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FDA Issues Warning Letters  to Companies Illegally Selling CBD  and Delta 8 THC Products

☷FDA Issues Warning Letters to Companies Illegally Selling CBD and Delta 8 THC Products

Food and Drug Administration
| 19| 2
   For Immediate Release: May 04 , 2022 Today , the U . S . Food and Drug Administration issued warning letters to five companies for selling products labeled as containing delta - 8 tetrahydrocannabinol ( delta - 8 THC ) in ways that violate the Federal Food , Drug , and Cosmetic Act ( FD&C Act ) . This action is the first time the FDA has issued warning letters for products containing delta - 8 THC . Delta - 8 THC has psychoactive and intoxicating effects and may be dangerous to consumers . The FDA has received reports of adverse events experienced by pat......ients who have consumed these products . There are no FDA - approved drugs containing delta - 8 THC . Any delta - 8 THC product claiming to diagnose , cure , mitigate , treat , or prevent diseases is considered an unapproved new drug . The FDA has not evaluated 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 . Delta - 8 THC is one of over 100 cannabinoids produced in the Cannabis sativa L . plant but is not found naturally in significant amounts . Concentrated amounts of delta - 8 THC are typically manufactured from hemp - derived cannabidiol ( CBD ) and have psychoactive and intoxicating effects . Products containing delta - 8 - THC are available in varying forms , including but not limited to candy , cookies , breakfast cereal , chocolate , gummies , vape cartridges ( carts ) , dabs , shatter , smokable hemp sprayed with delta - 8 - THC extract , distillate , tinctures , and infused beverages . The warning letters address the illegal marketing of unapproved delta - 8 THC products by companies as unapproved treatments for various medical conditions or for other therapeutic uses . The letters also cite violations related to drug misbranding ( e . g . , the products lack adequate directions for use ) and the addition of delta - 8 THC in foods , such as gummies , chocolate , caramels , chewing gum , and peanut brittle . “The FDA is very concerned about the growing popularity of delta - 8 THC products being sold online and in stores nationwide . These products often include claims that they treat or alleviate the side effects related to a wide variety of diseases or medical disorders , such as cancer , multiple sclerosis , chronic pain , nausea and anxiety , ” said FDA Principal Deputy Commissioner Janet Woodcock , M . D . “It is extremely troubling that some of the food products are packaged and labeled in ways that may appeal to children . We will continue to safeguard Americans’ health and safety by monitoring the marketplace and taking action when companies illegally sell products that pose a risk to public health . ” The FDA recently published a consumer update expressing serious concerns about the potential health effects of delta - 8 THC products . The FDA has received adverse event reports involving products containing delta - 8 THC from consumers , healthcare practitioners , and law enforcement , some of which resulted in the need for hospitalization or emergency room treatment . The agency is also aware of an increasing number of exposure cases involving products containing delta - 8 THC received by national poison control centers and alerts issued by state poison control centers describing safety concerns and adverse events with products containing delta - 8 THC . In addition to the violations related to FDA - regulated products containing delta - 8 THC , several of the warning letters outline additional violations of the FD&C Act , including marketing CBD products claiming to treat medical conditions in humans and animals , promoting CBD products as dietary supplements , and adding CBD to human and animal foods . CBD and delta - 8 THC are unapproved food additives for use in any human or animal food product , as the FDA is not aware of any basis to conclude that the substances are generally recognized as safe ( GRAS ) or otherwise exempt from food additive requirements . One of the letters expresses concerns regarding CBD products marketed for food - producing animals , and the potential safety concerns related to human food products ( e . g . , meat , milk , eggs ) from animals that consume CBD , as there is a lack of data on safe CBD residue levels . The FDA issued warning letters to:ATLRx Inc . BioMD Plus LLCDelta 8 HempKingdom Harvest LLCM Six Labs Inc . The FDA has previously sent warning letters to other companies illegally selling unapproved CBD products that claimed to diagnose , cure , mitigate , treat or prevent various diseases , in violation of the FD&C Act . In some cases , there were further violations because CBD was added to food products . The FDA has not approved any CBD products other than one prescription human drug product to treat rare , severe forms of epilepsy . The FDA has requested written 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 .


04 May 2022 ( May 04 2022 )



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FDA Issues Warning Letters  to Companies Illegally Selling CBD  and Delta 8 THC Products
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