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This misperception may in part exist because FDA has not fulfilled the Dietary Supplement Health and Education Act. Pharmavite has supported and endorsed , and long awaited formal GMPs to compliment our own efforts to build public confidence in the quality and safety of our products . However , if a dietary supplement claims to be a substitute for a drug that is not intended to treat or prevent disease ( i.e ., a drug intended to affect the structure or function of the body ) , the claim comparing the drug and the dietary supplement would not be a disease claim . " Congress defined the term ' dietary supplement ' in the Dietary Supplement Health and Education Act ( DSHEA ) of 1994 . However , the use of these terms on dietary supplements may deceive consumers into thinking they are purchasing a prescription drug without a prescription . Considers whether or not the magnitude of the risk-reduction effect in the target population is physiologically meaningful and achievable in the general US population or a subgroup of the US general population under intake and use conditions that are appropriate for such conventional human food and human dietary supplements that would be the subject of the claim . Consumption of vitamins and dietary supplements will become a part of their daily diet . The Dietary Supplement Health and Education Act of 1994 places dietary supplements in a special category of foods . Thus , to maximize the public health benefit of its claims review process , FDA intends to prioritize on a case-by-case basis all complete petitions according to several factors , including whether the food or dietary supplement that is the subject of the petition is likely to have a significant impact on a serious or life-threatening illness ; the strength of the evidence ; whether consumer research has been provided to show the claim is not misleading ; whether the substance of the claim has undergone an FDA safety review ( i.e ., is an authorized food additive , has been GRAS ( generally recognized as safe ) affirmed , listed , or has received a letter of " no objection " to a GRAS notification ) ; whether the substance that is the subject of the claim has been adequately characterized so that the relevance of available studies can be evaluated ; whether the disease is defined and evaluated in accordance with generally accepted criteria established by a recognized body of qualified experts ; and whether there is prior review of the evidence or the claim by a recognized body of qualified experts . Thymus extract products consist of peptides taken from the thymus glands of cows or calves and are sold as dietary supplements . The Commission on Dietary Supplement Labels examined the health claim authorization process for dietary supplements and also generally expressed agreement with FDA 's approach in its report ( 3 ) . Among other provisions , NLEA authorized FDA to allow statements that describe the relationship between a nutrient and a disease or health-related condition to appear in the labeling of foods , including dietary supplements . The Act , as amended by the Dietary Supplement Health and Education Act of 1994 ( DSHEA ) and the legislative history accompanying DSHEA do not define " substantiation . " This scientific standard applies to conventional food health claims by statute ; FDA applied the same standard to dietary supplement health claims by regulation . We recommend that the studies being used as substantiation for dietary supplement claims identify a specific dietary supplement or ingredient and serving size and that the conditions of use in the studies be similar to the labeling conditions of the dietary supplement product .