FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. 
 
T96-01                                             Brad Stone
January 2, 1996                                    (202) 205-4144
 
 
             FDA PUBLISHES DIETARY SUPPLEMENT RULES
 
     FDA has proposed standards for nutritional labeling formats
and terms that would apply to dietary supplement products.  These
proposed standards implement some major provisions of the Dietary
Supplement Health and Education Act of 1994, which covers
regulation of these products.
     This Act requires FDA to develop labeling requirements
specifically designed for dietary supplement products -- products
containing ingredients such as vitamins, minerals, herbs or amino
acids intended to supplement the diet.
     FDA is proposing that the labeling follow the same basic
format as that used on processed food labels.  The "Supplement
Facts" panel that would be on dietary supplement labels, like the
"Nutrition Facts" panel now on food labels, would provide
nutrition information about certain vitamins and minerals as well
as information about the level of other dietary ingredients.
     The proposal would also provide for some differences:  For
example, dietary supplement labels could list non-essential
dietary ingredients, such as herbs, on their labels and could
also use smaller type sizes in some instances.
                             -more-
                              Page 2, T96-01, Dietary Supplements
     Another proposal would set definitions for the terms
"antioxidant" and "high potency" on dietary supplement labeling.
     In addition, FDA has published a final rule establishing
Reference Daily Intakes (RDIs) for vitamin K, selenium,
manganese, chromium, molybdenum and chloride.  RDIs are reference
values developed to help consumers gauge the relative amounts of
certain essential nutrients in a product.  This rule will become
effective immediately.
     The proposed rules dealing with food labeling formats and
definitions will undergo a 90 day public comment period.  Written
comments on these proposals may be submitted to:
                FDA Dockets Management Branch
                (HFA-305)
                12420 Parklawn Drive
                Rockville, MD 20857-0001
 
     Under the Act, labeling rules for dietary supplements must
be finalized and in effect by Jan. 1, 1997.
                              ####

This is a mirror of the page at http://www.fda.gov/bbs/topics/ANSWERS/ANS00702.html


This document was issued on January 2, 1996.
For more recent information on Dietary Supplements
See http://www.cfsan.fda.gov/~dms/supplmnt.html

Dietary Supplements
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