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The law defines dietary supplements in part as products taken by mouth that contain a dietary ingredient dietary ingredients include vitamins minerals amino acids and herbs or botanicals as.
Dietary supplement vs food fda. Office of dietary supplement programs hfs 810 food and drug administration 5001 campus dr college park md 20740. The fda defines a dietary supplement as. A dietary supplement is considered new if it contains an ingredient not recognized as a food substance unless it was sold as a supplement before october 1994.
These products have a nutrition facts label and must contain ingredients that are generally regarded as safe gras or formally approved by the fda. However the food and drug administration fda claims that dietary supplements are not intended to diagnose treat cure or prevent any disease as done by drugs. In 1994 the dietary supplement health and education act dshea created a new legal class of food called dietary supplements which created a new subcategory of fda regulated foods.
A dietary ingredient is a vitamin. The term dietary supplement means a product intended to supplement the diet that contains one or more dietary ingredients. Fda acceptable labeling claims are often dependent upon whether your product is classified as a conventional food or as a dietary supplement fda s federal food drug and cosmetic act ffdca defines food as articles used for food or drink for man or other animals chewing gum and articles used for components of any.
However dshea carved out unique regulatory exemptions and requirements. A dietary supplement is a product intended for ingestion that contains a dietary ingredient intended to add further nutritional value to supplement the diet. In some countries including the usa and canada dietary supplements are a subset of food which can be regulated accordingly.
Many parts of the food drug and cosmetic act fd c still apply to dietary supplements. The ingredients listed on a food label must also come in quantities that the fda has deemed to be gras. If it is new the manufacturer must provide the fda with reasonable evidence that the new ingredient is safe before the supplement is marketed to the public.
A dietary substance for use by man to supplement the diet by increasing total dietary intake. An herb or other botanical. To contact the office of dietary supplement programs email.
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