According to the law dietary supplement is considered to be food which does not need pre-market approval by the FDA, and not as a food additive which needs a pre-market approval by the authority. A statement on the label of a dietary supplement is allowed if a benefit is claimed related to a classical nutrient deficiency, if the role of the ingredient is described, or if the documented mechanism of action to maintain a function is characterized. Also it must be clearly stated that this statement has not been evaluated by the FDA, and that this product is not intended to diagnose, treat, cure or prevent any disease. The ingredients, the plant and/or its parts and their quantities must be clearly listed. If the supplement claims to conform to an official compendia standard (USP) for which there is an official specification and fails to meet that standard, the product is regarded as misbranded. Products not covered by official compendia failing to meet the claimed identity, strength, quality and purity are also considered misbranded. The signing into law of the DSHAE has accelerated the recognition and importance of herbal products in the US market, with the law giving an opportunity to market these products as dietary supplements, provided there is data to support claims with reasonable substantiation and to show that the products are safe.

However since the FDA does not accept bibliographic evidence of effectiveness and prefers randomized controlled trials as evidence of efficacy, at present it is not possible to market a herbal product as a drug in the United States. Otherwise the guidelines for the manufacture of herbal products, quality of evidence to the claims made etc. like elsewhere are in accordance with GMPs established by the FDA.