Dietary Supplement Safety

Currently, manufacturers are responsible for ensuring the safety of the ingredients in a dietary supplement, but the FDA is not authorized by statute to require data supporting safety (double blind or placebo studies), as is the case for food additives or drugs. The FDA acts reactively to any supplement that is found to be harmful or contaminated. Actions to restrict the availability of a dietary supplement must proceed from a demonstration by the FDA of a significant or unreasonable risk of illness or injury to consumers under conditions of recommended use. Anything labeled as a dietary supplement is not guaranteed to be effective, safe, or legal.

Dietary supplements are widely available through a rapidly expanding market of products that are commonly advertised as being beneficial for health, performance enhancement, and disease prevention. There are hundreds of companies that manufacture and market these products through the internet, radio, magazines, health stores, and more. A search for creatine can bring up literally hundreds of different products made in different parts of the country and the world. The same can be said for a search for daily multivitamins, protein, and “legal steroids”. As a consumer, wading through this information can be overwhelming. Many consumers don’t research the products they are taking at all. They may see or hear something on the internet, TV, or radio that prompts them to buy a dietary supplement without any further thought. With tons of products claiming to “cause rapid weight loss”, “stop joint pain”, or “build large amounts of muscle” it is easy to see why. Behind these claims there is a lack of proof and an unknown risk.

It isn’t that all dietary supplements are harmful to our health; it is however the lack of regulation within the industry that causes concern. A good example of this would be ephedra. It took the FDA ten years to ban dietary supplement products containing ephedra, a weight loss and body building supplement ingredient that was found to cause serious medical risks and death. The evaluation of such products is especially difficult since many contain multiple ingredients, have a changing composition over time, or are used intermittently at doses difficult to measure. Because of these difficulties, it may take a long time for the current system of voluntary adverse event reporting to detect problems. Many dietary supplements have been taken off the shelves because they have been found to be contaminated with steroids that are dangerous and potentially deadly. BodyBuilding.com, one of the largest retailers of dietary supplements, voluntarily recalled 65 supplements that may contain steroids off their shelves in November 2009. Any dietary supplement can be contaminated and there is no guarantee that the ingredients listed on the label are all the ingredients in the product.

We should also note that “all natural” does not mean a product is safe to consume, especially if it is marketed and sold as a dietary supplement. There are plenty of natural berries and mushrooms that are poisonous to humans. Grass is natural but the human body can’t digest it (The cellulose makes it indigestible). Plants hold great power and with that power we have the ability to manufacture compounds for a wide variety of human uses: foods, dyes, medicines, construction materials, paper to name only a few. Whether to make a useful medicine or build the homes that we live in; the plant has to be studied, understood and tested. You wouldn’t move into a home that had the capability of being contaminated with a pollutant or poison, so why would you put something in your body with the same capability?

How do we change the current system?

In February, Senator John McCain introduced the Dietary Supplement Safety Act in an attempt to further regulate dietary supplements that may be harmful to health. The new legislation would require that manufacturers register with the FDA and disclose all ingredients in the supplement on the label. This legislation would also give the FDA mandatory recall authority if a product is found to be unsafe or harmful.

Opposition to this legislation is concerned about the authority of the FDA to ban certain products being sold as dietary supplements. There have been claims that pharmaceutical companies would then try to sell them as expensive drugs. There is also a concern that the inexpensive dietary supplement industry will be forced to raise prices on their products to compensate for the extra overhead of the paperwork and time required to be approved by the FDA.

Remember there are vested interests everywhere. Opponents of the bill will try to convince the public that the FDA is under the influence of large pharmaceutical companies who are trying to market former supplements as drugs at a higher cost. But these opponents also stand to lose a lot of money when required to prove their products are safe and effective. Money is a driving force for either side.

It comes down to health and safety. The products are not proven to be safe or effective. They could be a waste of time or money or they could not be. But before you spend the money and the time to find and use dietary supplements, wouldn’t it be nice to know that the products are safe and effective?

Drug Free Sport is a supporter of Supplement Safety Now, a public protection initiative urging Congress to establish regulatory framework to ensure over-the-counter supplements are safe and effective. Visit SupplementSafetyNow.com to learn more.

For more information and research on dietary supplements, please visit the National Institutes of Health website and PubMed.gov.

** The REC DOES NOT recommend the use of any dietary supplement. Always consult with a doctor before taking any type of dietary supplement.