from the it-cures-everything dept.
The FDA has grown increasingly concerned at the proliferation of products claiming to treat or cure serious diseases like cancer. In this case, the illegally sold products allegedly contain cannabidiol (CBD), a component of the marijuana plant that is not FDA approved in any drug product for any indication. CBD is marketed in a variety of product types, such as oil drops, capsules, syrups, teas, and topical lotions and creams. The companies receiving warning letters distributed the products with unsubstantiated claims regarding preventing, reversing or curing cancer; killing/inhibiting cancer cells or tumors; or other similar anti-cancer claims. Some of the products were also marketed as an alternative or additional treatment for Alzheimer's and other serious diseases.
Related: U.S. Federal Cannabis Prohibition Remains Intact
"Hollyweed" and More Cannabis Stories
According to Gallup, American Support for Cannabis Legalization is at an All-Time High
Study Finds That More Frequent Use of Cannabis is Associated With Having More Sex
The Obama administration has denied a bid by two Democratic governors to reconsider how it treats marijuana under federal drug control laws, keeping the drug for now, at least, in the most restrictive category for U.S. law enforcement purposes. Drug Enforcement Administration chief Chuck Rosenberg says the decision is rooted in science. Rosenberg gave "enormous weight" to conclusions by the Food and Drug Administration that marijuana has "no currently accepted medical use in treatment in the United States," and by some measures, it remains highly vulnerable to abuse as the most commonly used illicit drug across the nation.
"This decision isn't based on danger. This decision is based on whether marijuana, as determined by the FDA, is a safe and effective medicine," he said, "and it's not." Marijuana is considered a Schedule I drug under the Controlled Substances Act, alongside heroin and LSD, while other, highly addictive substances including oxycodone and methamphetamine are regulated differently under Schedule II of the law. But marijuana's designation has nothing to do with danger, Rosenberg said.
The Post article notes:
In the words of a 2015 Brookings Institution report, a move to Schedule II "would signal to the medical community that [the Food and Drug Administration and the National Institutes of Health] are ready to take medical marijuana research seriously, and help overcome a government-sponsored chilling effect on research that manifests in direct and indirect ways."
However, the DEA will expand the number of locations federally licensed to grow cannabis for research from the current total of... 1: the University of Mississippi.
Weeks after cannabis legalization was passed by voters in California and other states, pranksters edited the famous Los Angeles Hollywood Sign to read "Hollyweed". This previously occurred in 1976 following the passage of a California law decriminalizing cannabis.
The happy side-effect wasn't uniform, however; only seven states saw significant reductions, while two states saw increases. Nevertheless, the authors of the new report in the American Journal of Public Health argue that the data bucks the common criticism that more pot access should increase car crashes and injuries.
Drops in traffic deaths may, in part, be explained by people swapping alcohol for pot, leading to reduced drunk driving, the study's authors speculated. To back that up, the authors note that the lives spared tended to belong to younger people, particularly 25- to 44-year-olds—an age group frequently involved in alcohol-related traffic deaths.
64% of Americans now support the legalization of cannabis, an all-time high since Gallup first asked the question in 1969. Also for the first time, a majority of Republicans (51%) support legalization, up from 42% last year:
As efforts to legalize marijuana at the state level continue to yield successes, public opinion, too, has shifted toward greater support. The Department of Justice under the current Republican administration has been perceived as hostile to state-level legalization. But Attorney General Jeff Sessions could find himself out of step with his own party if the current trends continue. Rank-and-file Republicans' views on the issue have evolved just as Democrats' and independents' have, though Republicans remain least likely to support legalizing pot.
A study has found that people who smoke more cannabis have more sex than those who smoke less or abstain:
Tobacco companies put a lot of effort into giving cigarettes sex appeal, but the more sensual smoke might actually belong to marijuana. Some users have said pot is a natural aphrodisiac, despite scientific literature turning up mixed results on the subject. At the very least, a study published Friday [DOI: 10.1016/j.jsxm.2017.09.005] [DX] in the Journal of Sexual Medicine suggests that people who smoke more weed are having more sex than those who smoke less or abstain. But whether it's cause or effect isn't clear.
The researchers pulled together data from roughly 50,000 people who participated in an annual Centers for Disease Control and Prevention survey during various years between 2002 and 2015. "We reported how often they smoke — monthly, weekly or daily — and how many times they've had sex in the last month," says Dr. Michael Eisenberg, a urologist at Stanford University Medical Center and the senior author on the study. "What we found was compared to never-users, those who reported daily use had about 20 percent more sex. So over the course of a year, they're having sex maybe 20 more times."
Women who consumed marijuana daily had sex 7.1 times a month, on average; for men, it was 6.9 times. Women who didn't use marijuana at all had sex 6 times a month, on average, while men who didn't use marijuana had sex an average of 5.6 times a month.
When the researchers considered other potentially confounding factors, such as alcohol or cocaine use, age, religion or having children, the association between more marijuana and more sex held, Eisenberg says. "It was pretty much every group we studied, this pattern persisted," he says. The more marijuana people smoked, the more they seemed to be having sex.
An Anonymous Coward would like to remind you that he is "not cool enough" to acquire cannabis illegally from drug dealers.
Also at CNN.
The FDA is proposing a new, risk-based enforcement approach to homeopathic drug products (alternative medicine):
To protect consumers who choose to use homeopathic products, this proposed new approach would update the FDA's existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices.
Under the law, homeopathic drug products are subject to the same requirements related to approval, adulteration and misbranding as any other drug product. However, prescription and nonprescription drug products labeled as homeopathic have been manufactured and distributed without FDA approval under the agency's enforcement policies since 1988.
"In recent years, we've seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer. In many cases, people may be placing their trust and money in therapies that may bring little to no benefit in combating serious ailments, or worse – that may cause significant and even irreparable harm because the products are poorly manufactured, or contain active ingredients that aren't adequately tested or disclosed to patients," said FDA Commissioner Scott Gottlieb, M.D. "Our approach to regulating homeopathic drugs must evolve to reflect the current complexity of the market, by taking a more risk-based approach to enforcement. We respect that some individuals want to use alternative treatments, but the FDA has a responsibility to protect the public from products that may not deliver any benefit and have the potential to cause harm."
FDA draft guidance (8 pages).
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The Food and Drug Administration on Monday approved the country's first drug derived from marijuana, a medication that treats two rare and devastating forms of epilepsy.
The drug, GW Pharmaceuticals' Epidiolex, is made of cannabidiol, or CBD, a component of marijuana that does not give users a high. It is given as an oil, and in clinical trials, it was shown to reduce the number of seizures by about 40 percent in patients with Dravet or Lennox-Gastaut syndromes.
"This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies," FDA Commissioner Scott Gottlieb said in a statement. "And, the FDA is committed to this kind of careful scientific research and drug development."
The FDA's decision was expected. FDA officials had indicated they supported approving Epidiolex, and an advisory panel had unanimously recommended it get the green light. There was some concern about the drug's effects on the liver, but experts have said this risk could be addressed by doctors as they monitor their patients during treatment.
Before GW can market Epidiolex, though, the Drug Enforcement Administration will have to reclassify CBD, which in this case, because it comes from marijuana, is considered a Schedule I drug, meaning it has no medical value and a high risk of abuse. The agency is expected to do so within 90 days.
Also at TechCrunch.
Related: FDA Cracking Down on Unsubstantiated Cannabidiol Health Claims
World Health Organization Clashes With DEA on CBD; CBD May be an Effective Treatment for Psychosis
UC San Diego to Treat Autism Using Cannabidiol