Natural does not necessarily mean healthy. Although dietary supplements sometimes provide crucial health benefits, supplements often do not live up to the health hype proclaimed by manufacturers. In addition, quality varies between brands and even between batches of the same brand. In some cases, the difference in quality creates a slightly less-effective product. In other cases, the difference results in vitamin or mineral toxicity, harmful contamination and potentially irreversible health risks.
Pre-Market Approval
The U.S. Food and Drug Administration, or FDA, approves pharmaceuticals before they reach the market. Pharmaceuticals undergo rigorous testing for safety and efficacy. The FDA reviews research and retains the authority to deny approval to any pharmaceutical that does not meet strict standards of quality, safety and proven effectiveness. Many people assume that the same is true for supplements. In fact, the FDA lacks authority to decide whether supplements are unsafe or ineffective before they reach consumers.
Manufacturers' Role
The Dietary Supplement Health and Education Act, or DSHEA, tasks supplements manufacturers with the responsibility of warranting a supplement's safety before marketing it to consumers. DSHEA also requires manufacturers to label supplements with information that is truthful and not misleading. The DSHEA creates a sort of honor system that permits a manufacturer to state that its product is safe without presenting evidence to support its position. Manufacturers have no duty to disclose evidence to the FDA or consumers except when marketing a new dietary ingredient.
FDA's Role
Once a product reaches the market, the FDA has authority to review claims of safety. If the FDA receives evidence of a supplement's health risks -- sometimes in the form of injuries or deaths -- the FDA can review the evidence and ban the supplement or limit its use. The FDA posts on its website warnings about specific supplements that have received complaints or evidence of potential health risks.
GMP Certification
Good Manufacturing Practice, GMP, refers to a FDA-approved checklist of manufacturing practices that support production of quality products. To receive GMP designation, an independent company performs an inspection of the manufacturing facility, equipment, employees, raw materials, production methods, quality control procedures, record-keeping, labeling information and any complaints or medical reports associated with use of the product. According to the NIH Office of Dietary Supplements, GMP approval indicates proper manufacturing methods, truthful labeling and exclusion of contaminants, but does not guarantee a product's safety or efficacy. Companies that offer GMP testing include U.S. Pharmacopeia, ConsumerLab.com, NSF International and Natural Products Association.
Misleading Terminology
When marketing their products, manufacturers often use terms meant to convey the impression of quality. The word, "standardized," implies consistency. The term, "standardized," is not officially defined by a government agency or industry organization. Similarly, the terms, "certified" and "verified," are not industry or government defined terms and offer no guarantees about a product's safety or quality.
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