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FDA says Walnuts are Drugs

FDA says Walnuts are Drugs
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  • Post #61 - November 12th, 2011, 9:19 am
    Post #61 - November 12th, 2011, 9:19 am Post #61 - November 12th, 2011, 9:19 am
    Cynthia wrote:
    riddlemay wrote:
    Cynthia wrote:The issue I was addressing is the FDA making nutritional information hard to come by. Let them make sure food isn't tainted. Let them rigorously test drugs. But also let people selling nutritious food quote reports on nutrition.

    The FDA does permit sellers of nutritious food make health claims for their food--as long as they have clinical studies to back it up.

    Similarly, the FDA does permit sellers of pharmaceutical drugs to make health claims for their drugs--as long as they have clinical studies to back it up.

    It's a level playing field.


    But the whole discussion was triggered by a situation where the FDA did not allow the seller of a nutritious food to make claims, even though the claims were backed up by peer-reviewed, clinical studies. So I'm not really sure what you're saying.

    Here's what I'm saying.

    The makers of Lipitor have to prove that Lipitor itself, in clinical studies, can lower cholesterol for the FDA to approve that claim. They can't merely show articles--no matter how credible--that state that some of the components in Lipitor have been demonstrated to lower cholesterol, or that drugs of the same type as Lipitor have been demonstrated to lower cholesterol. They have to show that people specifically taking Lipitor Brand statin, versus a control group taking placebo, have experienced these beneficial effects to a statistically significant degree. If they can't show that, they don't get to make the claim.

    Similarly, the makers of Diamond Walnuts have to prove that Diamond Walnuts--not somebody else's walnuts, and not some of the ingredients contained in walnuts--have health benefits for the FDA to approve that claim. They can't merely show articles--no matter how credible--that state that some of the components in Diamond Walnuts have been demonstrated as beneficial. They have to show that people specifically eating Diamond Walnuts, versus a control group, have experienced these beneficial effects to a statistically significant degree. If they can't show that, they don't get to make the claim.

    Completely level playing field--as it should be.
  • Post #62 - November 12th, 2011, 11:37 am
    Post #62 - November 12th, 2011, 11:37 am Post #62 - November 12th, 2011, 11:37 am
    riddlemay wrote:Here's what I'm saying.

    The makers of Lipitor have to prove that Lipitor itself, in clinical studies, can lower cholesterol for the FDA to approve that claim. They can't merely show articles--no matter how credible--that state that some of the components in Lipitor have been demonstrated to lower cholesterol, or that drugs of the same type as Lipitor have been demonstrated to lower cholesterol. They have to show that people specifically taking Lipitor Brand statin, versus a control group taking placebo, have experienced these beneficial effects to a statistically significant degree. If they can't show that, they don't get to make the claim.

    Similarly, the makers of Diamond Walnuts have to prove that Diamond Walnuts--not somebody else's walnuts, and not some of the ingredients contained in walnuts--have health benefits for the FDA to approve that claim. They can't merely show articles--no matter how credible--that state that some of the components in Diamond Walnuts have been demonstrated as beneficial. They have to show that people specifically eating Diamond Walnuts, versus a control group, have experienced these beneficial effects to a statistically significant degree. If they can't show that, they don't get to make the claim.

    Completely level playing field--as it should be.


    Reasonably stated, and theoretically solid. However, given that the drug company will make millions of dollars selling a drug they developed and that you can pretty much only get from them, at least initially, is a lot different from a company that sells a natural product that many companies sell and people could even grow themselves, and will therefore bring in very little income. Also, Lipitor has many potential dangers (which is why you need a prescription), while eating walnuts is only an issue if you're allergic to tree nuts.

    I actually think it's quite reasonable for someone who invents something to prove it works -- especially when they stand to make millions if not billions of dollars.

    I don't think it's reasonable to ask someone to offer the same level of proof for a widely available nutritious food that is sold by many companies that they have simply packaged and not altered in any way to make it different from that same food offered by all those other companies. In cases like this, it should be acceptable only to prove that the "generic" product -- i.e., walnuts -- are safe.

    Which raises the question in my mind -- once the drug company proves their drug is safe, does the company producing the generic version have to go through the same process? I checked it out, and according to the FDA site, "The ANDA process does not require the drug sponsor to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness."

    So generic drugs don't get the same rigorous testing as brand-name drugs, because they have already been shown to be safe. So why can't "generic" foods be approved as a group, rather than by company, as you suggest?
    "All great change in America begins at the dinner table." Ronald Reagan

    http://midwestmaize.wordpress.com
  • Post #63 - November 12th, 2011, 1:01 pm
    Post #63 - November 12th, 2011, 1:01 pm Post #63 - November 12th, 2011, 1:01 pm
    Cynthia wrote:So generic drugs don't get the same rigorous testing as brand-name drugs, because they have already been shown to be safe. So why can't "generic" foods be approved as a group, rather than by company, as you suggest?

    Here I'm not so sure of the answer, but I think claims for all walnuts could be given the OK by the FDA, if the marketing communication came from, say, The Walnut Growers of America (or whatever their industry trade group is), and, of course, if said marketing communication were substantiatable by the WGofA with clinical studies that met the FDA's standard.
  • Post #64 - November 12th, 2011, 3:52 pm
    Post #64 - November 12th, 2011, 3:52 pm Post #64 - November 12th, 2011, 3:52 pm
    Cynthia,

    You want to have it both ways and you can't. In place in this thread you complain about adverse drug reactions. The only way to reduce the number of drugs that have adverse side effects, don't work, or have adverse reactions is to require more testing and make it more difficult to get drugs approved.

    Interesting, the classic libertarian position on this is the opposite: the FDA has too high a standard and lets drugs come to the market too slowly.

    But you also seem to want to make it easier for products to market health benefits, regardless of the scientific basis for these claims. This would lead to more adverse health events. I am having trouble reconciling your various views.
  • Post #65 - November 12th, 2011, 3:54 pm
    Post #65 - November 12th, 2011, 3:54 pm Post #65 - November 12th, 2011, 3:54 pm
    Health claims for foods have to be approved by the FDA. Currently there are only 12 approved health claims and 4 FDAMA health claims that are allowed to be used with foods. You can see the list here - http://www.fda.gov/Food/GuidanceComplia ... 064919.htm

    The only claim that Diamond Foods, Inc could make about walnuts and omega-3 fatty acids falls under 21 CFR 101.75 - Dietary Saturated Fat and Cholesterol, and risk of Coronary Heart Disease.
    When I grow up, I'm going to Bovine University!
  • Post #66 - November 12th, 2011, 5:31 pm
    Post #66 - November 12th, 2011, 5:31 pm Post #66 - November 12th, 2011, 5:31 pm
    Darren72 wrote:Cynthia,

    You want to have it both ways and you can't. In place in this thread you complain about adverse drug reactions. The only way to reduce the number of drugs that have adverse side effects, don't work, or have adverse reactions is to require more testing and make it more difficult to get drugs approved.

    Interesting, the classic libertarian position on this is the opposite: the FDA has too high a standard and lets drugs come to the market too slowly.

    But you also seem to want to make it easier for products to market health benefits, regardless of the scientific basis for these claims. This would lead to more adverse health events. I am having trouble reconciling your various views.


    I'm not sure how much more often I want to restate my point, but nothing you've said relates to what I'm saying.

    The comments about the dangers of drugs were entirely in the context of nutrition being safer than drugs (though a lot of people prefer to wait until they need drugs, rather than making adjustments to their nutritional intake to avoid that eventual need -- but that's a personal decision).

    I never said that I think the FDA needs to change the way they bring drugs to the market. I simply pointed out that the FDA is not without its failures. This contributes to my reasons for wanting to avoid drugs whenever a simple, nutritional approach will work. Sometimes, nutritional approaches don't work, and then it's good to have drugs. But my personal approach to health is that drugs aren't the first line of defense.

    And the Libertarian position to which I was referring was that the FDA should stop trying to "protect" us from useful nutritional information that might keep us from needing drugs. If there is useful and reliable information available, that has been widely published in recognized sources (not just medical journals, but also reliable news sources), then anyone should be able to repeat that information. I'm not saying that is how it works -- I KNOW that's not how it works. I'm saying that I think this should be changed. (As noted previously, I really don't see how someone reading about Omega 3s in Newsweek is any better off than someone reading about Omega 3s on the Diamond site.)

    For what it's worth, I'm also against the government banning salt in restaurants. If the government really cares about our health, they need to make as much nutritional information available as possible and then let individuals take care of themselves.
    "All great change in America begins at the dinner table." Ronald Reagan

    http://midwestmaize.wordpress.com
  • Post #67 - November 19th, 2011, 9:46 pm
    Post #67 - November 19th, 2011, 9:46 pm Post #67 - November 19th, 2011, 9:46 pm
    At the risk of looking like I'm feeding the trolls...

    EU bans claim that water can prevent dehydration
    What is patriotism, but the love of good things we ate in our childhood?
    -- Lin Yutang
  • Post #68 - September 29th, 2022, 3:00 pm
    Post #68 - September 29th, 2022, 3:00 pm Post #68 - September 29th, 2022, 3:00 pm
    The U.S. Food and Drug Administration (FDA) is looking to help consumers improve their nutrition and dietary patterns with a proposal that would update criteria for when foods can be labeled as "healthy." The proposed rule would be in alignment with current nutrition science, the updated Nutrition Facts label and the current Dietary Guidelines for Americans.

    https://progressivegrocer.com/fda-redefine-healthy
    Never order barbecue in a place that also serves quiche - Lewis Grizzard

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