SoylentNews is people
SoylentNews
When they're not potentially infectious, they have extraordinary health claims.
The maker of wide-ranging "water-based homeopathic medicines" has recalled 32 products marketed to children and infants due to microbial contamination, according to an announcement posted on the Food and Drug Administration's website this week.
The announcement does not provide any specifics about the contamination or potential risks. However, the North Carolina-based manufacturer behind the recall, King Bio, issued a similar announcement back in July. At that time, the company recalled three other products after an FDA inspection found batches contaminated with the bacteria Pseudomonas brenneri, Pseudomonas fluorescens, and Burkholderia multivorans.
Pseudomonas brenneri is a bacterium recently found in natural mineral waters, and its clinical significance is murky. However, Pseudomonas fluorescens is known to be an opportunistic pathogen, causing blood infections, and Burkholderia multivorans can cause infections in people with compromised immune systems and cystic fibrosis. It was also recently found to be a rare but emerging cause of meningitis.
[...] UPDATE 8/24/2018: King Bio updated its website to include a note about the recall. The company wrote that: "Within the past two weeks, microbial contamination was discovered in two children's products, but as an added measure of caution, we chose to recall all the children's products manufactured from August 2015 to August 2018." It added that no injuries or illnesses have been reported to date.
(Score: 4, Insightful) by ikanreed on Monday August 27 2018, @05:43PM (7 children)
Yes, and that law exists with a specific exception for garbage do-nothing fake medicine.
This seems like an asinine point to make. I don't think this is a technicality that anyone fails to recognize. But also you're wrong, because execution of law is a slippery subjective thing, and everyone knows that too, which is why we have courts.
(Score: 1, Troll) by jelizondo on Tuesday August 28 2018, @12:56AM (4 children)
Well, I was perhaps not very clear. You used the verb “banned” incorrectly; government is not “banned” from doing something, citizens are. If the law that establishes an agency, in this case the FDA, does not explicitly allows it to do something, then it can’t. No “banning” necessary.
Now, go read the 1906 Food and Drugs Act [procon.org] and see that the FDA had authority to regulate Homeopathic products because they were part of the law (Sec. 6) “That the term "drug," as used in this Act, shall include all medicines and preparations recognized in the United States Pharmacopoeia or National Formulary for internal or external use, and any substance or mixture of substances intended to be used for the cure, mitigation, or prevention of disease of either man or other animals.” I highlighted the relevant portion for you.
The act was changed in 1938 (go read it [house.gov]) and in Sec. 501 paragraph (b), the law clearly states “Whenever a drug is recognized in both the United States Pharmacopeia and the Homeopathic Pharmacopeia of the United States it shall be subject to the requirements of the United States Pharmacopeia unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the provisions of the Homeopathic Pharmacopeia of the United States and not to those of the United States Pharmacopeia.”
So you see, the FDA can and does regulate homeopathic products. And yes, I happen to be a lawyer.
(Score: 2) by ikanreed on Tuesday August 28 2018, @01:02AM
Yeah, I can tell you're a lawyer, as you're chasing a trivial technicality and irrelevant distinctions about the word choice I made as if ikanreed's posts are a body legal. Well either a lawyer or any person having an argument on the internet.
"The provisions for Homeopathic Pharmacopeia" are, to say the least, dramatically laxer. than anything we associate with drug review.
(Score: 2) by AthanasiusKircher on Tuesday August 28 2018, @02:13AM (2 children)
Geez. Don't be an ass.
Look, the FDA itself has traced the history [fda.gov] of this. Read the "background" section near the beginning of that document.
There you will find that: (1) the bill's senatorial sponsor in 1938 was a homeopathic doctor who sought to create a separate category of drugs under the FDA subject to different regulation, (2) due to technicalities about the wording, the FDA can't regulate many "homeopathic" drugs in the same way it does other drugs, and (3) the FDA has not reviewed or approved any homeopathic drugs under normal OTC drug review partly because -- in the FDA's own words -- "the Agency categorized these products as a separate category and deferred consideration of them."
So no, you're technically right that the FDA wasn't "banned" from regulating them. It was merely forced to recategorize them in such a way that they've historically been subject to basically no regulation.
Which is... Kinda sorta like "banning" them from their normal regulatory practices in all but the most legalistic sense.
You may be a lawyer but that doesn't abrogate your responsibility to present the facts and situation fairly.
(Score: 2, Troll) by jelizondo on Tuesday August 28 2018, @04:39AM (1 child)
Comes with the territory...
A technicality will get you out of jail...
I'm not a reporter, pal; I don't have a resposibility to present anything fairly. I present my side of the case, your lawyer presents your side, the jury decides.
(Score: 2) by AthanasiusKircher on Tuesday August 28 2018, @10:42AM
No, you're not a reporter, but I assume you are still a HUMAN BEING.
This is NOT a law forum or a courtroom -- so I was talking about abrogating your responsibilities as a rational human being. (But then again, you admitted you are a lawyer, so I guess that should be expected. Though I do have some friends who are both lawyers and rational human beings. It can happen.)
My goal (and the goal of rational human beings) is to come to a fair and nuanced understanding of the situation. You're trying to win an argument at all costs, regardless of whether it involves misrepresentation or incomplete facts. No one's on trial here.
All you've told me in this exchange is that I will never trust your opinion (legal or otherwise) on this forum again, because you've just admitted you don't give a crap about presenting things in a fair and truthful manner.
(Score: 0) by Anonymous Coward on Tuesday August 28 2018, @01:27AM (1 child)
You see it all the time, with people arguing that you don't have the right to do X because the Constitution doesn't explicitly mention such a right.
(Score: 2) by requerdanos on Tuesday August 28 2018, @11:54AM
To be fair, this is simply a factually inaccurate misstatement of the tenth amendment: "The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people."
It means roughly that the Federal government doesn't have the authority over X because the constitution doesn't explicitly mention such authority.
I suppose you could argue that the FDA, as part of the Federal government, doesn't have any but extremely limited, specifically enumerated power, but that kind of argument (while not outright unreasonable) usually dies when challenged in court, these things being interpreted rather more and more broadly with time.