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FDA Warns Amazon Over Supplements With Undeclared and Potentially Harmful Ingredients (fda.gov) 49

Posted by msmash from the holding-accountable dept.
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). [...]
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FDA Warns Amazon Over Supplements With Undeclared and Potentially Harmful Ingredients More

FDA Warns Amazon Over Supplements With Undeclared and Potentially Harmful Ingredients

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  • Specific language (Score:5, Informative)

    by sphealey ( 2855 ) on Thursday December 28, 2023 @11:09AM (#64112043)

    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

    • Amazon might receive a fine equal to 0.0002% of their yearly profits. They better watch out.

    • meanwhile the FDA has approved drugs that maim and kill, and allows foods banned by EU and smarter nations

      • Yes, and? I think it's good that the FDA would take enforcement action against Amazon. But does your comment about approval/allowance suggest they should allow Amazon to continue without taking action against Amazon? Why would you want to promote that line of thinking with your comment?

        • 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.

      • Re: (Score:2)

        by HiThere ( 15173 )

        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

      • meanwhile the FDA has approved drugs that maim and kill,

        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?

        • 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?

        • The FDA does not have the best reputation for speedy recalls. Often the products are in circulation for some time.

        • 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,

    • 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,

    • Yes, every company operating in FDA regulated markets is terrified of receiving one of these letters. I am asked twice a year to go through out marketing literature and double check that weâ(TM)ve not stepped outside the bounds of what we can legally say about our products, just to be safe.

      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
  • To become a stop sale? Or is this going to be like the unrelated robocall warnings that took years to get anywhere.

  • Time for a crackdown on supplements (Score:5, Insightful)

    by Somervillain ( 4719341 ) on Thursday December 28, 2023 @11:30AM (#64112119)
    Most supplements are garbage. Since they don't actually work, most people would never know if you replaced their magnesium or calcium supplement with chalk. Some supplements do work, but since they're not regulated, they're drowned out by nonsense and noise. OK, so you don't want to be a rube?...you do your research and then piece of shit fitness influencers tell you "ohh...that vitamin you bought form Walgreens or Costco didn't work?...of course not, you need to buy mine...it's CHELATED!!!!! thus is more BIOAVAILBLE...or some other random scientific work which is either incorrectly used or outright fraudulent.

    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.
    • A crackdown would be nice. Unfortunately, the supplement industry has excellent lobbyists and has convinced Congress to exempt them from most government oversight. The FDA has no power over them, and the FTC has very little. What they are being accused of here is selling actual pharmaceuticals labelled as supplements, which is a violation of FDA regulations and the law. As long as the products they sell are really useless nothing can be done about it.

    • Re: (Score:2, Interesting)

      by Brain-Fu ( 1274756 )

      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

      • 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.

    • Have you ever considered marijuana?

    • 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

    • 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

    • Chalk is calcium , vice versa.

    • 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.

  • The most significant thing going on here is that Amazon normally enjoys a level of immunity from liability for anything it sells because it sometimes acts as a "marketplace" but now it is being held directly accountable for the products it is selling.

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