The Food and Drug Administration (FDA) has sent warning letters to five companies that sell foods and beverages containing CBD\u2014the agency\u2019s latest stepped-up enforcement action that comes amid growing calls for a regulatory pathway for lawful marketing of the non-intoxicating cannabinoid.<\/p>\n
FDA didn\u2019t specify why it targeted these particular five companies out of the many more that market similar cannabidiol-infused consumables, but it said that they sell products \u201cthat people may confuse for traditional foods or beverages which may result in unintentional consumption or overconsumption of CBD.\u201d<\/p>\n
\u201cCBD-containing products in forms that are appealing to children, such as gummies, hard candies and cookies, are especially concerning,\u201d FDA said.<\/p>\n
\nFDA warns companies for illegally selling food and beverage products that contain #CBD<\/a>. These CBD products in forms that are appealing to children, such as lollipops, gummies, and cookies, are especially concerning. https:\/\/t.co\/bNVwItE3BU<\/a> pic.twitter.com\/pyR8GZRLbi<\/a><\/p>\n
\u2014 FDA FOOD (Ctr for Food Safety & Applied Nutrition) (@FDAfood) November 21, 2022<\/a><\/p>\n<\/blockquote>\n\n
There does seem to be a common thread connecting most of the businesses that received warning letters, with four of them selling CBD-infused candies or gummies, but it\u2019s unclear why these particular companies are being singled out. Plenty of hemp businesses started marketing such products across the country after the crop and its derivatives were federally legalized under the 2018 Farm Bill.<\/p>\n
\u201cToday\u2019s warning letters also outline additional violations of the [Food, Drug, and Cosmetic Act] Act, including that several of the companies are illegally selling unapproved CBD products that claim to cure, mitigate, treat or prevent various diseases, and adding CBD to animal foods, such as pet treats,\u201d the agency said.<\/p>\n
\u201cThe FDA has requested responses from the companies within 15 working days stating how they will address the issues described in the warning letters or providing their reasoning and supporting information as to why they think the 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.\u201d<\/p>\n
Another unique aspect of the FDA action is the agency\u2019s warning that evidence \u201csuggests that CBD may affect caffeine metabolism and may increase and\/or prolong caffeine\u2019s effects.\u201d<\/p>\n
In its notice<\/a> about the letters, FDA said that the \u201cuse of CBD raises safety concerns, especially with long-term use.\u201d<\/p>\n
\u201cScientific studies show possible harm to the male reproductive system, including testicular atrophy, harm to the liver, and interactions with certain medications. The FDA has not found adequate information showing how much CBD can be consumed, and for how long, before causing harm. This is particularly true for vulnerable populations like children and those who are pregnant. People should be aware of the potential risks associated with the use of CBD products.\u201d<\/p>\n
The scope of the enforcement action is limited in this case, but industry stakeholders say that it\u2019s part of a \u201cpattern\u201d within FDA that could have a chilling effect on the market.<\/p>\n
\u201cWe have a lot of really exciting new companies out there, particularly in the beverage space, that have popular, well-accepted products that have levels of CBD that studies demonstrate are not unsafe to the public,\u201d Jonathan Miller, general counsel for the U.S. Hemp Roundtable<\/a>, told Marijuana Moment on Tuesday.<\/p>\n
\u201cThose companies can continue to try to operate the space, but the louder the FDA displays its antagonism, the harder it is for them to find markets,\u201d Miller said.<\/p>\n
\nThis recent action by the @US_FDA<\/a> indicates the agency’s lack of urgency and reluctance to regulate #CBD<\/a> products, making it clear that Congress must act on behalf of our industry.<\/p>\n
Visit https:\/\/t.co\/26v8hrj7vS<\/a> to call on your members of Congress urging them to take action! https:\/\/t.co\/2daQ90Au0z<\/a><\/p>\n
\u2014 US Hemp Roundtable (@HempRoundtable) November 22, 2022<\/a><\/p>\n<\/blockquote>\n\n
Asked for clarification on why the five companies received warning letters, an FDA spokesperson told Marijuana Moment that the action was taken because the businesses were \u201cselling CBD containing products that people may confuse for traditional foods or beverages which may result in unintentional consumption or overconsumption of CBD.\u201d<\/p>\n
\u201cCBD-containing products in forms that are appealing to children, such as gummies, hard candies and cookies, are especially concerning,\u201d the spokesperson reiterated.<\/p>\n
In a separate blog post on FDA\u2019s CBD policy, the agency said that food ingredients \u201cmust be shown to be safe to be lawfully added to food\u201d and it hasn\u2019t yet \u201cfound sufficient information showing how much CBD can be consumed, and for how long, before causing the various types of harm we\u2019re concerned about.\u201d<\/p>\n
\u201cFor example, to date, we don\u2019t know whether regular or long-term CBD consumption could negatively affect fertility,\u201d it said<\/a>. \u201cCBD may also interact with other substances and alter their effect on the body. Studies suggest CBD may increase and\/or prolong caffeine\u2019s effects, which could be a problem for people who are sensitive to caffeine.\u201d<\/p>\n
FDA added that it is \u201cholding CBD to the same standard that we would any other substance that is intentionally added to food, like sweeteners or preservatives.\u201d<\/p>\n
Just this week, Truss CBD USA\u2014a joint venture of the beer giant Molson Coors and the cannabis company HEXO Corp\u2014announced that it will be exiting the U.S. market because of the lack of federal regulatory certainty around the hemp industry.<\/p>\n
The company said that there \u201cremains no near-term pathway to federal legalization, leaving uncertainty in the market,\u201d and that\u2019s \u201cleft some chain retailers and distributors hesitant to accept CBD beverage brands, complicating distribution and making the path to profitability a challenge,\u201d as Beverage Daily reported<\/a>.<\/p>\n
Other major companies like PepsiCo<\/a> and Carl\u2019s Jr.<\/a> have dipped their toes into the hemp product market with food and beverage items containing various amounts of CBD. It\u2019s unclear if FDA plans to expand its enforcement action in a way that would impact those product lines.<\/p>\n
Bipartisan lawmakers have repeatedly pressed FDA to create that marketing pathway for CBD in the food supply and as dietary supplements.<\/p>\n
Reps. Morgan Griffith (R-VA) and Brett Guthrie (R-KY) sent a letter to FDA Commissioner Robert Califf in September, demanding answers over the continued lack of regulations for CBD<\/a> for those purposes.<\/p>\n
Griffith and other bipartisan lawmakers\u00a0sent a separate, related letter to the FDA commissioner<\/a> in August. They expressed frustration over the \u201ccompletely insufficient response\u201d the agency provided in response to their bill calling for hemp-derived CBD to be permitted and regulated as a food additive.<\/p>\n
After the\u00a0CBD Product Safety and Standardization Act<\/a>\u00a0was filed in December 2021, the sponsors sought technical assistance from FDA to advise on key provisions. But four months after they sent the inquiry, FDA returned a \u201cone-page\u201d response that was \u201csimply a reformatting of a document provided to Congress over two years ago,\u201d the lawmakers said<\/p>\n
At a House Appropriations subcommittee hearing in May, FDA\u2019s Califf recognized that the agency\u00a0had moved slowly with rulemaking for CBD<\/a>\u00a0in the food supply, stating that the situation \u201clooks pretty much the same in terms of where we are now\u201d as compared to when he first worked on the issue in 2016.<\/p>\n
He said the FDA has taken steps to research the safety profile of cannabinoids to inform future rules, but he also punted the criticism about inaction to Congress, saying he doesn\u2019t feel that \u201cthe current authorities we have on the food side or the drug side necessarily give us what we need to have to get the right pathways forward.\u201d<\/p>\n
\u201cWe\u2019re going to have to come up with something new,\u201d Califf said. \u201cI\u2019m very committed to doing that.\u201d<\/p>\n
Stakeholders have strongly encouraged FDA to live up to its authority and provide guidelines and clarity for the industry. But the agency has largely limited its regulatory enforcement authority to sending warning letters to certain CBD businesses and denying cannabinoid marketing applications.<\/p>\n
In May, for example, the agency simply\u00a0sent warning letters to four cannabis companies<\/a>\u00a0for allegedly making unsanctioned claims about the medical benefits of CBD products they\u2019ve marketed for animals.<\/p>\n
FDA also warned consumers about marijuana-infused copycat food products<\/a>\u00a0that resemble popular brands and the risks of accidentally ingesting THC, particularly for children.<\/p>\n
The agency separately\u00a0issued its first set of warnings<\/a>\u00a0to companies over the allegedly illegal sale of products containing the increasingly popular cannabinoid delta-8 THC.<\/p>\n
It sent five warning letters to companies that are marketing products with the intoxicating compound and making what the agency says are unsanctioned claims about their therapeutic potential.<\/p>\n
FDA has been \u201cincreasing their public antagonism to CBD food and beverages,\u201d Miller said. However, from another perspective, their focus on that specific type of cannabis marketing \u201cmight signify that they\u2019re less antagonistic towards CBD as a dietary supplement.\u201d<\/p>\n
\u201cWe\u2019re hoping that there may be some some movement in that direction,\u201d he said. \u201cBut for this hemp industry to truly open up, we need to be able to see the cola companies and potato chip companies and candy companies follow up on their plans to add CBD to their product lines\u2014and it\u2019s very clear that from this FDA stance that the only way that that\u2019s going to happen is if Congress steps in and requires the regulation of these products.\u201d<\/p>\n
FDA said that it is aware \u201cthat there\u2019s great public interest in CBD products, even though CBD cannot lawfully be added to foods or dietary supplements.\u201d<\/p>\n
\u201cWhile we continue exploring policy solutions to address the large, violative market of CBD products, we will continue to monitor the marketplace and take action, as needed, against companies that pose the greatest risk of harm to the public,\u201d the agency said.<\/p>\n
In May, a top Republican on a key congressional committee also called on leadership to\u00a0schedule a hearing to hold FDA accountable<\/a>\u00a0for its lack of action to set regulations for CBD and delta-8 THC products.<\/p>\n
\nBiden Cheers Oregon For \u2018Following\u2019 His Lead With Marijuana Pardons<\/a><\/p>\n<\/blockquote>\n\n
Photo by Kimzy Nanney<\/a>.<\/em><\/p>\n
The post FDA Sends Warning Letters To Companies Selling CBD-Infused Foods And Beverages As Hemp Industry Awaits Regulations<\/a> appeared first on Marijuana Moment<\/a>.<\/p>\n
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