Posts tagged ·dietary supplements·...

The Microbial Solution

no comments

Bacteria follows the diet:

How changing your microbiome changes your health

Our body is home to microbes. The intestines alone host over 100 trillion bacteria, constantly competing with each other in this environment we call the microbiome. In fact the microbes in our body outnumber human cells 10:1. Like the rainforest, the healthy human microbiome is a balanced ecosystem. And like an ecosystem, if equilibrium is destroyed, these imbalances affect every function in its environment, often resulting in a slow downward spiral.

Many of these bacteria are helpful and necessary for key biological functions, while some are harmful and invasive. Many factors affect this balance of power in the gut, including environmental and dietary influences. Age, stress levels, exercise, diet and use of medications all have an impact.

When there is a “good” balance of microflora in the gut, the body is more effective in the absorption of many nutrients, better able to repress the growth of harmful bacteria that cause illness, form a protective barrier that keeps harmful bacteria and pathogens from entering the blood stream, and actually train the immune system to better respond to pathogens.

Furthermore, microbes perform essential functions such as digesting food and synthesizing nutrients. Studies are also linking the microbiome to human mood and behavior, as well as gut health, human development, and metabolic disorders. The human microbiome has profound consequences for our health. It has been correlated with a wide range of health conditions, from obesity, heart health, and IBD to autism, anxiety, and depression.

Hippocrates famously stated, “Let your food be your medicine, and your medicine be your food”. His prophetic words provide a guiding light as more and more progressive thinkers are taking action to reverse the scourge of our modern time – the chronic diseases, allergies and health conditions resulting from what I call our Malnutrition of Affluence, the devastating health results of our lifestyle of abundance. But before I can outline an enlightened direction that offers such a promising paradigm shift to our health and wellness, perhaps a little context is in order.

 

Malnutrition of Affluence

Traditionally, nutritional science has focused its attention on preventing malnutrition and deficiency diseases through the discovery and application of vitamins, minerals and other important micro nutrients. But as the western diet, hailed for its abundance of nutrition, migrated throughout the developed world, nutritional science has had to apply its ever evolving tools towards a greater problem; over-nutrition. As Paul Roberts, author of The End of Food notes, ”…the ironic prospect that the most serious threat to health would very soon be…food.”

Early humans relied on calories for survival. From foraging to hunting, man’s diet was extremely diverse and relatively unpredictable. We ate from hundreds of crops and wild animals, offing exceptional biodiversity in our diet, and our bodies adapted to the inconsistent intake of nutrients with an amazing ability to maximize its efficiency. Soon man was domesticating animals and mastering agricultural practices, which resulted in incredible benefits in health and mortality, as well as facilitating changes in lifestyle. In a relative short time span, man was eating for taste and satiety as our modern agricultural and food practices were born.

Today, two key factors dramatically affect our health as it relates to our evolutionary process. First, rapid lifestyle changes have occurred which include diminished physical activity, increased mental stress, dramatic physical relocations and more cross-cultural interactions. Second, our diet has radically changed (knowingly or not), as we consume a far less diverse diet, depleted of many bioactive nutrients and bacterial species. Furthermore, the explosive use of antibiotics, both for personal use and in the industrial animal farms we rely on, has limited the diversity of bacterial species and is breeding “superbugs” – bad bacterial strains resitant to antibiotics. Since these changes have occurred so dramatically and quickly (in relative terms), our evolutionary process of adaptive response has not been able to keep pace.

Antibiotics: Too much of a good thing

According to the Centers for Disease Prevention and Control, each year in the U.S., at least 2 million people become infected with bacteria that are resistant to antibiotics, and at least 23,000 people die each year as a direct result of these infections.[1]

Antibiotic-resistance is largely attributed to the routine use of sub-therapeutic doses of antibiotics on factory farms.[2] The factory farm industry says the antibiotics are needed to prevent disease—partly true, as animals confined indoors in cramped, inhumane conditions, are more susceptible to disease. But it’s widely known that industry uses the drugs to grow bigger animals, faster.

As food processing and lifestyle changes took root in the 20th century, nutrition has played an increasing role in public health. The concept that disease could be caused by an excessive intake or imbalance of nutrients, as opposed to a lack of them, has begun to receive much attention only in the last 20 years. It seems that the more affluent we have become, the less nutritious is our diet.

Dietary changes and processed foods

Post-industrial agricultural and food processing has removed phytonutrients heretofore thought “inactive” or useless. These compounds are routinely removed from plants through selective breeding and modern processing. Furthermore, we used to eat from over 800 plant foods; now most Americans eat only three, namely French fries (potato), ketchup (tomato) and iceberg lettuce. Modern practices are also introducing many chemicals to the plants and animals we eat, in efforts to increase yield and profitability. More and more studies have demonstrated a relationship between our (Western) diet and chronic diseases.

Diet is a big factor in chronic disease, responsible some say, for a third of most types of cancer. And our western diet, featuring large amounts of red meat and highly processed foods are often packed with large quantities of salt, fat, and sweeteners, not to mention hundreds of chemical additives.

The incidence of acute and chronic diseases is increasing worldwide, linked to the expansion of the western diet. This development is strongly associated with Western lifestyle, not just lack of physical exercise, mental stress, use of tobacco and alcohol, but also with consumption of refined and calorie-condensed foods, of which most create systemic inflammation that “paralyzes” the innate immune system and reduces resistance to disease.

The journal Atherosclerosis reported that volunteers eating a typical Western diet, consisting of 35% saturated fats, experienced increases in tumor necrosis factor-alpha (TNF-a) and interleukin-6 (IL-6): two cytokines actively involved in the inflammatory response. Chronic inflammation has been linked to a range of conditions such as heart disease, osteoporosis, cognitive decline and Alzheimer’s, type-2 diabetes, and arthritis.

Researchers from the US’ National Cancer Institute (NCI) report that increased consumption of red and processed meat may produce an increased risk of death from cancer or heart disease. This study follows years of research suggesting red and processed meats are linked to a host of ills. A previous study from the NCI reported high intakes of red and processed meats may raise the risk of lung and colorectal cancer by up to 20 per cent. The World Cancer Research Fund published a report in 2007 that directly linked diet to cancer, with alcohol and red and processed meats posing particular risks.

It’s important to note that our ancestors ate meat, which was naturally lean because the wild animals fed on grass, one of the few natural sources of omega-3 fatty acids. Hence, their body fat had a higher proportion of the “good” mono-saturated and polyunsaturated fats, and less of the “bad” saturated fats.

Today’s grain-fed livestock is specially bred not only to put on lots of fat, but also to partition that fat inside the muscle so as to produce a well-marbled piece of meat. By raising these animals in controlled and confined spaces on rations computer-designed to produce rapid weight gain and marbling, companies can maximize profits. In only about four months we can transform a six-month-old five hundred pound calf into a 1,350-pound, slaughter-ready steer.  By comparison, a grass fed steer takes two years to reach a slaughter weight of barely 1,100 pounds.

Lest you think red meat is the only culprit, our agricultural processes have been affecting us in many ways. Today’s scientifically bred produce grows so quickly that it contains measurably fewer micronutrients.  Research done at the University of Texas in Austin concluded that recently grown crops have shown decreases of up to 38 percent in protein, calcium, vitamin C, phosphorus, iron and riboflavin when compared with produce from past decades. Of the 13 major nutrients found in fruits and vegetables, six have declined substantially.

This may be an unintended result of the genetically uniform, mono-cropping systems that now dominate our agricultural industry. American’s are increasingly eating a diet that is devoid in essential phytonutrients to gain the advantages of convenience, taste and price. 

Consumption of a high caloric diet lacking bioactive phytonutrients from fruits, vegetables and whole grains has resulted in a 70% increase in obesity in Americans, a problem so profound as to be declared an epidemic and public health issue by the Centers for Disease Control.

The effects of the “western diet” and lifestyle are spreading globally. Almost one third of western Europeans are overweight and 1 in 10 is obese. Male obesity in Japan has doubled since 1982 and the Japan Ministry of Education is recognizing how serious the problem is. Cardiovascular disease will soon rein as the world’s leading cause of death and disability, overtaking infectious disease and malnutrition.

With the advent of a highly processed American diet and changes in our eating habits since World War II, the consumption of essential plant-derived nutrients (phytonutrients) is on the decline. Despite consumer and physician awareness about the importance of eating a diverse diet many of the same forces that are contributing to the epidemics of obesity, cardiovascular disease and diabetes contribute to the poor dietary state of Americans today.

Orphaned Phytonutrients

Modern food processing practices have depleted the diversity and quality of several classes of phytonutrients from the American diet; bioactive phytonutrients that are now demonstrating significant health benefit. The fact that these “orphaned phytonutrients” are now depleted from American’s diet may be responsible (in part) for causing or worsening chronic diseases such as diabetes, cardiovascular disease and Alzheimer’s.

Our post-industrial agricultural and food processing industry has devoted decades of work to removing certain phytonutrients heretofore thought “inactive” or useless. Most plants produce a host of phytochemicals to perform varying metabolic functions such as coloring agents (known as flavonoids) to protect against excessive sunlight and other stresses, and Sulforaphane (an astringent in broccoli) to discourage the plant from being eaten by animals. These compounds are routinely removed from plants through selective breeding and modern processing.

Modern science is now discovering tremendous value to these “orphaned phytonutrients”. As sensitive and specific biotechnology and pharmaceutical R&D tools are being applied to nutrition science, more and greater data is confirming the health benefits of these compounds, and epidemiological studies are linking their depletion from the food chain to increases in chronic diseases. For example, the sulforaphane that has been selectively bred out of commercial broccoli because of its bitter taste has been found to stimulate enzymes in the body that detoxify chemical carcinogens. Similarly, while there are hundreds of flavonoids, science has been uncovering a host of exceptional health benefits they confer, most significantly their cardiovascular benefit. In fact, it is the anecdotal data offered by the “French Paradox” (the fact that the French diet is exceptionally high in fat, yet the French have a disproportionately low incidence of cardiovascular disease) that has led researchers to identify the grape flavonoids (from wine) as the bioactive phytonutrient responsible for such cardiovascular health benefits.

Evidence is mounting as to the benefits of phytonutrients. Time and again rigorous scientific studies document that the more fruits, vegetables and whole grains we eat, the less likely we are to suffer from diseases. In 128 of 156 human studies reviewed in one meta-analysis, there was found a strong relationship between intake of phytonutrients and cancer prevention.

These bioactive phytonutrients– compounds in dietary fruits, vegetables and whole grains that have heretofore no recognized value in the diet but are now demonstrating an ability to combat and prevent disease– are no less “valuable” than vitamins.

While it has been well established that insufficient intake of vitamins can result in morbidity and mortality, it should not be surprising that the same is true for orphaned phytonutrients. It strikes one as ironic that at the same time Americans began to supplement and fortify their diet with vitamins, they conversely have depleted whole classes of phytonutrients from the diet.

The latest research into the microbiome is making further shocking revelations. It seems that the changes in our diet are causing a shift in the diversity of our microbiome; or some suspect it is the other way around. Since so much of the cells in our body are bacterial, and these bacteria cells proliferate based upon the foods they prefer, many scientists are speculating that the western diet is proliferating “bad” bacteria species, which compete against “good” bacteria. For example, with an abundance of simple carbohydrates and saturated fats, certain bacteria gain an advantage and overpopulate the gut, limiting the growth of more healthy bacteria, and perpetuating the biological signals to eat more of the same. That’s right, perhaps it is the over abundance of “bad” bacteria that is signaling your brain to eat more junk food!

Compounding the bacterial revelations that may be driving biological changes in our body is the over use of antibiotics. As with any ecology, the diverse bacterial colonies in our body are being disrupted and many species are being eliminated. As with the Orphaned Phytonutrients discussed earlier, it turns out that these heretofore-unrecognized bacterial species quietly living among us may have profound effect; their depletion may be our demise.

For instance, it was discovered many years ago that a specific species of bacteria, h. pylori, was related to gastric ulcers. So a concerted effort to exterminate the h. pylori bacteria was undertaken and, sure enough, the incidence of ulcers declined. But then a strange thing happened. There was a concurrent increase in GERD (acid reflux), which has led to an epidemic: Over sixty percent of adults will have GERD symptoms this year. As it turns out, the h. pylori bacteria have the positive effect of suppressing stomach acid secretions. Researchers are now recognizing that the thousands of bacteria strains living in our bodies are there for a reason. At some point, a single species may be needed to perform a function that no other species can. If we no longer host this missing species of bacteria, our survival may be threatened.

Diet & Lifestyle

But depletion of the diversity and quality of phytonutrients and bacterial species from the Western diet is only half the dietary setback. Compounding the problem facing Americans in post-industrial society is a change in dietary habits and lifestyle that is seriously eroding American’s health. Teenagers drink almost three times the amount of soft drinks than they did in the 1960’s.  Researchers warn that this trend will leave teenagers at higher risk of heart disease, osteoporosis and diabetes later in life. Twice as many American children today are eating snack foods than did kids 20 years ago, according to the US Department of Agriculture, and 91% of Americans don’t get the recommended minimum five servings of fruits and vegetables per day. Sadly, French fries and potato chips account for 25% of kid’s vegetable intake, only exacerbated by a sedentary lifestyle. Teenagers are consuming 17% less energy than in the 1960’s but are still gaining weight, a statement about the poor quality of their diet and lack of exercise. And support for the theory of bacterial depletion.

Paying the Price

Only now are we beginning to reconcile the effects of our “modern” diet and lifestyle. Today in America, 60 million people have cardiovascular disease, 16 million suffer the debilitating effects of type 2 diabetes, 10 million people have cancer and nearly 20% of the population has high cholesterol. National healthcare expenditures exceed $1 trillion, representing over 14% of GDP, a larger share of GDP than any other industrialized country.

As the economic forces drive change in the American healthcare system, and advances in science and technology impart greater insight into the health benefits of bioactive phytonutrients and a diverse microbiome, there will likely be a paradigm shift from the treatment-oriented “sick care” system we now have, towards a prevention-based true healthcare system.

As with all revolutionary changes, there is an exponential acceleration of the process whereby at some undefined point, critical mass is achieved and there is no turning back. Signs of acceleration abound in the current marketplace. Genomics research has gained significant insight into disease predisposition and gene expression. Technological advances in assay development and discovery techniques are rapidly delivering the capability to characterize and assess the bioactive health benefits of phytonutrients and specific probiotic strains. The popular movement against GMO has accentuated the interest in and growth of organic and sustainable agricultural practices, and will likely force broader changes in agricultural and food processing procedures. And consumer trends illustrate a growing interest in the diet-disease link and better nutritional habits. For instance, Seventy five percent of Americans surveyed believe food and nutrition play the greatest role in their health. In fact, 54% believe food can treat an ailment and more than 50% of households are currently using food/beverages to treat or manage specific health issues.

New Tools are offering Solutions

Both scientists and consumers are now recognizing this problem and are moving to take an active role in maintaining health & wellness through nutrition. For instance, ntegrating the new tools of biotechnology and nutrigenomics, innovative solutions are being created and applied to a new generation of “wellness” foods. Consumers want lifestyle solutions, where validated science and functional benefit meets pleasure and convenience.

Recognizing that many chronic diseases are closely related to diet and lifestyle, scientists are focusing much study towards how nutrition can optimize and maintain cellular health. This requires advanced understanding of nutrient interaction and metabolic processes at a cellular level, specifically the interaction of nutrients and their relationship with proteins and gene expression. Nutrigenomics is the study of this relationship between gene activity and cell function, and how food, genes and lifestyle interact in human health.

Nutrients from the diet, in relation to lifestyle events, not only nourish the body but send specific signals to the cells through transcript factors, which change gene expression (or how genes behave) and metabolite production. As a result, different nutrients (different diets) affect an individual’s gene and protein expression differently. In other words, what we eat changes the way our body acts and reacts. Certain diets, interacting with certain genotypes, can lead towards chronic diseases (or the prevention of them). This helps explain why two people eating the same diet may respond very differently.[3]

Biotech advances are identifying new compounds and the utility of existing food constituents that can support health & wellness. Through bioinformatics and genomic research, it is becoming increasingly possible to identify and predict the impact of diet on genotypes. For instance, a 3-week nutritional intervention with virgin olive oil may alter the expression of genes related to atherosclerosis. One of the goals of nutrigenomics is to devise genetic-based nutritional interventions to prevent, delay or treat diseases. But on a more practical (and user-friendly) basis, nutrigenomics provides insight into the effects of bioactive compounds and their effect on human health, which is currently aiding in the development of functional foods.

Functional foods: You are what you eat

Nobel Laureate Elie Metschnikof studied the longevity of Balkan peasants, who ate a diet consisting of large quantities of fermented milk. In theorizing why they had such robust lifespan, he suggested that aging was a result of proteolytic microbes producing toxins in the large bowel. As the body digests proteins, these proteolytic bacteria produce toxic by-products including phenols, indols and ammonia. As it turns out, the lactic acid in fermented milk inhibits the growth of the proteolytic bacteria. Metschnikof believed that fermented milk would seed the intestine with “healthy” bacteria (lactic acid) and thus suppress the growth of “bad” bacteria.

From this early theory of bacterial homeostasis in the gut, the study of probiotics began to take root. But not until the last 50 years has advanced science truly leveraged these insights into practice, seeding a prolific industry based around the introduction of “good” bacteria to the gut.

Functional foods, at its basic, are foods that deliver a functional biological benefit beyond “basic nutrition”. Besides the calories, fats, carbohydrates and protein needed for survival, the foods we eat provide phytochemicals and bacteria (or prebiotics, the food for bacteria) that are essential to health and wellness. This supports a better, more diverse ecosystem in the microbiome, which triggers a host of biological events in our body.

Emerging science is opening our eyes to a whole new approach to finding intestinal nirvana, or homeostasis as others may call it. It’s called Probiotics. The hundred trillion bacteria in the body of an adult human contain about 4 million distinct bacterial genes, with more than 95% of them located in the large intestine. This unique ecosystem in the gut is called the microbiome.

If you have an optimal microbiome in your gut, you will lead a healthy and happy life, free from digestive discomfort and even reduced cravings.

 

Some of the beneficial effects of probiotics include:

  • Since lactic acid bacteria convert lactose into lactic acid, several strains of probiotics have demonstrated benefit to individuals who are lactose intolerant.
  • The presence of probiotics vastly improves digestion and nutrient absorption.
  • Lower incidence of colon cancer among higher consumers of probiotics has led to clinical research in this area. Several studies have found certain probiotic strains exert anti-carcinogenic effects. Some pre- and probiotics may suppress the activity of certain enzymes in the colon, possibly reducing the production of toxic and carcinogenic metabolites, according to a study published in European Journal of Clinical Nutrition.
  • Probiotics reduce the levels of microorganisms such as E.coli, and salmonella in the gut, and they restrict pathogens ability to release into the bloodstream. A study published in The Lancet showed that 59% of subjects did not develop rotoviral diarrhea when a probiotic was administered before infection. The meta-analysis showed that the risk of necrotizing enterocolitis, one of the most common gastrointestinal problems in premature babies, might be cut by 74% with probiotic supplementation. They also observed a 53% reduction in the risk of mortality.
  • Both acute and travelers diarrhea are effectively treated with probiotics, and several strains have been effective at treating antibiotic-associated diarrhea. The British Medical Journal published a study demonstrating a 22% drop in the number of cases of diarrhea when probiotic drinks were consumed by hospital-bound elderly patients who were receiving antibiotics.
  • Inflammatory bowel disease can be modulated by probiotic consumption, as well as other inflammatory allergic responses.
  • Several probiotic strains have demonstrated improvement in treating irritable bowel syndrome and colitis, although there are only a handful of probiotic products on the market claiming to target the condition. IBS affects between 10 and 15 per cent of the population. Furthermore, a series of probiotic studies on mice have presented positive results in protecting newborns from intestinal infections and reducing inflammatory bowel disease. Probiotics may boost the number of bowel movements and relieve constipation, suggests a pilot study from the Netherlands.
  • Clinical studies have demonstrated probiotic’s ability to lower cholesterol, as it seems to inhibit re-absorption.
  • Probiotic milk has shown an ability to reduce blood pressure.
  • Probiotics protect against pathogens and help stimulate immune response. They also have demonstrated an ability to reduce respiratory tract infections and severity and duration of rotavirus infections. A study published in the British Medical Journal showed that children who drink probiotic milk have lower incidences of respiratory illnesses than those who do not drink the milk. The study showed a 17% reduction in the occurrences, as well as a reduction in the number of antibiotic prescriptions.
  • Workers who take probiotics daily are less likely to be off work with common illnesses, such as colds and gastroenteritis, than workers who don’t. An exploratory study published in the open access journal Environmental Health shows that workers who took a daily dose of probiotic bacteria were 2.5 times less likely to take sick leave than workers who took a placebo. Supplementation of probiotics can reduce the duration of the common cold by nearly a quarter, research has suggested. One study published in Clinical Nutrition compared the effects of probiotic supplements with standard vitamins and minerals and found that the probiotic bacteria shortened episodes of the common cold and reduced the severity of symptoms.
  • Probiotic bacteria could not only help fight viruses but they may also protect against autoimmune diseases like diabetes. Results from a clinical trial showed higher numbers of different types of white blood cells after subjects had consumed probiotics. Increased white blood cells have been linked to the protection against type 1 diabetes.
  • Several studies confirm probiotic benefit in the treatment of urinary tract infections and bacterial vaginosis.
  • Studies have shown some probiotics promote oral health by killing the bacteria that foster dental carries.
  • Probiotics produce short chain fatty acids that are converted into energy.

 

Microbes and weight management

The bacterial make up of our gut is interacting with us in a ways that drive our biology. As bacteria eat food (and as indicated, if you change your diet you change which bacteria species proliferate in the gut, and that in turn changes the foods you crave), they secrete metabolites and by-products that affect hormones and a host of biological activity including metabolism.

Scientists have used germ-free mice to study how the microbiome can affect weight and obesity. They showed that a high-fat, high-sugar diet changes the microbiome and that this promotes obesity[4]. Further investigation illustrates that it’s these microbial changes that encourage increased consumption of “bad” types of foods. Furthermore, in other studies researchers introduced the microbiome of normal weight (‘lean”) individuals into the gut of overweight subjects; the overweight individuals lost weight.[5]

It is in our gut where the vagus nerve connects 100 million nerve cells to the base of the brain. What you consume triggers a host of events in your gut that affects your entire body. Some bacteria can make us crave fats and sugars, contributing to obesity. Scientists believe these unique bacteria generate a preference for foods rich in their favorite diet, perhaps leading to negative consequences for their host.

I have already illustrated the increasing evidence of how our “modern” diet is changing the make up of our microbiome. Between the processed foods, lack of biodiversity in our diet and lifestyle changes including the over use of antibiotics, it’s no wonder why we are seeing dramatic increases in chronic disease, allergies and weight gain, even when calories are reduced.

“The use of antiobiotics may be eliminating bacteria that help people regulate appetite and metabolism”

-Wall Street Journal

In fact, the bacteria that colonize in our gut influence our sense of taste, they can produce toxins to make us feel bad, and they can influence the quality of our mood. Even chronic diseases such as diabetes are being tracked to changes in the microbiome.[6]

The scientific research demonstrating a link between gut microbiome and weight management is gaining strong momentum, as researchers are confirming the involvement of intestinal bacteria in obesity.[7]

 

“Obesity problem answers might be in the bugs in our stomachs”

–ABC World News

It seems that our diet changes the make up of our microbiome and that, in turn, affects the foods we crave, the way we feel and the way our body absorbs nutrients. It can become a vicious cycle. Or it can be as simple as changing our microbiome.

Functionally Targeted Probiotics

Companies such as OpenBiome, a research company which emerged out of MIT, are supplying hospitals around the country with prescreened human stool. These stool samples are used for fecal transplant, a somewhat invasive but highly successful procedure to treat deadly intestinal infections such as C. difficile. “C Diff” is unresponsive to antibiotic therapy. The concept is simple: the patient is missing a bacteria strain that can fight the harmful and resistant strain causing injury. The prescreened strain from someone else’s stool is introduced to the patient through a nasal tube or enema.

We are now able to faciliate the same concept in a much more targeted, and certainly less invasive manner. With advanced gene sequencing we can identify many bacterial strains that have specific functional benefit. By isolating and cultivating these strains, we can provide them to consumers who have depleted colonies of these strains, so as to proactively bring them into a healthier state of balance.

Our so-called modern plagues—obesity, diabetes, asthma—relate to how crucial parts of our gut microbiomes have been wiped out by the overuse of antibiotics or (in many cases) an overreliance on C-section births, which appear to deprive newborns of crucial bacteria.

Whether as a maintenance for sufferers of one of dozens of gastrointestinal disorders, or as a safe approach to weight management, mood enhancement or cholesterol reduction, functionally targeted probiotics are an emerging solution to better health and wellness.

Because of their inability to survive passage through the stomach, most basic yogurt cultures are not able to provide significant benefit beyond supporting digestive health and immune function. This problem of survivability through the harsh digestive process has been one of the biggest reasons why probiotics took so long to gain favor among the masses. But as research has advanced, industry now has several robust delivery applications and probiotic strains that are proving successful not only in surviving digestion, but also surviving the manufacturing process that would otherwise kill most strains of bacteria. And these advanced probiotics are addressing another issue that has hampered the advancement of probiotics in the marketplace: shelf stability.



[1] http://www.cdc.gov/drugresistance/threat-report-2013/

[2] http://www.sustainabletable.org/257/antibiotics

[3] https://www.youtube.com/watch?v=O1x7MunkjCc

[4] J. S. Flier, J. J. Mekalanos, Gut check: Testing a role for the intestinal microbiome in human obesity. Sci. Transl. Med. 1, 6ps7 (2009).

[5] https://www.youtube.com/watch?v=8CSZJECh6ss

[6] http://www.nutraingredients.com/Suppliers2/Cause-of-diabetes-could-be-changes-in-bad-gut-bacteria

[7] http://www.sciencedaily.com/releases/2014/11/141106132204.htm

Share

Functional Foods: Masquerading therapeutics or healthier snacks?

4 comments

Consumers don’t want to eat from their medicine cabinet

As an outgrowth of the nutrition industry, many companies have been working hard to aggregate nutrition, taste, convenience and targeted functionality into food and beverage products. While these so called “functional foods” are not a new class of products, because of their tremendous popularity we have created this moniker to distinguish them from conventional or processed foods.

While we can debate what products are “functional foods”, the U.S. market for functional foods is greater than $30 billion in sales a year — about 5 percent of the total U.S. food market, and it’s growing at up to 10 percent per year, far more than the 1 to 4 percent forecast for the conventional food market. The U.S. functional foods market is predicted to be worth around $43 billion by 2013.

Consumers are finding functional foods attractive for a host of reasons. Most consumers are more proactive about their health, especially baby boomers that are witnessing the health issues of their parents and vainly refuse to succumb to the demise of aging. Many are recognizing the need for reintroducing the many “lost” nutrients that are proving to be beneficial for optimal health. Advances in food science have helped bring a far superior taste and mouth-feel to the integration of some otherwise nasty tasting bioactive ingredients. And while consumers have accepted the need for vitamin supplementation, 55% would prefer to buy foods for nutritional benefits than supplements. But to be successful in marketing functional foods one must remember that science tells and emotion sells. In other words, successful functional foods are based in science but purchased for taste and convenience; they are not medicines.

What are functional foods?

There are three different types of functional foods. First, there are those products which are inherently healthy. This includes products that do not add any bioactives, but intrinsically contain nutritional compounds that have scientific data to support functionality. For instance, Welch’s grape juice sales increased 33% following the release of clinical data supporting antioxidant activity and cardiovascular benefits; Gardenburger sales increased 25% in the two months following FDA approved health claims for soy; Cranberry juice sales increased 20% after the results of a 1994 Harvard study demonstrating health benefits; and General Mill’s Cheerios sales jumped 11% after being marketed for heart health benefit.

The second category of functional foods is those which add a researched bioactive compound to provide a health benefit. The classic example here is Tropicana Pure Premium orange juice which reformulated its line with added calcium fortification, growing sales 173% and building a new category. This category of functional foods addressed the reintroduction of orphaned phytonutrients which provide a validated functional benefit as discussed previously.

Finally, engineered functional foods are those formulated specifically to deliver a desired functional benefit. Whether you knock back a Red Bull for an energy lift, a PowerBar for sports performance benefit or a Gatorade to replenish electrolytes, these products are based upon scientific research to deliver to the consumer a desired benefit.

Functional Foods are not a panacea and are certainly a product category bound to be “abused”, just as dietary supplements have been. What do I mean by abused? In controlled dosing, such as pills, one can specify the amount of certain bioactive compounds such as vitamin A. But when these compounds are in a food product, it is a bit more difficult to manage the dosing, especially when a good tasting snack product is involved. Maybe one just wasn’t enough and soon the consumer is doubling or tripling the amount of vitamin A, possibly reaching a potentially toxic level. Remember General Mill’s Cheerios? Well the FDA recently claimed that Cheerios were being marketed as a drug, since the company promoted cholesterol reduction of 4% in 6 weeks.

Another valid concern is the encouragement of additional caloric intake. Functional foods “delude people into thinking that [they] are healthy,” says author and New York University food scientist Marion Nestle. And many of the foods marketed as functional are not particularly “healthy”, aside from the bioactives involved.

Considering that over half of households are using food or beverages to treat or manage specific health issues, it is important to recognize the burden that must be carried by companies marketing these products. If consumers are eating medicine like its food, they will get too much of a good thing. And the consumption of additional calories simply feeds a real health pandemic: obesity. So it is very important that manufacturers think very carefully about what they are formulating and how they are marketing these functional food products. The key take away is this: functional food success will be defined by wellness, not disease treatment.

Share

The Bias Against Preventative Healthcare

8 comments

Listening to the ongoing debate about healthcare reform and witnessing the financial morass that we find ourselves in because of our healthcare system, it strikes me as odd that very few stakeholders are even looking at why the system is failing us. Without even questioning the basis of our healthcare system, legislators and the media seem hell-bent on defending or supporting a system which is clearly designed to feed a for-profit economic market.

Hold on everybody…isn’t the healthcare system supposed to support and enhance the health of the population? Isn’t the goal to reduce sickness and lower the costs to everyone, both patients and government? If this is the overriding goal of healthcare, then perhaps it is time to review our current system in the light of day, and hold the system up to the goals we aspire. It’s time to recognize that the emperor is wearing no clothes.

I for one am not so naive to believe that the American healthcare system can be transformed and corrected overnight. There are way too many stakeholders with deep economic interest in keeping the system just the way it is, or better yet, continue to slide the system towards their self-serving interests. But in a true democracy, when the light of truth illuminates the injustices of the many, the chemistry of change begins. Yet in order for change to occur it is critical that the facts be told and that each individual recognize their responsibility and their power. For too long Americans have been numbed into acquiescence by our affluence and dumbed into indifference by our legislative complexity.

Our healthcare system is failing because the current system is designed to support disease, not prevent it. The real questions are why is there a bias against preventative healthcare and where does it come from. The answers are found if, as with most investigations, we follow the money. But first, a historical perspective on health care and medicine in general.      

Mainstream vs. Traditional MedicineDoctors

There are two basic types of medical training: Allopathic and Osteopathic. Mainstream medical schools offering graduates an MD degree are Allopathic. Medical schools offering a DO degree are Osteopathic.

Osteopathic doctors are legally and professionally equivalent to medical doctors. The important difference between the two types of schools is that osteopathic medical schools have a holistic perspective on the practice of medicine based on a belief in treating the “whole patient” (mind-body-spirit) and the primacy of the musculoskeletal system in human health and the utility of osteopathic manipulative treatment.

Allopathic healthcare is symptom focused, primarily looking at resolution of dysfunction. Often the forms of treatment are technologically based and/or invasive such as surgery or drugs. While this form of medicine is often highly effective, especially for emergency or critical situations, because it is symptom based, one system might well be treated at the expense of another system.

As much as “mainstream” allopathic medicine has tried to subordinate osteopathic medicine, these “whole patient” doctors have refined a public image of being superior care givers that has been very well received by American consumers. It is an image drawn from a distinctive medical philosophy crafted in the early nineteenth century, and observed by alternative or “traditional” practitioners of all stripes ever since.

“Drugless Healing”

Osteopathic doctors are practitioners of “natural healing,” meaning they use remedies and procedures that support and stimulate the healing power of nature, the innate tendency of the body to react to illness and work to restore itself to equilibrium and wholeness.

What this means is that the doctor or physician tends to look at the whole person when making treatment judgments, taking great pains to figure out how one symptom or body system affects another. Conceptually based upon Chinese medicine and the Meridian System, this kind of medicine is really the more traditional form of health care, and focuses on maintaining health before it reaches the point of dysfunction.

As the counter-culture movement of the 1960’s gained strength, more people began returning towards a more natural way of life and healing. What was being called “alternative medicine” began snowballing throughout the 1970’s and 1980’s, culminating in 1992 in the establishment by Congress of the Office of Alternative Medicine (OAM) at the National Institutes of Health.

Conversely, Western allopathic medicine, with enormous economic interests supporting it, is designed to treat disease instead of preventing it. Not really a healthcare system, we should call it what it is ─ a disease care system. A true healthcare system would mitigate the causes of poor health and promote & encourage preventative lifestyles. Unfortunately, about 95 percent of public healthcare spending goes toward sick care and only 5 percent on prevention of illness or to public health.

As noted, one of the tools used by allopathic medicine and central to the current “healthcare” system is the use of medications. Sadly, prescription drugs don’t treat diseases; rather they mask the symptoms of our stressed-out, calorie-rich, toxic lifestyles. The pharmaceutical industry is a multi-trillion dollar machine that lines the pockets of many vested interests from Wall Street to K Street. Perpetuating a faulty “disease care” system, Big Pharma and their cronies are making out like bandits. It’s no wonder so many Americans are dying from prescription medications as they are not getting better, just masking the symptoms with medications.

Big Pharma

DrugsBig Pharma has earned its nickname because of the tremendous amount of money it generates. Pharmaceutical manufacturers rank among the nation’s most profitable industries (profit as a percentage of revenue), with profits of 15.8% compared to 5.7% for all Fortune 500 firms, including the oil companies.

While drugs are not the only problem with our “healthcare” system, prescription drugs are 10% of national healthcare spending and by far the fastest growing portion at +9%. From 1997-2007, the number of prescriptions in the U.S. increased 72% to over 3.8 billion prescriptions, that while the nation’s population only grew 11%. Per capita, the average number of prescriptions is over 12.6, and retail prices of these drugs increased more than 2.5 times the rate of inflation. HHS projects U.S. prescription drug spending to reach $516 billion by 2017. With more than 40% of the U.S. population now on prescription drugs, the drug content in human urine is now so high that trace amounts of antidepressant drugs can be found in public water supplies.

One way Big Pharma has grown so big is by convincing us that we are sick. The incredible amount of money the pharmaceutical industry spends on direct-to-consumer (DTC) advertising has mushroomed as have their profits. In 1997 a paltry $1 billion was spent on DTC advertising; in 2005 that number exceeded $4 billion. And that certainly makes sense from their perspective considering that there is a definitive and positive correlation between advertising spending and prescriptions written for those drugs. A GAO reviewed study found sales increases of $2 for every $1 spent on DTC advertising, and another study found $4.20 in sales generated from every DTC ad dollar spent. Yet DTC is overshadowed Big Pharmaby what Big Pharma spends on promotions to physicians, which was $3 billion more than DTC advertising in 2005, according to the GAO.

It seems that with all of their incomprehensible profit, Big Pharma is a massive marketing machine, convincing us that we are ill and pushing the doctors to promote their chemical cures. The pharmaceutical industry will vigorously defend their profits with the argument that research and development costs a lot, yet the facts don’t support them. Big Pharma spends almost twice as much on promotion of its products than it does on research & development. According to “The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States,” as a percentage of domestic sales in 2004, the pharmaceutical industry spent 24.4% on promotion and only 13.4% for R&D.

The lack of R&D funding is negatively impacting the market through a lack of innovation. It may surprise you to know that only a handful of truly important drugs have been brought to market in recent years, and they were based mostly on taxpayer-funded research at academic institutions, small biotechnology companies, or the National Institutes of Health (NIH). What passes as “new” drugs are not new at all but merely variations of existing drugs already on the market. This lucrative strategy involves producing something very similar to a top-selling drug. For instance, we now have six cholesterol-lowering statins on the market, each a variation of the first.

Of the 78 drugs approved by the FDA in 2002, only 17 contained new active ingredients, and the FDA classified only 7 of these as improvements over older drugs. The other 71 drugs were deemed no better than drugs already on the market.

Putting Government to Work

Capital HillFurthermore, Big Pharma feeds off the government through its dependence upon patent grants and FDA approvals, both of which offer the pharmaceutical industry exclusive monopolies. And the types of drugs they are securing monopolies to are significantly driven by lifestyle concerns as opposed to disease conditions ─ unless you consider restless leg syndrome, nail fungus and erectile dysfunction life threatening diseases. But they are conditions which drive revenue.

Beginning in 1980, Congress enacted a series of laws designed to speed the commercialization of tax-supported basic research into useful new products. Technology transfer, as it is known, is supposed to also help drive American-owned technology into world markets. One of these laws, the Bayh-Dole Act, enabled universities and small businesses to patent discoveries emanating from research sponsored by the National Institutes of Health, the major distributor of tax dollars for medical research, and then to grant exclusive licenses to drug companies. Until then, taxpayer-financed discoveries were in the public domain, available to any company that wanted to use them. But now universities, where most NIH-sponsored work is carried out, can patent and license their discoveries, and charge royalties. Similar legislation permitted the NIH itself to enter into deals with drug companies that would directly transfer NIH discoveries to companies. These laws essentially made the U.S. government, and taxpayer dollars, an exclusive research & discovery mechanism of Big Pharma, so these companies no longer have to rely on their own research for new drugs. In fact, they increasingly rely on academia, small biotech startup companies, and the NIH for research and instead plow more money into promotion and advertising.

It didn’t take long for these under-funded academic research facilities and non-profit medical schools and teaching hospitals to become enthusiastic “partners” with the drug companies. As the entrepreneurial spirit grew during the 1990s, medical school faculty entered into other lucrative financial arrangements with drug companies, as did their parent institutions.

In spite of their dependence upon taxpayer funded research, tax benefits and government supported market monopoly, Big Pharma has another incredible asset in the form of secrecy. The FDA is not allowed to reveal any of the research data the drug companies provide. So the only clinical research results the public hears about are those Big Pharma choose to make public, which tend to be the favorable ones.

And still, in the face of a deck stacked in their favor, the pharmaceutical industry is increasingly hit with government investigations and civil and criminal lawsuits. The barrage of charges includes illegally overcharging Medicaid and Medicare, paying kickbacks to doctors, engaging in anticompetitive practices, colluding with generic companies to keep generic drugs off the market, illegally promoting drugs for unapproved uses, engaging in misleading direct-to-consumer advertising, and, of course, covering up evidence.

A study conducted by USA Today found that more than half of the “experts” hired to advise the FDA on the safety and effectiveness of drugs have financial ties to the pharmaceutical companies that will be impacted by those decisions. While federal law prohibits FDA from using experts with such conflicts, FDA has waived the restrictions more than 800 times since 1998.

Drugs Kill

Although somPharmaceuticalse adverse drug reactions are not very serious, each year more than 2 million people in the United States are hospitalized or injured, including more than 100,000 fatalities. In fact, according to the Journal of American Medical Association, adverse drug reactions are one of the leading causes of death in the United States.

Every day more than 4,000 people have adverse drug reactions so serious that they need to be admitted to a hospital. What’s more, over 2,000 patients a day suffer an adverse event caused by drugs once they are admitted.

From 1998 through 2005, reported serious adverse drug events to the FDA increased 2.6-fold, and fatal adverse drug events increased 2.7-fold. The numbers reported have increased 4 times faster than the total number of outpatient prescriptions during the period. A few sobering facts about FDA approved drugs:

  • During the period from 1998-2005, the painkillers oxycodone and fentanyl caused at least 9000 deaths; The antipsychotic medication risperidone (Risperdal®) was responsible for at least 1093 deaths; The antipsychotic Clozapine caused at least 3277 deaths; Interferon-beta, a drug that helps regulate the immune system, and two immune-affecting drugs, Infliximab and Etanercept, were each responsible for over 1000 deaths.
  • Based on five years of data on 3,876 heart bypass patients from around the world, the death rate among the 1,072 patients given Bayer AG’s anti-bleeding drug aprotinin (Trasylol®) was nearly 21%, two-thirds higher than the mortality rate among surgery patients not given anti-bleeding drugs. Bayer failed to reveal to U.S. regulators the results of this large study.
  • In clinical trials by Merck, the cholesterol lowering drugs Zetia® and Vytorin® were found to not be effective at preventing heart attacks, and in fact caused fatty plaques to grow almost twice as fast as in the control.
  • A prostate study gave 28 men a one-year course of finasteride (Proscar®), the standard drug for benign prostate problems. The other 25 were given nothing. When the year was up, researchers gave each man a second biopsy. Nearly 30% of the men taking Proscar® developed prostate tumors.  Yet tumors were found in only one of the 25 men taking nothing. 

Recent analysis found that the makers of antidepressants like Prozac® and Paxil® never published the results of about a third of the drug trials that they conducted to win government approval, misleading doctors and consumers about the drugs’ true effectiveness. The fact is, when all data is considered the drugs outperform placebos, but by a modest margin. Furthermore, there are some herbal dietary supplements that have demonstrated comparable efficacy without significant side effects. What are some of these side effects?

SSRIs cause hyperprolactinimemia which results in erectile disfunction, increased breast cancer, autoimmune conditions such as lupus, etc. Children and young people treated with SSRI or SNRI more frequently exhibit suicidal thoughts and suicidal behavior as well as hostile behavior than comparable patients treated with a placebo. Another study shows an increased occurrence of malformation in children born by mothers who had used an SSRI antidepressant during early pregnancy.

Even OTC medications which seem harmless, medications long regulated and approved by the FDA, kill more people than any dietary supplement ever has. In any given year, Tylenol® (acetaminophen) is responsible for more than 14,000 unintentional overdoses, with about 100 of those cases resulting in death. In one large clinical trial, subjects taking acetaminophen every six hours for one week saw over 1/3 experiencing serious liver damage. 

Every year NSAID’s are responsible for an estimated 7,600 deaths and 76,000 hospitalizations in America. NSAID use has been linked to “leaky gut” syndrome and intestinal damage by a host of studies.  For instance, in a large group of arthritis patients with a history of NSAID use, it was found that 70% had intestinal erosion, and 25% had severe, large lesions. Ibuprofen (Advil®, Midol®, Motrin®, Nuprin®, Pamprin®), naproxen (Aleve®, Naprosyn®, Anaprox®), and indomethacin had the worst adverse effects. In those with a history of heart problems, NSAID use increased the risk of hospital admission over 10 fold. NSAIDs taken by pregnant women increase the risk of miscarriage by 80%. Between 8-20% of adult asthmatics experience bronchospasm following ingestion of aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs). Termed aspirin-induced asthma, this reaction is potentially fatal.

As a point of comparison, between 1993 and 1998, the FDA reported only 2,621 “adverse reactions,” including 184 fatalities for well over 3,000 different dietary supplements.

The Power of Plants

The challengePhytonutrients faced by natural therapeutics, or nutraceuticals, is that they are complex compounds with a host of variability. In other words, pharmaceuticals are usually single small molecules which are created synthetically so as to be laser focused on its structures, actions, mechanistic responses, etc. Plant based phytonutrients present so much variability, whether by species, genus, crop geography, seasonality, harvesting methods, processing methods, etc. And that’s just the plant. When you start to consider that in a particular plant extract there may be hundreds of molecules, representing millions of variable interactions, you can see why allopathic medicine favors a new chemical entity that they can create and manipulate.

As modern scientific tools have progressed, however, we are able to learn more about theses phytonutrients and the mechanistic actions of their involvement in a wide array of biological processes. We know that many of these compounds are involved in activation of antioxidant defenses, signal transduction pathways, cell survival-associated gene expression, cell proliferation and differentiation and preservation of mitochondrial integrity. Furthermore, many of these compounds exert anti-inflammatory actions through inhibition of oxidative stress-induced transcription factors (e.g., NF-kappaB, AP-1), cytotoxic cytokines and cyclooxygenase-2. According to proceedings from the Third International Conference on Mechanism of Action of Nutraceuticals, these phytonutrients play a crucial role in the protection against the pathologies of numerous age-related or chronic diseases.

Demonstrating the therapeutic benefits of foods by scientific means remains a challenge, particularly when compared with standards applied for assessing pharmaceutical agents. The real challenge lies not in proving whether foods, and their phytonutrients, have health benefits, but in defining what these benefits are and developing the methods to expose them by scientific means.

The practice of medicine ─ both past and present-often involves the prescription of specific foods (almost always plants) or their potent phytochemicals, to treat a wide spectrum of illnesses.

Many epidemiologic studies, including both cohort and case-control, have shown protective effects of plant-based diets on cardiovascular disease (CVD) and cancer, just to name a few diseases. These studies strongly suggest that plant foods also have preventive potential and that their consumption is lower in those who subsequently develop disease. This has fueled the research into, and discovery of, many unique phytochemicals, bioactive compounds found in plants.

Cardiovascular Disease: Pharmaceuticals versus Phytonutrients

As just one example of a phytonutrient capable of outperforming a pharmaceutical, we can look at garlic. There are now well over 2,200 credible scientific papers that have stugarlicdied garlic and its phytochemicals, including its chemistry, pharmacology, and clinical applications. After 70 centuries of human use, research on garlic is beginning to provide the hard data that supports anecdotal therapeutic and preventative health uses. 

Studies show that garlic may decrease the progression of cardiovascular disease, which is associated with several factors, including raised serum total cholesterol (TC), raised low density lipoprotein (LDL), and increased LDL oxidation (free radical damage), reduced high density lipoprotein (HDL), increased platelet aggregation, hypertension, and smoking. Garlic seems to help decrease LDL and TC levels while raising good cholesterol (HDL), decreasing platelet aggregation (helps the blood flow more easily), and decreasing blood pressure. Recently, garlic was also found to decrease two other markers of cardiovascular disease, homocysteine and C-reactive protein.

Normally, the body’s natural HDL prevents the build-up of nanoplaques through hindering the docking of LDL (Low-Density Lipoprotein, i.e. “bad cholesterol”) to its receptor sites in blood vessels or existing plaques. Therefore, high concentrations of LDL and low concentrations of HDL are high risk factors for the development of atherosclerotic plaques. Studies show that garlic reduces LDL-induced nanoplaque formation by 15%. In fact, existing nanoplaques are dissolved by up to 25% within minutes after the introduction of garlic. And garlic has been shown to reduce calcification of the cholesterol docking sites in the arteries by up to 50%.

In 37 randomized clinical trials, garlic supplements compared with placebo, consistently led to small, statistically significant reductions in total cholesterol. Statistically significant reductions in low-density lipoprotein levels (LDL) and in triglycerides were also found. In one double blind, placebo controlled clinical study published in American Journal of Medicine, serum TC levels in garlic supplement treatment subjects were lowered by 15 points vs. 2 points for placebo; Low-density lipoprotein cholesterol (LDL-C) was reduced by 11% by garlic treatment and 3% by placebo. Overall, treatment with standardized garlic supplements produced a significantly greater reduction in serum TC and LDL-C than placebo, and the garlic formulation was well tolerated without any odor problems.

Ten small, randomized trials, showed promising effects of various garlic supplements on platelet aggregation and mixed effects on plasma viscosity and fibrinolytic activity.

Two double-blind trials in participants with atherosclerotic lower extremity disease evaluated whether garlic increased pain-free walking distance at 12 to 16 weeks compared with placebo. In one trial, pain-free walking increased by approximately 40 meters with garlic supplements compared with approximately 30 meters with placebo. In the other trial, the maximum walking distance increased 114% among persons randomized to a combination treatment of garlic oil macerate/soya lecithin/hawthorn oil/wheat germ oil compared with those randomized to placebo.

Garlic may also reduce blood pressure. Numerous studies have reported that garlic is associated with reduced systolic and diastolic blood pressure. The one small trial that directly compared a standardized garlic supplement with an active antihypertensive drug found no differences in blood pressure between groups, meaning that the garlic worked as well as the drug.

In summary, numerous bioactive compounds appear to have beneficial health effects, and there is sufficient evidence to recommend consuming food sources rich in bioactive compounds. From a rational perspective, this translates to recommending a diet rich in a variety of fruits, vegetables, whole grains, legumes, oils, and nuts. From a practical perspective, since most people do not consume anywhere near the basic recommended daily allowance of phytonutrients, dietary supplementation becomes an important tool in preventative health and a viable therapeutic option.

Yet despite all the increasing data that supports the benefits and functionality of natural bioactive phytonutrients in a preventative modality, it is the FDA and other vested interests that continue to limit their viability in the marketplace. 

The FDA’s Role in Keeping You SickFDA

Starting in the 1960’s, and culminating with legislative changes in 1994, a popular uprising against systemic “sick care” and a belief in “wellness” and self-care options took root in America. One of the key tools of the wellness platform has been dietary supplements.

According to the FDA, a dietary supplement is a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet. The “dietary ingredients” in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet.

Whatever their form may be, the Dietary Supplement Health and Education Act (DSHEA) of 1994 places dietary supplements in a special category under the general umbrella of “foods,” not drugs, and requires that every product be labeled a dietary supplement.

A common myth abounds that dietary supplements are not regulated by the FDA and hence are unsafe, unproven and unwise. The fact is that dietary supplements are regulated by the FDA as a distinctly different modality from both food regulation on the one hand and pharmaceutical regulation on the other. With the passing of the popular DSHEA in 1994, the dietary supplement industry receives specific guidance for manufacturing, labeling, and selling dietary supplements.

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Since the FDA recognizes through DSHEA that there are health benefits in the distinct constituents within foods, and since these constituents have a long history of common use within foods, there is an assumption of overall safety. The logic follows that if it is common to eat vegetables, and the constituents in those vegetables are demonstrated to have specific health benefits, these components are assumed safe and shall not be required to provide the same level of qualification than is required of a new chemical entity marketed as a pharmaceutical therapeutic. Conversely, the FDA does not allow the marketing of those constituents to claim any therapeutic benefit.

Dietary supplements “claims” are regulated by both the Food and Drug Administration and the Federal Trade Commission. Claims that can be used on food and dietary supplement labels fall into three categories: nutrient content claims, health claims, and structure/function claims.

Nutrient Content claims describe the level (or lack) of a particular nutrient contained in a product. FDA regulations spell out which nutrient content claims are allowed and under what circumstances they can be used. There are eleven core terms: “free,” “low,” “lean,” “extra lean,” “high,” “good source,” “reduced,” “less,” “light,” “fewer,” and “more.”

Health claims describe a relationship between a food, food component, or dietary constituent, and reducing the risk of a disease or health-related condition. For example: An approved Calcium and Osteoporosis (21 CFR 101.72)claim would be “Regular exercise and a healthy diet with enough calcium helps teens and young adult white and Asian women maintain good bone health and may reduce their high risk of osteoporosis later in life.” FDA authorizes these types of health claims based on an extensive review of the scientific literature, generally as a result of the submission of a health claim petition, using the significant scientific agreement standard to determine that the nutrient/disease relationship is well established.

As you may have surmised, the awkward and overly qualified “claim” is anything but straight forward and definitive, regardless of the strength of the science behind it. Furthermore, the FDA’s standard of SSA (significant scientific agreement) is a nebulous and unqualified criterion which is usually only met by the time the issue no longer has relevance. For instance, it wasn’t until 1993 that the FDA felt there was Significant Scientific Agreement and approved the claim that calcium reduces the risk of osteoporosis, in spite of the preponderance of data that had been published for over 40 years!

Legally, health claims must meet the Significant Scientific Agreement standard, which imposes a burden of showing to the FDA’s satisfaction that the claims are supported by published studies and opinions from qualified professionals. Recognizing that the results of randomized, double-blind clinical studies are the best supporting data, however (here is the Catch-22), the FDA may consider a substance a drug if it has been the subject of published clinical trials. In fact, the FDA will block foods containing approved drugs or biologics from the food market. Thus, while tests must be conducted to support health claims, if those tests are clinical trials (the ideal type of test), they may cause the ingredients to be categorized as drugs and subject to more onerous safety regulations or removal from the market.

To make matters more confusing, the FDA provides for the use of qualified health claims when there is emerging evidence for a relationship between a food, food42-18474328 constituent, or dietary supplement and reduced risk of a disease or health-related condition. FDA uses its enforcement discretion for qualified health claims after evaluating and ranking the quality and strength of the totality of the scientific evidence. You can imagine that if it takes the FDA over forty years of mounting data to approve a “no-brainer” calcium claim, they likely are not on the leading edge of any real emerging evidence.

But the real sweet spot for dietary supplements are Structure/Function claims. Statements that address a role of a specific substance in maintaining normal healthy structures or functions of the body are considered to be structure/function claims. Structure/function claims may not explicitly or implicitly link the relationship to a disease or health related condition. If a dietary supplement label includes such a claim, it must state in a boxed disclaimer that FDA has not evaluated the claim. The disclaimer must also state that the dietary supplement product is not intended to “diagnose, treat, cure or prevent any disease,” because only a drug can legally make such a claim.

How Do You Spell Irony

Today the market for dietary supplements and natural health products is over $100 billion. Yet the irony is that many of the consumers of these products are the ones who need them the least. Generally speaking, consumers of health & wellness products are better educated, more affluent and consume a better diet than most Americans. They are the ones that can afford better health insurance, seek better care, and because of their lifestyle behaviors, are less likely to suffer the scourge of our “Malnutrition of Affluence”.

So when the FDA creates a constant barrage of hurdles, manipulates the rules of engagement, and denies clear and overwhelming facts that consumers should have access to, it should certainly make you wonder who the FDA is trying to protect.

It is slowly becoming clear that what most of us assumed to be the best, most advanced healthcare system, vetted and supported by our own government,  is in fact an economic system that enriches those stakeholders who have hitched their wagon to its mighty engine. The trail of money that supports our current “healthcare” system is spread wide to ensure its very survival. Yet this system of care is not living up to its original intent, it is not providing real healthcare, but in fact this system is bankrupting our nation economically and morally.

Share

The FDA’s “Catch-22”

1 comment

     The FDA is “raising questions” as to whether certain functional beverages are now legal or not. The U.S. Food & Drug Administration has just announced new guidance (see 21 CFR 10.115(g)(5)) related to the difference between liquid dietary supplements and beverages bearing novel ingredients.

     According to the FDA, “We have seen an increase in the marketing of beverages as dietary supplements, in spite of the fact that the packaging and labeling of many liquid products represent the products as conventional foods. Products that are represented as conventional foods do not meet the statutory definition of a dietary supplement…”

     The FDA further explains, “Liquid products that suggest through their serving size, packaging, or recommended daily intake that they are intended to be consumed in amounts that provide all or a significant part of the entire daily drinking fluid intake of an average person in the US, are represented as beverages.” Such products, the FDA said, “may not be marketed as a dietary supplement.”Killer

     I can’t help but to believe that the FDA is again using draconian hyperbole to attack the nutrition industry. In a bizarre Catch-22 way, the FDA is suggesting that these liquid dietary supplements, labeled as such and fully compliant with the federal labeling requirements, are more harmful to a consumer than conventional beverages such as carbonated soft drinks.

     Carbonated soft drinks, and the huge economic interests behind them, are the beverages of choice for most Americans. Yet, since the 1950’s the average size of a soda has increased 149%, from 6.5 oz to 16.2 oz. Soda is the #1 source of added sugar in the American Diet, and each American consumes an average of 50 gallons of soft drinks per year. In fact, almost half of the additional caloric growth in our diet since the 1970’s come from soda. And the calories keep mounting as America is facing an obesity epidemic. According to the World Health Organization, the U.S. has by far the highest proportion of overweight and obese consumers of any nation, with 65.8% of all adults in that category. These overweight Americans result in approximately $238 billion in medical costs each year, according to the Department of Health and Human Services and the National Institutes of Health. Childhood obesity doubled between 1980 and 1994. Meanwhile, according to U.S. Department of Agriculture (USDA) data, per capita soft-drink consumption has increased by almost 500% over the past 50 years. For each additional daily serving of soda the children drank, both body mass index and obesity risk increased by 60%.Obesity

     Not to villainize soft drinks, but it seems the FDA has bigger fish to fry. Consider also that the FDA is applying their subjective interpretation of a liquid product suggesting that it is a “conventional beverage”. While some of these beverages are not always marketed in the most ethical manner, you know like carbonated soft drinks have been over the past 50 years, most of them contain scientifically supported bioactive nutrients which promote health & wellness.

     I suppose as long as the American health care economic engine depends upon healing the sick, the FDA will continue to suppress and interfere with products and stakeholders who are promoting health and prevention.

Share