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Thread: Shame on Orrin Hatch - The Patron Saint of Quack Medicine

  1. #61
    The dude abides Jeff Lebowski's Avatar
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    A devastating takedown of Orrin Hatch, the DSHEA (his legislation), and the supplement industry.

    http://www.sciencebasedmedicine.org/...ment-industry/

    It sounds like Jason Chaffetz is being groomed to take Orrin's place. Oy vey.
    "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

  2. #62

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    Quote Originally Posted by Jeff Lebowski View Post
    Care to elaborate?
    I was going to ask about this, but you seemed pretty sure and I hate these folks as much as anyone, but from my understanding, they aren't allowed to make claims beyond very nebulous things like "promotes prostate health" and the like. I could be wrong though.
    At least the Big Ten went after a big-time addition in Nebraska; the Pac-10 wanted a game so badly, it added Utah
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  3. #63
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    Quote Originally Posted by Jeff Lebowski View Post
    A devastating takedown of Orrin Hatch, the DSHEA (his legislation), and the supplement industry.

    http://www.sciencebasedmedicine.org/...ment-industry/

    It sounds like Jason Chaffetz is being groomed to take Orrin's place. Oy vey.
    Jason Chaffetz and Mike Lee as Utah's Senators...

    I liked Bob Bennett. I think Utah replaced the wrong guy.
    "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.
    "I never preached in Texas, but I have preached in places as wicked..." -Brigham Young.
    "If we do nothing we'll be substantially behind (other Power leagues) a decade from now." -Bob Bowlsby on Big 12 expansion.
    GIVE 'EM HELL, BRIGHAM!

  4. #64
    The dude abides Jeff Lebowski's Avatar
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    Quote Originally Posted by snowcat View Post
    It is not legal for a supplement company to claim a product treats, prevents or cures and disease or it is immediately classified as an unapproved drug by the FDA.
    Ha. Yeah, we all know that the supplement industry would never make claims like that.

    http://www.sciencebasedmedicine.org/...ery-of-a-sham/

    What’s more frightening than this inexcusable lack of oversight is that many of the products marketed under DSHEA aren’t just vitamins and such, but products that claim to do the same things as real medicines. How do they get away with that?

    By using the Quack Miranda Warning, that’s how. Anyone who lives in the States knows this one almost as well as the “real” Miranda warning:

    *These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease."

    I put in the asterisk because there’s always an asterisk. The warning always appears at the bottom of a back page in very fine print. This statement is required when making any clinical claims regarding a product, and it is up to the manufacturer to make sure all claims are true.

    Here’s the thing: many products covered by DSHEA are, by their advertising, clearly “intended to diagnose, treat, cure or prevent…disease.”
    DSHEA was created specifically to allow these companies to make claims that would otherwise be of questionable legality. DSHEA, as it was written and as it was intended facilitates the legal marketing of quackery.

    This legislation must go. It’s dangerous and costly for consumers, and provides protection for business entities whose apparent purpose is to promote quackery for profit. The lawmakers behind this bill should be ashamed.
    "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

  5. #65
    The dude abides Jeff Lebowski's Avatar
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    More on the DHEA:

    http://www.sciencebasedmedicine.org/...-still-a-ruse/

    DSHEA is based on a fiction. It prohibits claims that diet supplements prevent or treat any disease and only allows structure/function claims alleging that they “support” health in various ways. DSHEA is a stealth weapon that allows the sale of unproven medicines just as long as you pretend they are not medicines. It allows the sale of products that are not intended to prevent or treat disease so people can buy them with the intent of preventing or treating diseases. People don’t buy St. John’s wort to correct a deficiency of SJW in their diet or in their bloodstream; they don’t buy it to “support” brain function; they buy it to treat depression. People don’t buy glucosamine to “support joint health” but to treat their arthritis pain. People don’t buy saw palmetto to “support prostate health” or correct a saw palmetto deficiency, but to relieve symptoms of benign prostatic hyperplasia or to prevent prostate cancer. The FDA’s “Quack Miranda warnings” are routinely ignored even by those few who actually read the fine print.
    "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

  6. #66

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    Quote Originally Posted by Jeff Lebowski View Post
    Ha. Yeah, we all know that the supplement industry would never make claims like that.

    http://www.sciencebasedmedicine.org/...ery-of-a-sham/
    What’s more frightening than this inexcusable lack of oversight is that many of the products marketed under DSHEA aren’t just vitamins and such, but products that claim to do the same things as real medicines. How do they get away with that?

    By using the Quack Miranda Warning, that’s how. Anyone who lives in the States knows this one almost as well as the “real” Miranda warning:

    *These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease."

    I put in the asterisk because there’s always an asterisk. The warning always appears at the bottom of a back page in very fine print. This statement is required when making any clinical claims regarding a product, and it is up to the manufacturer to make sure all claims are true.

    Here’s the thing: many products covered by DSHEA are, by their advertising, clearly “intended to diagnose, treat, cure or prevent…disease.”
    The above quote is not true. The FDA is aggressively going after the very thing they say they can't. I will post some instances.
    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

  7. #67

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    http://www.fda.gov/ICECI/Enforcement.../ucm377975.htm

    Your firm's product Night Bullet is labeled as a dietary supplement. However, Night Bullet is subject to regulation as a drug, as defined by section 201(g)(1) of the FD&C Act [21 U.S.C. § 321(g)(l)], because it is intended to prevent, treat, or cure disease conditions and affect the structure or function of the body. Labeling statements documenting the intended use of Night Bullet, include, but are not limited to, the following:


    • "Scientifically calculated to multiply your Sexual Drive and Stamina!"
    • "Maximize Orgasm Duration & Intensity!"
    • "Clinically proven to provide powerful Erections!"
    • "Designed for Sexual Stimulation"
    • "Increase Male Size and Firmness"
    • "Eliminate Premature Ejaculation"


    Under section 201 (g)(1) of the FD&C Act (last sentence), the structure/functions claims permitted for dietary supplements must be made in accordance with section 403(r)(6) of the FD&C Act [21 U.S.C. § 343(r)(6)]. However, the structure/function claims made for Night Bullet do not conform to section 403(r)(6). Therefore, the product is subject to regulation as a drug. Section 403(r)(6) authorizes claims that describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the body or that characterize the way in which a nutrient or dietary ingredient maintains the structure or function of the body.
    Additionally, under section 502(a) of the FD&C Act [21 U.S.C. § 352(a)], a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the FD&C Act [21 U.S.C. § 321(n)], provides that, in determining whether an article's labeling or advertising "is misleading, there shall be taken into account . . . not only representations made or suggested . . . but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations ....
    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

  8. #68

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    http://www.fda.gov/ICECI/Enforcement.../ucm367832.htm

    As presently formulated, labeled, and promoted, Arth 2000+ Cream is a drug, as defined by Section 201(g)(1) of the FD&C Act [21 U.S.C. § 321(g)(1)], because it is intended for use in the prevention, mitigation, treatment, or cure of disease, and/or intended to affect the structure or any function of the body. Examples of labeling statements documenting the intended uses of your product include, but are not limited to, the following:


    “Reduces Pain…Helps Inflammation…Improves mobility…”
    “For Joint Flexibility & Pain Relief”
    “Efficacy:…Applicable to these symptoms: muscle pain, joint pain, shoulder pain, back pain, rheumtoid (sic) arthritis….”
    “Kre-Celazine repairs damaged joints and makes the cells stronger, keeping your body feeling youthful.”
    In addition, FDA reviewed (1) your website at the Internet address http://www.yshealth.com, at which website you take orders for your HiBee Heart’n Brain Ultimate Omega-3 and Arth 2000+ For Joint Flexibility & Pain Relief (180 capsules), and (2) additional labeling of your products HiBee Heart’n Brain Ultimate Omega-3 and Arth 2000+ For Joint Flexibility & Pain Relief (180 capsules) products and has determined that both products are promoted for conditions which cause them to be drugs under Section 201(g)(1)(B) of the FD&C Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your labeling, including your website, establish that your products are drugs because they are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce violates the FD&C Act. Examples of some of the claims that provide evidence that your products are intended for use as drugs include:



    HiBee Heart’n Brain Ultimate Omega-3
    “It supports…the body’s natural anti-inflammatory response.”
    “Research shows that omega-3 fatty acids reduce inflammation and may help lower the risk of chronic diseases such as heart disease, cancer and arthritis.”
    “In fact, infants who do not get enough omega-3 fatty acids…are at risk for developing vision and nerve problems.”
    “Symptoms of omega-3 fatty acid deficiency include…heart problems…depression….”
    “A key component of the omega-3 EPA…inhibit blood clotting and prevent cardiovascular disease…”



    Arth 2000+ For Joint Flexibility & Pain Relief (180 Capsules)
    “Reduces Pain…Helps Inflammation…Improves mobility…”
    The name of your product, “[f]or…Pain Relief”
    Kre-Celazine, which is the main ingredient of Arth2000, a complex material consisting of bonding Kre-Alkalyn has been medically and clinically proven to reduce pain and rapidly improves joint…mobility along with reducing inflammation.
    “[K]re-Celazine also plays a role in suppressing inflammatory cell function…triggering cell death…”
    “Arth2000+ includes Glucosamine and MSM…helping inhibit joint inflammation…”
    “Glucosamine…help prevent cartilage degeneration and treat arthritis. Extracts of Boswellia have been clinically studied for osteoarthritis…particularly for osteoarthritis of the knee. Positive effects of Boswellia in some chronic inflammatory disease include rheumatoid arthritis, bronchial asthma, osteoarthritis, ulcerative colitis and Crohn’s disease have been reported.”
    “The benefits of White Willow Bark today are that it is an anti-inflammatory, a fever reducer, an analgesic, an anti-rheumatic…”
    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

  9. #69
    The dude abides Jeff Lebowski's Avatar
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    Dang it. What am I going to do without my Night Bullet?
    "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

  10. #70

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    http://www.fda.gov/ICECI/Enforcement.../ucm367896.htm

    This is to advise you that the Food and Drug Administration (FDA) reviewed your web site at the Internet address www.joltgum.com in June 2013 and has determined that you take orders there for the products Spearmint Jolt Energy Gum, Icy Mint Jolt Energy Gum, and Mint Flurry Energy Mints, which the website promotes for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your web site establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.



    Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:



    On the “Info” page on your site regarding the benefits of caffeine in your products:


    “Prevents Parkinson’s disease”
    “Prevents skin cancer”
    “Prevents dry-eye syndrome”
    “Helps control ADHD”
    “Can help breathing in young babies”
    “Curbs Depression”
    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

  11. #71
    The dude abides Jeff Lebowski's Avatar
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    From the FDA website:

    FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA):

    The manufacturer of a dietary supplement or dietary ingredient is responsible for ensuring that the product is safe before it is marketed.

    FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market.
    I.e., you go ahead and market whatever you want and we might try to shut you down later.

    Generally, manufacturers do not need to register their products with FDA or get FDA approval before producing or selling dietary supplements.* Manufacturers must make sure that product label information is truthful and not misleading.
    No registration or approval required. Just try to be honest. OK?

    http://www.fda.gov/Food/DietarySupplements/default.htm
    "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

  12. #72

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    http://www.fda.gov/ICECI/Enforcement.../ucm365431.htm

    This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.herbalpapaya.com in July 2013 and has determined that you take orders there for the products “Papaya Seed Extract”, “100% Papaya Leaf (Paw Paw Twig)”, “and “Papaya Leaf with Rooibos Tea”, which the website promotes for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)]. The therapeutic claims on your website establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.



    Examples of some of the claims on your website, www.herbalpapaya.com, that provide evidence that your products are intended for use as drugs include:



    On the page entitled “Papaya Seed Extract – 60 Veggie Capsules”:


    “Papaya seeds eliminate intestinal parasites … ”
    “Papaya seeds have anti bacterial properties.”



    On the page entitled “100% Papaya Leaf (Paw Paw Twig) – Dried, Cut and Sifted, 1LB”:


    “Papaya leaves have traditionally been used to … aid with malaria and dengue fever.”



    On the page entitled “Papaya Leaf with Rooibos Tea – 24 Teabags”:


    “[Q]uercetin [in Rooibos, an ingredient in your product] … helps to reduce the risk of various types of cancers [and] fights viruses.”
    “Aspalathin [in Rooibos, an ingredient in your product] ... helps to regulate blood sugar and therefore can play a role in reducing the risk of Type 2 diabetes … ”
    “The antioxidant nothofagin [in Rooibos, an ingredient in your product]…along with aspalatin … may help to reduce the risk of Alzheimer’s disease.”



    Examples of some of the additional claims on your website that provide evidence that your products are intended for use as drugs include the following:



    On the home page:


    “[P]apaya leaf extract … fight[s] virus & infections … ”
    “Papaya Leaf …exhibits anti-tumor effects.”



    In your August 28. 2012 blog post “Papaya And Evans Syndrome”:


    “Papaya leaf extract may be a natural remedy for Evans Syndrome … ”



    You provide links from your homepage www.herbalpapaya.com to videos that include the following claims that provide evidence that your products are intended for use as drugs:



    On the “Herbal Papaya Extract & Tea May Help Cancer, platelet blood count” video accessible at: www.youtube.com/watch?v=sRt23Ce_EOc:


    “Papaya leaf tea may treat cancer better than chemotherapy… ” (Text at 0:06)
    “[R]ecent clinical studies have found that papaya leaf tea may help treat cancer … ” (0:07)
    “Papaya leaf contains a rich source of papaya and antioixidants that … fight cancer … ” (0:18)



    Your Facebook account accessible at: https://www.facebook.com/HerbalPapaya, which includes a link to your website at www.herbalpapaya.com, also includes evidence that your products are intended for use as drugs. The following are examples of the claims in the “About” section:


    “Herbal Papaya makes Papaya leaf (Pawpaw Twig), Seed and Fruit preparations to treat yourself naturally. … treat cancer … and hepatitis. ”



    Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of products for the cure, mitigation, treatment or prevention of disease. Examples of such testimonials include:



    On the “Testimonials” webpage:



    You provide a link to the “ABC7 News” website that includes the following claim:


    “Papaya tea may treat cancer better than Chemo”



    You provide a link to the “Science Daily” website that includes the following claim:


    “Papaya Extract Thwarts Growth of Tumors in Lab Tests”



    You provide a link to “Barry’s testimonial – increase Platelet Count, Prednisone and Steroids Alternative” video. The testimonial states,


    “When I was 7, I was diagnosed with low platelet count… which means I had ITP [Idiopathic Thrombocytopenic Purpura]… recently I’ve been using an herbal solution, herbal treatment and what that herbal treatment is, is herbal papaya … I went onto herbalpapaya.com and bought the herbal extract. … I feel 100% now. ” (0:13 – 0:48)



    Moreover, when scientific publications are used commercially by the seller of a product to promote the product to consumers, such publications may become evidence of the product’s intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a dietary supplement is considered to be a claim about disease treatment or prevention if the citation refers to a disease use and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease. The following are examples of publications that are used to market your products for disease treatment and prevention on your website and are thus evidence of your products’ intended use as a drug:



    On the “FAQ” webpage”:



    Under “Do you have clinical studies to support Papaya Leaf Products”:


    “University of Florida researcher[s] … documented papaya’s dramatic anticancer effect against a broad range of lab-grown tumors, including cancers of the cervix, breast, liver, lung and pancreas. The scientists used an extract made from dried papaya leaves, and the anticancer effects were strong when cells received larger doses of the tea.”



    Under the title “Is there any scientific research around Papaya Leaf?”:


    Otsuki N, Dang NH, Kumagai E, et al., Aqueous extract of Carica papaya leaves exhibits anti-tumor activity and immunomodulatory effects. J Ethnopharmacol. Feb 17 2010; 12(3): 760-767.
    Ahmad N, Fazal H, Ayaz M, et al., Dengue fever treatment with Carica papaya leaves extracts. Asian Pacific Journal of Tropical Biomedicine. 2011: 330-333.
    Rahman S, Imran M, Muhammad N, et al., Antibacetial screening of leaves and stem of Carica papaya. Journal of Medicinal Plants Research. 2011; 5(2): 5167-5171.
    Indran M, Mahmood AA, Kuppusamy UR., Protective effect of Carica papaya L leaf extract against alcohol induced acute gastric damage and blood oxidative stress in rats. West Indian Med J. Sep 2008; 57(4): 323-326.



    The claims above are supplemented by the meta tags used to bring consumers to your website through Internet searches. Examples of meta tags targeted to consumers who are looking for products to prevent or treat various diseases include:


    “Papaya Leaf Tea treat Cancer”
    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

  13. #73

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    Dietary supplements have their own set of FDA regulations as do food and drugs. If your were to compare the regulatory requirements generally they would look like drugs>supplements>food. The FDA was painfully slow to act on their authority to regulate supplements per the 1994 legislation. It is really just recently they are starting to hit their stride on this. This is not be cause they did not have the legal authority, but because they chose not to act on it. It is not the law that needed changing, it was the enforcement. The FDA now seems to embrace their role in this and I think you will see less and less of the snake oil marketing as a result.

    I am not a fan of MLM's in general and specifically related to supplements because it is easy for individual "distributors" to make claims that are not legal. It would be nearly impossible for the FDA to do anything about it. It would make sense to me to reconsider the wisdom of letting MLM's market supplements accordingly.

    I do have a problem with the misleading information put out by folks like your science based medicine cited above.
    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

  14. #74
    𐐐𐐄𐐢𐐆𐐤𐐝 𐐓𐐅 𐐜 𐐢𐐃𐐡𐐔 Uncle Ted's Avatar
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    "If we do nothing we'll be substantially behind (other Power leagues) a decade from now." -Bob Bowlsby on Big 12 expansion.
    GIVE 'EM HELL, BRIGHAM!

  15. #75

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    Quote Originally Posted by Jeff Lebowski View Post
    DSHEA is based on a fiction. It prohibits claims that diet supplements prevent or treat any disease and only allows structure/function claims alleging that they “support” health in various ways. DSHEA is a stealth weapon that allows the sale of unproven medicines just as long as you pretend they are not medicines. It allows the sale of products that are not intended to prevent or treat disease so people can buy them with the intent of preventing or treating diseases. People don’t buy St. John’s wort to correct a deficiency of SJW in their diet or in their bloodstream; they don’t buy it to “support” brain function; they buy it to treat depression. People don’t buy glucosamine to “support joint health” but to treat their arthritis pain. People don’t buy saw palmetto to “support prostate health” or correct a saw palmetto deficiency, but to relieve symptoms of benign prostatic hyperplasia or to prevent prostate cancer. The FDA’s “Quack Miranda warnings” are routinely ignored even by those few who actually read the fine print.
    This is false. It is not legal to claim relieving symptoms of any disease even if the "Quack Miranda warnings" are included.
    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

  16. #76
    The dude abides Jeff Lebowski's Avatar
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    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

  17. #77
    вот так штука CardiacCoug's Avatar
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    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

  18. #78
    Chronic Poseur USUC's Avatar
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    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?

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    Quote 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.

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    Quote 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.
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  21. #81

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    Quote 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.

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  22. #82

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    Quote 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.
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    The dude abides Jeff Lebowski's Avatar
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    Quote 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.

    Quote 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.
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    Quote 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

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    Quote 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.


  26. #86

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    Quote 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

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    Quote 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.

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    Quote 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?

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    Quote 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.

  30. #90

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    Quote 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

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