Kratom (previously) is a plant that grows wild in Malaysia, Thailand, Indonesia, Myanmar, and Papua New Guinea, and is a relative of the coffee plant. For centuries, people have chewed or drunk teas brewed from its leaves for a mildly euphoric effect, and recently, the plant has come to the US, prompting many stories of incredible benefits in fighting opioid addiction and treating chronic pain, as well as some non-credible claims about curing cancer or producing morphine-like highs, as well as a moral panic that has led the FDA to (unsuccessfully) class it as a Schedule A narcotic, with no medical benefits. Read the rest

Thanks to the tireless efforts of the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS), the US FDA is clearing the way for ten clinics around the United States to treat PTSD patients with MDMA. It's likely that the FDA will grant full approval for the therapy in 2020, reports New Atlas. From the article:

MAPS has previously hypothesized thousands of psychedelic-assisted psychotherapy clinics will open up across the United States. In the near future these clinics may not only administer MDMA for PTSD but also psilocybin, which is currently proving promising for a variety of conditions, including major depression.

The FDA approval for Expanded Access is yet another validation of MDMA-assisted psychotherapy’s safety and efficacy following extraordinarily positive early clinical trial results. Current Phase 3 trials are set to run until 2021 and complete market approval could come as early as 2022.

Image by DMTrott - Own work. Originally published in The Drug Users Bible [ISBN: 978-0995593688]., CC BY-SA 4.0, Link Read the rest

Purdue Pharma (and its richer-than-the-Rockefellers owners, the Sackler family are increasingly being dragged into state courts to account for their role in the opioid epidemic, which has claimed more American lives than the Vietnam War. Read the rest

Medtronic is the most notorious maker of insecure medical implants in America, with a long history of inserting computers into people's bodies with insecure wireless interfaces, toolchains and update paths, and nothing has changed. Read the rest

In 2009, the bipartisan HITECH Act pledged $36 billion to subsidize the adoption of Electronic Health Records throughout America's fragmented, profit-driven health system, promising that the system would modernize American health care, save $80 billion (and countless lives), and deliver a host of other benefits; a decade later, the EHR industry has blossomed from $2B to $13B, and adoption is up from 9% to 96%, and it's a catastrophe. Read the rest

The FDA has issued a warning advising Americans not to engage in the practice of infusing plasma taken from young people's blood, a "treatment" promoted to treat "normal aging and memory loss... dementia, multiple sclerosis, heart disease and post-traumatic stress disorder." Read the rest

Prior to 1976, the FDA did not regulate medical implants, and so shoddy and even deadly devices proliferated, inserted into Americans' body. Read the rest

Medtronic (previously) is a notoriously insecure medical implant manufacturer whose devices have been repeatedly shown to be grossly insecure -- their pacemakers can be hacked before leaving the factory! Read the rest

Medical device security very, very, very, very, very, very, very bad. Read the rest

Ben Goldacre (previously) led a team that created the FDAAA Trials Tracker, "A live informatics tool to monitor compliance with FDA requirements to report clinical trial results." Read the rest

The FDA is finally putting a stop to food companies trying to tempt customers who can’t distinguish baking ingredients from symbolic forms of affection. Officials from the US Food and Drug Administration sent a letter to the owners of Nashoba Brook Bakery warning them the company was violating label regulations by listing “love” as an ingredient in its granola, according to Bloomberg News.

"Love" is not a common or usual name of an ingredient, and is considered to be intervening material because it is not part of the common or usual name of the ingredient,” the FDA wrote in the letter.

John Gates, CEO of Nashoba Brook Bakery, said the FDA’s warning about the granola “ingredient” was “silly.”

“I really like that we list ‘love’ in the granola,” Gates said in a telephone interview with Bloomberg News Tuesday. “People ask us what makes it so good. It’s kind of nice that this artisan bakery can say there’s love in it and it puts a smile on people’s face. Situations like that where the government is telling you you can’t list ‘love’ as an ingredient, because it might be deceptive, just feels so silly.”

The letter also warned food products were “prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.”

“Some of FDA’s observations, particularly on some of the sanitation issues, were helpful,” Gates said.

Image: pxhere Read the rest

The FDA's Sept 6 warning letter to Epipen manufacturer Meridian (a division of Pfizer) condemns the company for knowingly shipping out defective products that led to the death of the customers who paid hyper-inflated prices for the devices, which Meridian manufactured for notorious pharma profiteers Mylan. Read the rest

Looking for an appetite suppressant? The U.S. Food & Drug Administration can help. Just stop by FDA's Defect Levels Handbook to learn how many insect legs and rodent hairs are acceptable in various foods sold to the American public. Read the rest

When Purdue Pharma's patent on the MS Contin was close to expiry, the Sackler family who owned the company spent millions trying to find a product that could replace the profits they'd lose from generic competition on MS Contin: the result was Oxycontin, a drug that went on to kill Americans at epidemic scale. Read the rest

The Electronic Frontier Foundation just filed comments with the FDA in its embedded device cybersecurity docket, warning the agency that manufacturers have abused the Digital Millennium Copyright Act, threatening security researchers with lawsuits if they came forward with embarrassing news about defects in the manufacturers' products. Read the rest

Both the UK and Australian governments have issued reports describing homeopathy as bunk, and now the US Food and Drug Administration and Federal Trade Commission are holding hearings on the regulation of high-priced sugar-pills. Read the rest