FDA

Sleazy manufacturing and marketing practices are hardly news when it comes to the dietary supplements industry. But a company called Evig, which makes Balance of Nature supplements, seems to want to take it a step further. Actually, several steps …
Anyone want to be smarter? Clearly, there's a need; otherwise, I wouldn't have written an article called "Drowning in Morons" in 2020. Perhaps there's a solution. A company is selling a dietary supplement called Smart Drops, which don't just make you smarter but also increase your libido, treat your arthritis, and improve your athletic performance. Believable? Not so much. And let's not forget a Bigfoot spotting - in an MRI facility.
A teenager died recently after taking the "One Chip Challenge," eating Paqui's uber-spicy tortilla chip and going as long as possible without eating or drinking anything else. The cause of death remains unclear, but there's an interesting lesson here about the uselessness of "non-GMO" food labels. Meanwhile, actress Jessica Biel sells all-natural Tylenol — which is identical to plain ole' Tylenol. Another case of dubious health marketing? Yep.
Flu shots perform inconsistently because it's hard to anticipate which strains of the virus will be circulating in a given year. So far in 2023, it appears that the latest round of vaccines are working well. The FDA has determined that Sudafed PE doesn't work. Questions and accusations are flying as a result: why were we sold a useless decongestant in the first place? And more importantly, who's to blame for this public health blunder?
“Last month, California lawmakers passed a bill that would decriminalize the personal possession of small amounts of a few plant-based psychedelics. This raised hopes that this could be the first of many reforms to unlock the therapeutic potential of psychedelics. Unfortunately, Governor Newsom vetoed the bill, citing reasons that can only be characterized as specious.”
Americans need assurance of the availability of approved drugs and medical devices in the marketplace so that healthcare providers have more reliable inventory, experience fewer shortages, and more choices when shortages arise. Reciprocity of regulatory decisions would help to achieve that.
In the past week, two Senators questioned a planned study by the FDA on long-acting opioids. They write, “This study is intended to specifically look at the use of EERWs [enrichment enrollment randomized withdrawal] to approve new opioids.” That is not all they got wrong.
“It never made sense for the DEA to list marijuana as a Schedule I drug. Making it a Schedule III controlled substance will make researching the drug’s medicinal uses easier. But it still makes federal criminals of the millions of adults who have been using marijuana recreationally for millennia and makes as much sense as it does to require people to get a prescription to ingest beer, wine, or whiskey.”
The courts have found that FDA's tobacco policies are arbitrary and capricious. The medical community calls them unscientific and harmful.
Clinical researchers have recognized the therapeutic potential of psychedelics for decades. In recent years, veterans groups and some lawmakers have also begun to appreciate this. But none of that matters if law enforcement disagrees.
The Agency's drug approval and enforcement actions are falling through the cracks, while regulators are squandering time and resources on insubstantial trivia.
The virus leads to approximately 60,000-120,000 hospitalizations and 6,000-10,000 deaths yearly in people over 65 in the U.S. It also threatens young children and pediatric vaccine approvals are expected soon.