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Journal to CBD Manufacturers: Don’t Be an Outlaw

Anyone creating CBD products should grok FDA guidance, even if the market still feels like the Wild West

Dry Powder

Cannabidiol (CBD) and CBD-derived products are everywhere. That’s why it pays to remind ourselves that the U.S. Food and Drug Administration’s (FDA) rules remain straightforward and categorical: CBD is an approved drug and thus cannot be added to food, beverages or dietary supplements. And that’s that.

But … we know it isn’t. As we’ve reported many times before (see this list), debate over how to regulate CBD rages on even as the FDA seems to take its time releasing final rules. And in the interim, the number of CBD products grows by leaps and bounds.

Confusion

“Widespread availability of hemp and hemp-derived CBD products is confounding,” writes a trio of authors in the latest issue of Cannabis and Cannabinoid Research, a “journal dedicated to the scientific, medical, and psychosocial exploration of clinical cannabis, cannabinoids, and the endocannabinoid system.”

“To date,” the article continues, “FDA enforcement has been limited to sending warning letters to manufacturers, largely for mislabeling or misbranding their products as unapproved new drugs, or for making claims that a product is intended to treat a disease condition on labels and marketing materials.”

It’s a confusion that anyone involved in the market shares. But while confusion reigns, the authors offer helpful advice for CBD product manufacturers – advice that will not only help consumers but will also nudge the CBD industry toward the respectable side of the aisle.

Toe the Line

The article urges manufacturers to take their cue from labeling practices already established by the FDA for standard products. For instance, manufacturers should accurately report what they put in the product: “Widespread mislabeling of hemp and Cannabis products has been documented by both independent researchers and the FDA and other organizations. Underlabeling and overlabeling of both CBD and THC [tetrahydrocannabinol] content have been reported.”

The authors provide reminders on FDA labeling ethics. Manufacturers should provide a product identity as a dominant label feature – is the product a cracker, a cereal or a supplement? They should also provide accurate “Serving Size” and “Servings Per Container” information on their labels and refrain from making absolute claims (“THC-free,” for example) until regulatory guidance is in full effect. Nutrient claims on standard food products – “low-fat” or “high-fiber” – are carefully defined by existing regulation, but there is no similar set of definitions for CBD-related claims; they should be avoided for now. Health and drug claims are likewise well-defined and monitored and may court trouble if used on labeling.

The Takeaway

In short, “manufacturers of [CBD and hemp-based] products may reasonably be expected to understand and adhere to FDA regulations for labeling and marketing of food, dietary supplements, and drugs, both [over the counter] and prescription, even though FDA has interpreted federal law as excluding them from those categories.”

This is excellent advice, designed to set up manufacturers (and their label and package designers) for an easier ride once new regulations are revealed.

Journal to CBD Manufacturers: Don’t Be an Outlaw Anyone creating CBD products should grok FDA guidance, even if the market still feels like the Wild West Dry Powder Cannabidiol (CBD)

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