Nutritional Supplements and You

1. FDA Regulation

   The nutritional supplement industry has been poorly regulated since 1994, when Congress passed the Dietary Supplement Health and Education Act (DSHEA). Since the passage of this act, the ingredients used in nutritional supplements have not been subject to safety or even content accuracy evaluation before being put on the market. The Food and Drug Administration (FDA) has been charged with investigating whether a supplement is hazardous only after it is already on the market, being sold to the U.S. public. As a result, the supplement industry has become a virtually unregulated "free-for-all." Thousands of uninspected and unreviewed 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) recently announced its final ruling on Good Manufacturing Practices (GMPs) for dietary supplements. In order to ensure that finished products contain actual labeled contents, and do not contain contaminants, supplement manufacturers will now be required to show analyses of their production records. However, smaller companies have a longer period of time before they have to comply with these regulations than larger companies. Until the new regulations are enforced among all dietary supplement manufacturers, each consumer will still need to be concerned about the accurate labeling of the supplement, and its freedom 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.
    

2. Effectiveness

   Although the FDA generally prohibits supplement producers from making specific health claims for their products, nevertheless 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, and cranberries have been shown to decrease the risk of urinary tract infections. Your choice of a meaningful and effective nutritional supplement, like your decision to take certain prescription medicines, requires careful selection.
    

3. Safety

   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 health care provider is very important.
    

4. Accuracy and Purity

   Since 1994, 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 new requirements in 2007, and supplement companies will have to provide detailed analyses of their ingredients, the FDA will allow these requirements to phase in, and this will take still further time to enforce. It is therefore important to choose supplements that have been independently certified by NSF International or USP®.
    

5. Medication Interactions

   The health care provider who helps you carefully select your nutritional supplement can also help you monitor its use. Over the past years, a number of nutritional supplements have caused unwanted side-effects and have been found to be unsafe. Your health care provider can help monitor for side-effects and watch for negative nutrient-nutrient or drug-nutrient interactions. Many herbal ingredients have been found to interact with medications or other dietary supplements. For example, high doses of vitamin E and gingko biloba can increase the effect of blood-thinning medications (such as Coumadin) well beyond the desired result.

   Finally, your health care provider can monitor dosage and its effects. He or she will be sensitive to dosage-related issues, looking for complications that would result if a supplement contained more of an ingredient than listed on the label, or noting a supplement's failure to provide the promised benefits, perhaps because the supplement contains less of an ingredient than listed on the label. If you have further questions regarding the recommended dosage and safety of certain nutritional supplements, please contact our Registered Dietitian at questions@ConceptionXR.com.
    

The ConceptionXR® Difference-

• Evidence-based formulation: ConceptionXR® is a safe, evidence-based nutritional supplement formulated by a panel of leading fertility specialists.
   
• Medical Advisory Board oversight: The ConceptionXR® formulation is reviewed quarterly by our medical advisory board, and if needed, the formulation is updated to represent the latest scientific research.
   
• Independently certified: Fertility Sciences has always adhered to even more rigorous testing than the FDA’s new regulations will require. ConceptionXR is manufactured in an NSF-GMP certified facility and has received NSF® nutritional supplement certification for product content, accuracy, and purity. NSF International is a not-for-profit, non-governmental, third party organization that is the world's leader in standards development and product certification in the health and life safety industries. The NSF mark ensures the consumer that the product has been approved by the most demanding and comprehensive independent certification program employed by the nutritional supplement industry.
   
• No herbal content: As mentioned previously, herbal content can present problems such as difficulty in standardizing ingredients and potential adulteration with harmful contaminants. Therefore, ConceptionXR® contains no herbal ingredients.