the cannabidiol market unsettling. The commercial landscape supports a proliferation of CBD products: tinctures, gummies, salves, bath bombs and beverages. But thanks to CBD's position in regulatory purgatory, many of these products escape the scrutiny of professionals dedicated to ensuring consumer protection and well-being.

In 2021, FDA reported that the market for hemp-derived products had reached an estimated $4.6 billion and was predicted to hit close to $18 billion by 2026. As the commercial marketplace grows, it is time for brands to endure much more regulatory oversight and scrutiny.

All it will take is one terrible mistake with a single batch of a CBD product—a slipup that leads to illness and death—and the entire market will be upended. At the same, the market already supports products that contain low levels of lead, mercury, arsenic and cadmium, according to a study published in Science of the Total Environment. Studies like this, and the negative news that they generate, are damaging the industry's reputation.

The lack of oversight has also emboldened companies that manufacture and sell CBD products containing far less CBD than stipulated on labels—or none at all. The FDA, as well as independent labs occasionally test CBD products; sometimes, they find that the CBD companies are engaged in what amounts to fraud.

The FDA's 'plan' for CBD

In December, the FDA announced its plan to draft recommendations outlining ways for the federal government to make sure that products containing ingredients derived from the hemp plant are safe.

"You've got a widely unregulated market," Norman Birenbaum, an FDA senior adviser working on the issue, told The Wall Street Journal in December. "The safety profiles around these products are not what [consumers] are generally accustomed to and not the same as what they get from other products when they walk into a wellness store or grocery store or even a gas station."

While this public acknowledgement from the FDA seemed promising, one month later, the agency announced that in fact, it needs to work with Congress to "develop a cross-agency strategy for the regulation of these products."

The FDA realized something that I've been preaching for years: Cannabidiol products cannot be regulated in the same way that food is regulated; each requires very different safety standards.

"The FDA's existing foods and dietary supplement authorities provide only limited tools for managing many of the risks associated with CBD products," Janet Woodcock, FDA's principal deputy commissioner, said in a recent press release. "Under the law, any substance, including CBD, must meet specific safety standards to be lawfully marketed as a dietary supplement or food additive."

What about delta-8?

One matter of deep concern to me, which helped prod the FDA toward CBD product scrutiny, is the rise of intoxicating products derived from the hemp plant, such as delta-8 tetrahydrocannabinol. Hemp yields a wide diversity of cannabinoids, plant compounds including CBD that are found in abundance in hemp. While CBD is not psychoactive—it doesn't get anybody high—delta-8 brings about sensations quite similar to those caused by ingesting the most famous cannabinoid, delta-9-tetrahydrocannabinol, or THC.

Last year, the consumption of delta-8 gummies led to the death of one child in Virginia, and sickened teenagers in Iowa and Texas. With rigorous oversight, it is quite possible these tragedies could have been avoided.

Delta-8 remains much more niche than CBD. Eight states have banned these products, and unlike CBD, they aren't sold in mainstream consumer outlets. Regardless, delta-8 products still are legal in most states and enjoying mounting popularity. While data analytics firms don't yet have strong sales figures for delta-8, Hemp Benchmarks identified it as the fastest-growing segment of the hemp chemicals market in 2021.

Safeguarding CBD—with or without the FDA

One odd twist in what truly stands as a CBD saga: Products infused with CBD and other hemp-derived compounds are actually illegal, as the FDA excluded them from the dietary supplement definition. The agency says companies cannot sell hemp-derived products, neither food nor supplements, and it recently denied three citizen petitions requesting the agency engage in rulemaking to allow the hemp-based compound to be marketed in dietary supplements.

Of course, the FDA's stance has not led to much regulatory action—CBD is everywhere. To date, most penalties against CBD companies stem from marketing claims made by companies engaged in cross-state sales. While cracking down on health claims is critical—and I champion FDA action on this front—I think it is not as important as devoting resources to the most dangerous side of the food and supplements industries: manufacturing.

Some states have attempted to address the safety of hemp-derived products. But budgets are thin and in many states, all it takes to launch a hemp company is filling out applications and paying fees for licenses. States have more pressing concerns than overseeing the sprawl of hemp products.

Until the FDA invests resources into regulating the hemp market, brands should partner with organizations that work with hemp companies for the sake of assess and monitor manufacturing standards and safety. Some of the larger companies in the space have enlisted certification organizations to examine their existing manufacturing protocols and procedures and guide them toward standardized approaches to safety and quality.

It is fair to describe today's hemp-derived supplements and food industries, which largely lack federal and state oversight, as a lawless Wild West. Anything goes. But with the FDA pledging to work with Congress to finally bring order and structure to the environment—and with certification organizations already helping responsible companies ensure customer health—the commercial landscape is inching toward legitimacy.

Tyler Williams is consumer product safety and quality expert with significant experience in the food and beverage, cannabis and dietary supplement industries. As CEO of ASI Food Safety, he helps major brands worldwide improve food safety practices.

 

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About the Author(s)

Tyler Williams

CEO, ASI Food Safety

Tyler Williams is consumer product safety and quality expert with significant experience in the food and beverage, cannabis, and dietary supplement industries. As the CEO of ASI Food Safety, one of the largest food safety companies in North America, Williams helps major food and beverage brands across the globe improve their food safety practices. Williams graduated with his master’s degree in Food Safety and Certificate in International Food Law from Michigan State University, and he jumped into the cannabis industry in 2020 when creating CSQ Cannabis Safety & Quality, the first cannabis certification program to meet the GFSI Benchmarking Requirements, ISO requirements and regulatory cannabis requirements from seed to sale.

In 2019, Williams started a nonprofit, Show Me Food Safety, that provides resources to small food manufacturers and growers in Missouri to help improve their food safety practices and get on the shelves of local grocery stores.

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