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The use of cannabidiol, or CBD, in food and drink has exploded since Congress legalized hemp production and delisted CBD as a controlled substance, in 2018. Today it’s added to lattes, tea, kombucha, snacks like cookies and more. FDA has issued warning letters to 4 companies illegally selling unapproved animal drugs containing cannabidiol (CBD) that are intended for use in food-producing animals. The companies include Free State Oils, Hope Botanicals, Kahm CBD and Kingdom Harvest. These firms also market products for people.

Is your CBD latte safe? Don’t ask the FDA

The use of cannabidiol, or CBD, in food and drink has exploded since Congress legalized hemp production and delisted CBD as a controlled substance, in 2018. Today it’s added to lattes, tea, kombucha, snacks like cookies and more.

But is it safe for consumption?

CBD-infused products often come with outsize, unsubstantiated claims on their packaging about its healing powers for a wide array of ailments, like pain, depression and mood disorders , breast cancer, Alzheimer’s – even Covid-19.

Yet the Food and Drug Administration, tasked with ensuring the safety of our food supply, doesn’t know whether food and drink containing CBD is safe. It’s gone so far as to warn of the “real risks” of using CBD. But these products still make it to market.

Before a company can use a new food additive like CBD, in theory it must file a petition and get FDA approval. But CBD has never gone through that pre-market review process. In fact, most new chemicals added to food today are never formally approved by the FDA.

Instead, food companies often exploit a loophole that allows them, rather than the FDA, to decide a new substance is “generally recognized as safe,” or GRAS. Congress created the GRAS exemption in 1958 so that common and obviously safe ingredients like flour, vinegar and spices wouldn’t needlessly have to go through the FDA’s tough pre-market process.

But today food companies use the loophole in a way that was never intended – to make their own safety determinations, sometimes bypassing FDA review altogether. Companies can tell the FDA through a notification process that they’ve determined their ingredient is safe. But notification is entirely voluntary, so companies can and do decide to deem certain chemicals GRAS and use them in food, without ever notifying the FDA or consumers.

And no company has petitioned the FDA or provided a voluntary GRAS notification for CBD-infused food and drink. Instead, makers of these items are likely relying on secret GRAS determinations.

FDA fears of CBD’s ‘real risks’

The FDA strongly disagrees with food companies that CBD is GRAS, noting it is “currently illegal to market CBD by adding it to food or labeling it as a dietary supplement.”

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Based on limited safety data, the FDA has identified “real risks that need to be considered before taking CBD for any reason.” Since 2015, the agency has issued more than 80 warning letters to companies selling unapproved CBD products. [1]

In a recent letter to a CBD gummies maker, the FDA said existing data “ do not provide an adequate basis to conclude that the use of CBD in food meets the criteria for GRAS status. Many unanswered questions and data gaps about CBD toxicity exist, and some of the available data raise serious concerns about potential harm.”

Despite dozens of similar FDA letters, manufacturers continue to exploit the GRAS loophole and CBD remains ubiquitous in food.

In October, the FDA launched the Cannabis Derived Products Data Acceleration Plan to collect safety information on products containing CBD. But it’s unclear whether the plan will result in federal regulations on CBD in food and other FDA-regulated product categories.

The CBD Product Safety and Standardization Act of 2021, introduced in Congress last month, would force the FDA to write new regulations setting the maximum amount of CBD allowed per serving in food, labeling and packaging requirements, and placing limits on use, including in categories of foods.

Alarmingly, the legislation says these standards would apply to foods containing CBD, whether approved through a food additive petition, a voluntary GRAS notice, or a company’s own secret determination that CBD is GRAS in food. If enacted, the law could rob the FDA of the power to determine whether CBD is safe and give that power to food companies .

Congress should require the FDA to develop CBD rules to ensure consumers are safe, as proposed by the bill. Congress also should not undercut the FDA’s position that CBD is not GRAS. Instead, Congress should also ensure that the FDA, not food companies, determines whether and how CBD can be used safely.

Congress must also take steps to narrow the GRAS loophole for all food chemicals, not just CBD, and eliminate secret determinations, as proposed by the Toxic Free Food Act, introduced by Rep. Rosa DeLauro (D-Conn.). Only with strict rules in place can the FDA tell you it’s safe to sip your CBD latte.

[1] The FDA issued 5 warning letters in 2021, 8 in 2020, 22 in 2019, 1 in 2018, 4 in 2017, 22 in 2016, and 18 in 2015.

FDA Warns Four Companies for Illegally Selling CBD Products Intended for Use in Food-Producing Animals

The U.S. Food and Drug Administration (FDA) has issued warning letters to four companies illegally selling unapproved animal drugs containing cannabidiol (CBD) that are intended for use in food-producing animals. The companies include Haniel Concepts dba Free State Oils, Hope Botanicals, Plantacea LLC dba Kahm CBD and Kingdom Harvest. While the FDA does not know the current extent of CBD use in food-producing animals, the agency is taking steps regarding these unapproved and potentially unsafe products now to help protect animals and the safety of the food supply.

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Under the Federal Food, Drug, and Cosmetic (FD&C) Act, any product intended to treat a disease or otherwise have a therapeutic or medical use, and any product (other than a food) that is intended to affect the structure or function of the body of humans or animals, is a drug. The FDA has not approved any human or animal products containing CBD other than one prescription drug product to treat rare, severe forms of epilepsy in children. Therefore, all other CBD products intended for use as a drug are considered unapproved drugs and are illegal to sell. Some of the claims made by the companies in the warning letters refer to helping “farm animals with stress, anxiety, pain, inflammation, injuries…” and providing “support to help manage normal stress, promote a calming effect, maintain a healthy gut, maintain a normal and balanced behavior, maintain healthy joints, maintain a normal inflammatory response….” These claims, among others, establish the intended use of the products as drugs.

Unapproved drugs like these CBD products have not been evaluated by the FDA to determine whether they are effective for their intended use, what the proper dosage might be, how the products could interact with FDA-approved drugs, or whether they have dangerous side effects or other safety concerns.

The FDA is concerned about these CBD products for food-producing animals not only because CBD could pose a safety risk for the animals themselves, but also because of lack of data about the safety of the human food products (meat, milk and eggs) from the animals that have consumed these CBD products.

After a food-producing animal is treated with a drug, residues of that drug may be present in the milk, eggs, or meat if the animal is milked, eggs are collected, or the animal is sent to slaughter before the drug is completely out of its system. Part of the animal drug approval process includes setting a withdrawal period to establish the minimum amount of time between the last dose of a drug and the slaughter or harvesting of food products from the treated animals. Since CBD is an unapproved drug, the FDA has not had the opportunity to evaluate CBD residues in food or to establish an appropriate withdrawal period.

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To date, there is a lack of data on the residues that may result when food-producing animals consume CBD products. There is also a lack of data on what levels of potential residues are safe for a person consuming the foods that come from CBD-treated animals. In addition, the manufacturing processes of unapproved CBD drug products have not been reviewed by the FDA as part of the human or animal drug approval processes. The FDA has received reports of some CBD products containing contaminants such as pesticides and heavy metals, thus introducing additional concerns for the use of CBD products.

The FDA is also concerned that consumers may postpone seeking professional medical care for their animals, such as getting a proper diagnosis, treatment and supportive care, because they are relying on unproven claims associated with unapproved CBD products. Many of the products marketed by the four companies that received warning letters made claims about alleviating anxiety. Anxiety in animals can be a signal of a range of medical conditions requiring veterinary care from a licensed professional. This is why it is critical that consumers talk to a health care professional about the best way to treat medical conditions using approved treatment options that have been proven to be safe and effective.

In addition to the CBD products marketed for food-producing animals, Free State Oils, Hope Botanicals, Kahm CBD and Kingdom Harvest also sell CBD-containing unapproved new drugs for humans and adulterated human foods. Some of the products were also marketed as dietary supplements even though CBD-containing products do not meet the definition of a dietary supplement. These products include oils, creams, extracts, salves, and gummies.

The FDA has requested responses from the companies within 15 working days stating how they will address these violations and prevent their recurrence. Failure to promptly address the violations may result in legal action, including product seizure and/or injunction.

The FDA encourages human and animal health care professionals and consumers to report adverse reactions associated with these or similar products to the agency. To report a problem with an animal product, visit fda.gov/vetproductreporting. To report a problem with a human product, use FDA’s MedWatch program.

Additional Information

Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.

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