CHARLOTTE, N.C. — Do you count yourself among retailers who would like to see the U.S. Food and Drug Administration (FDA) get off the sidelines and set some standards for the legal sale of cannabinoid (CBD) products? Be careful what you wish for, said attorney Jonathan Havens of Saul Ewing Arnstein & Lehr LLP, Baltimore.
Speaking at CSP’s CBD & Convenience Retail conference in Charlotte, N.C., Havens said the FDA is purposely leaving its standards murky, and that’s to the advantage of the industry.
“The FDA doesn’t want to regulate CBD,” Havens said Oct. 28. “And if they do, it’s going to take years.”
The FDA has said CBD product manufacturers need to avoid making medicinal claims about their products, even though the main driver of CBD sales is claims of therapeutic results. These claims, which cannot be listed in marketing for CBD products, include remedies for stress, insomnia, muscle pain and general well-being. Currently, the FDA is taking a hear-no-evil, see-no-evil stance in regulating the ingredient, Havens said. “Basically, they’ve said, officially, you can’t [sell products with CBD], but unofficially, we’re not going to go after it unless you make [medicinal] claims.” That is, as long as no one is complaining, manufacturers and retailers should be left alone by federal regulators.
Instead, the FDA would like to see the industry regulate itself, keeping in mind what’s best for the consumer. If, however, a product claim is extreme—such as it cures cancers—and someone complains, the FDA will get involved. The best way to earn a subpoena from the FDA is to make outlandish claims, Havens said.
“If it seems too good to be true, be careful,” he said, predicting that a swell of CBD regulatory challenges is likely to come as the number of manufacturers increases and their marketing tests the boundaries. “I think we are just seeing the tip of the iceberg in claims lawsuits,” he said.
“The FDA doesn’t know why people are putting CBD in products, and the industry isn’t providing a lot of good answers without making therapeutic claims. Is it legal? No. But is the FDA coming after you? No. The FDA will use its resources to focus on products that are making the most outlandish claims.”
So why not push the FDA to publish standards for CBD products? Havens said there’s a concern that those guidelines will be too strict.
“There’s a very real chance that, pushed into a corner, the FDA could say CBD products must be limited to 5 milligrams or less,” he said, suggesting an amount that would be ineffective to most consumers. “That would be the worst thing possible.”
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