FDA Issues New Warnings About Health Risks Of CBD


The Food and Drug Administration has significantly ramped up its warnings about the potential health hazards of CBD infused into food, beverages and other products.

The stark warnings come just as Edible Arrangements dips its toes into the CBD realm with the launch of Incredible Edibles, and CBD-laced Recess seltzer is planning a campaign to bypass Facebook and Instagram's ban on CBD advertising.

As the FDA bluntly stated on Nov. 25, “CBD has the potential to harm you, and harm can happen even before you become aware of it.” The agency lists as potential dangers liver injury, “serious side effects” from the effect of CBD on the metabolizing of other drugs, combining CBD with alcohol and other central nervous system depressants, changes in alertness, gastrointestinal distress and such mood changes as irritability and agitation.

“It is currently illegal to market CBD by adding it to food or labeling it as a dietary supplement,” the FDA said. “The FDA has seen only limited data about CBD safety and these data point to real risks that need to be considered before taking CBD for any reason.”

The FDA’s concern with the risk of liver damage stems from its approval in 2018 of the drug Epidiolex for the treatment of two rare and severe seizure disorders.

“This serious risk can be managed when an FDA-approved CBD drug product is taken under medical supervision, but it is less clear how it might be managed when CBD is used far more widely, without medical supervision, and not in accordance with FDA-approved labeling.”

This comes as no surprise to Tom Vierhile, vice president of strategic insights North America for Netherlands-based Innova Market Insights, who has been anticipating the impact of the approval of Epidiolex.

“It looks like this is just beginning to play out and I think it puts a huge black cloud over consumables that currently contain CBD,” Vierhile tells Marketing Daily. “With the stroke of a pen, government agencies like the Food and Drug Administration could make CBD-based food and beverage products go away until testing verifies that CDB is proven to be generally recognized as safe.”

It’s not known when the FDA will conduct enough research to create a regulatory framework for CBD in consumer products.

“The good manufacturing process standards established by the FDA for food, cosmetic and dietary supplement manufacturers is a good place to start in assuring the quality and safety of hemp oil and CBD products," says Dr. Steven Kraus, president and COO of hemp-based product provider Functional Remedies. “Companies that do not take the effort to adhere to these standards may be lacking in their commitment to quality and safety."  

On Nov. 26, Mobile Marketer reported that Recess, which cannot advertise its CBD-infused seltzers on Facebook or sister company Instagram, would pay cash to Venmo users who mention the brand on Instagram from Black Friday to Cyber Monday. For each repost, direct message or Instagram story that shows a Recess tag and sale information, Recess will send $3 to the user’s Venmo account.

While the move by Recess is a creative way to get around Instagram’s regulations, it remains to be seen how it will fulfill its customer acquisition goals, according to Nicole Amsler, vice president of marketing at loyalty specialist Formation.

“This type of transactional offer — versus a personalized promotion designed to drive additional brand engagement — may help acquire new customers in the short-term, but it won’t encourage loyalty or keep customers around in the long run,” Amsler says.

On Nov. 21, Incredible Arrangements announced the launch of its Incredible Edibles line of hemp-derived CBD products, which include smoothies and chocolate-dipped fruit.

“Consumers are showing an increasing demand for CBD products, and now is the perfect time for us to make our mark on this flourishing industry," Tariq Farid, founder and CEO of Edible Arrangements, said in a release.

The Edible Arrangement website home page associates the “power of CBD” with “nourishing healthy, happy lives.” The FAQ section says it is currently illegal to use CBD in food products "under the drug exclusion rule which prevents any active substance in a pharmaceutical from being added to a food."

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