Dmnkly wrote:If true, the issue wouldn't be with any of the studies nor of the sale of walnuts, but rather with a walnut seller making medical claims, wouldn't it? If I say my bacon cures cancer, that statement needs to be evaluated by the FDA (reasonably, I think... snake oil comes in many forms). It doesn't mean that the FDA is going to regulate bacon from now on.
Matt wrote:Not sure how this is being reported (and I believe this story dates back to sometime earlier this year), but I think saying that walnuts are now going to be treated as drugs across the board is probably overstating it a bit. This is really directed to what claims the advertising and marketing materials are making. If an entity simply wants to sell walnuts without making any health claims, it will continue to be able to do so.
The FDA took a similar stance against General Mills with respect to health claims for Cheerios back in 2009.
Cynthia wrote:If you made an unsupported claim that a product cured cancer, that would be questionable. However, if you said "the following scientific studies have shown that this product lowers cholesterol" -- and then list the studies -- that is not questionable. It is educational.
Cynthia wrote:The media regularly releases reports on health benefits of various foods or compounds in those foods. To share those reports would fall into the category of "freedom of speech," I would think.
Cynthia wrote:If the FDA wants to evaluate something, they should evaluate the scientific studies, not the person reporting the studies.
Dmnkly wrote:Depends. Were the studies performed by eight individuals who were paid by the makers of the product to eat it and then lick each other to see if they can taste less cholesterol in each other? There are good studies and bad studies. The purpose of the FDA review is to separate the former from the latter, is it not? Otherwise, I could devise any study I want and use its results to promote my bacon as a cure for cancer.
Certainly. But as we all know, there are certain limits on freedom of speech. Advertisers aren't allowed to make bogus medical claims. I think that's a pretty good limit, though it's certainly a topic for debate.
I believe that's exactly what they do. What leads you to believe something other than that is happening here? If a walnut producer wants to use studies to make health claims about walnuts, those studies have to be evaluated by the FDA.
Cynthia wrote:More than 35 peer-reviewed studies have been published in several countries about the health benefits of walnuts. It is not some group of 8 guys who are off in a corner making this stuff up.
Cynthia wrote:To list a few of the studies on one's website should constitute freedom of information.
Cynthia wrote:The FDA has a track record of ignoring scientific studies related to nutrition. In this case, it did not review the scientific research, it simply went after the walnut sellers because they quoted some of the scientific studies.
...they may not be legally marketed with the above claims in the United States without an approved new drug application.
Matt wrote:Whether one likes it or not, the FDA does have authority (or at least exerts authority in a manner that has not, to date, been overturned by the courts) over health claims made with respect to foods. There is a process to permit qualified health claims on labels and marketing materials if there is sufficient scientific support for the claim. Here is a listing of certain food-related (and some vitamin-related) claims that the FDA has permitted, subject to certain conditions, even where the scientific evidence was less than clear. Not sure what the specific issue was with the walnuts, but it seems that perhaps there was a bit of a pissing contest between the FDA and Diamond (incidentally, it appears that a complaint was initiated with FDA against Diamond in 2007 by the execrable Center for Science in the Public Interest) that pushed it to this level; seems there might have been an avenue to go through the qualified health claim process to get the claims approved (but I allow for the fact that there may be nuances about the types of claims and how they fit within the FDA regs that I just am not getting).
Cynthia wrote:As for a process to approve listing health claims, as far as I'm concerned, if you just say "These scientific studies show...," there shouldn't be a need to get FDA approval to quote the studies. The company is not making the claim. They're just sharing the results of a study. It's freedom of information.
Cynthia wrote:Congress still has oversight over the FDA, so I'd just like to see folks become aware of what the FDA does so that they can contact their representatives if an issue arises that resonates for them. As for a process to approve listing health claims, as far as I'm concerned, if you just say "These scientific studies show...," there shouldn't be a need to get FDA approval to quote the studies. The company is not making the claim. They're just sharing the results of a study. It's freedom of information. If the FDA is worried about the statements, they should look at the studies, not the people quoting them.
Try to imagine how long it would take to get a newspaper onto the street if the government had an approval process for every information source quoted in every story.
Dmnkly wrote:Cynthia wrote:As for a process to approve listing health claims, as far as I'm concerned, if you just say "These scientific studies show...," there shouldn't be a need to get FDA approval to quote the studies. The company is not making the claim. They're just sharing the results of a study. It's freedom of information.
So just to be clear, you're okay with a bacon producer referencing studies such as my bacon licking example, because they're "just sharing the results of a study"? Because if so, that's definitely our point of disagreement
JoelF wrote:Oh, and one more thing: FDA isn't saying Walnuts are Drugs, FDA is saying that Diamond's claiming they are, and they need to stop or prove it before marketing them as such.
Cynthia wrote:JoelF wrote:Oh, and one more thing: FDA isn't saying Walnuts are Drugs, FDA is saying that Diamond's claiming they are, and they need to stop or prove it before marketing them as such.
That would still be wrong. First, the assertion was that walnuts have health benefits. A vast number of foods have health benefits. In fact, the whole reason anyone (including the government) cares what you eat is because some foods have greater health benefits than others. That is NOT the same as saying it's a drug.
Second, Diamond wasn't making the claims about health benefits -- reliable, highly regarded research universities and laboratories were sharing the results of their research, and Diamond simply shared that information. They did not make any claims. They were just saying, "Research shows this stuff is good for you."
leek wrote:I think I missed something, is there a quote on exactly what the walnut marketers said? I think they can say "Research shows this stuff is good for you". I think they can't say "Walnuts cure cancer, read the studies".
Q. I’d love to hear your take on the recent walnut flap [accusations that the FDA now considers walnuts to be drugs]. I suspect walnuts got caught with such offenders as Pom, Froot Loops, and Juicy-Juice, but I’d love to find out what the FDA actually said about this. For some odd reason I don’t believe the article is presenting the whole truth.
A. This is a health claims issue. The FDA is not saying walnuts are drugs. It is saying that Diamond Walnut is claiming walnuts as drugs on package labels. How so?
The labels say the omega-3 fatty acids in walnuts may help lower cholesterol; protect against heart disease, stroke and some cancers (e.g. breast cancer); inhibit tumor growth; ease arthritis and other inflammatory diseases; and even fight depression and other mental illnesses. These are disease claims for which the FDA requires scientific substantiation.
The company’s petition did not provide that substantiation so the FDA issued a warning letter. In general, you should be skeptical any time you see a nutritional factor advertised for its ability to prevent or treat such a broad range of problems.
Cynthia wrote:
The statements have been removed, so an exact quote is not now possible, but the site simply quoted research that walnuts lower cholesterol and reduce risk of heart disease. It didn't claim to end heart disease (or cure cancer) and didn't recommend going off your meds.
The Internet, Where Nothing Ever Goes Away wrote:According to New America the benefits claimed by Diamond Foods and listed on the company's website include, "the omega-3 fatty acids found in walnuts have been shown to have certain health benefits, including reduced risk of heart disease and some types of cancer."
Darren72 wrote:Cynthia, I presume you got your information from The New American articleon this topic. They've completely misrepresented the situation. I leave it to Marion Nestle to clean up:Q. I’d love to hear your take on the recent walnut flap [accusations that the FDA now considers walnuts to be drugs]. I suspect walnuts got caught with such offenders as Pom, Froot Loops, and Juicy-Juice, but I’d love to find out what the FDA actually said about this. For some odd reason I don’t believe the article is presenting the whole truth.
A. This is a health claims issue. The FDA is not saying walnuts are drugs. It is saying that Diamond Walnut is claiming walnuts as drugs on package labels. How so?
The labels say the omega-3 fatty acids in walnuts may help lower cholesterol; protect against heart disease, stroke and some cancers (e.g. breast cancer); inhibit tumor growth; ease arthritis and other inflammatory diseases; and even fight depression and other mental illnesses. These are disease claims for which the FDA requires scientific substantiation.
The company’s petition did not provide that substantiation so the FDA issued a warning letter. In general, you should be skeptical any time you see a nutritional factor advertised for its ability to prevent or treat such a broad range of problems.
You can read the warning letter here and it should be very clear what the issues are.
stevez wrote:The Internet, Where Nothing Ever Goes Away wrote:According to New America the benefits claimed by Diamond Foods and listed on the company's website include, "the omega-3 fatty acids found in walnuts have been shown to have certain health benefits, including reduced risk of heart disease and some types of cancer."
JoelF wrote:Yes, but a newspaper doesn't have the potential for effects that can hospitalize you.
Dmnkly and others have it straight: FDA must specifically approve claims. If scientific studies are published, but the results are not statistically conclusive, or not well controlled, or have unscrupulous investigators, they're not good enough. Two studies, even one, can be enough if the claims are solid and the health benefit large.
Cynthia wrote:As for things that have potential effects that can hospitalize you, FDA-approved drugs don't have a really good track record. I don't think too many folks are dying from walnuts, however.
Cynthia wrote:stevez wrote:The Internet, Where Nothing Ever Goes Away wrote:According to New America the benefits claimed by Diamond Foods and listed on the company's website include, "the omega-3 fatty acids found in walnuts have been shown to have certain health benefits, including reduced risk of heart disease and some types of cancer."
As noted above, even the FDA letter states that the site said "Research indicates" and that it "may help." So again, it does not say it will change things. Even the FDA acknowledges that the website was quoting research.
Cynthia wrote:Also, Nestle is wrong about its being on the label -- even the FDA letter (linked from the Nestle comment) says that the comments were made on the website -- it does not mention labels at all.
Cynthia wrote:And it doesn't say it will cure anything, just that it MAY help protect against these things.
Darren72 wrote:Cynthia wrote:As for things that have potential effects that can hospitalize you, FDA-approved drugs don't have a really good track record. I don't think too many folks are dying from walnuts, however.
I think we've just thrown the last shred of reasonable, intelligent thought out the window.Cynthia wrote:And it doesn't say it will cure anything, just that it MAY help protect against these things.
You'd be an excellent representative of the snake oil industry. I think the problem here is that you simply don't understand the purpose of product labeling laws.