Thursday, April 24, 2008

Under-the-Radar Petition at the FDA from American Dietetic Association and Others

Now that the pharmaceutical industry has its first FDA approved weight-loss drug available to the public, over-the-counter (OTC) no prescription needed Orlistat, it's time to eliminate the competition in the marketplace - dietary supplements - used by many Americans to help with weight loss.

On the website, an interesting petition exists that has had virtually no attention in the media - Treat Weight Loss Claims for Dietary Supplements as Disease Claims - filed as a citizen petition to the FDA by the American Dietetic Association, the Obesity Society, Shaping America's Health and GlaxoSmithKline Consumer Healthcare.

The full document PDF is available here as well as on the page linked above.

The document is quite interesting and it's obvious the petitioners do not want input from the public or an open comment period - they just want the FDA to take the action they request, no questions asked, no comments, no looking at anything other than what they've provided the FDA. Basically telling the FDA to just trust them!

The petition requests FDA to require manufacturers of weight loss supplements to obtain FDA review of their claims before the products can be sold, asserting such claims are "disease claims" as clearly indicated by the title page of the petition document - "Citizen Petition of the American Dietetic Association, The Obesity Society, Shaping America's Health, and GlaxoSmithKline Consumer Healthcare requesting the Food and Drug Administration to determine that claims that dietary supplements promote, assist, or otherwise help in weight loss are disease claims under Section 403(R)(6) of the Federal Food, Drug and Cosmetic Act."

We learn more in the section Action Requested, "In support of this action, petitions present extensive scientific evidence and consumer survey data that has been developed during the past decade. This new information conclusively establishes three critical facts. First, the condition of being overweight is a significant risk factor for serveral serious diseases, including diabetes, cardiovascular disease and cancer. Second, many Americans understand the health risks of being overweight and they rely on dietary supplements to lose weight. Third, there is little, if any, evidence, indicating that dietary supplements marketed for weight loss actually work. As a result of these three facts, many Americans are being thwarted in their efforts to lose weight, and reduce the risk of disease, by ineffective weight loss supplements."

To support their postion, they assert that claims such as the above are "qualified health claims" that require authorization and approval from the FDA and state they believe "there is no credible evidence whatsoever to support any type of qualified health claim for a weight loss supplement...In the case of weight loss supplements, there is no credible evidence to indicate that supplement themselves assist in weight loss or, even if they do so, that there is a commensurate risk reduction of disease from the use of any such supplements."

A qualified health claim is a claim authorized by the US Food and Drug Administration (FDA) that must be supported by credible scientific evidence regarding a relationship between a substance (specific food or food component) and a disease or health-related condition. Both of these elements -- a substance and a disease -- must be present in a health claim. An example of a qualified health claim is: "Calcium may reduce the risk of osteoporosis."

The petitioners even go so far as to strongly suggest public input and comment is not necessary, they carefully take the position that overweight need not be redefined as a disease, but rather a risk factor for disease; thus providing the FDA an opportunity to act in their favor without notice or comment rulemaking.

"Finally, in this context, petitioners must emphasize that FDA is not required to engage in norice and comment rulemaking under the Administrative Procedures Act (APA), 5 USC 553, before implementing the actions requested in the petition. That is because the petitioners are not asking FDA to change its earlier interpretation of the way that two of the criteria in the structure/function rule apply to weight loss claims. Rather petitioners are requesting FDA to apply a particular provision in its existing regulations to weight loss claims in light of the substantial body of literature and consumer survey data developed during the past decade. An agency's application of its regulations to particular factual scenarios certainly does not require notice and comment rulemaking under the APA. Moreover, to the extent that FDA concludes that granting this petion woudl require the agency to modify its earlier statements about weight loss claims in the preamble to the structure/function rule, such statements constitute "advisory opinions" that can be modified at any time following notice in the Federal Register."

At least we find public comments are open online (even if nothing is found elsewhere online to hint this petition even exists)....the public comment and submission page is here.

Time to get to work!

Tuesday, April 22, 2008

The Solar Powered Plate

I feel a rant coming on today - Earth Day - when as if on cue, the media is hot and heavy with the message that the best thing any one of us can do to reduce our carbon footprint is to eat less meat. In newspapers, magazines and blogs we find all sorts of reasons behind the rush to banish meat from our diets:

Toronto Star: "Eat less meat. Raising cattle, sheep and pigs uses up resources."

Sacramento Bee: "Another thing is, gosh, if you can reduce demand, get people to eat less meat, all those things would be great."

The Day: "People should eat less meat. You would be healthier and so would the planet,” because of the tremendous resources used in raising and processing meat for consumption."

The Guardian: "But there is a bigger reason for global hunger, which is attracting less attention only because it has been there for longer. While 100m tonnes of food will be diverted this year to feed cars, 760m tonnes will be snatched from the mouths of humans to feed animals - which could cover the global food deficit 14 times. If you care about hunger, eat less meat."

The Guardian: "For both environmental and humanitarian reasons, beef is out. Pigs and chickens feed more efficiently, but unless they are free range you encounter another ethical issue: the monstrous conditions in which they are kept. I would like to encourage people to start eating tilapia instead of meat. This is a freshwater fish that can be raised entirely on vegetable matter and has the best conversion efficiency - about 1.6kg of feed for 1kg of meat - of any farmed animal. Until meat can be grown in flasks, this is about as close as we are likely to come to sustainable flesh-eating."

PETA: "Mr. Gore likes to be thought of as an environmentalist steak-and-potatoes kind of guy, but there's no such thing as a meat-eating environmentalist," says PETA Vice President Bruce Friedrich. "He needs to confront the 'inconvenient truth' that meat production is the main culprit in global warming."

I could continue with more quotes, but I think you get the point - we're being told, repeatedly, we need to eat less meat!

With all the urgency in this message, the question begs - is eating meat really an environmental problem?

The answer really is a "yes" and "no" - meat from livestock is an excellent source of complete protein, vitamins, minerals and fatty acids essential to human health.

The big problem isn't so much the meat, but the way we in the United States (and more and more countries around the world) raise livestock today - intensive feedlot operations which demand huge amounts of "inputs" to fatten cattle quickly.

The various reports on the global impact of raising livestock are based on factory farming practices which are indeed damaging to the environment. To really understand how, we need to look at how livestock in the US, and in other parts of the world, is now routinely raised for food and how the messages about the "inputs" is virtually ignored by the popular and politically correct message to eat less meat. All of these "inputs," interestingly, are also required for growing the plant-based vegetarian/vegan diet being promoted as the way for us to save the plant....but those promoting that message don't bother telling us that in their cries we must eat less meat.

Like I said, the problem isn't the meat - it's the method used to produce the meat. You see, cattle, pigs, turkeys and chickens are no longer pastured - that is allowed to graze in fields all day - instead, they're raised in what has been rightly named "factory farms" [CAFO - Confined Animal Feeding Operations] where they're raised in huge numbers - apparently the largest operations in the United States have tens of thousands of cattle in one facility at a time.

The practice of CAFO is fairly new, gaining ground in the US since the 1960's and was/is seen as a way to produce food while controlling cost and a uniform standardized product output.

But to achieve the output desired requires some intense "inputs" - namely fossil fuel based fertilizers, chemical pesticides, diesel and fuel for transportation, energy for manufacturing ferilizers, pesticides and feeds, pharmaceuticals to maintain animal health (somewhat) while feeding a diet they are not designed to eat, supplements to provide vitamins, proteins and such not in the feed, energy and resources to house and maintain the animals from birth to slaughter and managing large volumes of waste that is unsuitable for use as fertilizer since the diet teh animal is raised on renders it toxic.

While the industry calls these practices "efficient" - they're anything but, and I'd say are part of the problem we're trying to solve.

The equation looks sort of like this:

Synthetic Fertilizer & GMO Patented Seeds [$] ----> Pesticides [$] ---> Feed [$] ---> Cows [$] ---> Building [$] ---> Electricity [$] ---> Pharmaceuticals [$] ---> Manure Lagoons [$] ---> Transportation [$] ---> Food

On the other hand, properly raised livestock is solar powered food, it's equation looks like this:

Sun [free] ---> Grass [free] ---> Hay & Silage [$] ---> Cow [$] ---> Food & Organic Fertilizer

Funny, while the politically correct message these days is eat less meat, it truly should be eat more - from livestock raised properly - that is livestock that turns the energy of the sun into high quality food for human consumption rather than requiring intensive energy inputs as the means to an end.

This food - pastured meats - is food that truly is created from the sun to become a solar powered plate of delicious and nutritious quality food for us to enjoy, not only guilt-free, but that also is environmentally friendly too!

You see, what those repeating the message above fail to disclose is that livestock, especially cattle, are not naturally grain consumers - they eat mostly grass, ground covering legumes, and an assortment of weeds and other plants that are indigestible for humans.

These plants grow in abundance in rich soil, turning the energy of the sun into food for the cow - which in turn allows us to consume that same energy that's not usually available to us when we consume the flesh of the animal.

Not only that, but grazing animals do more than turn the energy of the sun into food for us - they fertilize and replenish the soil upon which they graze, allowing rich soil to accumulate and grow plants rich with nutrients, which in turn squesters carbon in the soil and those plants sucking CO2 out of the air.

Farmers from long ago understood the relationship between their animals and their crops too - livestock did much of the necessary "work" for the health of the total farm - grazing in the fields, depositing manure to provide food to birds that followed along behind them (chickens, turkeys, etc.) and create rich soil deposits to optimize the grass and ground covering plants growth, and consuming silage from crops planted on the farm and hay baled throughout the warm months.

All this in a dynamic that allowed the farmer to not only have quality protein from the meat, but also healthy soil to grow nutrient-dense plant foods to provide for both his animals, his family and his community.

This dynamic is lost in factory farming of animals and in monoculture crop farming of plant-foods, where one crop dominates again and again, requiring the use of synthetic fertilizers, pesticides and now, even patented seeds year after year.

And rather than address this issue, we're being told to eat less meat to save the planet.

We're told that's green and good and that it's the way of the future; that it's healthier for us and the environment; that we'll all benefit if we just eat less meat.

Sorry, no can do - I'm simply not going to be part of growing an industry that will continue to require, in higher and higher quantity, synthetic fertilizers, fossil fuels, chemical pesticides, sterile patented seeds farmers need to buy from the industry year after year since storing seed is either useless or illegal whle still requiring huge amounts of energy to transport and process the resultant crops into foodstuff...!

I'm not going to enhance their profits while they destroy our health and the balance of nature with unnatural and intensive input requirements to grow their self-defined "healthy" food products.

Soyburgers? No thanks!

Soymilk? You're kidding, right?

Quorn? Oh, don't even go there!

Tofurky? What's up with mock "meat" anyway?

This Earth Day my commitment is not to enhance the bottomline of ADM, Cargill or Monsanto, but to:

A) Support my local farmers commited to traditional farming practices that enhance the health of the planet and those eating from its bounty - those who pasture their animals and grow crops using organic methods

B) Grow some of our food this summer - tomatoes, lettuce, beans, cucumbers, carrots and more, in our garden

C) Try my best to create and eat foods that really are on a solar powered plate - local fruits, vegetables, nuts and seeds and yummy pastured meats, eggs and dairy!

Monday, April 21, 2008

When Good Intentions Have Unintended Consequences

Unlike adults, children - especially those under five - are quite unique in their requirements for calories and nutrients each day. That is because they're on a trajectory of growth that requires significant calories, making it is next to impossible to estimate accurately their energy needs by any formula that applies to adults.

Yet this fact doesn't stop the well-intentioned from taking the standard dietary recommendations for adults and simply downsizing portions, in the assumption that smaller portions of the same foods recommended for adults will translate to adequate nutrition for children.

Back in January 2007, I wrote about a study in Sweden that found children fed a diet low in fat were found to have a higher incidence of insulin resistance, significant nutritional deficiencies, and weighed more with higher BMI's than children fed a diet higher in fat.

As I noted in that post, "In previous generations the focus was mainly on getting and providing enough food to meet these energy needs; today we've modified our view and extrapolated our notions about a "healthy diet" - carbohydrate-rich, low-fat - to our children. Not a day goes by that there isn't an article or segment in the news that we need to feed our kids less fat and more "good" carbohydrates."

Also in January of last year, I shared with readers a day in the life of my son by posting pictures of the foods he consumed throughout the day, along with how his menu stacked up for nutrients and calories, along with how his eating differed from the sample menu offered by the American Academy of Pediatrics (AAP) as an example of "healthy eating" for children.

In that post I noted, "the menu [from the AAP] fails to provide adequate intake of Vitamin E, Vitamin K, Copper, Selenium, Potassium and omega-3 fatty acids" for a toddler.

I also wrote, "We seriously need to start re-thinking our dietary recommendations for children; right now our dietary recommendations and policy are failing them because our phobias about dietary fats have seeped into their lives as we've modified their diet to limit fat and include an abundance of carbohydrate-rich foods that does not, at the end of the day, have the desired effect."

The desired effect these days is prevention of childhood obesity and rather than truly look at how children are eating, the experts continue to downsize adult dietary recommendations and assume they'll meet the requirements of children. The worst of the assumptions is that if parents feed their children a downsized adult diet, with a variety of foods while limiting dietary fats, their children will learn good eating habits and avoid obesity.

While I was away on vacation, I read the disturbing findings reported in the Observer - a survey of nursery preschools in the UK found that 70% are feeding children inadequate calories each day because they're feeding them too many fruits and vegetables in an attempt to make sure they're eating enough fiber!

As Sarah Almond, a pediatric dietitian, noted, "We expected the study to show nurseries were serving children food that was too high in calories, fat, saturated fat and salt, and low in vegetables and fruit. Instead, we found that the majority of nurseries had gone to the other extreme and appeared to be providing food that was too low in calories, fat and saturated fat and too high in fruit and vegetables."


"Because a significant number of children attend nurseries from 7am until 7pm, the food and nutrition they receive there are key to their health," said Almond. "Nurseries are applying requirements of healthy eating for school-age children and adults to the one-to-four age group, who have entirely different requirements."

These findings speak volumes about the unintended consequences of good intentions that are based on dogma and assumptions rather than hard data. And when hard data points to the opposite of the assumptions and dogma, it's ignored.

In our desire to prevent childhood obesity, we're missing the forest for the trees and ignoring the critical requirement they have for both energy and nutrients to grow properly. It is easy to assume that a child under five doesn't need a lot of calories, especially when we think about how many we need as adults. If we believe the average adult needs about 2000-calories a day, then that tiny little kid should only need a fraction of what we need since they are much shorter and weigh a lot less, right?


Check out the Energy Calculator online, created by the USDA/ARS Children's Nutrition Research Center, designed to help parents and caregivers estimate calorie needs for children.

If you input the numbers for an average three year old boy (38", 32-pounds and active 1-hour or more a day) you'll learn he needs 1710-calories a day on average!

What do you feed a three-year old boy to meet his energy requirements and nutritional needs? I can tell you this - it's not a low-fat diet!

Tuesday, April 08, 2008

Where's Regina?

I know, I know, I've been remiss in my blogging duties!

For those wondering where I've been - I recently launched a new website for families with children, here in Missouri - Mid-Missouri Family. I've been a bit taken aback by the overwhelming response to its launch - a lot more visitors each day than I'd anticipated (a good thing) with many, many emails to answer each day, and subscriptions to the newsletter far exceeding my expectations (a great thing)!

And now, just as I'm getting into a routine for time to update that each day and write for my blog - I'm off on vacation through the 19th - so I'll be back here again, posting to my blog, on April 21st (that is if I don't blog while I'm on the road - just no promises that I will be able to).

Time for Critical Appraisal

Dietary carbohydrate restriction in type 2 diabetes mellitus and metabolic syndrome: time for a critical appraisal

Current nutritional approaches to metabolism syndrome and type 2 diabetes generally rely on reductions in dietary fat. The success of such approaches has been limited and therapy more generally relies on pharmacology. The argument is made that a re-evaluation of the role of carbohydrate restriction, the historical and intuitive approach to the problem, may provide an alternative and possibly superior dietary strategy. The rationale is based on the accepted idea that carbohydrate restriction improves glycemic control and reduces insulin fluctuations which are primary targets. Experiments are summarized showing that carbohydrate-restricted diets are at least as effective for weight loss as low-fat diets and that substitution of fat for carbohydrate is generally beneficial for risk of cardiovascular disease. These positive effects of carbohydrate restriction do not require weight loss. Finally, the point is re-iterated that carbohydrate restriction improves all of the features of metabolic syndrome.

Anthony Accurso
Richard K Bernstein
Annika Dahlqvist
Boris Draznin
Richard D Feinman
Eugene J Fine
Amy Gleed
David B Jacobs
Gabriel Larson
Robert H Lustig
Anssi H Manninen
Samy I McFarlane
Katharine Morrison
Jorgen VESTI Nielsen
Uffe Ravnskov
Karl S Roth
Ricardo Silvestre
James R Sowers
Ralph Sundberg
Jeff S Volek
Eric C Westman
Richard J Wood
Jay Wortman
Mary C Vernon

Full-Text PDF


You'll note the above list includes two individuals that I've recently posted about, Dr. Annika Dahlqvist and Dr. Katharine Morrison, along with a number of individuals you all know from their books, published studies and commitment to the science of carbohydrate restriction.

They're all members of the Nutrition & Metabolism Society, an organization committed to "providing research, information and education in the application of fundamental science to nutrition. The Society is particularly dedicated to the incorporation of biochemical metabolism to problems of obesity, diabetes and cardiovascular disease."

If you haven't done so, you can join today - membership helps NMS in the "promotion of scientific information in an environment where such information is not adequately supported by government and private health agencies. "

Gorillas Dying Prematurely

What happens when you feed this to a gorilla?

Ground corn, Soybean meal, Cracked wheat, Sucrose,Wheat germ meal,Animal fat (preserved with BHA, propyl gallate and citric acid), Dried whole egg, Dicalcium phosphate, Calcium carbonate, Iodized salt,Vegetable oil, Choline chloride, Stabilized ascorbic acid (source of Vitamin C), Ethoxyquin (a preservative), Ferrous sulfate, Zinc oxide, Copper chloride, Manganous oxide, Cobalt carbonate, Calcium iodate, Sodium selenite,Vitamin A supplement,Vitamin D3supplement,Vitamin E supplement, Thiamine (Vitamin B1), Niacin, Calcium pantothenate, Pyridoxine hydrochloride (Vitamin B6), Riboflavin (Vitamin B2), Folic acid, Biotin,Vitamin B12supplement.

Apparently they develop heart disease and die prematurely.

Maybe they need more soy, corn and wheat with less animal fat, eh?

Your Leg or the Bread?

While Dr. Annika Dahlqvist is challenging the conventional wisdom of diet and health in Sweden, so too is Dr. Katharine Morrison in the UK; a GP who "is one of a vocal minority who contend that the orthodox advice given to type one and type two diabetes patients is not only unhelpful but might be counterproductive."

In today's Herald, Are Diabetics Suffering for No Reason, provides readers with a look at the benefit experienced by those with diabetes who modify their diet to restrict carbohydrates.

John Gibson's leg had been ulcerated, swollen and inflamed for weeks. "It looked like a damson from my toes to my knee," the 61-year-old recalls. His specialist suggested it would have to be amputated. "He whipped out a camera and photographed it. I said, Is this going to be the last time you see it?' and he said, It might be.'"

But when he next visited, Gibson explains as he sits at home in Mauchline, Ayrshire, the specialist was astonished to see that the leg had healed. "He asked me, Where's the ulcer?'" The former army nurse explained that his diabetes was now being managed on a special low-carbohydrate diet, recommended by his GP. "The specialist told me, Oh, we don't believe in that.'"

Truly amazing, isn't it?

A man's leg, saved from amputation....but that's no reason to even consider a carbohydrate restricted diet if you have diabetes.

No siree, no can do, let's not forget, "Diabetes UK continues to recommend that diabetic people follow the same balanced diet recommended for the rest of the population. Low in fat, sugar and salt, with plenty of fruit and vegetables, meals can contain some starchy foods such as bread, potatoes, cereals, pasta and rice."

And who really wants to give up eating bread, pasta, rice, potatoes and cereal anyway?

"Hope Warshaw says many study subjects are unable to stick with Bernstein-style diets. "Diabetes lasts the rest of your life. You need to find an eating plan that you can follow for that long as well."'

I don't know about you, but if I had to choose between my leg or the bread.....mmmm, thinking......thinking......

How about you?

Do They Serve Exclusively Grass-Fed Meat at the Funny Farm?

I'll be waiting for the men in white jackets to take me away.

Seems I suffer this new eating disorder, orthodexia, characterized by shunning foods with "artificial ingredients, trans fats or high-fructose corn syrup."

Oh, I also read labels and plan my menus (gasp!) for the week ahead; which according to Dr. Steve Bratman (who coined the name for the condition) is a sure sign I need help.... “If you get a thrill of pleasure from contemplating a healthy menu the day after tomorrow, something is wrong with your focus."

What do you think? Is orthorexia a health concern or hype?

Wednesday, April 02, 2008

Translation? Food Fight

In the months since Dr. Annika Dahlqvist won concession from a key government group in Sweden, the National Board of Health and Welfare, on January 16, 2008 that a low-carb diet is "in accordance with science and well-tried experience for reducing obesity and Type 2 diabetes," a storm has been brewing, with the National Food Administration (SLV) [a different government group in Sweden] protesting Dr. Dahlqvist's open letter to schools calling for more fat in the diets of children.

Apparently it's playing out in all the national papers in Sweden Arbetarbladet, Helagotland, Dagens Nyheter, Gefle Dagblad, Nerikes Allehanda, Eskilstuna-Kuriren, Blekinge Läns Tidning, Privata Affärer, Vestmanlands Läns Tidning,, Västerviks Tidningen, Norra Västerbotten, Svenska Dagbladet, Göteborgs-Posten, Barometern, Webfinanser and more) with Aftonbladet opening a poll to their readers.

Vad tror du att barn mår bäst av?
[translation: What do you think that children are better off with?]


Fet mjölk och smör
[translation: Fat milk and butter]

Lättmjölk och margarin
[translation: Skim milk and margarine]

As of this writing, 27,836 have cast a vote in the poll and 89.6% have answered the Fat milk and Butter!