Op-Ed: Are Humans Evolving? the question is back, with new answers

Op-Ed: Are Humans Evolving? the question is back, with new answers

FDA to hold first public hearing on legalizing CBD in foods

The U.S. Food and Drug Administration will hold its first public hearing Friday, May 31, into how it should regulate CBD products. The FDA wants data on CBD's safety in food products so it can form a regulatory framework.

An entire industry is being built around cannabidiol, or CBD, one of the many chemical constituents of the cannabis and hemp plant. Once hemp was legalized in the U.S. in December 2018, it didn't take long before CBD became a hot wellness trend.

Many retailers, including and CVS Health Corp., already sell hemp oils, CBD creams, sprays, and lotions but the substance hasn’t yet been approved for use in food and drinks by the FDA. This is because, unlike THC, a mind-altering compound found in cannabis, CBD doesn’t give users a high.

While the FDA is working to create a regulatory framework with sensible guidelines, last month the agency also sent out warning letters to companies they view as irresponsibly marketing CBD products and making unsanctioned claims about their medical benefits.

Op-Ed: Are Humans Evolving? the question is back, with new answers

HOMEGROWN: Oregon decriminalization advocate Paul Stanford stands in the marijuana garden maintained by his organization, The Hemp and Cannabis Foundation, in Portland in 2013.

Paul Stanford / Wikimedia Commons (CC BY-SA 4.0)

And despite the FDA's warning that CBD is not approved for use in foods and dietary supplements, this has not stopped the increasing use of the compound in foods and drinks across the country. Burger chain Carl Jr. openly defied the agency, selling CBD-infused hamburgers on April 20.

“From the CBD companies’ perspective, if they don’t keep pushing forward they’re going to miss their window of opportunity to gain market control,” said Robert DiPisa, co-chair of the cannabis law group at New Jersey-based firm Cole Schotz.

“As an attorney, I try to read everything that the FDA is putting out, I try to gather as much information as possible to guide them in the best direction I can, but the truth of the matter is everyone is running blind right now.”

“The FDA wants to protect consumers. The last thing it wants is companies out there marketing CBD products and claiming health benefits without any clinical research to validate that," he told Market Watch.

What does the FDA want out of the hearing?

The biggest question facing regulators is the concentration and dosage of CBD. The FDA is rightly concerned about allowing the substance in food, beverages, and supplements because there are no industry standards in place.

Carl’s Jr.

Today marked the single-day debut of our Rocky Mountain High Cheese Burger Delight in Denver, CO. Big shouts to our first customer Michael Blackwell as well as a few gentlemen who drove 850 freakin miles from St. Louis to take a bite outta history!

When he announced the May 31 public hearing, then-FDA Commissioner Scott Gottlieb said in a statement that there are “open questions about whether some threshold level of CBD could be allowed in foods without undermining the drug approval process or diminishing commercial incentives for further clinical study of the relevant drug substance.”

The purpose of the hearing is to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.

“What they might end up doing is reserve the higher dosages of CBD for pharmaceutical drugs and only permit lower dosages to be incorporated in food and drinks,” he said. “That in itself would hopefully keep an incentive for the pharmaceutical companies to continue to invest in clinical research.”

Representing the Hemp industry

In a press release today, David Heldreth, Chief Science Officer for True Terpenes, announced he will represent the expanding hemp and terpene markets at the FDA hearing on Friday.

Terpenes are the compounds responsible for the scent and taste of plants such as lavender (linalool), rosemary (alpha-pinene) and hops (myrcene) and even cannabis.

True Terpenes is a Portland, Oregon based company focused on utilizing botanically-derived terpenes to replicate the aroma, flavor, and effects of cannabis. The lack of any actual cannabis allows their products to be food grade and utilized in food, drink and related products. Currently, even hemp-derived terpenes are not technically allowed in food products.

The True Grade system Heldreth's company has devised as a model standard for the industry to adopt for consumer safety. While food grade is a designation regulated by the FDA and related laws, True Grade is representational of the toughest standards for cannabis inhalation products in the United States.

Leave a Reply

Your email address will not be published. Required fields are marked *