Saturday, January 3, 2009

Nutritional Supplements: Are You "Clear" on What You Are Taking?

The U.S. Food and Drug Administration website provides some enlightening, yet alarming, insights into the lack of supervision over the manufacturing and sale of nutritional supplements. Manufacturers of these products are allowed to produce, market, and sell these supplements with minimal government regulation. The following statement is posted on their website: (

“FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products (prescription and Over-the-Counter). 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. The FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements. Manufacturers must make sure that product label information is truthful and not misleading.

“FDA's post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising.”

So, what does this mean?

According to the DSHEA, the FDA has the duty to provide evidence that a dietary supplement is "unsafe," prior to taking any steps to restrict its use or to remove it from the marketplace. These actions can only take place after the product has been marketed. Firms have the legal right to disclose or not disclose any and all information regarding nutritional content and product safety. FDA's Center for Food Safety and Applied Nutrition (CFSAN) is responsible for the agency's oversight of these products, however, their role is limited to monitoring the marketplace for “potentially illegal products (that is, products that may be unsafe or make false or misleading claims) include obtaining information from inspections of dietary supplement manufacturers and distributors, the Internet, consumer and trade complaints, occasional laboratory analyses of selected products, and adverse events associated with the use of supplements that are reported to the agency.” The FDA does not analyze dietary supplements before they are sold because they lack the resources and by law, this responsibility lies with the manufacturer.

So what does the FDA regulate?

The FDA is an agency of the U.S. Department of Health and Human Services whose motto is, “Improving the Health, Safety, and Well-Being of America. Congress laid the foundation for modern food and drug law when it passed the Food and Drugs Act of 1906. This first nationwide consumer protection law made it illegal to distribute misbranded or adulterated foods, drinks and drugs across state lines. ( They approve and regulate products including food, prescription drugs, medical and farm equipment, and cosmetics. (I find it ironic that prescription drugs have harmful and potentially fatal side-effects, but that the FDA still approves them for sale in the marketplace. On the other hand, the FDA only takes action against supplement manufacturers once the damage is done and the consumer reports it. This raises some serious questions about the role and purpose of the FDA in the products that they govern and the ones that they don’t.)

What does this mean for consumers?

While the absence of government regulation may be great news for corporations, there are frightening implications for the average consumer. The lack of availability of quality foods and subsequent declining health often leads many of us to supplement our diets with these nutritional supplements. We can’t be sure of what we are actually taking and what the long-term effects these products will have on our health. Proving that the consumption of a supplement causes any kind of physical impairment can be a lengthy and expensive legal battle. Law firms advertise on television to inform consumers of pending class action suits against companies whose products have already harmed or even caused the death of those who used them. Even if the petitioners win, the physical and emotional damage done could be irreversible which makes the victory bittersweet.

How do we protect ourselves?

There are many safe and effective ways to supplement your diet. Until more measures are taken to protect the consumer, we must take steps to become more informed. We must see our doctors regularly and inform them of what supplements we are taking. I recommend that we buy certified Kosher or USDA-certified organic foods and whole supplements in reputable environments. These regulatory agencies are required to certify and document farming and processing methods to strict standards. Avoiding processed foods and fast food while balancing our diets with fresh fruits, vegetables, protein, and whole grains should curtail the need for supplements, thus minimizing the risk of injury. You might also consider herbal teas and tinctures. Avoid all supplements that contain stimulants such as ephedra and caffeine. And lastly, if you are a collegiate or professional athlete, contact the NCAA, USOC, or governing league official before you take any substance--failing to do so could lead to being declared ineligible for competition or being banned from your sport for life. Be informed!

More next time...

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