In 1971 at the age of 19, I walked into my first health food store in Dearborn, Michigan with no idea what it was but I felt compelled to go. 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 (antioxidants) 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 become a billion dollar enterprise and have 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 to impress upon us 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 some 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 has 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 that would have been found in the soil prior.
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 to determine the efficacy and effect on the human body of our foods and herbal nutrients.
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 not have reached the pinnacle we have today, or the understanding we have of our bodies and the realm of nature in which we live. 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 of pharmaceutical drugs, surgery, and radiation for 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 American 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.
Many weight loss products having adverse effects contain undeclared prescription drugs, do not list the manufacturer on the label or in advertisements and many have been manufactured in China. China’s manufacturing policies are certainly not as stringent as the U.S. 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. The FDA 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 or active ingredients that are 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 the production process due to poor manufacturing practices when produced outside the U.S. There is also evidence of deliberate adulteration of products by manufacturers. Some of the tainted products contain ingredients from China as a result of manufacturers seeking low-cost ingredients. Many 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 many 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 bona-fide “nutritional” supplement. With the sales of supplements in the billions, any enterprising company 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. The majority of legitimate companies are trying to keep the historical knowledge gained from thousands of years of experience using foods and our natural resources 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. This information was compiled from http://www.naturalnews.com/024632_drugs_health_adverse_events.html.
Even more disturbing is the number of reported deaths – 4,824 human deaths were reported as a result of 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 2008 quarter.
Obviously, when compared to pharmaceutical drugs, proper nutritional supplement use from legitimate companies is safer, offers similar and even better results in treating illness, without the side effects from 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 having them forced into the category of drugs.
However, since the passage of the DSHEA, efforts have been made to subvert the laws set down by the DSHEA. 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. These sound bites speak about the intent of the FDA to “protect” the consumer from a “disease provoking” herb or vitamin. The intent of the FDA is not questioned but the sound bites do instill a certain level of fear in consumers.
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 U.S. 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.
A recent good example of this type of activity is in the relatively new product, Truvia. This product is based on rebiana, part of the natural sweetener stevia. Stevia has been used for decades in Japan but is only allowed to be sold in the U.S. as a supplement by the FDA rather than as a sweetener. If you consider that stevia cannot be patented because it is naturally occurring in nature, you can connect the dots to discover that Truvia is not actually “natural” as stated in all of the well-developed marketing materials designed to attract the growing number of actively involved wellness consumers. Unfortunately in this case and many others, the controversy and regulation of natural supplements often involves the money that can be gained and the political allies that can be formed from introducing legislation. Luckily, at least to date it appears that the voices of our citizens have been effective in protecting our rights in regards to the regulation of our food supplements.
In recent months, 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 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. No substantive action has been taken 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.”
As is sometimes the case with controversies, often there are larger issues in the background that need investigation prior to reaching a conclusion. In the case of nutritional supplements, this certainly appears to be the case. There is more happening behind the scenes of the desire to develop more stringent regulations than appears at first blush with most of the media reports. Your health is valuable enough to investigate what you put in it, particularly if there are chemicals that have had numerous safety studies indicating a high degree of risk, whether those products are currently “approved for use” or not.
