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Which is more regulated – Dietary supplements or the media declaring them unregulated?

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    According to the prevailing mantra, repeated in nearly every major media format, dietary supplements are completely (and shockingly) unregulated. We have been told that products can be made with no oversight, labels need not accurately disclose the contents of the product, and that outrageous claims of miracle cures are permitted without proof; furthermore, they claim that FDA has no power to do anything about it. The truth is, none of these characterizations are even remotely factual- no matter how often they are repeated.

    The latest and loudest critique of the dietary supplement world has come from HBO’s John Oliver, where he ridiculed Dr. Oz’s congressional testimony on his “Last Week Tonight” show, before “exposing” the unregulated dietary supplement industry and the lawmakers he deemed responsible for allowing its deregulation. Whether or not you believe Dr. Oz is good or bad for the supplement industry (or the medical world in general), the ignorance of dietary supplement regulations displayed by Oliver was simply shocking and should be defined as a form of  media malpractice. What Oliver has really exposed is a shockingly unregulated agenda-driven media industry; where humor, rather than truth, feeds the bottom line.

    Of course, HBO is not the only offender. Nearly every medical journal editor or medical writer for news outlets permits similar statements to be printed without qualification. Even positive stories about dietary supplements include such statements. When Time magazine did a piece on the use of herbal medicine in the Cleveland Clinic, they included this gem in passing: “The FDA doesn’t regulate herbs and supplements.” A statement obviously written by someone who has never endured a 3-week FDA inspection of a dietary supplement manufacturing facility or read any of the hundreds of warning letters sent by FDA to supplement company owners; or for that matter, has taken the time to peruse the hundreds of pages of guidelines outlining how FDA regulates the dietary supplement industry.

    But there appears to be something more insidious going on of late. For years we have had to deal with these unwarranted statements, usually tagged on to the latest adverse event report or “failed” vitamin study (see my blog on editorial bias in research media). However, over the past several years there seems to be an increasing emphasis in these statements targeting DSHEA (the Dietary Supplement Health Education Act) and those in congress who believe it to be a sufficient framework to protect the American people from harm while allow appropriate access to dietary supplements. Oliver went out of his way to point out that it was the massive amount of money used to lobby congress that has led to the shocking lack of regulation. Again, the unregulated staffers on Oliver’s HBO show must have been short on time to do some fact checking, so we will help them out.

    According to Opensecrets.org (the same source used by Oliver) the dietary supplement industry’s lobbying dollars reached their peak in 2013 at $3.6 million. How does this compare with the pharmaceutical industry? Well in 2013, the pharmaceutical industry spent over $140 million lobbying congress (the highest amount of all industry sectors). If lobbying dollars equates to deregulation, as Oliver clearly concludes, then he and HBO must have a mini-series in the works exposing Big Pharma. And these numbers pale in comparison to the promotional dollars used by pharmaceutical companies to lobby doctors, insurance companies and consumers. In 2012, nearly $15 billion dollars was spent detailing doctors, including another $5 billion in free samples. When you total all the promotional dollars, including over $3 billion in direct to consumer marketing, the pharmaceutical industry spent over $27 billion in 2012 (an amount equaling 85% of the total revenues of all dietary supplements that same year). Remember that the amount of money spent in advertising by pharmaceutical companies is mostly spent through the same medical journals and media outlets claiming dietary supplements are unregulated- a coincidence, perhaps.

    This is such an important topic that when putting together our last book (Supplementing Dietary Nutrients- A Guide for Healthcare Professionals), we specifically wanted to tackle this issue head-on. Not only is there a large chapter on the nuances of dietary supplement quality control and regulatory issues, we were able to reprint the HerbalGram article “Myths of an Unregulated Industry Dispelled” in its entirety (thanks American Botanical Council). This is a must-read for anyone who questions whether FDA has the ability or authority to properly regulate the dietary supplement industry or anybody recommending the use of dietary supplements to others.

    Like all regulated industries, the dietary supplement world has companies and rogue players at its margin. Nearly all of the issues related to dietary supplement safety have come from these groups- mostly in the form of products that contain illegal drugs masquerading as dietary supplements for weight loss, sexual enhancement or sports performance. The responsible majority of dietary supplement companies would like to see FDA use its authority to remove these players from the market, an authority given to them by congress through DSHEA. So the next time you read an article declaring that FDA has no ability to regulate herbs or dietary supplements, you ought to consider asking which is more regulated: the dietary supplement industry or the media declaring it unregulated.

Get our new book: Supplementing Dietary Nutrients- A Guide for Healthcare Professionals Today.

 

 

 

 

 

 


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Why water should be your primary beverage

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With the recent discussion of water intake and health- here is an excerpt from The Original Prescription that discusses the principle of using water as our main source of hydration and a little bit about the origins of the 8 glasses per day “rule.”

This is just one of over 50 Lifestyle principles discussed in the Original Prescription.

Principle #6: Water should be your primary beverage; drink enough, and try to limit the number of liquid calories you consume.

Water is one of the quintessential nutrients of life and yet is often one of the most commonly neglected. Despite its great importance for nearly every bodily function, many of us are still at a loss when it comes to knowing how much we’re supposed to drink each day and which other beverages count toward our daily needs. All this confusion about water needs comes as no surprise considering that the first official recommendation for adequate intake (AI) of water was only established in 2004 by the Institute of Medicine, coinciding with an increase in popular awareness about water needs for preventing conditions such as cancer, heart disease, and weight gain (27). Prior to that, the RDA concluded that it was impossible to set a recommendation for water needs, and the National Research Council used a general rule of thumb of 1 ml/ kcal (that would be two liters of water per 2000 calories consumed, if you’re getting out your calculator) (28). Today’s recommendations for daily water requirements, however, are based on national averages from the NHANES III data, although individual needs vary greatly. It’s estimated that most of us need to get 80% of our daily hydration through beverages, mostly water, while about 20% of our hydration comes from the food we eat (less if you happen to avoid fresh fruits and vegetables) (28).

Throughout history, humans have relied on water as their primary source of hydration, struggling to ensure both an abundant and a clear source was available for their survival. Unfortunately, this struggle still exists in many locations around the world today. In the West, water abundance (at least for drinking) is rarely in jeopardy, and yet many choose other options. Countless individuals have replaced water with soft drinks to quench their thirst, and, as a result, sweetened beverages have become one of the major sources of calories in the American diet. Consumption of high fructose corn syrup, the major sweetener in commercial soft drinks, increased over 1000% between 1970 and 1990, and today, half of all Americans consume soft drinks every day. In fact, these beverages now constitute the leading source of added sugar in the average diet (29,30). To make matters worse, the calories provided by soft drinks often fail to satisfy hunger the way solid food does, nor do they quench our thirst in the way water can, making sugary beverages a key player in the obesity epidemic (30–33). If you want to maintain those good signals that your body is waiting for, limit the number of calories you consume through drinks. So how much water should you drink per day?  Well, that depends. How much you weigh (roughly 60% of that is water), how much water you lost recently to perspiration, and relative humidity will all affect the ultimate answer. The Institute of Medicine says that the adequate intake of total water per day is 3.7 liters for men and 2.7 liters for women.† The “8 by 8 rule” (8 glasses of 8 oz. each) equates to about 2 liters. Many rely on their thirst to tell them when to drink, and while it is true that most people’s thirst and hunger mechanisms can help manage their net water balance, in many people the thirst mechanism is blunted and mild dehydration can set in well before their body tells them to drink. Others try to rely on the color and darkness of their urine as a gauge of hydration, but this is not always a reliable indicator of the need for water (35)

So what’s the bottom line when it comes to hydration and water?

  • If you aren’t already doing it, drink mostly water to keep yourself hydrated.
  • Make sure your water source is clean and free of contaminants.
  • Tea and coffee are fine for most people (in moderation); if the caffeine causes you to urinate frequently, consider offsetting this loss with additional water.
  • Alcohol is dehydrating—plain and simple.
  • Remember to include water-based soups and stews, herbal teas, and low-sugar fruit juices.
  • Drink more water when you are physically active and when the weather turns hotter.

† The AIs provided are for total water in temperate climates. All sources (according to IOM) can contribute to total water needs: beverages (including tea, coffee, juices, sodas, and drinking water) and moisture found in foods. Moisture in food accounts for about 20% of total water intake.

Get your copy of The Original Prescription on our Website or on Amazon.

The Diabetes drugs pipeline

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November is Diabetes Awareness Month and there are some interesting facts you might want to be aware of. According to the latest data released by the CDC, diabetes rates have been increasing at an alarming rate over the past two decades; but not to worry; over 200 new drugs are currently in the pipeline to save us. If you didn’t detect my sarcasm, let me be clear: these two ”unrelated” pieces of information show that we still have much more to be aware of before we can make any headway in our current diabetes crisis.

The CDC released data this month that shows that the number of diagnosed cases of diabetes between 1995 and 2010 grew by 50% or more in 42 states (in the US), and by 100% or more in 18 states. States with the largest increases over the 16-year period were Oklahoma, up 226%; Kentucky, up 158%; Georgia, up 145%; Alabama, up 140%, Washington, up 135%, and West Virginia, up 131%.

And our “hope” to slow this colossal devastation of our health and healthcare system? More drugs, of course. According to the Pharmaceutical Research and Manufacturers of America (PhRMA) there are no less than 221 drugs in clinical trials or in the process of FDA approval for diabetes (Type 1, type 2, or diabetes complications) [See News Report here]. Billions of dollars will be spent so a few of these can make it to market; and if I can make a prediction, 10 years from now the diabetes rates will continue to increase and many of these drugs will have been approved and recalled by FDA due to their sides effects. (I can’t help from thinking that the rampant use of statin drugs in the past decade has played a significant role in driving the diabetes numbers in the previous story- but I digress)

While it is agreed upon by most researchers that 70-80% of the cases of diabetes (Type 2) are preventable with lifestyle prevention/intervention; the vast majority of research dollars are still spent on finding solutions which avoid this solution! This is the type of “awareness” that is desperately needed if we are truly to reverse this, and most of the chronic diseases that are plaguing us today- and also the reason I wrote the Original Prescription in the first place. Our solutions must address the root cause if we hope to change the numbers the CDC reports a decade from now.

Should you eat breakfast like a king?

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We have all heard the old adage that “Breakfast is the most important meal of the day,” but can such an adage be proven scientifically? And if so, by what criteria do we measure the importance of one meal over another, and perhaps most importantly, would this be true for everyone?

 

In the dietary principles we lay out in chapter 8 of The Original Prescription, principle #3 reads: “Unless purposely fasting, don’t skip meals. Start each day with a balanced breakfast containing both protein and fiber.” I mention, among other things, that the glycemic dynamics after the morning meal have a powerful impact on hunger signals throughout the day. I also mention how the diurnal rhythm of the stress hormone cortisol, which peaks in the morning just after awakening, is supposed to steadily drop during the time one normally consumes breakfast. Of course, cortisol is one the body’s modulators of glucose and insulin action and, I believe, one of the reasons that stress, insulin sensitivity, eating breakfast and risk for obesity and metabolic disorders are related. Skipping breakfast, as most of you know, is linked with increased risk for obesity, insulin resistance, diabetes and heart disease. Among other things, the need for our bodies to maintain higher cortisol to sustain our glucose levels when we skip our breakfast meals (remember cortisol is a gluco-corticoid), diminishes our insulin sensitivity and increases the overall catabolic effect of cortisol- driving more metabolic dysfunction.
 

As we discuss in the book in detail, our bodies are designed to take in the “signals” of our life(style) and convert this into health. As with many of the signals that follow a circadian rhythm like cortisol, researchers have now identified that insulin secretion and action follows a pattern based on a diurnal pattern of pancreatic beta cell function. And would you believe, glucose tolerance and insulin sensitivity is highest after breakfast. Researchers at the Mayo Clinic measured a number of parameters of beta-cell function and insulin and glucose metabolism and discovered that total beta cell responsiveness was over 20% higher after breakfast than after either lunch or dinner [Pub Med Link]. Overall, this pattern was maintained amongst most of the participants, but it was not so in every person measured (they studied “healthy” normal weight volunteers with normal fasting glucose). They found, that in a few individuals, morning insulin sensitivity and beta cell function was dramatically lower after breakfast than after lunch or dinner. What is going on in these individuals?
 

The authors speculate that individual responses may be influenced by sleep-wake cycles, age, gender, shift work or jet lag. Of course, my first question was “What are the cortisol levels in these individuals?” The author emailed me that cortisol, among other hormones, was monitored in these individuals and the data is being studied for a future publication (we will have to wait). I think this information will help us understand why some individuals responded differently to the group as a whole. I can tell you, as someone who attempted a similar study; that performing a glucose/insulin test after breakfast without controlling for wake time and shift work will dramatically influence the individual responses.
 

How I read this data with what we know already:

  • Insulin sensitivity follows a diurnal rhythm- corresponding with the normal sharp drop in cortisol in the AM (the hypothalamus is controlling all of this).
  • After an 8-12 hour fast, the body appears to be designed to dispose of a larger meal by increasing beta-cell function and peripheral insulin action.
  • Eating breakfast helps to ensure the normal drop off in cortisol levels after awakening.
  • Skipping breakfast means we miss the window when our body is designed to most efficiently deal with a meal and, among other things, triggers cortisol production and a subsequent increased desire for comfort foods.
  • This pre-programmed increase in insulin and beta cell action after breakfast can be eliminated by improperly timing the first meal of the day due to awakening time (shift work, jet lag, poor sleep) or HPA axis stress.
  • The link between elevated stress, skipping breakfast and a wide-range of metabolic disorders is not a coincidence.

In my next post, I will discuss how exercising before breakfast might affect your metabolism.
 
Here are few more related articles to ponder:

Fulfilling the Original Prescription: The empowering potential of lifestyle medicine

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(Preface of The Original Prescription)
Those who know me are well aware that I have spent over 16 years researching and developing evidence-based nutritional supplements (nutraceuticals) for use by clinicians and their patients. You might think it curious, then, that the first manuscript I decided to expand into a book is about lifestyle medicine. The reason is simple. I firmly believe that every therapy, including nutritional supplementation, must be rooted in the fundamental signaling pathways designed to keep us healthy. Those signals and that design are what this book is all about. In many ways, I have been thinking about some of these ideas since my graduate school days, studying molecular immunology and debating the meaning of life with my fellow students. When you really begin to understand the elegant processes that drive the functions we call “life,” you will just shake your head in amazement. My hope is that in my description of the simple complexity that converts our lifestyle decisions into health, you will first be amazed and then inspired to leverage these ideas to pursue your own optimal health. The fundamental principles we outline here are not “new” per se; they are, after all, The Original Prescription. What is new is that our understanding of how and why these interventions work has been expanded with recent scientific research; and when we understand how something works, we are able to leverage its benefits. In this case, understanding the mechanisms behind lifestyle signals allows you to create a synergistic effect using multiple lifestyle intervention strategies. Knowing how these interventions work will also allow you to modify them to fit your unique health history and circumstance, and, because these concepts are fundamental principles, they won’t become useless once the next health fad or research paper comes and goes. As an aside, my other great pursuit is the study of biblical history, language, culture and influence. I have included a few brief anecdotes from these pursuits, mostly in the form of footnotes, for your consideration as well. It would have been easy in a book like this to point the finger of blame toward all those who have contributed to the poor lifestyles driving our healthcare crisis. The usual suspects of agribusiness, Big Pharma, insurance companies, fast-food chains, government regulation, FDA, poor parenting, and the like are easy targets. The fact is there is plenty of blame to be shared by all. Ultimately, most of the decisions that affect your health are yours to make. The principles outlined in this book have a powerful potential to turn your health around but are impotent if left neglected and untried. My hope is that you will, instead, choose to fulfill The Original Prescription.
– Dr. Thomas Guilliams