Filed under: Dietary supplements
When you choose a multivitamin or supplement from the store, have you ever wondered how to choose? Or if there’s any regulation to ensure the one you choose is safe, and that you’re getting what you’re paying for? Regulation is perhaps the least understood aspect of the dietary supplement industry. We, here at HPRC, hope we can shed some light on the matter. Look for the quickest way to ensure quality and safety in your supplements at the end of the article.
Dietary supplements are regulated, but not as strictly as many might want. Oversight of dietary supplements began with the 1994 Dietary Supplement Health and Education Act (DSHEA). Since supplements are intended to supplement one’s diet, they are regulated the way food is, and not as drugs are. Under DSHEA, the U.S. Food and Drug Administration (FDA) regulates dietary supplements by holding manufacturers accountable in five important areas: Manufacturers are required to ensure that the supplement is safe; make truthful claims; abide by current Good Manufacturing Practices (cGMPs); submit to FDA all reports of serious adverse events, and notify FDA before it markets a supplement containing a “new dietary ingredient” (NDI).
What consumers should know is that manufacturers cannot sell unsafe, ineffective supplements; they have to document that their product will not harm anyone, and provide convincing evidence that the product does what it claims. To further ensure safety and effectiveness, the FDA closely regulates supplement labels for accuracy and honesty. All information on the label must be truthful and conform to all FDA standards. It has to list the sources of all components, and the amount of key nutrients and ingredients. Manufacturers are also required to report to the FDA before marketing supplements containing new dietary ingredients, which must have data supporting safety of the ingredient. The FDA also regulates manufacturing standards using the current Good Manufacturing Practices (cGMP) to ensure product quality and safety. Violation of cGMP is a violation of the law. Lastly, the FDA requires manufacturers to report on serious adverse events that may occur from consumers using their products.
Despite this oversight, there’s a misconception that dietary supplements are not regulated. This could be because supplements don’t require pre-market approval, and the post-market responsibility of FDA simply ensures compliance with the regulations listed above. The downside of this is that some unsafe and contaminated products end up on the market. Once there, the FDA has to prove that the product is unsafe (or show that the information on its label is untruthful or misleading), before it can be removed from the market. Also, although supplement labels are highly regulated, the content of separate brochures and fliers is not subject to FDA rules.
Enforcing regulations take time and resources. Since the cGMP rule went into effect in June 2008, the FDA has conducted approximately 55 inspections for compliance with the new regulations – and in light of the thousands of companies manufacturing supplements, there’s some dissatisfaction with the progress of the FDA.
So how can you protect yourself, as a consumer, from ineffective or even potentially unsafe supplements? There’s a simple answer: When purchasing dietary supplements, choose products approved by independent organizations that offer certification or verification. Look for supplements whose labels display a seal from the United States Pharmacopeia (USP), the non-profit NSF International, or the Natural Products Association (NPA). Since these verifications are voluntary and are performed at the company’s expense, you can be certain that approved products have little or no contaminants, that the ingredients are present in the labeled amounts, and the labels are accurate.
Recent research suggests that antioxidant (vitamins A and E) supplementation has no effect on exercise performance after strenuous endurance training in individuals without vitamin deficiencies. Instead of taking antioxidant supplements to enhance performance, it’s more beneficial to eat a balanced diet with lots of fruits and vegetables.
Recent surveys of dietary supplement use indicate that about 20 percent of active duty personnel are using some type of protein powder. The percentage of users is likely higher among special operations personnel, and this is of concern, given the July 2010 Consumer Reports® alert on protein drinks. These powder products are typically mixed with milk, water, or another liquid to make a shake and promoted as a sure way to increase muscle mass. The products often come in different flavors, with strawberry and chocolate the mainstays.
The Consumer Reports® Alert indicated that most of the 15 protein drink products analyzed contained miniscule to concerning amounts of selected contaminants – arsenic, cadmium, lead, and/or mercury – each of which is toxic to various organs in the body. Military personnel commonly use several of the products noted in the report. These include EAS Myoplex Original Rich Dark Chocolate Shakes; Muscle Milk chocolate, vanilla crème, and nutritional shake beverages; MuscleTech Nitro-Tech Hardcore Pro-Series Vanilla Milkshake; selected GNC products, and BSN and Optimum Nutrition whey protein products.
It is important to note that if three servings of these products were taken per day, consumers could be ingesting amounts of these contaminants in excess of the maximum limits proposed by the United States Pharmacopeia, the authoritative standard for health products. Importantly, toxic effects have been reported from using these products and are of concern because the Food and Drug Administration does not require such products to be tested to confirm the absence of contaminants and other potentially dangerous products before they are sold.
Take Home Message: A chicken breast, three 8-oz glasses of milk, and three eggs are inexpensive sources of high quality protein, whereas protein powders are expensive sources of uncertain quality, and potentially contaminated, protein. It is both better and cheaper to eat real foods.
The FDA does not strictly regulate dietary supplements. As a result, supplements may not be as pure as stated on the label and may have potentially harmful contaminants. When purchasing dietary supplements, choose products approved by United States Pharmacopeia (USP) or other reputable sources.
Dietary supplements may interact with medications or other dietary supplements, and may even contain ingredients not listed on the label. To help ensure coordinated and safe use, inform your health care provider about any dietary supplements you are using.
Remember, taking dietary supplements alone will not reduce your disease risk. You must engage in complementary behaviors such as healthy eating and regular physical activity. Visit the "Dietary Guidelines for Americans" publication for more information.
MuscleMaster.com, Inc. (www.MuscleMaster.com) announced that it is conducting a voluntary nationwide recall of all lots and expiration dates of the seventeen listed dietary supplements sold between June 1, 2009 and November 17, 2009 (hereinafter "Recalled Products"). Click here to read more.