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FDA Sample Collection Criteria and Information for Vaping Related Incidents 09/13/2019	The FCC (Forensic Chemistry Center) is currently prioritizing samples that are most likely to enhance our understanding of this outbreak, i.e., vaping samples that are associated with cases of patient lung injury. If you have identified product samples with direct-association to case-illnesses in your state as part of your ongoing investigations, please reach out your local FDA District Emergency Response Coordinator or write to FDAVapingSampleInquiries@fda.hhs.gov for follow-up, collection, and shipment of samples to FCC through the utilization of FDA field staff. Vaping, FDA, FCC
FDA Warning Letter Curaleaf 07/29/2019	FDA has determined that your “CBD Lotion,” “CBD Pain-Relief Patch,” “CBD Tincture,” and “CBD Disposable Vape Pen” products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, these products are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1). FDA has also determined that your “Bido CBD for Pets” products are unapproved new animal drugs that are unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5) FDA, Curaleaf
FDA warns company marketing unapproved cannabidiol products with unsubstantiated claims to treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety 07/29/2019	Today, the U.S. Food and Drug Administration announced that it has issued a warning letter to Curaleaf Inc., of Wakefield, Massachusetts, for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases. FDA, Curaleaf
American Epilepsy Society (AES): Written Comments to Norman E. “Ned” Sharpless, MD, Acting Commissioner of Food and Drugs, U.S. Food and Drug Administration (FDA) 07/16/2019	The AES believes that these compounds need to be under the full regulatory control of the FDA and that distribution should be limited to the well-developed legend drug process. While drug regulation is desired, in the interim, the following equally important steps should be taken to assure continuous and safe access to CBD products for patients who are currently benefiting from them. american epiliepsy society, FDA, SAGE Journals
Warning Letters and Test Results for Cannabidiol-Related Products 09/13/2018	Over the past several years, FDA has issued several warning letters to firms that market unapproved new drugs that allegedly contain cannabidiol (CBD). As part of these actions, FDA has tested the chemical content of cannabinoid compounds in some of the products, and many were found to not contain the levels of CBD they claimed to contain. It is important to note that these products are not approved by FDA for the diagnosis, cure, mitigation, treatment, or prevention of any disease. Consumers should beware purchasing and using any such products. FDA, warning
Drug Made From Cannabis Plant Gets Backing From FDA Staff 05/22/2018	The treatment, which GW Pharma hopes to market under the name Epidiolex, is produced in the U.K. from a plant that has been bred to have a high cannabidiol, or CBD, content, Chief Executive Officer Justin Gover said in an interview earlier this month. The chemical is purified and made into a strawberry-flavored oral solution, he said. gw pharm, Epidiolex, seizure, FDA
FDA APPROVES SYNTHETIC LIQUID MARIJUANA COMPOUND 07/28/2016	The FDA just approved a new, synthetic THC product for use in treating a variety of ailments, in liquid form. But despite being the first liquid THC replacement on the market, this may not be worth the buzz. FDA, Prescription, dronabinol
5 reasons marijuana is not medicine 04/30/2016	To approve a medicine, the FDA requires five criteria to be fulfilled...marijuana legalization via ballot amendments or legislative bills does not meet any of the FDA requirements. Smoking dope, getting high and saying I feel better is not a criteria for medicine. medicine, madras, FDA
Is Medical Marijuana Really A Miracle Cure? 06/25/2015	“Individuals considering cannabinoids as a possible treatment for their symptoms should discuss the potential benefits and harms with their doctor,” said Penny Whiting of University Hospitals Bristol NHS Foundation Trust in the UK. FDA, Medical
Federal Judge Refuses to Reschedule Marijuana Under Controlled Substances Act 05/17/2015	Five legal standards are: Does marijuana have a known and reproducible drug chemistry? Does marijuana have adequate safety studies? Are there adequate and controlled studies showing marijuana’s efficacy? Are marijuana’s therapeutic benefits accepted by qualified experts? Are scientific data available for scrutiny? To sustain the view that marijuana should remain in Schedule I, the prosecution team also had to show that marijuana has: A high potential for abuse, No currently accepted medical use in treatment in the United States, and Unacceptable safety standards for its use under medical supervision. madras, Medical, FDA
Two 24-Week Phase 3 Studies of Lumacaftor in Combination with Ivacaftor Met Primary Endpoint with Statistically Significant Improvements in Lung Function 06/24/2014	Cystic Fibrosis, FDA, Research