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Shame on Orrin Hatch - The Patron Saint of Quack Medicine

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  • #76
    From the FDA website (my emphasis):

    http://www.fda.gov/food/dietarysuppl...ts/default.htm

    Who has the responsibility for ensuring that a dietary supplement is safe?

    By law (DSHEA), the manufacturer is responsible for ensuring that its dietary supplement products are safe before they are marketed. Unlike drug products that must be proven safe and effective for their intended use before marketing, there are no provisions in the law for FDA to "approve" dietary supplements for safety or effectiveness before they reach the consumer.
    Do manufacturers or distributors of dietary supplements have to tell FDA or consumers what evidence they have about their product's safety or what evidence they have to back up the claims they are making for them?

    No, except for rules described above that govern "new dietary ingredients," there is no provision under any law or regulation that FDA enforces that requires a firm to disclose to FDA or consumers the information they have about the safety or purported benefits of their dietary supplement products.
    How can consumers inform themselves about safety and other issues related to dietary supplements?

    It is important to be well informed about products before purchasing them. Because it is often difficult to know what information is reliable and what is questionable, consumers may first want to contact the manufacturer about the product they intend to purchase...
    I.e., just ask the snake oil salesman. He will tell you! Except that we don't require them to tell you (see previous quote).
    "There is no creature more arrogant than a self-righteous libertarian on the web, am I right? Those folks are just intolerable."
    "It's no secret that the great American pastime is no longer baseball. Now it's sanctimony." -- Guy Periwinkle, The Nix.
    "Juilliardk N I ibuprofen Hyu I U unhurt u" - creekster

    Comment


    • #77
      Those letters are funny, Snowcat. Provo's own Nature's Sunshine has a bunch of warning letters that are pretty entertaining. The funniest for me is the third link here -- they were putting prescription lovastatin in their "all natural Cholester-reg" supplement and had to be warned that lovastatin isn't approved for over-the-counter use. So funny and hypocritical for that natural diet/supplement people to secretly put a prescription statin in their stuff.

      http://www.fda.gov/ICECI/Enforcement.../ucm146910.htm

      http://www.fda.gov/ICECI/Enforcement.../ucm167702.htm

      http://www.fda.gov/iceci/enforcement.../ucm178424.htm

      Comment


      • #78
        So... my family practitioner had been pushing me to take fish oil for the last two years. I'm not consistent with it because the aftertaste and smell is less than ideal. How doors fish oil stack up in this debate?

        Comment


        • #79
          Originally posted by USUC View Post
          So... my family practitioner had been pushing me to take fish oil for the last two years. I'm not consistent with it because the aftertaste and smell is less than ideal. How doors fish oil stack up in this debate?
          snake oil and placebo.
          "Guitar groups are on their way out, Mr Epstein."

          Upon rejecting the Beatles, Dick Rowe told Brian Epstein of the January 1, 1962 audition for Decca, which signed Brian Poole and the Tremeloes instead.

          Comment


          • #80
            Originally posted by USUC View Post
            So... my family practitioner had been pushing me to take fish oil for the last two years. I'm not consistent with it because the aftertaste and smell is less than ideal. How doors fish oil stack up in this debate?
            FDA sez… http://www.fda.gov/siteindex/ucm108351.htm

            And it's good for your brain if you are a woman...

            THIS Has Been Linked With Bigger Brains For Women

            Fish has long been hailed as "brain food," and now new data suggest fish contains ingredients that may contribute to brain health.


            Researchers studied 1,000 postmenopausal women, looking at their levels of two fatty acids found in fish, called eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).


            They found that women with significantly higher levels of the two fatty acids in their red blood cells also tended to have larger brains, and larger hippocampuses, the part of the brain associated with forming memories.


            Studies have shown that in older adults, the brain generally shrinks with aging.
            […]
            http://www.huffingtonpost.com/2014/0...n_4651699.html

            And there is hope for us men…
            Although the study was done in women, Pottala said similar results would be expected in men.


            The hope is that the larger brain volumes seen in the study are an indication that fish consumption or fish oil supplementation can help ward off dementia or Alzheimer's disease. But that effect was not directly measured, and "has yet to be determined," Pottala told LiveScience,
            So shut up and eat your fish.
            "If there is one thing I am, it's always right." -Ted Nugent.
            "I honestly believe saying someone is a smart lawyer is damning with faint praise. The smartest people become engineers and scientists." -SU.
            "Yet I still see wisdom in that which Uncle Ted posts." -creek.
            GIVE 'EM HELL, BRIGHAM!

            Comment


            • #81
              Originally posted by Jeff Lebowski View Post
              From the FDA website (my emphasis):

              http://www.fda.gov/food/dietarysuppl...ts/default.htm

              I.e., just ask the snake oil salesman. He will tell you! Except that we don't require them to tell you (see previous quote).
              By law (DSHEA), the manufacturer is responsible for ensuring that its dietary supplement products are safe before they are marketed. Unlike drug products that must be proven safe and effective for their intended use before marketing, there are no provisions in the law for FDA to "approve" dietary supplements for safety or effectiveness before they reach the consumer.
              That is because they are not drugs. By definition a dietary supplement is:
              The Dietary Supplement Health and Education Act (DSHEA) of 1994 defined both of the terms "dietary ingredient" and "new dietary ingredient" as components of dietary supplements. In order for an ingredient of a dietary supplement to be a "dietary ingredient," it must be one or any combination of the following substances:
              •a vitamin,
              •a mineral,
              •an herb or other botanical,
              •an amino acid,
              •a dietary substance for use by man to supplement the diet by increasing the total dietary intake (e.g., enzymes or tissues from organs or glands), or
              •a concentrate, metabolite, constituent or extract.

              A "new dietary ingredient" is one that meets the above definition for a "dietary ingredient" and was not sold in the U.S. in a dietary supplement before October 15, 1994.
              In other words it is stuff people already consume. The law did allow products in the market prior to 1994 to continue to be sold. However, if you want to introduce anything new that meets the criteria on list above you are required to conduct full safety studies and submit them to the FDA for approval prior to introducing into the market.
              One of the grandest benefits of the enlightenment was the realization that our moral sense must be based on the welfare of living individuals, not on their immortal souls. Honest and passionate folks can strongly disagree regarding spiritual matters, so it's imperative that we not allow such considerations to infringe on the real happiness of real people.

              Woot

              I believe religion has much inherent good and has born many good fruits.
              SU

              Comment


              • #82
                Originally posted by CardiacCoug View Post
                Those letters are funny, Snowcat. Provo's own Nature's Sunshine has a bunch of warning letters that are pretty entertaining. The funniest for me is the third link here -- they were putting prescription lovastatin in their "all natural Cholester-reg" supplement and had to be warned that lovastatin isn't approved for over-the-counter use. So funny and hypocritical for that natural diet/supplement people to secretly put a prescription statin in their stuff.

                http://www.fda.gov/ICECI/Enforcement.../ucm146910.htm

                http://www.fda.gov/ICECI/Enforcement.../ucm167702.htm

                http://www.fda.gov/iceci/enforcement.../ucm178424.htm
                Yes, there have been those who break the law. The original premise of this thread was that the evil Orrin Hatch took blood money from evil corporations so they could hide behind a law that allows them to steal money from people with cancer. I am not expressing an opinion on whether or not Orrin Hatch is evil. I am not defending bad corporations or those who would take money from people dying of cancer by selling a false hope.

                I am only debating the law (DSHEA). In my opinion, the law is fine and establishes an adequate framework to regulate dietary supplements. It has been (and continues to be) violated. It has been very slow to be implemented by the FDA which has enabled some bad actors to continue to break the law. The FDA has finally embraced their role in implementing the law and we should see the less and less of the bad actors still in operation.

                One issue that is still a problem. The law regulates the dietary supplement manufacturer. They cannot legally be snake oil salesmen. But, it does not cover what others, who might happen to actually be the ones to sell the products to the consumer, are marketing. If you go to a guru who tells you to rub fish oil on you for male enhancement, this is not the manufacturer who is violating the law (and selling the false hope).
                One of the grandest benefits of the enlightenment was the realization that our moral sense must be based on the welfare of living individuals, not on their immortal souls. Honest and passionate folks can strongly disagree regarding spiritual matters, so it's imperative that we not allow such considerations to infringe on the real happiness of real people.

                Woot

                I believe religion has much inherent good and has born many good fruits.
                SU

                Comment


                • #83
                  Originally posted by snowcat View Post
                  That is because they are not drugs. By definition a dietary supplement is:
                  That is one of the main problems with the DSHEA. Hatch et al., made the list so broad that it is easy to fit a huge variety of product under thats umbrella, and thereby circumvent the situation where you actually have to back up your product with science. For example: "an herb or other botanical". Why should that be an exemption? Lots of drugs are plant-based.

                  Originally posted by snowcat View Post
                  In other words it is stuff people already consume.
                  What does that even mean? If people were using it prior to 1994, it should be given a special exemption? Why?

                  Furthermore, note the wording of this FDA quote:

                  By law (DSHEA), the manufacturer is responsible for ensuring that its dietary supplement products are safe before they are marketed. Unlike drug products that must be proven safe and effective for their intended use before marketing, there are no provisions in the law for FDA to "approve" dietary supplements for safety or effectiveness before they reach the consumer.
                  In other words, the supplement industry is supposed to ensure that their products are safe (on their own - there is no proof required and no approval process), but the drug industry has to prove both safety AND EFFECTIVENESS before being allowed to market. The DSHEA explicitly gives the supplement industry a pass on proving that their products actually work.

                  I am amazed that you would defend this POS legislation.
                  "There is no creature more arrogant than a self-righteous libertarian on the web, am I right? Those folks are just intolerable."
                  "It's no secret that the great American pastime is no longer baseball. Now it's sanctimony." -- Guy Periwinkle, The Nix.
                  "Juilliardk N I ibuprofen Hyu I U unhurt u" - creekster

                  Comment


                  • #84
                    Originally posted by USUC View Post
                    So... my family practitioner had been pushing me to take fish oil for the last two years. I'm not consistent with it because the aftertaste and smell is less than ideal. How doors fish oil stack up in this debate?
                    My doctor pushes it too. The book mentioned in the OP actually speaks positively of fish oil as being something with some actual science/data to back it up. He said it is not difficult to get enough in your diet, but if you aren't eating fish and certain veggies, it might help to take it as a supplement.
                    "There is no creature more arrogant than a self-righteous libertarian on the web, am I right? Those folks are just intolerable."
                    "It's no secret that the great American pastime is no longer baseball. Now it's sanctimony." -- Guy Periwinkle, The Nix.
                    "Juilliardk N I ibuprofen Hyu I U unhurt u" - creekster

                    Comment


                    • #85
                      Originally posted by Jeff Lebowski View Post
                      My doctor pushes it too. The book mentioned in the OP actually speaks positively of fish oil as being something with some actual science/data to back it up. He said it is not difficult to get enough in your diet, but if you aren't eating fish and certain veggies, it might help to take it as a supplement.
                      What about taking flaxseed pills instead for the omega 3s? No fish oil aftertaste.
                      Fitter. Happier. More Productive.

                      sigpic

                      Comment


                      • #86
                        Originally posted by Jeff Lebowski View Post
                        In other words, the supplement industry is supposed to ensure that their products are safe (on their own - there is no proof required and no approval process), but the drug industry has to prove both safety AND EFFECTIVENESS before being allowed to market. The DSHEA explicitly gives the supplement industry a pass on proving that their products actually work.

                        I am amazed that you would defend this POS legislation.
                        Show effectiveness for what? If they are showing and claiming effectiveness at treating, preventing or curing any disease, they are considered drugs and are then regulated accordingly.

                        I am amazed that you are so vehemently attacking a law you clearly do not understand.
                        One of the grandest benefits of the enlightenment was the realization that our moral sense must be based on the welfare of living individuals, not on their immortal souls. Honest and passionate folks can strongly disagree regarding spiritual matters, so it's imperative that we not allow such considerations to infringe on the real happiness of real people.

                        Woot

                        I believe religion has much inherent good and has born many good fruits.
                        SU

                        Comment


                        • #87
                          Originally posted by USUC View Post
                          So... my family practitioner had been pushing me to take fish oil for the last two years. I'm not consistent with it because the aftertaste and smell is less than ideal. How doors fish oil stack up in this debate?
                          With my recent diagnosis of arthritis, I've bought some fish oil. It is nasty and I've pretty much given up on it. The burps were horrible.

                          Instead, I'm sprinkling ground flax seed on a lot of the things I eat. It reminds me of wheat germ were it adds a bit of a nutty taste. If you need DHA, I don't think this works. It has lots of ALA and it gets converted into EPA, but not DHA. (http://www.webmd.com/heart-disease/n...fish-oil-pills)

                          Also, snake oil really is an effective product.

                          http://www.wisegeek.com/what-is-snake-oil.htm

                          That being said, the fish oils are just as effective and cheaper.

                          I haven't tried the snake oil, so I don't know if it is as gross as fish oil.

                          Comment


                          • #88
                            Originally posted by snowcat View Post
                            Show effectiveness for what? If they are showing and claiming effectiveness at treating, preventing or curing any disease, they are considered drugs and are then regulated accordingly.

                            I am amazed that you are so vehemently attacking a law you clearly do not understand.
                            The law is not enforced effectively, and allows the slime of the supplement industry to skirt its periphery to scam people. What is not to understand?
                            "Guitar groups are on their way out, Mr Epstein."

                            Upon rejecting the Beatles, Dick Rowe told Brian Epstein of the January 1, 1962 audition for Decca, which signed Brian Poole and the Tremeloes instead.

                            Comment


                            • #89
                              Originally posted by Jeff Lebowski View Post
                              In other words, the supplement industry is supposed to ensure that their products are safe (on their own - there is no proof required and no approval process), but the drug industry has to prove both safety AND EFFECTIVENESS before being allowed to market. The DSHEA explicitly gives the supplement industry a pass on proving that their products actually work.

                              I am amazed that you would defend this POS legislation.
                              Exactly. Those will no double-blinded control studies have a lower standard than those with them. Go figure.
                              "Guitar groups are on their way out, Mr Epstein."

                              Upon rejecting the Beatles, Dick Rowe told Brian Epstein of the January 1, 1962 audition for Decca, which signed Brian Poole and the Tremeloes instead.

                              Comment


                              • #90
                                Originally posted by Topper View Post
                                The law is not enforced effectively, and allows the slime of the supplement industry to skirt its periphery to scam people. What is not to understand?
                                Then criticize its implementation and criticize the slime of the industry, not the law.
                                One of the grandest benefits of the enlightenment was the realization that our moral sense must be based on the welfare of living individuals, not on their immortal souls. Honest and passionate folks can strongly disagree regarding spiritual matters, so it's imperative that we not allow such considerations to infringe on the real happiness of real people.

                                Woot

                                I believe religion has much inherent good and has born many good fruits.
                                SU

                                Comment

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