The DSHEA amended previous statutes to encompass dietary supplement-specific provisions including the definition of a “dietary supplement”, product safety, nutritional statements and claims, ingredient and nutritional labeling, good manufacturing procedures, and the classification of “new” dietary ingredients.
What does the FDA require of “supplements”?
Under DSHEA, the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. The 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 the FDA nor get FDA approval before producing or selling dietary supplements. Manufacturers must however make sure that product label information is truthful and not misleading.
What does DSHEA consider a “supplement”? A product:
- (other than tobacco) that is intended to supplement the diet, which contains one or 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
- that is ingested in pill, capsule, tablet, or liquid form
- that is not represented for use as a conventional food or as the sole item of a meal or diet
- that is labeled as a “dietary supplement”
DSHEA also addresses safety concerns by imposing the burden of proof of ingredient safety on the manufacturers of dietary supplements, just as has traditionally been done in the food industry. DSHEA also regulates third-party literature regarding dietary supplements: informational materials (i.e., articles, fact sheets, etc.) may be displayed in commercial retail sites provided they are displayed separately from the product, do not contain false or misleading information, and do not promote a specific brand of supplement.
Perhaps most importantly, DSHEA regulates the labeling of dietary supplements. Under this provision, any claims to prevent, treat, or cure a specific disease are expressly prohibited (unless approved by the FDA). For example, a claim linking folic acid and the reduced risk of neural tube birth defects may be allowed, but a product label that claims the product “cures cancer” or “treats arthritis” is not allowed. Manufacturers, however, can make statements about nutrient deficiency diseases, as long as these statements disclose the prevalence of the disease in the United States. Also, statements describing the supplement’s effects on the “structure and function” or general “well-being” of the body are allowed, as long as they are truthful and bear the statement “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” The product label must identify the product as a dietary supplement.
Finally, like food products, dietary supplements must bear nutritional labeling. This information must include the name and quantity of each dietary ingredient, and if the ingredient is botanical in origin, must state the part of the plant from which the ingredient is derived.
DSHEA also grants the FDA the authority to establish good manufacturing processes (GMPs) governing the production of dietary supplements.
The only negative in this equation is that since nutritional supplements cannot bet tested as drugs, supplement makers whose products really are amazing and life-changing in some cases are not legally allowed to share with you, the general public, the nature and true extent to which their products may help you. It is therefore illegal for a supplement maker or wellness networker to advise you that a product may help you with a specific disorder or condition, even if all evidence, science and sound logic support the fact that the product “actually does something”. You may wonder why supplement companies don’t just come out and say to you what their products actually can do for you. Legally, they can’t. The government and the FDA won’t let them.
For more information visit http://www.fda.gov/food/DietarySupplements/default.htm.