FDA Issues Final Rule for Supplements

**builtbeast** · 06-24-2007, 09:24 PM

Quote:

FOR IMMEDIATE RELEASE
June 22, 2007

Media Inquiries:
Michael Herndon
Kimberly Rawlings
301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Issues Dietary Supplements Final Rule

The U.S. Food and Drug Administration today 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 Andrew 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 Robert 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 Select Docket.

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: US FDA/CFSAN - Backgrounder: Final Rule for Current Good Manufacturing Practices (CGMPs) for Dietary Supplements

Fact Sheet: US FDA/CFSAN - Dietary Supplement Current Good Manufacturing Practices (CGMPs) and Interim Final Rule (IFR) Facts

To see a consumer article called "Final Rule Promotes Safe Use of Dietary Supplements," visit Final Rule Promotes Safe Use of Dietary Supplements.

ref: FDA Issues Dietary Supplements Final Rule

**mr_min** · 06-25-2007, 01:31 AM

that write-up seems to help the consumer a lot more now than before in a good way from the skimming i did of the article.

no more bullshit labels and there no-where to be found ingredients..

its better than that rumored dietary control act or organization they were thinking of...

**powerman2000** · 06-25-2007, 01:51 AM

Well, let's hope all the supp manufacturers adhere.

**madman911** · 06-25-2007, 02:37 AM

Seems like a good thing. They don't have to report what compounds are in the supps, just what testing is in place to validate the composition and to detect contamination.

**romanaz** · 06-25-2007, 08:48 PM

hope this helps with all the copy cat products out there.

**Ikaika** · 06-25-2007, 08:49 PM

Quote:

Originally Posted by madman911

Seems like a good thing. They don't have to report what compounds are in the supps, just what testing is in place to validate the composition and to detect contamination.

Thank god for cliff notes.

EzyRyder · 06-25-2007, 09:53 PM

Quote:

Originally Posted by Ikaika

Thank god for cliff notes.

x2....

06-25-2007, 01:31 AM	#2
mr_min IronMass Vip Join Date: Aug 2005 Location: connecticut Posts: 502 Recipes: 0 Rep Power: 10	Re: FDA Issues Final Rule for Supplements that write-up seems to help the consumer a lot more now than before in a good way from the skimming i did of the article. no more bullshit labels and there no-where to be found ingredients.. its better than that rumored dietary control act or organization they were thinking of...

06-25-2007, 01:51 AM	#3
powerman2000 The Old Moderator Join Date: Apr 2005 Location: Colorado Posts: 4,082 Recipes: 0 Rep Power: 197	Re: FDA Issues Final Rule for Supplements Well, let's hope all the supp manufacturers adhere. __________________ Don't forget to periodize Best BP 507 lbs competitive Best Squat 705 lbs competitive Best DL 650 lbs competitive Guns don't kill people, men who come home early do. My workout log http://www.ironmass.com/forums/showthread.php?t=6247

06-25-2007, 02:37 AM	#4
madman911 Metamorphosizing Join Date: Sep 2005 Location: Boston Area Posts: 1,526 Recipes: 0 Rep Power: 60	Re: FDA Issues Final Rule for Supplements Seems like a good thing. They don't have to report what compounds are in the supps, just what testing is in place to validate the composition and to detect contamination. __________________ Millennium Sport Technologies Sponsored Athlete http://www.millenniumsport.net IMPC 2006 Novice Division Champ IMPC 2007 Open Division Champ Never underestimate the power of the bandana.

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