The Theralogix Medical Advisory Board has authorized the development of nutritional supplements that meet the highest standards of evidence-based science in the following Specialty Divisions. Choose any Division to see the products available in that Specialty.
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The Nutritional Supplement Industry: A Poor Reputation, Richly Deserved
The nutritional supplement industry has a history of poor regulation. Though the Dietary Supplement Health and Education Act of 1994 (DSHEA) requires that companies use safe ingredients, the Food and Drug Administration (FDA) does not approve nutritional supplements or even review the ingredients for safety before they are put on the market. Instead, FDA can only investigate whether a supplement is hazardous after it is already being sold to the U.S. public. As a result, the supplement industry has become a virtually unregulated "free-for-all." Thousands of potentially unsafe nutritional supplements are sold over the internet, in drugstores, through mail order, even via radio and television. Looking to introduce some legitimacy to this market, the Food and Drug Administration (FDA) issued its final ruling on Good Manufacturing Practices (GMPs) for dietary supplements in 2007. This rule sets forth minimum requirements needed to ensure the quality of dietary supplements, and requires companies to establish and follow strict procedures for manufacturing, packaging, labeling, and holding dietary supplements. While these regulations are an improvement, FDA cannot inspect every facility and still does not review and approve supplements before they are sold. Therefore, consumers still need to be concerned about the accurate labeling of supplements, and whether their ingredients are safe and free from contaminants. In addition, despite the new regulations, consumers must always be aware of potential interactions between certain nutrients, herbal supplements and prescription medications, and whether the supplement ingredients have actually been shown to be effective for a certain condition or population group.
Although the FDA generally prohibits supplement producers from making specific health claims for their products, the industry has succeeded in misleading consumers about the benefits of many widely sold supplements, suggesting that a certain ingredient has a certain result on a certain condition or disease without any scientific evidence. This has tarnished the image of all nutritional supplements. Even so, there are some nutritional supplement ingredients that have been studied in well-designed clinical trials, which appear to offer real benefits to people with specific health problems or to patients who are at an increased risk for certain diseases. For example, coenzyme Q10 has shown benefit for those in the early stages of Parkinson's, omega-3 fish oil has been shown to decrease the risk of sudden death from heart disease, cranberries have been shown to decrease the risk of urinary tract infections, and vitamin D has been associated with a decreased risk of several cancers and a variety of other health conditions. Your choice of a meaningful and effective nutritional supplement, like your decision to take certain prescription medicines, requires careful selection.
Over the past several years, a number of nutritional supplements such as kava, ephedrine, Lipokinex, and PC-SPES have been found to be either adulterated or unsafe. Often these problems were discovered only after widespread use was already underway. Just because a product is derived from "natural" or "herbal" sources does not assure safety. It is up to the consumer to choose a supplement that is safe, evidence-based, and effective. Formulas and ingredients should be overseen by credentialed experts, and involvement and oversight from your healthcare provider is very important.
Dietary supplement manufacturers have not been required to show any proof of their products' content accuracy, purity, or freedom from contaminants. Although the FDA finalized the GMPs in 2007 and supplement companies need to conduct detailed analyses of their ingredients, it is clear from FDA enforcement actions that not all companies are in compliance. It is therefore important to choose supplements that have been independently certified by NSF International or USP®.
The healthcare provider who helps you carefully select your nutritional supplement can also help you monitor its use. Your healthcare provider can help monitor for side-effects, and also watch for negative interactions: between nutritional supplement ingredients, medications, and other treatments. For example, high doses of vitamin E and gingko biloba can increase the effect of blood-thinning medications well beyond the desired result. Finally, your healthcare provider can monitor dosage and its effects. If you have further questions regarding the recommended dosage and safety of certain nutritional supplements, please contact our Registered Dietitian.
Theralogix was established to address the problems presented above.