2004N-0454 - Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Reopening of Comment Period
FDA Comment Number : EC420
Submitter : Dr. Joe Garza Date & Time: 02/23/2005 08:02:29
Organization : Look-out Mountain Youth Facility
Health Professional
Category :
Issue Areas/Comments
January 30, 2005
Re: Docket 2004N-0454

Dr. Lester M. Crawford
Dockets Management Branch (HFA-3 05),
Food and Drug Administration,
5630 Fishers Lane, Room 1061,
Rockville, MD 20852.

DSHEA (the Dietary Supplement Health Education Act) guarantees my ability to choose a wide-range
of dietary supplements and ensures the FDA regulates these products appropriately - as foods, not as
food additives or drugs.

Recall that 2.5 million concerned consumers contacted Congress between 1992 and 1994 to support
DSHEA and assure access to their supplements. In response, Congress passed DSHEA and
deliberately created new and different regulations for dietary supplements. Congress enacted DSHEA
to stop the FDA from treating dietary supplements like food additives or drugs and to protect
consumer~ s rights to purchase these products.

I applaud the FDA?s initiatives to fully implement DSHEA and to develop clear guidelines for
manufacturers to follow when introducing new ingredients to the market, but I?m concerned that the
questions FDA poses in their draft comments may lead to barriers that may preclude many safe
products from reaching the market place.

Specifically, I am concerned about any new guidelines that require onerous food additive and drug like
notifications for new ingredients. Given that FDA has a history of such actions, please do not create
new guidelines that will require excessive testing and documentation, making the introduction of new
products unnecessarily expensive. This will assuredly lead to the reduction of many products that can
benefit the health of Americans and reduce the cost of health care. These actions are counter to the
intent of DSHEA and consumer health interests.

I am heartened by FDA?s recent initiatives to fully implement DSHEA but any changes to the way FDA
interprets and implements DSHEA must remain true to congressional intent. I implore the agency to
use a transparent and participatory process with multiple public meetings and ample time for
community comment to develop guidelines that are sound, reasonable and consumer focused.

Supplements provide a low cost, natural alternative to help consumers maintain their good health. The
creation of any new standard that will undermine that intent will constitute an injustice to the American people.


Joe Garza, Ph.D. 7403 S. Robb, Littleton, CO 80127-2833