After nearly a decade of negotiations between the government, consumer advocates, and the supplement industry, the FDA has issued rules to establish common standards for the manufacture of supplements. The new rules will generally benefit both consumers and the supplement industry, which currently lacks common manufacturing standards.

The new rules apply to all domestic and foreign supplement companies selling in the United States.

The rules will govern manufacturing, packaging, storage and labeling and will set testing guidelines for ingredients and final products, and establish what are called “current good manufacturing practices (CGMPs)” for dietary supplements.

It is estimated that 150 million+ Americans who take dietary supplements each year, spending over $20 billion a year. With the growing concern about declining health in the U.S> and continues to grow.

Spokespersons for the supplement industry’s leading trade association, Steve Mister, said manufacturers welcome the new standards and are eager to implement the guidelines.

According to the FDA release, the current good manufacturing practices (CGMPs) final rule will require: 1: That proper controls are in place for dietary supplements so that they are processed in a consistent manner, and meet quality standards.

2: The CGMPs apply to all domestic and foreign companies that manufacture, package, label or hold dietary supplements, including those involved with the activities of testing, quality control, packaging and labeling, and distributing them in the U.S.

3: The rule establishes CGMPs for industry-wide use that are necessary to require that dietary supplements are manufactured consistently as to identity, purity, strength, and composition.

The requirements include provisions related to:

1: the design and construction of physical plants that facilitate maintenance, cleaning,
2: proper manufacturing operations,
3: quality control procedures,
4: testing final product or incoming and inprocess materials, handling consumer complaints, and
5: maintaining records.

Companies with less than 500 employees have until June 2009 and companies with fewer than 20 employees have until June 2010 to comply with the regulations.
Source
FDA