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Since 1994 supplements have been regulated by the Dietary Supplement Health & Education Act (DSHEA), which for all intents and purposes, classifies supplements and dietary ingredients as food. Oversight of the law falls under the Food & Drug Administration (FDA), which has as its primary mission, to ensure that supplement ingredients are safe, not adulterated or misbranded, and to oversee claims made by supplement marketers. Unlike pharmaceutical companies which can make disease claims, supplements are limited to “structure/function” claims which describe the role a nutrient or ingredient plays on the structure or function of the body.
Recently, the FDA made alarming statements regarding N-Acetyl Cysteine (NAC), stating that they do not recognize NAC as a supplement. This has led a number of high profile companies to stop making NAC supplements. While no official ruling has been made, the handwriting is on the wall. Access to supplements is becoming increasingly difficult.