Are supplement users protected at all?

Consumer Reports points out that the supplement industry is legally allowed to sell "products without first having to demonstrate that they are safe and effective," unlike medicine manufacturers who have to follow stricter requirements." This statement ignores a number of important facts:

First, supplements have been widely used by hundreds of millions of people worldwide for decades. Second, supplements have an excellent track record of safety, whereas drugs (both prescription and over-the-counter) have many instances of recall for safety reasons. In fact, since the 1950's more than forty drugs have been removed from the market due to patient deaths and side-effects-including Thalidomide, DES, Vioxx, Bextra, Diethylstilbestrol, Methaqualone, and Fen-phen. Third, supplements are regulated like food, and like food are expected to be safe, regardless of where the ingredients come from, and manufacturers must now follow current good manufacturing processes (cGMP) as regulated under DSHEA. Finally, because supplements are not patentable it is not reasonable to expect commonly used products that sell for pennies to undergo the same level of scrutiny as powerful drugs that can be extremely dangerous that, if approved, can generate billions in profits.

Consumer Reports does not tell the full story. Their concerns, some of which are certainly justified, do not mean that there is no regulatory oversight or no evidence that these products work and are safe to use when taken in amounts that have been shown to be well tolerated. The Food & Drug Administration has complete authority to pull unsafe or adulterated products from the market-and it has done so in the past. For example, the ingredient ephedra was banned from supplements by the FDA in 2004. Moreover, with the FDA's involvement, manufacturers withdrew the Total Body Formula product described in the Consumer Reports article from the market.

The Consumer Reports article classifies all but one of the "Dirty Dozen" list as "possibly" or "likely" unsafe. This classification does not address either effectiveness or recommendations for safe use. Almost anything, taken incorrectly or at too high a dose, can be unsafe.

Because of the low barriers to entry, Consumer Reports raises valid concerns about the ingredient chain for supplement products. This is an issue that should be addressed by all manufacturers and distributors, and be something that consumers are aware of. However, under DSHEA the FDA does have additional tools to regulate and survey supplement manufacturers by ensuring dietary supplement current good manufacturing practices (cGMPs) are met.

Do supplements even work?

The supplement industry sells many products that through research, traditional use, or both are known to be safe and effective. For general health, supplementing with vitamins and minerals has been shown to help prevent or compensate for many deficiencies of the established US Recommended Daily Intake (RDI) nutritional requirements for health. In addition, there are over twenty thousand studies, including many well-designed double-blind, placebo-controlled human studies published in respected peer-reviewed journals, which have shown a range of evidence for many supplements that suggest some safe range or route of administration (orally vs. topically, for example). Even so, to help avoid confusion between supplements and drugs, federal law does not allow supplement manufactures to make any health claims about their product.

Fortunately, research detailing supplements' potential limitations and benefits has been growing exponentially over the past two decades, and reported risks and side effects of the products such as described in the Consumer Reports piece have been well documented by organizations that track this information, such as the Natural Medicines Comprehensive Database (used to inform their article) and the Aisle7 Healthnotes database. Getting that information into public hands is therefore critical to consumer well-being.

Best practices for picking supplements

Supplements can be an effective option when considering how best to prevent and manage health problems. Any person considering supplements should talk to their pharmacist or healthcare practitioner in order to understand the risks and benefits. It is worth repeating recent comments by Alan R. Gaby, MD, chief science editor at Aisle7, published in a related Healthnotes Newswire story on supplement safety: "While it is important to identify the purest sources of vitamins, minerals, herbs, and other natural substances, the majority of the evidence indicates that the benefits of taking recommended amounts of dietary supplements for proven benefits outweighs the risks."

Fortunately, many products and brands on the market are already created and sold by credible retailers and manufacturers that take consumers' health seriously, and demand for high-quality products forces less conscientious groups to follow in kind. To get the most out of all the healthcare resources at our disposal, there are plenty of things that you can do to choose your supplements safely:

• Research before you buy. Avoid "miracle cures" by learning what you should realistically expect from supplements. Look for unbiased, science-based resources (online and in-store, such as those provided by Aisle7) that can help you make informed decisions on whether supplements are right for you and what is safe to take with your medications.
• Understand the potential risks. Supplement users sometimes mistakenly assume that "natural" automatically means "beneficial" (or at least "nonharmful"). Take supplements with as much care as you do your medicines, and discuss your options with your doctor first if you are already under treatment with medicines.
• Read product labels carefully and rely on credible third-party information to help you to interpret the message. "This product helps lower blood pressure" does not mean the same thing as "This product supports heart and vascular health."
• Do not listen to anyone other than your doctor if they recommend you take a supplement in place of your medication. ("Take red yeast rice instead of your atorvastatin cholesterol medication.")
• Consider the source. Buy only from reputable and established companies. High-quality companies manufacture according to FDA regulated "good manufacturing practices," which require thorough record keeping, quality testing, and standards consistent with the manufacture of drugs. Buying from these companies helps you buy with confidence.

In these days of soaring healthcare costs, it is reasonable for consumers to take advantage of every safe, affordable self-care option at their disposal. All health recommendations-diet, exercise, mammograms, flu shots, fats, carbs, all of it-is constantly changing, and whether policy changes with it or not, people need to take charge of their health and base their healthcare decisions on objective information that helps them minimize potential risks and optimize potential benefits.