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.
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.
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 use CBD products.
[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.
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