On June 25, 2007, FDA published in the Federal Register a final rule that established a regulation (21 CFR part 111) entitled Current Good Manufacturing Practice (CGMP) In Manufacturing, Packaging, Labeling, Or Holding Operations For Dietary Supplements (72 FR 34752). The Dietary Supplement (DS) CGMP rule in 21 CFR part 111 (“the DS CGMP rule”) requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record.

Consumer Benefits: 

Consumers should have access to dietary supplements that meet quality standards and that are free from contamination and are accurately labeled. 

The rule will give consumers greater confidence that the dietary supplement they use has been manufactured to ensure its identity, purity, strength, and composition. 

The rule addresses the quality of manufacturing processes for dietary supplements and the accurate listing of supplement ingredients. It does not limit consumers' access to dietary supplements, or address the safety of their ingredients, or their effects on health when proper manufacturing techniques are used.

Manufacturers:

Under the Dietary Supplement Health and Education Act (DSHEA), manufacturers have an essential responsibility to substantiate the safety of their products and for determining that any representations or claims made about their products are substantiated by adequate evidence to show that they are not false or misleading.

The CGMPs will help to ensure manufacturers produce unadulterated and properly labeled dietary supplements.

Under the CGMP rule, manufacturers are required to:

Employ qualified employees and supervisors;

Design and construct their physical plant in a manner to protect dietary ingredients and dietary supplements from becoming adulterated during manufacturing, packaging, labeling and holding;

Use equipment and utensils that are of appropriate design, construction, and workmanship for the intended use;

Establish and use master manufacturing and batch production records;

Establish procedures for quality control operations;

Hold and distribute dietary supplements and materials used to manufacture dietary supplements under appropriate conditions of temperature, humidity, light, and sanitation so that the quality of the dietary supplement is not affected;

Keep a written record of each product complaint related to CGMPs; and

Retain records for 1 year past the shelf life date, if shelf life dating is used, or 2 years beyond the date of distribution of the last batch of dietary supplements associated with those records.

1. The final product must be produced in an FDA certified facility

2. Your Company must have been in operation for a Minimum of 2 years and be fully insured.

3. Your Company must have a spotless track record