The Implications of NDI Denials for CBD in Food and Beverage

During a recent SFA Regulatory Update webinar, attorney Jeni Lamb Rogers of PSL Law Group, shared the latest federal regulation updates related to CBD in food and beverage and what it means for the future of the food industry.

Recent Regulatory Events

On December 20, 2018, Congress passed the Farm Bill, which legalized the lawful marketing of hemp that contains less than 0.3 percent THC. However, the Farm Bill didn’t change the framework for the FDA in terms of regulating food, drugs, and supplements, which means that, since CBD is considered an investigational drug by the FDA, it cannot be added to food or beverages.

Even so, after the Farm Bill was passed, there was an explosion of CBD products in the market, said Rogers.

As a result, on May 31, 2019 the FDA held a public hearing on CBD in food and dietary supplement products. The focus of the hearing was the safety of CBD products, and whether they should be in food and beverage and dietary supplement products.

At that time, many were hopeful that the FDA would start to make a lawful pathway for CBD in food and beverage, said Rogers.

But that has not happened. Since then, the FDA has sent warning letters to companies that are making “egregious” disease claims about their CBD products, with the reasoning that CBD in supplements, food, or beverage is unlawful under the Dietary Supplements Exclusionary Rule or the Prohibited Acts provision.

New Dietary Ingredient Denials

Rogers shared that in May 2021, Charlotte’s Web and Irwin Naturals, two dietary supplement manufacturers, submitted New Dietary Ingredient Notifications to the FDA for their full spectrum hemp extract products. The reasoning behind the submissions was that because full spectrum hemp extract contains a smaller amount of CBD than broad spectrum extract, it should be evaluated differently.

When a company submits an NDI Notification, it must explain the product, its intended use and amount, as well as provide data to substantiate its safety, said Rogers. Then the FDA reviews and either rejects or accepts the conclusion of safety.

In this case, the FDA rejected the products for two reasons, explained Rogers. First, the agency concluded that full spectrum hemp extract was not different from any other CBD-containing product. And second, the agency said that inadequate safety data was provided around hepatoxicity (liver issues) and reproductive toxicity.

Implications for Specialty Food Makers

Because the FDA has rejected the argument that the full spectrum hemp extracts are the same as CBD, the agency is unlikely to initiate notice and comment rulemaking on the subject, said Rogers. This means that the only path forward is through legislation introduced by the House or Senate to exempt CBD, full spectrum, and broad spectrum hemp from the Dietary Supplements Exclusionary Rule or the Prohibited Acts provision.

“What this all boils down to is that CBD in food and beverage, as well as supplements, remains the wild West of the industry,” said Rogers. “I think some companies making CBD products will still follow food safety regulations, even though FDA doesn’t provide oversight or enforcement. I think there will also be other companies who, because there isn’t oversight, will not follow the safety regulations.”

Rogers noted that this leaves states in the difficult position to require testing, labeling, and setting their own standards for these types of products.

View the full recording now.

Related: What to Know About The First Critical Steps of a Food RecallUSDA Seeks Comments on Cell-Cultured Meat, Poultry.

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