In 1971 at the age of 19, I walked into my first health food store in Dearborn, MI having no idea what it was but felt compelled. I thought they might have something I could use to protect my lungs and provide extra protein – like a shake. Looking back I have no idea why I thought this store would have such things. I had just been hired by Great Lakes Steel to shovel coal on the midnight shift on Zug Island in Detroit. Naturally, I would be wearing a protective dust mask issued by the company but I wondered if there wasn’t something more I could do. Today, that “something” would be vitamins A, C and E (anti-oxidants) along with magnesium and an herbal supplement to help clear the lungs.
Since that day 40 years ago, I have watched an industry grow to a billion dollar enterprise and seen the field of nutrition become a legitimized science, applicable in medicine and healing. We are constantly flooded by media reports, infomercials and doctors jumping on the bandwagon spewing forth their “wisdom” and products. While there has been some controversy on which diet program works best, the importance of food and nutrition has taken its place in our society via clinical studies and in a more colorful way in reality shows.
But what about food/nutritional supplements? What exactly are they and why does the Food and Drug Administration (FDA) and those in the medical field brand them as placebo or worse, dangerous to human health. A nutritional supplement initially was a nutrient from food meant to “supplement” one’s diet. It is based on the notion that over farming of land in the last 75 years depleted the soil of its nutrients. Therefore, food grown and harvested does not contain the same amount or ratio of nutrients originally found in the plant. That being the case, it makes sense to “supplement” the diet with extra nutrients as would have been found in the soil.
Even though this holds true for minerals and vitamins, the term nutritional supplement has come to include amino-acids, herbs, and other little known components found in food that exhibit a beneficial influence on the body. To date, there are thousands of clinical studies carried out determining the efficacy of food and herbal nutrients’ affect the body.
Herbs, spices and other food components have been utilized throughout human history in culinary and medicinal traditions. In fact, were it not for their use, humans may have not reached the pinnacle we have today, or the understanding we have of our bodies and the realm of nature we live in. The interrelationship of humans and nature owes itself to the trial and error of our early ancestors treating disease with food and herbs. Recently, the term “evidence based medicine” has come into parlance. This is another way to question the use of anything outside pharmaceutical drugs, surgery and radiation in the treatment of disease. What more evidence is needed than the thousands of years that humans have used herbs and food to treat disease; and rather successfully when you really think about?
Every few years, the FDA complains about nutritional supplements and how dangerous they are to consumers and that without greater powers ceded to them, they cannot protect the public. They make false and misleading statements claiming their hands are tied and woe to the consumer who meets with unexpected complications from food supplements. If only they could have more powers they could prevent such tragedies. If only their statements were true.
In its most recent annual report, the America Association of Poison Control Centers documented no adverse events or deaths occurring from a nutritional supplement in 2009. In fact, no adverse events or deaths have taken place since 1983 when this information began being reported to the organization. But what about the news media’s reports on the mishaps from supplements? If you carefully examine the details you’ll find the information is manipulated. Anyone can alter statistics to meet their needs.
Many weight loss products having adverse effects contain undeclared prescription drugs; do not list the manufacturer on the label or in advertisements and most have been manufactured in China. China’s manufacturing policies are certainly not as stringent as the US. Other products sold over the Internet or in stores that contain various drugs are for sexual enhancement supplements. The FDA has found many of these products or their active ingredients imported into the United States. It is working closely with U.S. Customs and Border Protection to effectively screen and stop these shipments from entering the country. Most often these drugs included in a so-called “supplement” are not labeled.
In the case of muscle building products used by athletes, some deceptively “harmless” supplements contain ingredients that aren’t declared on the label and are prohibited by the doping regulations of the National Collegiate Athletic Association, the International Olympic Committee (IOC), and the World Anti-Doping Agency. As a result, athletes may test positive for banned substances. Contaminants that have been identified include a variety of anabolic androgenic steroids (including testosterone and nandrolone, as well as the pro-hormones of these compounds).In most cases, the contamination occurs during production process due to poor manufacturing practices when produced outside the US. There is also evidence of deliberate adulteration of products by manufacturers. Some of the tainted products contain ingredients from China because manufacturers seek low-cost ingredients. May times raw material from China may look the same as was ordered but in fact is not.
This is where the FDA needs to improve its monitoring of nutritional supplements as authorized by the Dietary Supplement Health and Education Act. Looking at the information one must ask the question how much of these adverse events and deaths are actually from the herb, vitamin, mineral or amino-acid? Again, since 1983 no event or death has been reported from a bon-fide “nutritional” supplement. With the sales of supplements in the billions, anyone hungry for money can make a “supplement”. Even if it is from food or an herb, just add a little bit of a drug, or import a cheap version and sell it. Unfortunately, this does more harm to those companies who have ethical standards and a sincere desire to manufacture goods for the benefit of others. These are the majority of legitimate companies trying to keep tradition alive while documenting the science behind the clinical use of food components, herbs, amino-acids, vitamins and minerals.
Anyone familiar with alternative medicine understands the double-speak of the FDA when it comes to supplements. When one examines the data on adverse events and deaths from pharmaceutical drugs, it is quite shocking. According to information gathered from the FDA during the first quarter of 2008, there were 20,745 reported serious injuries associated with drug therapy, up 34% from the previous quarter, and up 38% from 2007’s average. Even more disturbing is the number of reported deaths – 4,824 people were reported killed from pharmaceutical drugs in the first quarter of 2008, a 2.6 fold increase from the previous quarter. This figure represents the highest number of patient deaths ever reported in a single quarter as a result of pharmaceutical drug use. It also accounts for more deaths than those due to homicide during the same period. (A further Internet search could not establish the rest of the statistics for 2008)
Obviously, when compared to pharmaceutical drugs, proper nutritional supplement use from legitimate companies is safer offering similar and even better results in treating illness without the side effects presented by drugs.
In 1994 Congress passed the Dietary Supplement Health and Education Act (DSHEA). It was a victory for the public and manufacturers of nutritional supplements. Congress received more faxes, letters and telephone calls on the DSHEA than any other legislation. The thought of more government interference led to the public outcry that passed the DSHEA and made it law to protect nutritional and food supplements, rather than force them into the category of drugs.
However, since the passage of the DHSEA, efforts have been made to subvert the laws set down by the DHSEA. Many of these attempts have been to bypass the normal routes in Congress as stealth attachments to other bills. The media is quick to blare out misleading reports of a supplement causing an adverse effect. It speaks about the intent on the FDA to “protect” the consumer from a “disease provoking” herb or vitamin. It never questions the intent of the FDA only becomes it mouth piece.
Nutritional supplements are competition for the drug industry. The vast majority of drugs are obtained and developed from their botanical or bacterial counterpart. Drugs are synthesized from petroleum or coal tar leaving out other natural constituents that balance the isolated chemical. Hence the serious side effects. What is more, in the US it is illegal for drug companies to patent any naturally occurring substance. So there ends any real research and development of a natural substance to be used in medicinal ways. Even in those few situations where an element is found to be beneficial, the company must isolate the ingredient, then synthesize and alter it to make it ever so slightly different than the its source.
And so it was in the recent months when Senator McCain introduced a bill designed to give more power to the FDA which would undermine the DSHEA. Information on the bill was leaked to certain of the media and the public said “No!” McCain withdrew his support of the bill and it died. In May of 2010, Senator Henry Waxman of California tried to sneak an anti-supplement provision attachment to the Wall Street Reform and Consumer Protection Act. At the last minute it was dropped as supporters flooded Senate offices with thousands of emails, faxes and phone calls. At the end of May, the staff of the Senate Committee on Aging, led by Senator Kohl (D-WI), was preparing a surprise ambush of dietary supplements in a Senate hearing. So far, no action has been taken.
The 1994 law governing supplements (DSHEA) ordered the FDA to establish good manufacturing practices (GMP’s) for supplement makers. The FDA dragged its heals for years. GMP’s for supplement makers will only finally come into force for all supplement companies next month, sixteen years after passage of the bill! As with any field, there always have been and probably will continue to be some bad apples among supplement companies. The FDA should move against them as it has plenty of regulatory authority to do so, but does not. One can only ponder why. As Thomas Jefferson said, “The price of Freedom is eternal vigilance.” We must be ever so vigilant to safeguard our freedom and right to decisions we make about what we choose as “medical” treatment no matter how unpopular it may be.
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