FDA FACTS PRIVATE LABELERS 

NEED TO KNOW

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.

(b) You must hold packaging and labels under appropriate conditions so that the packaging and labels are not adversely affected.

(c) You must hold components, dietary supplements, packaging, and labels under conditions that do not lead to the mixup, contamination, or deterioration of components, dietary supplements, packaging, and labels.

21 CFR 111.460

(a) You must identify and hold in-process material under conditions that protect against mixup, contamination, and deterioration.

(b) You must hold in-process material under appropriate conditions of temperature, humidity, and light.

21 CFR 111.465

(a) You must hold reserve samples of dietary supplements in a manner that protects against contamination and deterioration. This includes:

(1) Holding the reserve samples under conditions consistent with product labels or, if no storage conditions are recommended on the label, under ordinary storage conditions; and

(2) Using the same container-closure system in which the packaged and labeled dietary supplement is distributed, or if distributing dietary supplements to be packaged and labeled, using a container- closure system that provides essentially the same characteristics to protect against contamination or deterioration as the one in which you distribute the dietary supplement for packaging and labeling elsewhere.

(b) You must retain reserve samples for 1 year past the shelf life date (if shelf life dating is used), or for 2 years from the date of distribution of the last batch of dietary supplements associated with the reserve samples, for use in appropriate investigations.

21 CFR 111.470

You must distribute dietary supplements under conditions that will protect the dietary supplements against contamination and deterioration.

21 CFR 111.475

Subpart M

(a) You must make and keep records required under this subpart M in accordance with subpart P of this part.

(b) You must make and keep the following records:

(1) Written procedures for holding and distributing operations; and (2) Records of product distribution.