Before knowing answer to this question we should have a clear understanding of what is FDA?
The U.S. Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for the safety regulation of most types of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics.
The Dietary Supplement Health and Education Act of 1994 mandated that the FDA regulate dietary supplements as foods, rather than as drugs. Therefore, dietary supplements are not subject to safety and efficacy testing and there are no approval requirements. The FDA can take action against dietary supplements only after they are proven to be unsafe.
FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products (prescription and Over-the-Counter). Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements.* Manufacturers must make sure that product label information is truthful and not misleading.
What is a dietary supplement?
A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet. Whatever their form may be, DSHEA places dietary supplements in a special category under the general umbrella of "foods," not drugs, and requires that every supplement be labeled a dietary supplement.
L-Glutathione is considered a food/dietary supplement. Therefore, it is not necessarily need to be FDA / BFAD approved. Only manufactured drugs, foods, medical devices and cosmetics required undergo these departments quality control. Also, there are no provisions in the law for FDA to "approve" dietary supplements for safety or effectiveness before they reach the consumer.
No compounded product is FDA approved in the narrow sense of the definition, but Glutathione is in the GRAS (generally regarded as safe) category
About the Author
ABOUT THE AUTHOR: Cecille and Lindley Miras specializes on topics of Glutathione and skin whitening. Their website, www.insideout-quality.com and their blog www.livebestlifenow.com provides a wealth of informative articles and resources on everything you'll ever need to know about Glutathione and skin whitening.
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