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EnduraQ is Gluten-Free and FDA GRAS

EnduraQ is Gluten-Free and FDA GRAS

EnduraQ has obtained many certifications. It is natural, non-GMO, pesticide-free, and gluten-free. However, EnduraQ’s most prestigious and rigorous designation is being on the Food and Drug Administration’s “Generally Recognized as Safe” list, also known as the FDA GRAS list.

Obtaining “generally recognized as safe” status for a dietary supplement is a very thorough and complex process. Supplement manufacturers can either submit GRAS notifications to the FDA for approval, or they can conduct a “self-affirmed” GRAS notification in which the manufacturer does not submit a GRAS notification to the FDA, but has the evidence to defend the product’s GRAS status. In both scenarios, the manufacturer must demonstrate safe use, either by demonstrating a “substantial” history of safe consumption, or through a scientific review process conducted by a panel of qualified experts.

Using the latter method to obtain a GRAS designation requires a panel of outside experts (qualified by “scientific training and experience”) to evaluate the safety of the dietary ingredient in the context of using the supplement as indicated on the product’s label. Simply put, in order to obtain GRAS status, the ingredient must be safe and the information showing it to be safe must be agreed upon by qualified scientific experts. For a more in-depth explanation of the process and requirements, read this article.

A thorough explanation of what exactly qualifies an ingredient as “safe” can be found here. According to the FDA, safety is defined as “reasonable certainty that the substance is not harmful under the intended conditions of use.” Reasonable certainty is achieved on the basis of “common knowledge about the ingredient throughout the scientific community knowledgeable about the safety of substances added to foods” and “through scientific procedures,” which encompasses “scientific data, information, methods, or principles, which ordinarily are published and may be corroborated by unpublished scientific data, information or methods.” Scientific information supporting the safety of a substance may include analytical, in vitro, animal and human studies.

EnduraQ is very proud to be a product that meets all of the high standards required to obtain FDA GRAS status. EnduraQ is plant-based, natural, non-GMO, pesticide-free, gluten-free, and—most importantly—EnduraQ is safe.

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