- CBD is a chemical compound naturally found in cannabis and hemp plants, which are both versions of the plant species Cannabis sativa.
- At the federal level, cannabis is considered a Schedule 1 substance, so it is illegal. But many states allow CBD to be sold on it’s own or in food and beverages.
- The FDA said on its website that it is “actively working to learn more about the safety of CBD and CBD products.”
More food manufacturers are cashing in on the public’s interest in cannabidiol, or CBD, and adding this compound to beverages and food products, including meals sold at high-end and fast-food restaurants.
Although several states have passed laws to legalize CBD, products containing this compound are technically illegal at the federal level. This includes CBD dietary supplements, as well as CBD-infused sodas, sparkling water, and cold brew coffee.
In spite of this conflict between federal law and the patchwork of state laws, the U.S. market for cannabis beverages in 2022 was an estimated $752 million, accounting for over 70% of the global market, reports Yahoo Finance.
The growth of this market is driven in part by the legalization of cannabis and CBD in certain states, but also by strong consumer interest in these products.
But don’t expect to see cannabis-infused beverages — or food products — to show up just yet in Walmart, Target and other big box stores, say some experts. These stores may wait for federal clarity on CBD foods and beverages before entering the market.
Murky legal status of CBD
CBD is a chemical compound naturally found in cannabis and hemp plants, which are both versions of the plant species Cannabis sativa.
The main difference between the two is that hemp typically contains lower levels of THC, the main intoxicating psychoactive compound found in cannabis. While CBD is also a psychoactive compound, it won’t produce the same “high.”
At the federal level, cannabis is considered a Schedule 1 substance, so it is illegal — as are the flower of the cannabis plant and any compounds derived from the cannabis plant, including THC and CBD.
However, the 2018 Farm Bill legalized at the federal level the production and sale of hemp plants and compounds extracted from it. Under this law, hemp plants can’t contain more than 0.3% THC by dry weight; otherwise they would be considered illegal.
Likewise, CBD extracted from hemp is considered legal at the federal level if it contains 0.3% or less THC. States may have different restrictions on CBD. For example, in Idaho CBD can’t contain more than 0.1% THC.
CBD foods illegal under regulatory law
Complicating matters, in 2018 the Food and Drug Administration approved Epidiolex, a pharmaceutical grade CBD oral solution for the treatment of seizures related to two rare forms of epilepsy.
Under federal regulatory law, once a substance is used as the active ingredient in an approved drug — or has undergone substantial clinical investigations as a medication — foods and dietary supplements containing this substance can’t be introduced into interstate commerce.
“This makes sense because you would not want your food to be laced with medication, for several obvious reasons,” said Dr. Harrison Weed, a professor of internal medicine at The Ohio State University College of Medicine in Columbus, Ohio.
So the FDA’s approval of Epidiolex effectively made all foods and dietary supplements containing CBD illegal at the federal level.
THC is illegal at the federal level for the same reason — it is the active ingredient in the FDA-approved drugs Marinol and Syndros.
There are exceptions to this aspect of the Federal Food, Drug, and Cosmetic Act, such as if a substance was marketed in food before the drug containing it was approved or underwent clinical investigations.
However, “the FDA has determined that neither CBD nor THC qualifies under this exception,” said Weed.
As a result, he said the FDA can use its authority to regulate foods and dietary supplements that contain CBD or THC. The agency has already sent warning letters to several companies for selling food products containing CBD.
FDA’s safety concerns about CBD
While both CBD food products and dietary supplements are illegal according to federal regulatory law, the FDA appears to be taking a more hardline position against foods and beverages containing this compound compared to the supplements.
Jamie Corroon, ND, MPH, the founder and medical director of the Center for Medical Cannabis Education in Del Mar, California, said this is understandable because there is a higher standard for safety when it comes to food additives compared to dietary supplement ingredients.
“Given this higher threshold, if the FDA is unsure that CBD is safe as a dietary ingredient, it means they are also unsure it is safe as a food additive,” he said.
The FDA recently warned Congress that legalizing CBD foods would put the public’s health at risk, reports Forbes.
Among its concerns are potential risks of liver injury, drug interactions and negative effects on male fertility from use of CBD products.
The FDA said on its website that it is “actively working to learn more about the safety of CBD and CBD products.” But Weed said right now we don’t know enough to draw strong conclusions about the safety of CBD and THC.
Given this gap in our knowledge, “it seems to me that the duty to restrict sales, or regulate content and labeling, falls upon the individual states that have chosen to ‘legalize’ cannabis products despite the federal ban,” he said.
Corroon pointed out that the risks that come from ingesting CBD foods or dietary supplements depend on the dose of CBD and how quickly it is consumed.
“It’s possible that the milligram amount of CBD in a single gummy would be greater than the milligram amount of CBD in a large bag of CBD-infused popcorn,” he said. “In that case, the exposure could be lower in the food product, unless a consumer ate the entire bag [of popcorn] in one sitting.”
Risks will also be different for specific populations.
“For example, there are potential drug interactions between CBD and anti-epileptic medications,” said Corroon. However, “the dose of CBD required [for a drug interaction] far exceeds what would reasonably be included in a food product.”
Calls for legal, but regulated CBD
Others are concerned that the legal grey area that CBD exists has allowed unscrupulous companies are using the lack of oversight to put dangerous products on the market.
Without regulation, it is up to companies to ensure that the CBD used in their food is free of contaminants, mold, solvents, pesticides and heavy metals.
Some companies use independent laboratories to ensure that the CBD in their products is high quality; these companies may share the certificate of analysis on their website.
This month U.S. Representatives H. Morgan Griffith (R-Virginia) and Brett Guthrie (R-Kentucky) sent a letter to FDA Commissioner Dr. Robert Califf advocating for the agency to protect public health by changing its approach to CBD products.
“Rather than denying new products from coming to market, the FDA must take action and establish a clear set of standards for companies to adhere by, especially since these products are already being sold in states across the nation,” they wrote.
“There must be a uniform and established standard that responsible actors can follow that will allow for safe CBD and CBD-derived products to come to market,” they added.
CBD Food and Drinks are Becoming More Popular, But the FDA isn’t Biting
Source: Pinoy Lang Sakalam
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