YOU ARE RESPONSIBLE
for the distribution of the products being marketed under your firm’s name (i.e., labels)
YOU ARE RESPONSIBLE
for the manufacturing and quality control operations of your contract manufacturer. (Read below)
Who is the FDA?
The U S. Food and Drug Administration (FDA) is a scientific, regulatory, and public health agency that oversees cosmetics, dietary supplements, drugs, medical devices, foods, tobacco, etc. The agency ensures that the products in the market place are safe.
The FDA established regulations to require “current Good Manufacturing Practices (cGMPs)” for dietary supplements.
The cGMP final rule requires that proper controls are in place for dietary supplements so that they are processed in a consistent manner, and meet quality standards.
US FDA made effective 21 CFR Part 111 cGMPs for Dietary Supplements in 2007.
Just as important, 21 CFR Part 111 indicates that the name of the company on the dietary supplement label is responsible for the product content as well as the product supply chain, from raw materials to finished product.
Because manufacturers set their own standards, the same product from different manufacturers may not be equivalent in composition, strength, or bioavailability. Manufacturers are not required to confirm the identity of all ingredients supplied to them, and following cGMP guidelines does not guarantee the absence of all contamination.
FDA requires companies that manufacture, package, label, or hold dietary supplements to comply with the cGMPs.
Code of Federal Regulations(CFR)Part 111
21 CFR 111.453
You must establish and follow written procedures for holding and distributing operations.
21 CFR 111.455
(a) You must hold components and dietary supplements under appropriate conditions of temperature, humidity, and light so that the identity, purity, strength, and composition of the components and dietary supplements are not affected.