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Article Title:
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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@...



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Dietary Supplements Must Be Tested by Scientifically Valid Methods
Copyright (c) 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.




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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


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