FDA Issues Dietary Supplements Final Rule

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FDA Issues Dietary Supplements Final Rule

http://www.medicalnewstoday.com/medicalnews.php?newsid=75799

The U.S. Food and Drug Administration recently announced a final

rule establishing regulations to require current good manufacturing

practices (cGMP) 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 Commissioner of Food and Drugs

C. von Eschenbach, M.D. " In addition, as a result of recent

amendments to the Federal Food, Drug, and Cosmetic Act, by the end

of the year, industry will be required to report all serious dietary

supplement related adverse events to FDA. "

The regulations establish the cGMP 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 the finished

product. It also includes requirements for recordkeeping and

handling consumer product complaints.

" The final rule will help ensure that dietary supplements are

manufactured with controls that result in a consistent product free

of contamination, with accurate labeling, " said E. Brackett,

Ph.D., director of FDA's Center for Food Safety and Applied

Nutrition.

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.

The final rule 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 is issuing an interim final rule

that outlines a petition process for manufacturers to request an

exemption to the cGMP requirement for 100 percent 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. FDA is soliciting comment from the public on the interim

final rule. There will be a 90-day comment period, ending on

September 24, 2007. Comments may be addressed to the Division of

Dockets Management Branch at www.fda.gov/dockets/ecomments.

The final CGMP and the interim final rule are 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.

Backgrounder: www.cfsan.fda.gov/~dms/dscgmps7.html

Fact Sheet: www.cfsan.fda.gov/~dms/dscgmps6.html