FDA Dietary Supplement Labeling Consultant

Dietary supplements are products that are ingested and intended to supplement or “supplement” the diet. Supplements can come in many different forms, including tablets, capsules, softgels, gel tablets, liquids, gummies, powders, and bars.

Popular dietary supplements include:

  • Vitamins (such as multivitamins or individual vitamins such as vitamin D and biotin)
  • Minerals (such as calcium, magnesium and iron)
  • Plants or herbs (such as echinacea and ginger)
  • Plant compounds (like caffeine and curcumin)
  • Amino acids (such as tryptophan and glutamine)
  • Live microorganisms (often called “probiotics”)

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA): Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing adulterated or labeled products. wrong brand. The FDA has the authority to handle any dietary supplement product that is adulterated or misbranded after it reaches the market.

Some regulations on labels on boxes and packaging of dietary supplements are required;

1) Identity statement: The statement of identity for a dietary supplement is the name that appears on the label of the dietary supplement. As a general matter, the statement of identity of a food (including dietary supplements) is the name specified by federal law or regulation, or, if no such name is specified, the common or usual name of the food. Also, dietary supplements are required to have a statement on the front of the product identifying it as a “dietary supplement” or similar term (e.g., “vitamin supplement”).

2) Net quantity declaration (amount of food supplement): The net quantity of contents statement for a dietary supplement is the statement that informs consumers of the amount of dietary supplement that is in the container or package.

3) Supplement fact  label: The supplement facts component of a dietary  supplement label has the most important and complex requirements. Information that must be included includes: Serving size information; Total calories – Lists the number of calories per serving; Calories from and types of fat; Percent Daily Value (DV)…

4) Ingredient list: All ingredients in the food must be listed, unless the ingredients are exempt from the requirement. Ingredients are listed in descending order of weight, with the ingredient used in the largest amount first, followed by the ingredient in smaller amounts. Warning information about allergens.

5) Name and place of business of the manufacturer, packer or distributor.

Additionally, under the FD&C Act and FDA regulations, the following types of claims are required to be submitted, if applicable: health claims (statements about the relationship between a nutritional ingredient or other food substance and the reduction of disease or health risk). – relevant conditions), structure/function claims (claims about effects on the structure or function of the human body) and nutrient content claims (claims describing the level of another nutrient or nutritional ingredient in a dietary supplement).

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