In late June, FDA published a final rule establishing regulations for current good manufacturing practices (cGMPs) for dietary supplements. The rule ensures that dietary supplements are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled.

“This rule helps to ensure the quality of dietary supplements so that consumers can be confident that the products they purchase contain what is on the label,” said FDA commissioner Andrew von Eschenbach, MD. “In addition, as a result of recent amendments to the Federal Food, Drug, and Cosmetic Act, by the end of the year industry will also be required to report all serious dietary supplement related adverse events to FDA.”

The regulations establish the cGMPs needed to ensure quality throughout the manufacturing, packaging, labeling and storing of dietary supplements. The final rule includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and finished products. It also includes requirements for recordkeeping and handling consumer product complaints.

Under the final rule, manufacturers are required to evaluate the identity, purity, strength and composition of their dietary supplements. If dietary supplements contain contaminants or do not contain the dietary ingredient they are represented to contain, FDA would consider those products to be adulterated or misbranded.

The aim of the final rule is to prevent inclusion of the wrong ingredients, too much or too little of a dietary ingredient, contamination by substances such as natural toxins, bacteria, pesticides, glass, lead and other heavy metals, as well as improper packaging and labeling.

It is important to note that dietary ingredient manufacturers are exempted from this rule. Loren Israelsen, executive director, United Natural Products Alliance (UNPA), Salt Lake City, UT, believes there are a few reasons FDA made this decision: (1) The conventional food industry expressed strong concerns about being forced to comply with both conventional food and dietary supplement regulations with regard to nutrients, vitamins, minerals, etc.; (2) FDA is aware that the majority of dietary ingredient manufacturers are off shore and that there is no practical way for them to assert inspection and audit authority over such facilities; (3) To remedy points 2 and 3, FDA places the burden of assuring ingredient identity on the dietary supplement manufacturer. The third point will likely place more emphasis and importance on Certificates of Analysis (CoAs).

The final rule also includes flexible requirements that can evolve with improvements in scientific methods used for verifying identity, purity strength and composition of dietary supplements.

As a companion document, FDA also issued an interim final rule that outlines a petition process for manufacturers to request an exemption to the cGMP requirement for 100% identity testing of specific dietary ingredients used in the processing of dietary supplements.

Under the interim final rule, the manufacturer may be exempted from the dietary ingredient identity testing requirement if it can provide sufficient documentation that the reduced frequency of testing requested would still ensure the identity of the dietary ingredient.

After reading the 800-plus pages of the final rule, Mr. Israelsen had this to say: “I think the tenor and language of this final regulation are distinctly different from the 2003 proposed final rule in that it is more humble, cooperative and transparent. My personal feeling is that FDA ‘got it’ and tried very hard to develop a GMP regulation that recognizes industry concerns.”

The final cGMP and the interim final rule became effective August 24, 2007. To limit any disruption for dietary supplements produced by small businesses, the rule has a three-year phase-in for small businesses. Companies with more than 500 employees have until June 2008 to comply, companies with less than 500 employees have until June 2009 to comply, and companies with fewer than 20 employees have until June 2010 to comply with the regulations. (For more details on the new cGMPs, turn to page 72.)