FDA Proposes Regulations Governing Nutrition Labeling on Dietery, Vitamins, etc.

NEWS 06/15/1993 FDA Proposes Regulations Governing Nutrition Labeling on Dietery, Vitamins, etc.


P93-24                                Food and Drug Administration
FOR IMMEDIATE RELEASE                 Brad Stone (202) 205-4144
                                    

     The Food and Drug Administration today proposed regulations
governing nutrition labeling and nutrient content and health
claims for all dietary supplements--vitamins, minerals, amino
acids and other similar nutritional substances.  The agency is
also asking for comments on how it should regulate dietary
supplements to ensure their safety.
     "FDA's goal is simple:  We want people to have access to
products that are safe, and we want to assure consumers that
claims made about the health and nutritional benefits are
truthful," said FDA Commissioner David A. Kessler, M.D.  "We
recognize that the body of knowledge about the benefits and risks
of many of these products is growing and changing each day.  We
will take advantage of that knowledge, but hype cannot overwhelm
science."
     The proposal would require dietary supplement product labels
to carry the same kinds of nutrition information as virtually all
processed foods.  A label panel would have to include the level
and percent of daily intake of nutrients in a serving.
     Health claims on dietary supplement labels would be
permitted if FDA finds significant agreement among qualified
experts that these claims are scientifically valid.
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                           Page 2, P93-24, Dietary Supplements
The Nutrition Labeling and Education Act established this
standard for health claims on food labels, and the same standard
would apply to dietary supplement products.   
     In addition, the agency announced its intention to work with
food and supplement manufacturers and the scientific community on
additional health claims that should be permitted on labels.  For
example, in July FDA intends to publish a proposal authorizing a
health claim for folic acid in the prevention of neural tube
defects.  Antioxidant vitamins in the prevention of cancer and
other diseases will be the next area given priority.        
     Amino acid dietary supplements are a class of products that
are of special concern to FDA.  Products containing the amino
acid L-tryptophan, widely sold as a dietary supplement, were
associated with at least 1,500 cases of a painful muscle
disorder, including at least 38 deaths, several years ago.  One
of the Federal Register notices announced today calls on
manufacturers of amino acid supplements to submit information
substantiating the safety of their products and explaining the
basis upon which they believe their products could be lawfully
marketed.   
     In 1990, FDA commissioned an examination by the Federation
of American Societies for Experimental Biology of scientific data
bearing on the safety of amino acids.  An expert panel analyzed
nutritional, physiological and pharmacological data on the 22
amino acids most commonly used as dietary supplements.  The 
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                            Page 3, P93-24, Dietary Supplements
Federation's panel concluded that the fragmentary nature of
scientific data on amino acids precluded a definitive judgment on
their safety.  A summary of the panel's report is included in the
Federal Register notice.    
     FDA also asked for comments on how to establish the upper
limits of safe use of vitamins and minerals.  Much research is
being conducted on the health benefits of these substances, and
FDA believes the public health will be served if questions about
the safety of high potency vitamins and minerals are finally
resolved.           
     The Federal Register notice also seeks public comments on
the final report of FDA's Dietary Supplements Task Force, an
internal agency group convened in 1991 to examine alternatives
for regulating various types of dietary supplement products. 
This report recognized the interest of many consumers in having
ready access to dietary supplements.  It made recommendations to
the commissioner that FDA consider specific changes designed to
improve the safety and labeling of supplement products that are
of questionable safety.  The task force report does not represent
FDA's official position.  FDA is soliciting comment on the
report's recommendations before considering possible actions.    
     FDA's announcement of the three proposed nutrition labeling
regulations meets the June 15, 1993, deadline set by the Dietary
Supplement Act of 1992. 
     Comments should be sent, within 60 days of the publication 
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                            Page 4, P93-24, Dietary Supplements
date, to Dockets Management Branch, HFA-305, Food and Drug
Administration, Room 1-23, 12420 Parklawn Dr., Rockville, Md.
20857.
     FDA is one of eight Public Health Service agencies within
HHS.
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