FDA Warns Amazon Over Supplements With Undeclared and Potentially Harmful Ingredients (fda.gov) 49
FDA, in a letter to Amazon CEO: This letter concerns your firm's distribution of products that violate the Federal Food, Drug, and Cosmetic Act (the "FD&C Act"). The United States Food and Drug Administration (FDA) purchased on your website, www.amazon.com, products that are labeled as energy enhancing supplements or food, but laboratory analyses confirmed that they contained undeclared and potentially harmful active pharmaceutical ingredients. As discussed further below, your firm is responsible for introducing or delivering for introduction into interstate commerce products that are unapproved new drugs under section 505(a) of the FD&C Act, 21 U.S.C. 355(a).
Furthermore, the products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. 352. As explained further below, introducing or delivering these products for introduction into interstate commerce is prohibited under sections 301(a), 301(d), and 505(a) of the FD&C Act, 21 U.S.C. 331(a), 331(d), and 355(a). Your firm is also responsible for introducing or delivering for introduction into interstate commerce a food that is prohibited under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll). [...]
Furthermore, the products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. 352. As explained further below, introducing or delivering these products for introduction into interstate commerce is prohibited under sections 301(a), 301(d), and 505(a) of the FD&C Act, 21 U.S.C. 331(a), 331(d), and 355(a). Your firm is also responsible for introducing or delivering for introduction into interstate commerce a food that is prohibited under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll). [...]
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They're all dickpills.
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Probably not. Many American supplements companies are poorly regulated and will readily sell crap to gullible consumers. It's the American way.
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There's even a law protecting them in this, the 1993 Snake Oil Protection Act, which creates a third class of things that aren't medicine and aren't food and therefore aren't regulated as such, allowing companies to sell snake oil essentially unregulated.
Had to google its official name since it's so well-known under the Snake Oil name, it's the "Dietary Supplement Health Education Act" [science.org]. Anyone want to guess which political party was behind it? You don't even need to Google it, it should be that obvious.
The Democrats, obviously (Score:2)
After all they are committed to belief that the traditions of ancient cultures have something to teach us moderns, so will allow the sale of chemicals which are believed to make a difference...
Isn't political theory complicated? Let's try not to be partisan when it is makes no sense.
Specific language (Score:5, Informative)
One thing about the FDA is that it uses very specific and, to the untrained reader, peculiar language in letters of this type. Which can lead those without the specific pharmaceutical and legal background to underestimate what is being alleged and what the consequences could be. "Unapproved new drug" and "misbranded", and "adulterated" are as bad as it gets in FDA letters and can lead directly to referral for criminal prosecution of both the organization and its officers as individuals. Civil penalties can include shutdown of the entire business, as well as oversight agreements, massive fines, etc. If you or an organization of which you are an officer or you as named individual [1] ever receives a letter of this type run do not walk to an attorney admitted to the Federal bar for both regulatory and criminal law and do exactly what they say.
[1] the FDA can issue orders barring specific individuals by name from working in the pharmaceutical or food industry for periods from one minute to life - any individual, not just an officer of an incorporated entity
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Amazon might receive a fine equal to 0.0002% of their yearly profits. They better watch out.
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Criminal prosecutions of executives are another matter. (Not that it'll happen.)
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meanwhile the FDA has approved drugs that maim and kill, and allows foods banned by EU and smarter nations
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FDA often not qualified and for sale at times is what I'm saying. other countries do better, maybe we should follow their guidance and live longer, with less cancer, diabetes, brain tumors, feces leaking through loosened intestinal lining, etc.
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I do agree that the FDA is often excessively lax. And in this particular case they've allowed the practice to go on for an unreasonably long time. They need to get it stopped right now...and then stop being so slow. And stop approving drugs that have known dangerous "side effects" which don't treat the disease they are approved for, but only some detectable effect. (I'm thinking of their recent Alzheimer's drug, which reduced amyloid plaques, but didn't slow the disease progression.) That there is no g
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Yes, they do need to forbid the sale of aspirin [mayoclinic.org]. Why would they allow a drug which has side effects of bloody or cloudy urine, change in consciousness, seizures, or vomiting of blood or material that looks like coffee grounds?
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the good outweighs the bad in a healthy person, and can outweigh the bad in unhealthy person with certain ailments.
great for dental pain
all medicines are poisons, you do know that?
That's a straw man (Score:2)
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Are you just trolling?
For normal people these side effects are almost unheard of. The odds of them happening are vanishingly small. The benefits far outweigh the risks, when used as directed.
All medicines have side-effects. Hell, food can have side-effects in some people. Wheat can cause reactions so severe that it can be fatal, in a very small fraction of people. Peanuts, too. It does not make sense to deny these things to the huge numbers of people that can consume them safely and benefit from them,
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I can't imagine ordering food (or supplements) from Amazon, ever.
From what I have read, amazon is vulnerable to a kind of scam where a provider registers themselves with Amazon as being able to provide a list of products based on a unique identifying number. Then, when you order something through amazon, even from a specific provider, Amazon might change which provider actually fulfills the order based on who is physically closer to you.
The scam is, providers register as able to provide specific products,
Re: Specific language (Score:3)
now, realistically, Bezos will be fine. The FDA tends to give companies a lot of time and opportunity to come into compliance. They tend to reserve the criminal prosecution of management for willful and repeat offe
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Re: Specific language (Score:1)
So how long for the warning.. (Score:2)
Time for a crackdown on supplements (Score:5, Insightful)
Half of my family spends a huge fortune on supplements, most of which are placebos. If you're young, you may not understand, but for us over 40, life starts to suck, physically. When you're young, your body is very fault-tolerant...have 6 beers and a cheeseburger for supper every day for a week?...nothing a few tums can't fix. Now that I'm over 40, I do everything right (daily exercise, eat healthy, get sleep, etc) and still feel like shit most of the day....same with most my age...thus we're desperate for anything that will make us feel better and not have any side effects that make things worse.
Supplements are the dream and an age-old scam. Maybe punishing big retailers who tolerate fraud will not only reduce false claims, but make the public more aware that so called health experts online are ignorant, scammers, or both.
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Now that I'm over 40, I do everything right (daily exercise, eat healthy, get sleep, etc) and still feel like shit most of the day....same with most my age...
Really? I felt pretty good until about 65. Now not so much. I didn't realize it, but I guess I was lucky.
For me it all started falling apart at 45 (I'm 53 now). Arthritis, high blood pressure, weight gain, etc. Everything is harder to do that it used to be. Everything requires actual thought and care (what I eat, don't hurt back, etc). And everything takes twice as long to heal as it used to. I can't imagine how hard 60, 70, etc will be if I make it that long.
Varies from individual to individual, obviously (Score:3)
Really? I felt pretty good until about 65. Now not so much. I didn't realize it, but I guess I was lucky.
I noticed it first when I went on prednisone for some inflammation. I never realized how shitty I felt until I took a steroid to make the pain and inflammation go away. It creeps up on you slowly. I never noticed how I hated getting out of chairs. Unfortunately, the choices are either take drugs with side effects I don't want or find more subtle ways to just feel less crappy, like tylenol on occasion + rehab exercises...its not debilitating by any means. It's just at 25, I never thought about getting i
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It's multiple scams.
The first scam is that you need supplements at all. All the vitamins and minerals you need come from food. Eat a balanced diet, and you get what you need. This may require some effort and planning on your part, but it is totally do-able. A supplement should not be used as a "substitute." It should normally be something you take in addition to your diet just to shore up minor deficiencies.
One interesting exception I read about is vitamin D. You normally don't get that from food, but
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It reminds me of a radio show that stopped about 10 years ago, Dr. Dean Edell. He did general health stuff and took phone calls. His family was in the vitamin industry and even with that, he would read study after study showing that multivitamins and most supplements were useless.
On the flip side, Joe Rogan is so into supplements of so many types. I'd like him to have a serious discussion with a scientist about whether they do anything.
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Have you ever considered marijuana?
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Try reading PubMed sometime instead of spouting 1980's nonsense from Skeptic Magazine.
There is not some big cabalistic conspiracy to promote cheap unpatentable herbs, vitamins, and minerals.
Why would somebody use tryptans for the management of migraine with the side effects when riboflavin will prevent them, for the populations with the SNP?
Why would you take anxiety meds instead of NAC if you have the genotype where it works?
Believe me, Pharma is not happy about these results and they have much more pull a
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My mom was buying some stuff online because I put a stop to it (and took over finances). Many of those supplements had "proprietary formulas" so you really had no idea what was actuallly in them from the label on the bottle. Some of these only sell from their own web site, probably because most stores won't stock them because they're too expensive if they put them next to the more generic suppliement.
With their own web sites, many of them like to trick people into "subscriptions". Which means they'll send
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Chalk is calcium , vice versa.
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If you read the linked letter, you will see that those supplements will definitely work. They had generic Viagra and Cialis in them. They might also kill you if you have a bad drug interaction. OTOH, this should make Amazon execs take a deep breath. Not only are they exposed to criminal prosecution for selling illegal drugs, but now that they have been made publicly aware of the problem, they can get sued by anybody who has an adverse reaction.
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Have you complained about this to the FDA? If not, how do you expect them to know about it or investigate?
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tell me more
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Holding Companies Accountable for Products Sold (Score:1)