FDA Issues Dietary Supplements Final Rule

[Guest guest]

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01657.html

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 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:

http://www.cfsan.fda.gov/~dms/dscgmps7.html<http://www.cfsan.fda.gov/%7Edms/dscg\

mps7.html>

 

Fact Sheet:

http://www.cfsan.fda.gov/~dms/dscgmps6.html<http://www.cfsan.fda.gov/%7Edms/dscg\

mps6.html>

 

To see a consumer article called " Final Rule Promotes Safe Use of Dietary

Supplements, " visit

http://www.fda.gov/consumer/updates/dietarysupps062207.html.

 

 

 

[Guest guest]

They make it sound so benign. The FDA wants to be the only game in

town, and in 3 years they will be because this will put the small

companies out of business within 3 years. America has been a sleep on

this one. There is no turning back now. Stock up while you can.

 

 

 

 

, " Toni Roberts "

<TRobertsLMT wrote:

>

> http://www.fda.gov/bbs/topics/NEWS/2007/NEW01657.html

> 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 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:

http://www.cfsan.fda.gov/~dms/dscgmps7.html<http://www.cfsan.fda.gov/%7Edms/dscg\

mps7.html>

>

> Fact Sheet:

http://www.cfsan.fda.gov/~dms/dscgmps6.html<http://www.cfsan.fda.gov/%7Edms/dscg\

mps6.html>

>

> To see a consumer article called " Final Rule Promotes Safe Use of

Dietary

> Supplements, " visit

> http://www.fda.gov/consumer/updates/dietarysupps062207.html.

>

>

>

[Guest guest]

While much of what the FDA does protect big pharmas I personally am not

against the assurance of quality control. How that will be worked out and

put down on paperwork

will remain to be seen. as with any other commodity herbals and such should

not enjoy the anonymity of its contents and packaging procedure. However

that should be all the involvement they have with any item. Unless there is

a substance that has proven itself to be so across the board potentially

dangerous that it is causing massive destruction of health and death then

they need to keep their paws off.

 

 

medusa

 

>> http://www.fda.gov/bbs/topics/NEWS/2007/NEW01657.html

>> 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. <snip>