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DSHEA Summary

SHEA Summary

he Dietary Supplements Health and Education Act of 1994 (DSHEA) amended previous statute

compass dietary supplement-specific provisions including the definition of a "dietary supplement"

oduct safety, nutritional statements and claims, ingredient and nutritional labeling, good

anufacturing procedures, and the classification of "new" dietary ingredients.

nder the DSHEA, a dietary supplement:

q is a product (other than tobacco) that is intended to supplement the diet, which contains one o

more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an

amino acid, a dietary substance to supplement the diet by increasing the total daily intake, or a

concentrate, metabolite, constituent, extract, or combinations of these ingredients.

q is ingested in pill, capsule, tablet, or liquid form.

q is not represented for use as a conventional food or as the sole item of a meal or diet.

q is labeled as a "dietary supplement."

SHEA addresses safety concerns by imposing the burden of proof of ingredient safety on the

anufacturers of dietary supplements, just as has traditionally been done in the food industry. DSHEso regulates third-party literature regarding dietary supplements: informational materials (i.e., artic

ct sheets, etc.) may be displayed in commercial retail sites provided they are displayed separately f

e product, do not contain false or misleading information, and do not promote a specific brand of

pplement.

erhaps most importantly, DSHEA regulates the labeling of dietary supplements. Under this provisio

y claims to prevent, treat, or cure a specific disease are expressly prohibited (unless approved by th

DA). For example, a claim linking folic acid and the reduced risk of neural tube birth defects may b

lowed, but a product label that claims the product "cures cancer" or "treats arthritis" is not allowed.anufacturers, however, can make statements about nutrient deficiency diseases, as long as these

atements disclose the prevalence of the disease in the United States. Also, statements describing the

pplement's effects on the "structure and function" or general "well-being" of the body are allowed,

ng as they are truthful and bear the statement "This statement has not been evaluated by the Food

nd Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any

sease." The product label must identify the product as a dietary supplement (ie, "Powdered Garlic

ietary Supplement").

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DSHEA Summary

nally, like food products, dietary supplements must bear nutritional labeling. This information mus

clude the name and quantity of each dietary ingredient, and if the ingredient is botanical in origin,

ust state the part of the plant from which the ingredient is derived.

upplement manufacturers may not use ingredients that were not marketed before October 1994, unl

e ingredient was already in common use with a history of safety usage similar to its use today.

anufacturers wishing to use new dietary ingredients must notify the FDA 75 days before marketing

oduct, and must provide the FDA with evidence demonstrating that the ingredient "will reasonablypected to be safe."

SHEA also grants the FDA the authority to establish good manufacturing processes (GMPs) govern

e production of dietary supplements.

or a more information about the DSHEA Act, go to:

DA's Summary of DSHEA

tp://vm.cfsan.fda.gov/~dms/dietsupp.html

ull text of DSHEA at HealthWorld Online

tp://www.healthy.net/public/legal-lg/fedregs/S784_ENR.HTM>http://www.cfsan.fda.gov/~dms/

etsupp.html

ast modified 11/April/2003 by IS

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