FDA Says It "Cannot Conclude" That CBD Is Safe as a Food Additive

This article is published by Cannabis Wire on NOV. 25, 2019. Read the original article here.

The CBD industry has long awaited the FDA's regulatory approach to CBD products, which the agency says it will unveil "in the coming weeks."

NOV 25, 2019 10:11PM EST	CBD
Alyson Martin@alysonrmartin Co-founder of Cannabis Wire. See more

In a pre-Thanksgiving news dump, the Food and Drug Administration released an update that lays out new "safety concerns" regarding CBD products. This update is the FDA's strongest statement to-date as to what its long-awaited regulations might be for the wildly popular cannabis compound when it comes to food.

"Based on the lack of scientific information supporting the safety of CBD in food, the FDA is also indicating today that it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food," the release reads.

The cannabis industry has been eagerly anticipating FDA rules on CBD products since the passage of the 2018 Farm Bill, which legalized hemp (and hemp is abundant in CBD). Since the FDA hosted its historic public meeting in June about how to regulate products that contain cannabinoids like CBD, the agency has been gathering information to help determine "potential pathways for various types of CBD products to be lawfully marketed."

Those regulations, according to the FDA release, are expected in the "coming weeks." Meanwhile, the CBD industry has continued to boom in a legal gray area, as products from topical lotions to ingested capsules hit shelves across the US, including mainstream stores like CVS.

Food products are a potentially lucrative channel for the CBD industry, but there has remained one major rub: the fact that there is already an FDA-approved CBD product available by prescription. The product, Epidiolex, is made by GW Pharmaceuticals. In general, products that are available as medicine cannot be added to foods. But so far, that has been seen as a hurdle for the CBD industry, not an obstacle.

A noteworthy section of this latest FDA release suggests there are concerns about adding CBD to foods that go beyond its use in a medicine (italics added): "the agency is not aware of any other exemption from the food additive definition that would apply to CBD. CBD is therefore an unapproved food additive, and its use in human or animal food violates the FD&C Act for reasons that are independent of its status as a drug ingredient."

CBD products have also become popular among pet owners in recent years, and the FDA emphasized its "concerns" regarding these products. Therefore, the "pot for pets" segment of the CBD market faces uncertainty, as well.

"Concerns regarding CBD products with unproven medical claims and of unknown quality equally apply to CBD products marketed for animals," the FDA noted, urging pet owners to talk to their vets about "appropriate treatment options for their pets."

As Cannabis Wire covered in June, Ashley Morgan, who spoke on behalf of the American Veterinary Medical Association, said "we believe there is therapeutic potential in the development of cannabis-derived and cannabis-related compounds and we would like to see the potential realized."

The FDA panel asked Morgan if veterinarians are currently recommending medical cannabis.

"No," Morgan said quickly. "Well. Not legally," said, which was met with laughter from those attending the meeting.

The FDA also issued warning letters to 15 companies on Monday because they claimed that CBD could "prevent, diagnose, treat, mitigate, or cure serious diseases such as cancer, Alzheimer's disease, psychiatric disorders and diabetes."

The companies include:

Koi CBD LLC, of Norwalk, California

Pink Collections Inc., of Beverly Hills, California

Noli Oil, of Southlake, Texas

Natural Native LLC, of Norman, Oklahoma

Whole Leaf Organics LLC, of Sherman Oaks, California

Infinite Product Company LLLP, doing business as Infinite CBD, of Lakewood, Colorado

Apex Hemp Oil LLC, of Redmond, Oregon

Bella Rose Labs, of Brooklyn, New York

Sunflora Inc., of Tampa, Florida/Your CBD Store, of Bradenton, Florida

Healthy Hemp Strategies LLC, doing business as Curapure, of Concord, California

Private I Salon LLC, of Charlotte, North Carolina

Organix Industries Inc., doing business as Plant Organix, of San Bernardino, California

Red Pill Medical Inc., of Phoenix, Arizona

Sabai Ventures Ltd., of Los Angeles, California

Daddy Burt LLC, doing business as Daddy Burt Hemp Co., of Lexington, Kentucky

Tags: CBD, Food Additive, FDA, Safety

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