Nutritional Supplements - Are They Safe?

How safe are nutritional supplements and do we know what is in them? Natural supplements are not systematically tested for safety or content.

According an article written by Mayo Clinic Staff, “Herbal supplements: What to know before you buy” (November 17, 2009), manufacturers of herbal supplements do not have to go through the rigorous process of FDA approval before going on the market. Are they safe?

Tale of Two Searches: a Hypothetical Example

Here is an example of how a layperson can fail to obtain important information about a supplement, by relying on one or a few sources of information:

1. Amber is under medical care for polycystic ovarian syndrome and can’t get pregnant. She does a search and takes the herb blue cohosh, an herbal supplement for hormonal balance. Later, she becomes pregnant. She continues to take the supplement, because she thinks it is beneficial.
2. Mary has painful periods. She searches the net and finds a site that mentions the herbal supplement blue cohosh is helpful for dysmenorrhea. But the article also says that the supplement has been used traditionally to induce abortion and should not be used at any time during pregnancy.

Amber, the newly pregnant woman, is still taking the supplement. There is no question that in her case, the supplement should not be taken.
How the FDA Regulates Nutritional Supplements

In 1994 Congress passed the Dietary Supplement Health and Education Act (DSHEA). An article by Stephen Barrett MD, “How the Dietary Supplement Health and Education Act of 1994 Weakened the FDA,” (2007), explains in depth how “Amber” and her hypothetical pregnancy were not protected.
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DSHEA defined dietary supplements not as drugs, but as a separate category. DSHEA also expanded supplements to include herbal supplements. The only regulatory protection for consumers were (1) that product labels could not state that their purpose was prevention or treatment of disease, and (2) the name of the product could not include the word “cure.” Written articles about supplements, which are the primary source of purchases, were not prohibited from making any sort of claim about the supplement.

According to Barrett, this meager protection was thwarted. In 2000 the FDA loosened regulations, allowing labels of supplements to state “support or health maintenance,” such as “supports heart health” or “maintains muscle strength.”
Ingredients of Nutritional Supplements - a Mystery

Herbs are often touted to be natural sources of components of pharmaceutical products. However, pharmaceutical products are the result of years of testing and refining raw substances from their natural state, purifying them from harmful side effects.

In the case of natural supplements, Barrett explains that the FDA is limited to “after the fact” protection of consumers. Numerous cases of cancer of the urethra occurred in Belgium in 2000. According to Barrett, the active ingredient in an herbal supplement, “ aristolochia” was the culprit, and had been banned in several countries. Not until December 2007, in response to the side effects of ephedra, did the FDA require manufacturers of natural supplements to report deaths, serious side effects and birth defects.
Manufacturers of Nutritional Supplements are Concerned

The Federal Trade Commission (FTC) established requirements for “good manufacturing processes” (GMP’s) for supplements in 2008. In spite of this, the Nutrition Business Journal published an article, “Ingredient Adulteration Still a Problem Despite GMPs” (Oct 1, 2009). The article claimed that adulterated ingredients and supplements laced with drugs were more rampant than ever. Wrong ingredients included pesticides and lead.

Supplement manufacturers lament the lack of standardization of ingredients that would help the development of proper dosages and product descriptions. In order to protect consumers, private, not-for-profit organizations such as the Natural Products Association and NSF International have been established to police nutritional supplements by investigating ingredients and researching benefits and side effects.
How Can We Choose Appropriate Supplements?

The Mayo Clinic article cited above asked the question “What to know before you buy.” The answer was to consult a doctor, pharmacist, the manufacturer or do extensive research before taking a supplement. Can a layperson interpret the results of scientific studies, even if they are available? The average person will read an article written on a level that they can understand, like the example of Amber and Mary. Articles may have dubious information and may be written with the sole intent to sell the product.
Let the Buyer Beware

A person who takes a natural supplement is acting under the rule of cavet emptor, “let the buyer beware.” No one, except the manufacturer, knows what is in it. People can buy a Toshiba TV and if a Samsung arrives, they know it is the wrong item. When a person buys a supplement, they have no idea what is really in the pill. Unlike the TV, the product will affect the body and long-term health. Before taking a supplement, individuals should seek trusted sources with expertise in nutrition and the supplement industry.

Sources:

The National Center for Complementary and Alternative Medicine(NCCAM )

Natural Products Association

NSF International

Office of Dietary Supplements (ODS)

U.S. Food and Drug Administration (FDA)

Center for Food Safety and Applied Nutrition (CFSAN)