Dietary Supplements Must Be Tested by Scientifically Valid Methods

[Guest guest]

Free-Reprint Article Written by: Norm Howe

See Terms of Reprint Below.

*****************************************************************

*

* This email is being delivered directly to members of the group:

*

*

*

*****************************************************************

We have moved our TERMS OF REPRINT to the end of the article.

Be certain to read our TERMS OF REPRINT and honor our TERMS

OF REPRINT when you use this article. Thank you.

This article has been distributed by:

http://Article-Distribution.com

Helpful Link:

The Digital Millennium Copyright Act - Overview

http://www.gseis.ucla.edu/iclp/dmca1.htm

---------------------------------------------------------------------

Article Title:

==============

Dietary Supplements Must Be Tested by Scientifically Valid Methods

Article Description:

====================

Are you a Dietary Supplement manufacturer trying to figure out

what FDA means by " Scientifically Valid Method " ? Here are some

hints.

Additional Article Information:

===============================

424 Words; formatted to 65 Characters per Line

Distribution Date and Time: 2008-09-03 12:24:00

Written By: Norm Howe

Copyright: 2008

Contact Email: mailto:info@...

For more free-reprint articles by Norm Howe, please visit:

http://www.thePhantomWriters.com/recent/author/norm-howe.html

=============================================

Special Notice For Publishers and Webmasters:

=============================================

If you use this article on your website or in your ezine,

We Want To Know About It. Use the following URL to let

us know where you have used this article, and we will

include a link to your website on thePhantomWriters.com:

http://thephantomwriters.com/notify.php?id=6253 & p=load

HTML Copy-and-Paste and TEXT Copy-and-Paste

Versions Of Article Are Available at:

http://thePhantomWriters.com/free_content/db/h/dietary-supplements-must-be-teste\

d.shtml#get_code

---------------------------------------------------------------------

Dietary Supplements Must Be Tested by Scientifically Valid Methods

Copyright © 2008 Norm Howe

Validation and Compliance Institute

http://www.vcillc.com

Are you a Dietary Supplement manufacturer trying to figure out

what FDA means by " Scientifically Valid Method " ? Here are some

hints.

Under the Dietary Supplement Health and Education Act of 1994

(DSHEA), the dietary supplement manufacturer is responsible for

ensuring that a dietary supplement is safe before it is marketed.

FDA is responsible for taking action. As such, FDA's Department

of Health and Human Services recently rolled out new dietary

supplement regulations. The 815-page document, titled " Current

Good Manufacturing Practice in Manufacturing, Packaging,

Labeling, or Holding Operations for Dietary Supplements " ,

reflects the final ruling on the subject.

In short, this ruling establishes the good manufacturing practice

for dietary supplements, outlining the minimum standards

necessary for activities related to manufacturing, packaging,

labeling, or holding dietary supplements to ensure the quality of

said dietary supplement.

According to the ruling, testing methods must be scientifically

valid. The ruling proposes that tests must include at least one

of the following: (1) Gross organoleptic analysis, (2)

microscopic analysis, (3) chemical analysis, or (4) other

appropriate test. (The requirement that methods be scientifically

valid applies to all the tests and examinations manufacturers

use, rather than to quantitative tests alone, thus the term

''analytical'' is not used.)

While the proposed definition of ''appropriate test'' (i.e.,

''a scientifically valid method'') mandates specific methods,

some manufacturers are concerned because valid test methods are

not always available for testing dietary ingredients or dietary

supplements.

In response to that concern, the ruling states: ''If an AOAC or

FDA method is not available, a scientifically valid analytical

method is one that is based on scientific data or results

published in, for example, scientific journals, references, text

books, or proprietary research...We recognize that certain tests

for identity, purity, quality, strength, or composition for

certain finished product may not be available due to complex

finished matrices that would make such testing impracticable. "

In addition, manufacturers may exempt a product specification

from the verification requirements if they show that: (1) The

specifications selected to verify that the product meets all

product specifications are not able to verify that the control

system is producing a dietary supplement that meets the exempted

product specification and (2) there is no scientifically valid

method for testing or examining the exempted product

specification at the finished batch stage.

Beyond this ruling, FDA's post-marketing responsibilities

include monitoring safety, e.g. voluntary dietary supplement

adverse event reporting, and product information, such as

labeling, claims, package inserts, and accompanying literature.

For more information see

http://www.fda.gov/OHRMS/DOCKETS/98fr/cf0441.pdf or call an

experienced consultant to gain more insight into your particular

question.

---------------------------------------------------------------------

Norm Howe, Senior Partner at Validation and Compliance Institute,

consultants for the pharmaceutical and medical device industries.

He got his BS at UC, Berkeley, and a Ph.D. in chemistry at UCLA.

He has held many management positions in FDA regulated industries,

most at BASF. http://www.vcillc.com