from the B-b-b-but-the-Salmonella-is-natural,-too! dept.
The U.S. Food and Drug Administration (FDA) has issued its first-ever mandatory recall for kratom-containing "food products", because the company selling them did not comply with the agency's request for a voluntary recall:
Federal drug regulators issued their first-ever mandatory recall Tuesday to a company selling several products containing the herbal supplement kratom and contaminated with Salmonella.
The Food and Drug Administration (FDA) said it issued the order because Triangle Pharmanaturals of Las Vegas refused to cooperate.
The Centers for Disease Control and Prevention said last month that the kratom Salmonella outbreak was linked to 11 hospitalizations among 28 people who caught the strain.
The FDA is advising consumers to discard the products that are part of the mandatory recall, which it says include, but isn't limited to: Raw Form Organics Maeng Da Kratom Emerald Green, Raw Form Organics Maeng Da Kratom Ivory White, and Raw Form Organics Maeng Da Kratom Ruby Red. The company, which promotes itself as a consulting firm, may "manufacture, process, pack and/or hold additional brands of food products containing powdered kratom, FDA says.
The FDA has issued a public health advisory warning of deaths related to kratom (Mitragyna speciosa) and warning against using it to treat opioid withdrawal symptoms. The DEA attempted to temporarily regulate kratom as a schedule I drug in 2016, but stopped short of doing so after a public backlash. From FDA Commissioner Scott Gottlieb's statement on the advisory:
It's very troubling to the FDA that patients believe they can use kratom to treat opioid withdrawal symptoms. The FDA is devoted to expanding the development and use of medical therapy to assist in the treatment of opioid use disorder. However, an important part of our commitment to this effort means making sure patients have access to treatments that are proven to be safe and effective. There is no reliable evidence to support the use of kratom as a treatment for opioid use disorder. Patients addicted to opioids are using kratom without dependable instructions for use and more importantly, without consultation with a licensed health care provider about the product's dangers, potential side effects or interactions with other drugs.
There's clear data on the increasing harms associated with kratom. Calls to U.S. poison control centers regarding kratom have increased 10-fold from 2010 to 2015, with hundreds of calls made each year. The FDA is aware of reports of 36 deaths associated with the use of kratom-containing products. There have been reports of kratom being laced with other opioids like hydrocodone. The use of kratom is also associated with serious side effects like seizures, liver damage and withdrawal symptoms.
Given all these considerations, we must ask ourselves whether the use of kratom – for recreation, pain or other reasons – could expand the opioid epidemic. Alternatively, if proponents are right and kratom can be used to help treat opioid addiction, patients deserve to have clear, reliable evidence of these benefits.
FDA Commissioner Scott Gottlieb has released a new statement denouncing the drug kratom. The statement says that the FDA has learned about new deaths that "involved" kratom use, additional adverse effects associated with its use have been found, and that Public Health Assessment via Structural Evaluation (PHASE) "3-D computer technology" has been used to analyze the chemical compounds in kratom:
Using this computational model, scientists at the FDA first analyzed the chemical structures of the 25 most prevalent compounds in kratom. From this analysis, the agency concluded that all of the compounds share the most structural similarities with controlled opioid analgesics, such as morphine derivatives.
The FDA continues to discourage the use of kratom, which it is calling an opioid.
An outbreak of 28 salmonella infections in 20 states has been linked to kratom products, the US Centers for Disease Control and Prevention said in a statement Tuesday. Though no deaths have been reported, 11 people have been hospitalized.
[...] California had the highest number of salmonella cases (three). North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania and Utah each reported two cases while Alabama, Arizona, Colorado, Florida, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, North Dakota, New York, South Carolina and Tennessee each reported a single case, the CDC found.
Kratom should not be consumed in any form, the CDC said, because the source of salmonella contamination has not been identified.
Previously: DEA Welcomes Kratom to the Schedule I List Beginning September 30
The Calm Before the Kratom Ban
FDA Blocks More Imports of Kratom, Warns Against Use as a Treatment for Opioid Withdrawal
FDA Labels Kratom an Opioid
U.S. Senate Minority Leader Chuck Schumer (D-NY) has come out in support of federal cannabis decriminalization, just in time for 4/20:
The Minority Leader of the Senate is making it official the day before 4/20: He's down with legal weed. In an exclusive interview with VICE News, Sen. Chuck Schumer (D-NY) confirmed he is putting his name on legislation that he said is aimed at "decriminalizing" marijuana at the federal level. For Schumer, this is a shift. While he has backed medical marijuana and the rights of states to experiment with legal sales of pot, what he is proposing is a seismic shift in federal drug policy.
"Ultimately, it's the right thing to do. Freedom. If smoking marijuana doesn't hurt anybody else, why shouldn't we allow people to do it and not make it criminal?" Schumer said.
The legislation should be available within a week or so, and would remove cannabis (still listed as "Marihuana") from the Drug Enforcement Administration's list of Schedule I substances. States would then be free to regulate or continue to prohibit the plant. Cannabis advertising would be regulated as are alcohol and tobacco advertising. (Also at NPR, CNN, The Washington Post, and CNBC, as well as Reason taking a shot at Schumer for not doing it sooner.)
A majority of Americans support the legalization of cannabis, including, for the first time, a majority (51%) of Republicans, according to Gallup. Nine states and the District of Columbia have legalized cannabis for recreational use. 29 states, D.C., Guam, and Puerto Rico have legalized medical use of cannabis, and another 17 states have legalized the use of cannabidiol (CBD). Cannabis became available for recreational purposes in California on January 1.