From: Doris Meade [DorisM@Magno-Humphries.com]
Sent: Monday, August 11, 2003 2:26 PM
To: 'fdadockets@oc.fda.gov'
Cc: Vladimir Kuna; Thelma Magno
Subject: Comment on Docket ID 1996N-0417

Economic Impact of Proposed cGMP Regulations for Dietary Supplements

The FDA estimates the average cost for small businesses to implement
proposed cGMP regulations will be $99,000 the first year, and $61,000 in
annual maintenance costs thereafter.  Magno-Humphries, Inc., in Tigard,
Oregon, has been in business over 20 years, and manufactures and distributes
over 1,000 dietary supplements.  The company employs approximately 100
employees.  Herein we have attempted to calculate the cost to implement
proposed cGMPs, and our calculations indicate the initial cost alone would
be ten times greater than the FDA estimate, as explained below.

Laboratory fees were based on those of an average laboratory, American
Analytical Lab Corporation (AALC).   The average cost of testing for 34
vitamins and minerals was determined to be $70 per constituent.  For the
10-month time period between July 2002 and May 2003, testing for each
constituent in all of our finished products would cost $311,190.  Including
$36,610 for microbiological testing at an average cost of $70 per
microbiological test, the total cost for testing on finished products would
be $347,800.  The cost of raw material testing was calculated for the same
time period (July 2002 - May 2003).  Data extracted from logbooks of raw
materials received during this time indicate that 1,010 lots of raw
materials were received, not including excipients.  Assay of raw materials
and testing for impurities was estimated at an average cost of $500 per raw
material.  Therefore, the total cost of raw material testing would be
$505,000.

In conclusion, the total cost of testing on finished products and raw
materials would be:
  $347,800 for testing of constituents and microbiological testing on
finished products
+$505,000 for assay and impurity testing on raw materials
  $852,800 for the first 10-month period

Extrapolation of this result to a 12-month period would be over $1 million.
This does not include costs of labor incurred for processing Certificates of
Analysis, time waiting for results, warehousing of finished goods awaiting
test results, reformulation of products, the impact on labeling due to
possible reformulation, writing new SOPs, hiring additional personnel, or
training personnel on cGMPs.

Thank you,

Doris Meade
Regulatory Affairs
Magno-Humphries, Inc.
Tigard, OR  97223
(503) 684-5464 x153
DorisM@magno-humphries.com