In today’s world health has become a big business. You can not watch television with out seeing a commercial for a “memory enhancing” pill or a magic weight loss supplement. America’s perception of beautiful has sent many Americans running to their local health store in hopes of finding their “miracle cure”. It is estimated that more than half of all Americans take some type of dietary supplement. Currently, there are about 30,000 products marketed in the United States as dietary supplements, making the industry worth more than $17 billion per year. Despite the fact that dietary supplements have become big business, manufacturing standards for quality, potency and effectiveness are inconsistent in many cases.
According to the Dietary Supplement Health and Education Act approved by Congress in 1994, the term "dietary supplement" refers to a wide range of products including “vitamins, minerals, herbs or other botanicals, amino acids, enzymes, hormones, concentrates, extracts and metabolites taken orally that contain an ingredient meant to supplement the diet”(USFDA.) Unlike food and drugs, which are highly regulated by the U.S. government, the Food and Drug Administration does not require supplements to be tested for safety and effectiveness before they are sent into the marketplace. Some manufacturers take advantage of the limited regulations placed on supplements by using questionable marketing tactics and possibly providing misleading information.
When Congress passed the Dietary Supplement Health and Education Act (DSHEA) in 1994 the FDA's control over products labeled a dietary supplement was limited. The DSHEA states that manufacturers don't have to prove the safety or efficiency of a product before they put it on the market. With this act, Congress acknowledged that consumers believe supplements provide health benefits and that they want greater responsibility for deciding if the supplements are helpful to them. As a result, dietary supplements are not subjected to the same rigorous standards as are prescription drugs or those sold over the counter. Dietary supplements can be marketed with limited proof of effectiveness or safety. Vendors can make health claims about products based on their own review and interpretation of studies without FDA authorization. However, the FDA can pull a product off the market if it is proved dangerous.
In November of 2004 the FDA initiated a new plan to place stronger regulations on manufacturers of dietary supplements. The FDA plans to work collaboratively with its partners to improve the evidence base it uses to make safety and enforcement decisions about dietary ingredients and dietary supplements. Those partners include the National Institutes of Health Office of Dietary Supplements and National Center for Complementary and Alternative Medicine, the National Toxicology Program in the Department of Health and Human Services, the University of Mississippi's National Center for Natural Products Research, FDA's National Center for Toxicological Research, and several others (USFDA.)
The FDA's regulatory actions will be based on the scientific evidence available, including the pharmacology of the substance, scientific literature, adverse event reports, and evidence-based reviews. It has a variety of options for pursuing its mission, including determining unreasonable risk, issuing public health advisories, educating consumers, conducting research, and requiring labeling changes. The agency says it is committed to taking action against unsafe products. After determining that products containing androstenedione posed significant health risks the FDA sent warning letters to 23 companies in March 2004 asking them to cease distributing products sold as dietary supplements that contain androstenedione and warning them that they could face further enforcement actions if they did not take appropriate measures.
Another aspect to the agency’s strategy is ensuring product quality. This addresses the need to establish industry-wide standards to help ensure that dietary supplements are manufactured consistently as to identity, purity, quality, strength, and composition. Because the FDA is committed to protecting consumers against dietary supplements that make false or misleading claims the agency will also continue to monitor and evaluate dietary supplement labeling and take enforcement action, as appropriate. This measure will include monitoring of labeling claims, including claims in literature such as flyers, brochures, and catalogs, and in Internet labeling.
The FDA will be identifying and taking enforcement action against products whose labeling fails to reveal material facts, targeting those products that pose the greatest risk to consumers. They plan to obtain and analyze samples of dietary supplements in the marketplace to verify that the contents are consistent with the labeling and review supplement facts panels to determine whether the substances listed as dietary ingredients can be lawfully marketed in dietary supplements.
The FDA also sent a letter to major retailers of dietary supplements to inform them that products labeled with unsubstantiated claims are misbranded and that the FDA may take enforcement action against misbranded products in their possession. The FDA intends to start a program of inspections of retail establishments to identify products bearing unsubstantiated claims in their labeling. (USFDA)
The independent Institute of Medicine (IOM) and National Research Council of the National Academies developed a report designed to boost the FDA’s ability to evaluate the safety of dietary supplements. They believe the FDA does not need to wait for evidence of harm to humans to take action. In studies done by the IOM, glucosamine, used to support joint health, was discovered to possibly pose risks to people with insulin resistance. Supplement manufacturers are facing greater FDA action and there are now several government bills calling for tighter regulation, including mandatory adverse reporting. The report calls for supplement makers, the public, and others to increase their reporting of health problems related to supplement use to in order to help the FDA protect consumers. It also suggests that to further boost reporting, labels on supplements should include a toll-free number for consumers and health professionals to call in health problems or concerns related to the product. This is because lack of reporting has significantly hampered the agency's ability to actively monitor supplement safety.
The IOM report argues that the assumption of safety of a dietary supplement before reaching the market means the FDA does not need to wait for evidence of harm to humans to take action. The agency must show that a product poses an unreasonable risk to users. Historical use is not always enough by itself to prove the safety of a supplement, even if it has been consumed for centuries, changes in how an ingredient is formulated or processed raise the potential for new adverse effects. (NOVIS)
There for, the American Dietetic Association offers guidelines for supplement use such as checking with your doctor before using any supplement, take exactly as directed, and looking for products labeled with the voluntary USP (United States Pharmacopeia) or NF (National Formulary) letters, which indicate that the manufacturer self-reports voluntary standards of quality. As doctors and researchers continue to explore the safety and effectiveness of dietary supplements, more is learned about both their promises and their pitfalls. At the same time, legislators at the national level continue to press for effective laws to protect consumers from potentially harmful dietary supplements. (Kendall)
Whether Americans are purchasing dietary supplements to improve their appearance, promote general health, or help them maintain a healthier lifestyle, they may fall victim to products that cheat them out of their money or steer them away from products that are proven to achieve the results they are seeking.

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