DIETARY SUPPLEMENTS

Question 1

A product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:
o a vitamin (Vit A, B, 16, 12)
o a mineral; an herb or other botanical; an
amino acid; a dietary substance for use by man to supplement the diet by increasing the total dietary intake.
o a concentrate, metabolite, constituent, extract, or combination of any ingredient above.
o a product intended for ingestion in tablet, capsule, powder, soft gel, gel cap, or liquid form; or if not intended for ingestion in such a form,
o is not represented as conventional food and is not represented for use as a sole item of a meal or of the diet; and labeled as a dietary supplement.

Answer 1

DIETARY SUPPLEMENTS

Question 2

In 1994, Congress enacted the ________________________, amending several portions of the FDCA pertaining to dietary supplements and ingredients of dietary supplements.

Answer 2

Dietary Supplement Health and Education Act (DSHEA)

Question 3

regulates the sale and use of dietary supplements as a distinct subset of foods under the Federal Food, Drug, and Cosmetic Act.

Answer 3

Food and Drug Administration (USFDA)

Question 4

This legislation is intended to balance consumer access and the need for regulation to ensure product safety. The Act essentially confirms the status of all dietary supplements as foods and subjects such products to regulations accordingly.

Answer 4

Dietary Supplement Health and Education Act of 1994

Question 5

_____________, these are processed food products that help supplement the diet. A food supplement may contain dietary ingredients such as vitamins, minerals, herbs, amino acids, and other dietary substances made from plant, animal, natural, or artificial matter. It may take various forms, including those liquids, capsules, pills, tablets, powders, and gels. It is not marketed as a conventional food or as a replacement for drugs and medicines.

Answer 5

Administrative Order No. 2014-0029