Submitted by: Urmi Patel
The dietary supplements are regulated by FDA as “foods” but the regulations are different from drugs and other foods. The dietary supplements are known by various other names such as: Nutraceuticals, Phytaceuticals, Herbaceuticals, Nutrapharmaceuticals, Foodiceuticals, Phytomedicines, Therapeutic foods, Pharmafoods, Phytofoods and Parnuts (food of Particular nutritional uses).
FDA regulates food supplement safety and labeling and FTC i.e., Federal Trade Commission regulates food supplement advertising and marketing. Together, the agencies maintain cooperative relationship and coordinates enforcement and educational efforts.
The dietary supplements are regulated by following acts:
1. NLEA- Nutritional Labeling and Education Act of 1990
It specifies “national uniform nutrition labeling” provision which enacts food nutrition and content labeling requirements which varies from FDCA.
2. DSHEA- Dietary Supplements Health and Education Act of 1994
The act amended the FDCA to define dietary supplements as “foods” for most federal regulatory purposes.
Moreover, the company needs to register Bioterrorism Act with FDA before producing or selling supplements. It specifically involves the FDA to take steps to protect the public from threatened or terrorist attack on U.S. food supply.
DEFINITION OF DIETARY SUPPLEMENTS:
The dietary supplements as defined by Congress in the Dietary Supplement Health and Education Act, which became law in 1994, a dietary supplement is a product (other than tobacco) that
is intended to supplement the diet;
contains one or more dietary ingredients (including vitamins; minerals; herbs or other botanicals; amino acids; and other substances) or their constituents;
is intended to be taken by mouth as a pill, capsule, tablet, or liquid; and
is labeled on the front panel as being a dietary supplement.
A new dietary ingredient is a dietary ingredient that was not sold in the United States in a dietary supplement before October 15, 1994. The FDA requires specific safety information from a manufacturer intending to market a dietary supplement containing a new dietary ingredient. This information is not required for older dietary supplement ingredients.
The companies, who manufacture, package, label or hold dietary supplement products should follow cGMP in following aspects: Quality control procedures, designing and constructing manufacturing plants, testing ingredients and finished product, record keeping and handling consumer product complaints.
There are no provisions in the law for FDA to "approve" dietary supplements for safety or effectiveness before they reach the consumer. FDA has to prove the product is not safe in order to restrict its use or remove it from the market once it is marketed.
LABELING REQUIREMENTS OF DIETARY SUPPLEMENTS:
1. General information
It includes: Name of product (including the word "supplement" or a statement that the...