FDA Puts the Brakes on CBD-Infused Snacks at the Supermarket — More Research Needed
Federal officials say they aren’t ready to allow cannabidiol in food products since it’s being used in medications right now.
Don’t expect to find a new Ben & Jerry’s ice cream flavor containing the word “cannabidiol” anytime soon.
The company that gave the world Magic Brownies and Cherry Garcia ice cream recently announced its intention to make ice cream flavored with cannabidiol (CBD), which is derived from the hemp plant.
However, federal regulators are making it clear that CBD-infused munchies won’t be on store shelves soon.
Ice cream isn’t the only thing food companies want to infuse with CBD.
The Carl’s Jr. hamburger chain made headlines in April when it rolled out a CBD burger in Colorado — where recreational marijuana use is legal — during the weekend of 4/20, the national holiday for cannabis users.
Dirk Van de Put, chief executive officer of Mondelez, the international company that makes Oreo cookies and other snack foods, told CNBC in May the company is “getting ready” to produce CBD-infused food, pending government approval.
A few weeks later, Ben & Jerry’s made its CBD-infused announcement.
“You probably already know that we’re fans of all things groovy — think: Half Baked and Dave Matthews Band Magic Brownies,” the company said in a statement. “So it’s no surprise that we can’t wait to get into the latest food trend: cannabidiol, or CBD. We are open to bringing CBD-infused ice cream to your freezer as soon as it’s legalized at the federal level.”
But while the 2018 Farm Bill legalized CBD oil derived from the hemp plant, the Food and Drug admin2istration (FDA) hasn’t yet approved its use as a food additive.
The FDA says that’s because CBD has already been approved as a drug to treat pediatric seizures (Epidiolex in June 2018), it cannot legally be added to food or dietary substances.
“Although the law says that FDA can issue regulations to create new exceptions to these statutory provisions, FDA has never issued a regulation like that for any substance,” Dr. Norman Sharpless, the FDA’s acting commissioner of food and drugs, said at a May 31 hearingTrusted Source where the agency took 10 hours of public testimony on products containing cannabis and cannabis-derived compounds.
“So, if we were thinking about doing that for a substance like CBD, it would be new terrain for the FDA,” he said.
Questions also remain about the quality and purity of CBD products, including whether some contain more than the trace amounts of the psychoactive THC allowed by law.
“There are real risks associated with both those substances and critical questions remain about the safety of their widespread use in foods and dietary supplements, as well as other consumer products,” said Sharpless.
“And given the new interest in marketing cannabis products across the range of areas FDA regulates, we will need to carefully evaluate how all these pieces fit together in terms of how consumers might access cannabis products.”
“Nowhere is this truer than with CBD,” he added. “While we have seen an explosion of interest in products containing CBD, there is still much that we don’t know.”
Brian Baum, president and chief executive officer of Cannovia, which makes and markets CBD-infused products such as oils, chewing gum, and lotions, told Healthline that a lack of labeling standards is especially confusing for consumers.
“A lot of products on the market don’t have a therapeutic dose” — which Baum defined as 500 to 1000 milligrams (mg) of CBD — “so labeling requirements will play an important role,” he said.
“The industry is very interested in some sort of intelligent regulation to bring in some standards and protect consumers and manufacturers,” said Baum.
In a public statementTrusted Source about CBD products in April, FDA Commissioner Dr. Scott Gottlieb said that research on Epidiolex demonstrated that there are “serious risks that can be managed when the product is taken under medical supervision in accordance with the FDA-approved labeling for the product, but it is less clear how this risk might be managed in a setting where this drug substance is used far more widely, without medical supervision and not in accordance with FDA-approved labeling.”
Gottlieb said the FDA still has questions about cumulative CBD exposure, the intended functionality of the cannabis derivative in consumer food products, and where the threshold could or should be set for CBD levels in food “without undermining the drug approval process or diminishing commercial incentives for further clinical study of the relevant drug substance.”
CBD purity levels also remain a concern.
A 2017 studyTrusted Source of commercially available CBD extracts, for example, found that 31 percent were accurately labeled, with about 43 percent containing more CBD than advertised and 26 percent containing less.
Still, interest in CBD — touted for health benefits that may include anti-inflammatory properties, pain relief, and reducing blood pressure — remains high among food companies and chefs.
Baum noted that food is a good medium for masking the “hemp-y” flavor of CBD oil, although Cannovia also sells a flavorless, refined CBD powder that can be added to drinks.
When the National Restaurant Association asked its member chefs to identify the top food trend for 2019, 77 percent said cannabis/CBD-infused drinks — the top response — and 76 percent said cannabis/CBD-infused food.
Ben & Jerry’s urged customers to submit comments to the FDA, which also has formed an internal agency working group to “explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed; including a consideration of what statutory or regulatory changes might be needed and what the impact of such marketing would be on the public health.”
Maine legislators approved a law in March that allows for hemp and hemp products to be in foods after initially banning CBD in food.
Other states, such as Colorado, have also legalized CBD-infused foods in contrast to the FDA policy. The California legislature is considering doing so, too.
“As states start to move down the regulatory path, it puts more pressure on Congress and the FDA to address this,” said Baum.
“So much has happened so quickly. It’s been a long time since hemp and hemp-derived products have been available, and the industry is just catching up to speed,” added Baum.
“I think we’ll see a lot more clinical studies to define specific health benefits and refine dosages for CBD, and more specialized CBD products coming onto the market.”
As states move to legalize hemp cultivation, CBD supplies should rise and prices should drop, said Baum.
“I think in the next 12 to 18 months there will be a regulatory path for ingestible with CBD,” he said.
See the original Healthline article here