On the heels of a Food and Drug Administration (FDA) warning letter to the manufacturer of CBD-coated tampons marketed to relieve period pain, the company says it has pulled the products off the U.S. market.<\/p>\n
FDA had written to the company, Anne\u2019s Daye, maker of Daye tampons, in mid-December, asserting that the \u201cadulterated\u201d tampons are not approved for sale in the U.S. and are being \u201cmisbranded\u201d due to the addition of the cannabinoid<\/a>. The agency said at the time that it had previously raised the issue with company leadership last April.<\/p>\n Although FDA cleared the company\u2019s products \u201cfor insertion into the vagina to absorb menstrual discharge,\u201d the agency said, Daye \u201cdid not notify FDA regarding changes and modifications in the device that could significantly affect the safety or effectiveness of the device.\u201d<\/p>\n On Wednesday, a representative for Anne\u2019s Daye told Marijuana Moment that the company will no longer sell the products in the U.S.<\/p>\n \u201cIn light of this feedback and given the sensitive regulatory landscape surrounding cannabinoids in medical devices within the U.S., we have made the decision to voluntarily remove the CBD Daye Tampons from the U.S. market while we evaluate alternative pathways for regulatory compliance,\u201d the company said. \u201cWe are actively working with the FDA to address their concerns and clarify any misunderstandings about our products\u2019 regulatory status.\u201d<\/p>\n FDA declined to comment for this story, saying the agency won\u2019t weigh in on an \u201copen compliance matter.\u201d<\/p>\n A representative noted that, in general, FDA can issue a \u201cwarning letter close-out letter\u201d acknowledging a company has taken corrective actions to address underlying violations, pointing to an FDA webpage<\/a>\u00a0about the process. But for now, the matter remains open.<\/p>\n \u201cA close-out letter may issue when, based on FDA\u2019s evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter,\u201d the site says. \u201cA close-out letter will not be issued based on representations that some action will or has been taken. The corrective actions must actually have been made and verified by FDA. Usually, the standard for verifying that corrections have been implemented will be a follow-up inspection.\u201d<\/p>\n If FDA identifies further violations through subsequent inspections or other means, it adds, \u201cenforcement action may be taken without further notice.\u201d<\/p>\n In last month\u2019s warning letter, FDA cited as possible risks \u201cthe potential for local and systemic exposure of CBD, potential adverse events (e.g., reproductive\/developmental toxicity) associated with CBD, and potential effects due to the uncertainty of the potency and quality of the CBD (e.g., psychoactive effects from possible contaminants like Delta-9-tetrahydrocannabinol).\u201d<\/p>\n \u201cAlthough FDA has repeatedly identified your product as being marketed without the necessary premarket authorization,\u201d the agency told the company, \u201cyou continue to market the device.\u201d<\/p>\n In July, company founder and CEO Valentina Milanova responded to FDA\u2019s earlier communication, the agency\u2019s new letter says, though it does not include the executive\u2019s reply.<\/p>\n Daye emphasized to Marijuana Moment this week that the company operates \u201cunder rigorous international standards\u201d and \u201cfollows Good Manufacturing Practices (GMP) for pharmaceuticals.\u201d<\/p>\n \u201cAdditionally, all Daye products undergo continuous laboratory testing, randomized controlled clinical trials, biocompatibility testing as per FDA requirements, and post-market surveillance to ensure they meet the highest benchmarks for safety and performance,\u201d the company said. \u201cWe regularly go over and above regulatory requirements, and we are proud to be the only tampon brand to manufacture menstrual products to the highest medical device and pharmaceutical standards.\u201d<\/p>\n The company also clarified that the CBD in its tampons \u201cis exclusively THC-free\u201d and that the products \u201chave undergone extensive clinical testing, including the full FDA biocompatibility testing panel for medical devices, which features subacute and chronic toxicity analysis. Toxicity was not identified in the CBD Tampon.\u201d<\/p>\n Daye\u2019s response to Marijuana Moment did not, however, directly address the unauthorized product violations around adding CBD to tampons without FDA clearance or claiming the tampons relieve period pain. The company didn\u2019t immediately reply to follow-up questions.<\/p>\n To be clear, while FDA has not approved the CBD tampons for sale in the U.S., there is some emerging evidence that CBD may relieve menstrual pain.<\/p>\n Daye CEO Milanova\u2014to whom the new FDA warning letter\u00a0was addressed\u2014was the lead author on a study published in the Journal of Endometriosis and Uterine Disorders in late 2023 into the effects of CBD tampons on menstrual pain. It concluded that\u00a0tampons infused with CBD \u201cachieved statistically significant pain reduction\u201d<\/a>\u00a0and could offer \u201cfewer side effects than anti-inflammatories, while producing a similar pain-relieving effect.\u201d<\/p>\n Looking at a percentage change in pain 2 hours after tampon application, the randomized, placebo-controlled study found \u201ca statistically significant reduction in pain on the second day of the first month, and the first and second days of the third month, attributable to the CBD-infused tampon.\u201d Less than 5 percent of participants, meanwhile, experienced irritation related to the CBD-infused tampon, while between 37 percent and 40 percent reported \u201cimprovement in the level of vaginal dryness.\u201d<\/p>\n Two patients also reported experiencing vertigo while using product. \u201cThe events elapsed rapidly without need for medical attention after removal of the CBD-tampon,\u201d the study said.<\/p>\n FDA has\u00a0issued a rash of warning letters to cannabinoid businesses since the legalization of hemp<\/a>\u00a0through the 2018 Farm Bill. For the most part, that agency and the Federal Trade Commission (FTC) have exercised discretion in taking enforcement action against businesses targeting those whose packaging or claims about medical benefits are especially misleading.<\/p>\n While CBD was a chief target early on, more recent enforcement actions have emphasized intoxicating cannabinoids such as delta-8 THC. Last summer, for example,\u00a0FDA and FTC sent warning letters to several companies for allegedly marketing products containing delta-8 THC<\/a>\u00a0\u201cin packaging deceptively similar to many foods children eat such as Froot Loops and Chips Ahoy! chocolate chip cookies.\u201d<\/p>\n The agencies noted at the time that it was the second time they\u00a0sent joint cease-and-desist letters to hemp companies over unapproved marketing<\/a>\u00a0of the cannabis products. They made contact with another set of businesses about the \u201ccopycat\u201d issue last July.<\/p>\n Meanwhile, bipartisan lawmakers and industry stakeholders have sharply criticized FDA for declining to enact regulations for hemp-derived CBD, which they say is largely responsible for the economic stagnation.<\/p>\n Questions around how to\u00a0free up hemp businesses to legally market products like CBD<\/a>\u00a0as\u00a0dietary supplements or in the food supply<\/a>\u00a0have also come up in\u00a0discussions around the next Farm Bill<\/a>.<\/p>\n The hemp industry continues to face unique regulatory hurdles that stakeholders blame for the crop\u2019s value plummeting in the short years since its legalization. Despite the economic conditions, however, a recent report found that\u00a0the hemp market in 2022 was larger than all state marijuana markets<\/a>, and it roughly equaled sales for craft beer nationally.<\/p>\n Overall, the hemp market started to rebound in 2023 after suffering significant losses the prior year, the\u00a0latest annual industry report from the U.S. Department of Agriculture (USDA)<\/a>\u00a0that was released in April found.<\/p>\n President-elect\u00a0Donald Trump\u2019s pick to lead FDA, meanwhile, is a medical marijuana skeptic<\/a>, having promoted claims that cannabis use is linked to cardiovascular issues and mental health problems for youth. He has also suggested that marijuana is a gateway drug.<\/p>\n As for CBD\u2019s possible effects on pain, a\u00a0scientific review published last April listed pain as one of a variety of ailments the cannabinoid could help manage<\/a>, along with aspects of epilepsy, cancer, schizophrenia, diabetes and COVID-19, among others.<\/p>\n The National Football League also announced last year a partnership with Canadian researchers on a clinical trial\u00a0to test the safety and efficacy of CBD for pain management and neuroprotection from concussions<\/a>.<\/p>\n In 2023, meanwhile, researchers at Rutgers University and the University of Texas published research indicating that\u00a0CBD may alleviate acute dental pain and may provide an equally effective but far safer alternative to opioids<\/a>.<\/p>\n Legalizing Medical Marijuana Leads To \u2018Significant Decrease\u2019 In Opioid Companies\u2019 Payments To Pain Doctors, Study Shows<\/a><\/p>\n<\/blockquote>\n\n Photo courtesy of Chris Wallis \/\/ Side Pocket Images.<\/em><\/p>\n The post CBD Tampon Maker Pulls Products Off U.S. Market Following FDA Warning Letter<\/a> appeared first on Marijuana Moment<\/a>.<\/p>\n
On the heels of a Food and Drug Administration (FDA) warning letter to the manufacturer of CBD-coated tampons marketed to relieve period pain, the company says it has pulled the products off the U.S. market. FDA had written to the company, Anne\u2019s Daye, maker of Daye tampons, in mid-December, assertingContinue Reading<\/a><\/span><\/p>\n","protected":false},"author":24,"featured_media":0,"comment_status":"false","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[1335],"tags":[],"_links":{"self":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/79633"}],"collection":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/users\/24"}],"replies":[{"embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/comments?post=79633"}],"version-history":[{"count":1,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/79633\/revisions"}],"predecessor-version":[{"id":79634,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/79633\/revisions\/79634"}],"wp:attachment":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/media?parent=79633"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/categories?post=79633"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/tags?post=79633"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}\n
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\nRead More: CBD Tampon Maker Pulls Products Off U.S. Market Following FDA Warning Letter<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"