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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. Today, the U.S. Food and Drug Administration issued warning letters to two companies for selling products labeled as containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act.

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.

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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.”

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.

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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 Companies Illegally Selling Over-the-Counter CBD Products for Pain Relief

Products Listing CBD as Inactive Ingredient Cited for Unapproved Drug and Misbranding Violations

The U.S. Food and Drug Administration has issued warning letters to two companies for selling products labeled as containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the warning letters address the illegal marketing of unapproved drugs labeled as containing CBD. The FDA has not approved any over-the-counter (OTC) drugs containing CBD, and none of these products meet the requirements to be legally marketed without an approved new drug application. The letters explain that, as CBD has known pharmacological effects on humans, with demonstrated risks, it cannot be legally marketed as an inactive ingredient in OTC drug products that are not reviewed and approved by the FDA. Additionally, the letters cite substandard manufacturing practices, including failure to comply with current good manufacturing practices.

“The FDA continues to alert the public to potential safety and efficacy concerns with unapproved CBD products sold online and in stores across the country,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “It’s important that consumers understand that the FDA has only approved one drug containing CBD as an ingredient. These other, unapproved, CBD products may have dangerous health impacts and side effects. We remain focused on exploring potential pathways for CBD products to be lawfully marketed while also educating the public about these outstanding questions of CBD’s safety. Meanwhile, we will continue to monitor and take action, as needed, against companies that unlawfully market their products — prioritizing those that pose a risk to public health.”

The FDA issued warning letters to:

The products that are the subject of the warning letters issued today have not gone through the FDA drug approval process and are considered unapproved new drugs. There has been no FDA evaluation of whether these unapproved drug products are effective for the uses manufacturers claim, what an appropriate dose might be, how they could interact with FDA-approved drugs or other products or whether they have dangerous side effects or other safety concerns.

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The FDA has previously sent warning letters to other companies illegally selling unapproved CBD products that claimed to prevent, diagnose, mitigate, treat or cure various diseases, in violation of the FD&C Act.

Under the FD&C Act, any product intended to diagnose, cure, mitigate, treat or prevent a disease, and any product (other than a food) that is intended to affect the structure or function of the body of humans, is a drug. OTC drugs must be approved by the FDA or meet the requirements for marketing without an approved new drug application under federal law, including drug products containing CBD, regardless of whether CBD is represented on the labeling as an active ingredient or an inactive ingredient.

The FDA has not approved any CBD-containing drug products other than one prescription drug for the treatment of seizures associated with tuberous sclerosis complex, Lennox-Gastaut syndrome and Dravet syndrome in human patients.

The FDA has requested written responses from these companies within 15 working days stating how they will address these violations or providing their reasoning and supporting information as to why they believe these products are not in violation of the law. Failure to adequately address the violations promptly may result in legal action, including product seizure and/or injunction.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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