Monday, July 25, 2011

The FDA Cracks Diamonds 'Walnuts'

Q:  What do you call nuts on the wall? 
A:  Walnuts.

Q:  What do you call nuts in DC?
A:  Federal Employees

"When walnuts are outlawed, only outlaws will have walnuts..."  -- The FDA

In a letter to Diamond Walnuts, the FDA has 'warned' the company that its advertising for Diamond's "walnut products are in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and the applicable regulations in Title 21, Code of Federal Regulations (21 CFR)."

Additionally (per the FDA):  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. The following are examples of the claims made on your firm's website under the heading of a web page stating "OMEGA-3s ... Every time you munch a few walnuts, you're doing your body a big favor.":







• "Studies indicate that the omega-3 fatty acids found in walnuts may help lower cholesterol; protect against heart disease, stroke and some cancers; ease arthritis and other inflammatory diseases; and even fight depression and other mental illnesses."


• "[O]mega-3 fatty acids inhibit the tumor growth that is promoted by the acids found in other fats ... "

• "[I]n treating major depression, for example, omega-3s seem to work by making it easier for brain cell receptors to process mood-related signals from neighboring neurons."

• "The omega-3s found in fish oil are thought to be responsible for the significantly lower incidence of breast cancer in Japanese women as compared to women in the United States."

Okay, the people at Diamond Walnuts may have 'stretched' the marketing verbiage a bit here, but seriously, all they've said is the following:


  1. Walnuts scientifically have been shown to provide Omega-3 fatty acids
  2. Eating walnuts 'may help' you get needed Omega-3 fatty acids into your diet
  3. And, if complementary research is to be believed, there may be other implied benefits (noting the usage of the words 'seem', 'are thought', and 'may help' in the excerpt above) associated with Omega-3.  They never claim that you receive these benefits by busting their (please excuse the expression) 'nuts', but the inferrence is clear enough.  If you eat Diamond Walnuts, you 'may help', you may 'seem to increase' your Omega-3 levels which 'may help' you to be...  healthier.   
Continuing from the FDA Warning Letter:  The back of your product label also bears the following statement: "The omega-3 in walnuts can help you get the proper balance of fatty acids your body needs for promoting and maintaining heart health. In fact, according to the Food and Drug Administration, supportive but not conclusive research shows that eating 1.5 oz of walnuts per day, as part of a low saturated fat and low cholesterol diet, and not resulting in increased caloric intake, may reduce the risk of coronary heart disease. Please refer to nutrition information for fat content and other details about the nutritional profile of walnuts."

Although FDA exercises enforcement discretion over the last two sentences of this statement, which meet the criteria for a qualified health claim for walnuts and coronary heart disease, the last two sentences read in conjunction with the first sentence makes the entire statement an unauthorized health claim.

The statement suggests that the evidence supporting a relationship between walnuts and coronary heart disease is related to the omega-3 fatty acid content of walnuts. There is not sufficient evidence to identify a biologically active substance in walnuts that reduces the risk of CHD. Therefore, the above statement is an unauthorized health claim. This letter is not intended to be an inclusive review of your products and their labeling. It is your responsibility to ensure that all of your products comply with the Act and its implementing regulations.

You should take prompt action to correct these violations. Failure to do so may result in regulatory action without further notice. Such action may include, but is not limited to, seizure or injunction.

The first paragraph above is most likely where Diamond got into trouble - they quoted the FDA.  The FDA can't have THAT - people quoting them?!?!  

The good news is that this letter is only a 'Warning'.  What's the worst that could happen from a 'warning'? 

Oh, upon further reading I see that the FDA can 'Seize' Diamond Walnuts' products (their livelihood) or prevent them from doing business (via an 'injunction').  Well, that's a completely different thing, now isn't it?

That IS kind of a big deal.  

Luckily for US (as in United States), the FDA extends its angry fingers into all US-based businesses.  There is no company able to elude the FDA's bony grasp...

Right?

No.

Check out the following excerpt from 'Life Extension Magazine' online:

FDA Allows Potato Chips to Be Advertised as “Heart Healthy”

Frito-Lay® is a subsidiary of the PepsiCo, Inc., makers of Pepsi-Cola. Frito-Lay® sells $12 billion a year of products that include:
Lays® Potato Chips
Doritos®
Tostitos®
Cheetos®
Fritos®
You might not associate these mostly-fried snack foods as being good for you, but the FDA has no problem allowing the Frito-Lay® website to state the following:

“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, corn and soybean oils contain good polyunsaturated and monounsaturated fats, which help lower total and LDL ‘bad’ cholesterol and maintain HDL ‘good’ cholesterol levels, which can support a healthy heart. Even salt, when eaten in moderation as part of a balanced diet, is essential for the body.”37
FDA Allows Potato Chips to Be Advertised as “Heart Healthy”
Actual FDA Researcher
She's kinda cute
for a Federal Worker!

Wow! Based on what Frito-Lay® is allowed to state, it sounds like we should be living on these snacks. Who would want to ingest walnuts, pomegranate, or green tea (which the FDA is attacking) when these fat calorie-laden, mostly-fried carbohydrates are so widely available?

According to the Frito Lay® website, Lays® potato chips are “heart healthy” because the level of saturated fat was reduced and replaced with sunflower oil.38 Scientific studies do show that when a polyunsaturated fat (like sunflower oil) is substituted for saturated fat, favorable changes in blood cholesterol occur.39

Fatally omitted from the Frito-Lay® website is the fact that sunflower oil supplies lots of omega-6 fats, but no omega-3s.40 The American diet already contains too many omega-6 fats and woefully inadequate omega-3s.

Excess omega-6 fats in the diet in the absence of adequate omega-3s produce devastating effects, including the production of pro-inflammatory compounds that contribute to virtually every age-related disease, including atherosclerosis.41-45

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.

"Treason against the health of the American public..."
Sooooooo, I guess the FDA hasn't ticked off the folks at "Life Extension Magazine" too much?  Those people at Life Extension Magazine had better watch out or they'll find themselves looking at 'Seizure' or 'Injunction'.  Because when it comes to opinions, SIZE does matter. 

In this instance, the FDA is much larger than LEM, and Frito-Lay is much larger than Diamond Walnut Growers. 

To be sure, I looked it up (RESEARCH!  You know how much I love it...):

Diamond Walnut Growers in Linden, CA is a private company categorized under Seeds-Coating Manufacturers. Current estimates show this company has an annual revenue of $2.5 to 5 million and employs a staff of approximately 50 to 99.

Frito-Lay North America Frito-Lay is the undisputed chip champ of North America. The company makes some of the best-known and top-selling savory snacks around, including Cheetos, Doritos, Lay's, Ruffles, and Tostitos. On the sweet side, Frito-Lay also makes Grandma's cookies, Funyuns onion-flavored rings, Cracker Jack candy-coated popcorn, and Smartfood popcorn. It also offers Funyuns onion-flavored rings, Smartfood popcorn, and a line of chips made with the fat substitute, Olestra under the Light brand name. Owned by PepsiCo, Frito-Lay North America (i.e., the US and Canada) accounts for about one-third of the soda maker's sales. Frito-Lay's Mexican sales are reported within Pepsi's Latin America Foods segment.

Annual revenue for PepsiCo in 2010 was $58.4 BILLION.  Since Frito-Lay accounts for roughly 29% of PepsiCo's total revenue, figure Frito-Lay's total revenue for 2010 was $16.9 BILLION.

Don't get me wrong, I'm a 'Free Market Kind of Guy'.  I LIKE when companies make money, sell products, expand their business, and hire workers, but the fact that the FDA is looking at Diamond and NOT Frito-Lay's 'Healthy Advertising' activity is kind of surprising to me.  

I wonder why the lack of oversight?


The 'New' Pepsi Logo looks a lot like President Obama's
approval rating - mostly "Down and to the right"

Nah, it couldn't be that easy, could it? 

You know me, I'm a simple guy.  I'm thinking that something that GROWS ON A FREAKING TREE is going to be better for you than a product that is pulled from the ground in June, shipped, processed, sliced, fried, salted, and stuffed into an aluminum foil pouch in October?  Yeah, I'm thinking the tree nuts are a healthier option. 

But you know, that's just me.  I don't work for the FDA.

Maybe YOU do!  If so, please let us know why Diamond is in your crosshairs and Frito-Lay doesn't even appear to be on the radar screen. 

That'd be great - thanks!

BONUS Video (having almost nothing at all to do with today's post)!
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