It seems absurd. Yet thanks to the regulations set forth by the U.S. Food and Drug Administration, any food that makes a non-FDA approved health claim is advertising itself as a drug, not a food. Of course, if the food is actually a drug, then it suddenly becomes subject to all the laws, testing, and requirements of regulated drugs. Translation: foods as benign as walnuts are regulated like illegal drugs.
For years, the FDA has been using this reasoning to target companies that market foods using health claims. In general, I’m of a mixed opinion about such targeting. On the one hand, it’s good to hold food makers responsible for the claims they make when marketing food. We wouldn’t want Cocoa Krispies to advertise itself as an effective way to keep your kids from contracting the Swine Flu, would we? (O Wait! You mean they did that already?)
But on the other hand, where’s the harm in a walnut distributor’s website linking to studies found in scientific journals that demonstrate that eating walnuts can lower LDL cholesterol?
I grow particularly upset when I see perfectly normal, healthy, whole foods targeted by these regulations. Recently, the FDA sent a warning letter to Diamond Foods, Inc. — a distributor of walnuts — warning them to remove the scientifically substantiated health claims about walnuts on their website. Here are a few choice excerpts from the FDA’s letter:
“Based on claims made on your firm’s website, we have determined that your walnut products are promoted for conditions that cause them to be drugs because these products are intended for use in the prevention, mitigation, and treatment of disease.
“Because of these intended uses, your walnut products are drugs within the meaning of section 201 (g)(1)(B) of the Act [21 U.S.C. § 321(g)(B)]. Your walnut products are also new drugs under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for the above referenced conditions. Therefore, under section 505(a) of the Act [21 U.S.C. § 355(a)], they may not be legally marketed with the above claims in the United States without an approved new drug application.
“Additionally, your walnut products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, your walnut products are also misbranded under section 502(f)(1) of the Act, in that the labeling for these drugs fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)].”
Rather than facing fees amounting to hundreds of thousands of dollars, as well as the seizure and destruction of their entire inventory of walnuts, Diamond Foods did what any business would do. They removed the health claims from their website.
I grow even more upset when I see the FDA approving health claims for radically unhealthy, industrial foods. You know which foods I’m talking about. One walk down the snack food aisle of the grocery store is enough to do the trick. How many times have I gagged when seeing a bag of “heart-healthy” Frito-Lay potato chips?
Frito-Lay’s own website reads like one giant health claim:
Frito-Lay snacks start with real farm-grown ingredients. You might be surprised at how much good stuff goes into your favorite snack. Good stuff like potatoes, which naturally contain vitamin C and essential minerals. Or corn, one of the world’s most popular grains, packed with Thiamin, vitamin B6, and Phosphorous – all necessary for healthy bones, teeth, nerves and muscles.
And it’s not just the obvious ingredients. Our all-natural sunflower, canola, corn and soybean oils are considered to be healthier oils by the FDA because they contain good polyunsaturated and monounsaturated fats, which help lower total and LDL “bad” cholesterol and maintain HDL “good” cholesterol levels. They also contain <20% of the bad saturated fat, which raises LDL, cholesterol and 0g fo trans fat. Even salt, when eaten in moderation as part of a balanced diet, provides sodium which is essential for the body.
Why, after reading that spiel you’d think we should all be eating this heart-healthy food in huge quantities to stave off heart disease!
What kind of world do we live in where it’s okay for a junk food maker to market their so-called “foods” made from industrial waste products as “heart-healthy,” but it’s not okay for a walnut distributor to link to actual scientific studies demonstrating that walnuts are a healthy food?
I get the most upset, however, when I think about the implications this has for our food supply.
I like how William Faloon put it in his August 2011 Life Extension magazine article on this topic:
For the FDA to allow Frito-Lay® to pretend there are heart benefits to ingesting their unhealthy snack products, while censoring the ability of walnut companies to make scientifically substantiated claims, is tantamount to treason against the health of the American public.
The combined sales of the companies attacked by the FDA are only a fraction of those of food giant Frito-Lay®. Yet some of these companies are fighting back against the FDA’s absurd position that it is illegal to disseminate scientific research showing the favorable effects these foods produce in the body. The makers of pomegranate juice, for example, have sued the FTC for censoring their First Amendment right to communicate scientific information to the public.
As a consumer, you should be outraged that disease-promoting foods are protected by the federal government, while nutritious foods are censored. There is no scientific rationale for the FDA to do this. On the contrary, the dangerous foods ubiquitously advertised in the media are replacing cigarettes as the leading killers in modern society.
(photo by gimmefood)
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It IS absurd…!!
Some poor walmart farmer or company that processes and sells walnuts either pissed off someone in the FDA or they just didnt have the right amount of money to grease the proper wheels or big pharma got pissed because of the advertising of health benefits of walnuts. I think the fda and big farma are in bed so tight that they cant stand people trying to eat.healthier because then they wont need or take the drugs.
Pharma, sorry-kids were talking while i typed lol
And now that we have the president appointing the CEO of Monsanto as the Head of the FDA we can expect more sacred foods to become illegal. Even more absurd.
Nuts are such a great snack. What a waste of decent snacks!! You are definitely asking the right questions! Starting to make me wonder who the real nuts are.
The war on nuts…
The war on nuts…by nuts.
Aloe Vera has also been classified as a narcotic.
For the Subcommitee to do we contact our reps in each catagory listed?
Oh the FDA – funny it can find the time , money, and manpower to worry about this kind of thing and things like raw milk ( horror of horrors) But, can’t do anything about E.Coli tainted meat and produce, or billions of pounds of illegal honey that smuggled ( pretty openly) from China that’s tainted with Lead and chemicals, or Ban BPA ….
If they say this about walnuts then they have to say it about eggs, milk, fruit…….if you look at ads for REAL food-they all have some health benefits claim. I mean really-foods from the Earth are drugs now?
@Lynna — They *have* targeted many of these other foods, too, including coconut oil, apple cider vinegar, grass-fed beef, and a host of others. Basically, once you’re on their radar as advertising health claims with your whole food, you’re pretty much screwed.
I KNOW WALNUTS IS GOOD FOR US.
I refuse to waste energy being surprised/alarmed by the FDA anymore. They’ve jumped the shark and become a parody of themselves.
Amen.
Seconded.
I’m a newbie to real food, but seriously walnuts a drug…that’s a load of …I love putting them in my homemade granola! Think I’ll have a nice handful of “drugs” for a snack this afternoon!
funny feeling that someone wants to keep the population sick and unhealthy… for reasons… hmmmmmm we all know !
You would think free speech would already be a right which is protected for all. Do you have the text of that act or a link to it?
Hi Cathy, click on the link to the name of the bill in the post. It was broken earlier, but now I fixed it!
Wow…so absurd. It always makes me wonder when intelligent, educated people can get it so backwards. But then I remember the motivator…$$$$….and it makes me very sad. BUT we can at least help spread the word! Thanks so much for this!
“Based on claims made on your firm’s website, we have determined that your walnut products are promoted for conditions that cause them to be drugs because these products are intended for use in the prevention, mitigation, and treatment of disease.”
Pardon me, but isn’t ALL (good) food intended for use in the prevention, mitigation and treatment of disease, specifically, you know, death? I’m so tired of this gigantic goverment juggernaut that is wedging its way into every aspect of our lives. What is happening to our hard fought freedoms and personal liberty here in the USA? Why are we allowing our goverment to regulate us into serfdom?
Jaytee — That’s yet one more reason that these regulations offend me. Whatever happened to “Let thy food be thy medicine”? The regulations conveniently forget the link between food and health, assuming that any health claim automatically makes the food a drug subject to all the regulations of other medicines. (Except, of course, when they’ve actually approved the health claim, which seems to have more to do with money than science.)
Thanks, great article.
Don’t you know there’s a bagillion dollars to be made (FDA) if we keep the population teetering on sickness and poor health, heavens we can’t be eating beneficial raw foods untouched by anything but what nature intended now can we!!!! This has really gotten out of hand, I’m wondering how long until we see radical changes to food laws here in Oz, next thing we will be getting randomly searched and fined for food possession! Honestly this is so screwed up! Mad much..
I want some of what you’re smokin” ! <3
the FDA stands for drug companies, not consumers.
Resistance is futile… Eat as much real local food as you can. Support the people that do it for the love of it. We cannot change what “they” do.
3 votes a day, every day.
Peg: Serious about the Aloe Vera?
Also, not too long ago, they did the same thing to elderberry juice producers. Unreal.
And yes, I thought we already had free speech. Now we’re going to have protected classes of free speech?
Well…..the FDA has not made the walnuts themselves illegal, only requested that the health claims cannot be made by the producers themselves. Nothing is stopping others from making those claims. I abhor what the FDA is doing too, but lets stay clear on the facts. No one is taking walnuts away from us.
You’re right. No one is taking walnuts away. BUT, the FDA *would have* confiscated Diamond’s entire inventory of walnuts as illegal drugs if they didn’t remove those health claims. Other brands could have kept selling walnuts, but not Diamond, and not if they continued making health claims about them.
Furthermore, these restrictions are not just limited to producers. Two years ago the FDA completely shut down the Wilderness Family Naturals (WFN) affiliate program because of health claims affiliates were making about WFN’s foods. According to the FDA, affiliates (who were all bloggers like me) are a paid sales force since they receive a small commission on any sale. So WFN was held legally responsible for all the health claims ANYONE who helped them sell their foods was making.
In other words, it’s all about how the product is being marketed — whether it’s the producer doing the marketing or an affiliate (even a small time blogger).
The FDA has lost their minds… here’s some direction for the walnuts as medicine. Crack shell. Throw away shell. Place in mouth. Chew. Swallow. Eat a half cup. Eat a whole cup. Whatever. It doesn’t matter. This “drug” won’t kill you.
Hey man, any body got any walnuts? (scratch, itch, scratch)
I hope we can fix this before the people who enact these stupid laws have to find out that they really miss having walnuts in their brownies (for example).
I’ve really enjoyed your blog and the information you give. However, it’s difficult for me to read, since in your RSS feed, it only gives the short intro to your posts and I have to clickthru to read the whole thing. Would you consider changing the settings to show the whole post?
I have experimented with that in the past, but always end up regretting it.
First, it becomes very easy for other websites to simply import my full feed and duplicate all my content. Not only is that stealing/copyright infringement, but it also dings me in search engine results.
Second, if those of you who follow me entirely in an RSS reader never come to my site, I lose a lot of page views and a lot of ad revenue. That money contributes greatly to the income this blog generates, and it helps pay the (expensive!) costs required to keep the site up and going and serving tens of thousands of individual readers daily.
these days Popeye would be arrested for promoting spinach
and didn’t your mom make health claims for carrots? was she a doctor?
You’re telling me that in the US of A it’s illegal to claim that *healthy foods* are good for you?
But it’s okay for Oreo to put out a “healthy” 100 calorie snack pack of cookies?
It’s hard for me to decide exactly which part of this post is so maddening, that it’s true or that it’s practically impossible to get anything done about it.
Couldn’t walnut farmers start a lobby or even an advertising initiative using the same unsavory tactics as whoever makes cookies and cereal?
I understand “BIG PHARMA” funds the FDA in the tune of 350 to 450 million a year to keep them afloat.
They have been doing that since the FDA was established. It’s called donations for the better-ment of society. It’s not a conspiracy theory – IT IS A CONSPIRACY!! What is Obama thinking when he turns his head to the horrible facts of GMO’s, and puts a Hitler in charge of our food supply? The FDA is the “SS” following the commands. Their headquarters are located at MONSANTO. I ‘m so glad to see so many people are starting to see the conspiracy….
Uh Oh! I just bought a parasite cleanse as a precaution, and it contains black walnut extract. Clearly the FDA thinks this is a drug and it must be pulled from the shelves. Get rid of Obama and all his regulatory czars and much of these problems go away. Just make sure to elect a real conservative, not some flip-floppin’ phoney stuffed suit like Romney.
Sheree – Big farma, big pharma… is there a difference?
Dave: It doesn’t matter what side of the aisle they’re on. These agency people have longevity. Our elected officials are temps. The agency people get what they want no matter who’s in office. We need a new strategy.
I read this the other day!! Freaking stupid!!
“I grow even more upset when I see the FDA approving health claims for radically unhealthy, industrial foods.”
I’m totally with you on that. So many harmful food additives floating around in so called healthy processed foods – most consumers have no idea.
This is what happens when people give up their right to choose nature and choose/vote for agencies and regulators!!!
Yeah I agree never underestimate how much big pharma companies are in bed with the gov and how deep their roots run. People think the government runs the country but it’s really all the companies and with secret motives and money.
I just calld Rep. Scott Tipton’s office and had a friendly chat with an aide about how ridiculous the whole “walnut as new drug” letter was and she assured me that Rep. Tipton, who has not yet taken a position on the legislation, would support it so long as nothing else aggregious was tacked on to the bill, as so often happens becase he is against the FDA overstepping its bounds such that bureaucracy becomes tyranny!
I think every food/drink that is out there should should have a health claim on it. What will they do then, take all our food away? All companies need to do it though.
Edited for errors; I thought I fixed these, my apologies.
I think that the FDAs stance is absurd. However, before I go on I feel it’s appropriate to unfold some key things from the other side.
It is understandable that the FDA regulating every claim by every company on every website is an astronomical effort for which they are charged with the keeping of, along with many other very critical tasks, all on virtually nonexistent funds considering the enormous scope of their endeavors. And, it stands to reason to offer rewards and incentives for those who follow the laws, as Frito Lays apparently did. (Interesting that my phone wrote dud there, isn’t it? Maybe it’s trying to say something.) The government too, with a limited number of tax dollars, can only afford to offer so much funding to go so far. Yes, funds sorted and spent by the government could maybe be better done, but that’s a whollllle ‘nother discussion for another time…the matter at hand, here, is American health and safety. And I don’t fancy that argument, for the moment, so let’s move on.
(Later on, politicians will be mentioned. I feel it necessary to note, that only the politicians with excessive pay and/or tax evasion on their resume are called out for this discussion; which excludes an ethical president [especially one with a history of efficacy], who does a very hard job fraught with situations sewn with the seeds of their own distruction and built upon foundations crumbling before they were finished curing let alone the rest of the matter later built upon it… despite what many people may say.)
With regards to safety, it is appropriate to be sure that foods aren’t wrongfully advertised so that the sighters of said information (like the independent scientific studies) can be misconstrued to be saying “our food is a drug, to be used in the treatment of this or that”…. such as the use of tiger bones or elephant testicles for one ailment or another… because, yes, it will happen, and even the most clueless, from lack of sleep, or over working, or poor health and a spacy moment, or other causes, also deserve protection from fallacies, and perhaps need even more protection from their gullibility… all of us run into something where understanding the simplest aspect of it eludes us, even for the smartest of humans. And so, governments are to be there to save us in those moments that, sooner or later, happen to us all.
With all that being said… Wanuts are not drugs, and Frito Lays most definitely are not… unless you’re in a country where paying for your suicide is legal (yes, that is something that does exist. Or, it did about 5-10 years ago, I’m not sure on current stances on that matter, but anywhoo.)… and if you are interested in such morbid things, shouldn’t U pay more for quality? Well, I suppose buying a lifetime of these food in excessive excess (yes, I said “excessive excess”) would actually cost quite a lot. But, quality of purchase is another matter… is sounds awfully slow to me, with emphasis on the awful part. And, speaking of funds…. perhaps, just maybe, that’s why they want your business… even at the knowing expense of the quality and length of peoples’ lives with the creation of said marketing campaigns? We can ask to be sure, though, if we want. I am curious to hear their thorough, thoughtful, scientific, scientifically broad and thorough, and honest responses, with any loopholes or gaps in information non-existant.
The healthy foods lost favor so long ago…providing rich funds to the companies who then found favor on our tables and in our bellies. So, now, it’s up to citizens to be willing to advocate said foods… get specialists hard to target on their side, and get this information out there! Perhapse, find retired doctors on limited time to live with no living family to offer such information readily, freely, and “loudly” as it were, so that they can do it without impunity…and should they be jailed, they can be martyrs – and that, my friends, is a ludicrous desperate last resort of an effort that the companies in place to regulate consmer products for SAFETY have DRIVEN CONSUMERS TO in order to PROTECT CONSUMERS HEALTH. My question is, which is actually crazier? What about less ethical? Cause, quite frankly, I’m not quite sure. (Asking said doctors for help, or the FDA putting the people it’s supposed to help in such a terrible position in the first place with such ineffective and counterproductive practices run rampant! Which can lead to the deaths of millions or billions.) Or, on the other hand, little companies can sue with pittlie profits, while the unhealthy foods companies profiting off the poor nature of the current condition of our country shell out billions to keep selling their products in excess, which will keep Americans bloated, fat, lethargic, and sick, struggling all the more to do the minimum efforts in their livelihoods…. wracking up the health issues, expending more on health care costs…. and so trying harder for the same amount of work, building up stress, developing poor heath and it’s accompanying challenges and pains, and spending more for healthcare, so that we have less money to buy wholesome foods and so go to the snack isle to fill the gaps in our carts and bellies, and to cope with the stress in our lives and the gaps in social stimulation due to being lethargic &/or having a lower self esteem from a poor figure from poor health… I see a circle forming, but maybe it’s just me.
And, as a side note… I understand that Americans are called rude by outsiders? I will admit that, compared to others, Americans may seem entitled…but, maybe being forever sick plays a role in people’s perceived attitudes?? As well as actual attitudes. Who hasn’t gotten snippy when they have a migraine, or are having tummy troubles and that need for the toilet hits NOW… and all toilets are occupied. Feeling well matters, beyond our own needs. Better diet could even facilitate better inter-country relations! U paying attention, Mr. Government? Its a small thing… but all things add up, and all things matter. For us at home, it means a more enjoyable family, work, and private life.
Its a good idea to take everything ever said to anyone about anything with a grain of salt. Time can prove laws of life to just simply not be true. And, even experts can be wrong, and they have wallets and families with needs just as we all do, even if your family is exactly numbero uno large.
It’s sickening that the FDA let’s such things stand. Aren’t the people working there concerned for their families health? Or, maybe they don’t have to be, seeing as they SEE the horrors in the productions of such foods, and so are grossed out enough to never want to eat another of these gross things…
and their little ones, well, let’s just say that they learn fast enough.
It’s up to the public to do their research, and to make the best informed decisions that they can. And hope that this is enough. I wish the best of luck to every one, especially those who can’t afford a doctor in these dim and harsh days.
For those of you who do have the resources, please, please, please, keep up with posting pages upon pages about these things… you are a lifeline for many many people. And, please advocate, because, sadly, for many, it takes stumbling into this world of healthy foods to find out it exists, and to learn all the knowledge to be had that has been lost through that last few gegenerations. (I found it some time ago trying to make real bread, because, let’s be frank, commercial bread is cardboard! I’ve always like rye and potato breads… made with sour dough starters, no less! Closer to real food. And so, my real food journey began.) Your efforts matter, please, please, please help. Keep helping, always, till our government learns to be responsible, and, like a youngun, keep an eye on the government, forever, always watching for that bad stumble, to catch ’em when they fall… lest we all fall together. Cause, well, we’re all children to someone, even brain children such as concepts like the government, and all children make mistakes! Please, and thank you if you head this.
One request… will someone make a health.org page with certified information by trust-able experts, regarding all of this… and keep everything in one damn place?? Include experts from all known stances on the matter, EVEN AFTER a debate is COMPLETELY RESOLVED. Include the experts, their comments, their point of view, supporting research, and reasons why the stance ultimately chosen was chosen. Do this as new information comes to light, throwing knowledge that is stable, even for hundreds of years, into doubt. Let people be FULKY INFORMED. Please do this, even if the best the experts can say is, “well, I’m not sure….all i know is what the facts show… and they show this which MIGHT mean that, or not. We just don’t know. But hopefully people will keep researching to find out, funds permitting.” As I said before, knowledge is always growing, developing, changing… and, as this happens, so some things will be left behind for whatever reasons, and perhaps rediscovered another day for another reason. The site should include this disclaimer, so that people will have less reason to get huffy with the changes as they occur. Older information always has more knowledge and experience to back it up, and more time to be beaten by the critics as well, nothing is set in stone, and this information is mearly meant to be a guide for informed decision making, and not to be an all-encompassing and forever correct information source. This is an age of discovery! Lets all remember the benefits, and negatives of that fact. And remember that there is a whole world full of traditional practices pregnant with old knowledge to be learned from and remember. Traditions may be considered archaic, but the knowledge of their foundation is eternal, even as the world changes. At the end of the day, trial and error proved the worth of some of the parts of these cultures, throughout the millennia of the existence of the culture, for several thousands of years for some, hundreds for others. And, all people though out time had to eat, and their health is easy enough to discern, through the experiences also pregnant throughout the stories of their culture. Make your best informed decision. If you need help with that, the tried and true answer is “ask your doctor what is right for you. If you don’t like the answer you get or it seems incomplete get a second opinion. Your doctor knows YOU best,” but every doctor has their strengths, like anyone, and second and third opinions can be a wise decision. If more opinions overwhelms you in things you have trouble grasping, then this is something to ask for help on… help that the FDA should provide, with regards to this matter of food! If your decision is to support research…. let’s find somebody to set up said sites… and a place to donate money, so that citizens can be sure that some of their money gets a useful use…. In this case, to fund the expansion of real health knowledge, such as by funding the site, researchers, etc. And, maybe someone needs to start a petition along with boycotts of things that are causing such problems, to help empty the pockets if the unfairly money-bloated. Maybe new laws with strict regulation are needed… not against lowly walnuts, but people misusing the system set up to protect Americans! Like Frito Lays, & also the FDA for complicity in this heinous act. Yes, contributing knowingly to Americans poor health by knowingly allowing for advertising that will lead to misconception of the healthful quality of said product is to willfully and knowingly jeopardize the health of their charges! – ie., the American PEOPLE! If they were a guardian, the counts would remove this honored designation and deem that the FDA needed to see a psychiatrist for evaluation of ability to maintain healthful self-care.
FDA & the Government, shame on you. You can do better.
If U need funds… you’ve got many many pockets to dig into, of those people whose pockets are getting fat to the bursting off of others suffering… I believe their called politicians … and the CEOS who have the politicians in their fat laps? (FRITO LAYS, I’m calling you out! Since it’s already been done.) But, I could be wrong. Check that for me, would U, Sr. Government? Maybe I missed someone. Thanks!
Counts is supposed to be courts. 😉 Have a good one!
Walnut oil has a rich, nutty flavor that is perfect for salad dressings, to flavor fish and steaks, to toss with pasta, and to jazz up desserts.