News
12/29/1993
Labeling of Dietary Supplements
P93-46 Food and Drug Administration
FOR IMMEDIATE RELEASE Brad Stone (202) 205-4144
The Food and Drug Administration today announced standards
to ensure that the labeling of dietary supplements is truthful
and scientifically valid. Consumer access to dietary supplements
will not be affected by the new rules.
The new regulations provide that dietary supplement labels
will have to provide the same basic nutritional information that
is found on the labels of nearly all conventional foods. The new
rules also make dietary supplements subject to the same standard
for providing disease-related health information as Congress
previously mandated for conventional foods.
In addition, the rules announce that a health claim on folic
acid and the risk of neural tube birth defects has been
authorized on dietary supplements. FDA earlier approved a health
claim for calcium and osteoporosis.
"Consumers should have access to dietary supplements that
are truthfully labeled and marketed," said FDA Commissioner David
A. Kessler, M.D. "These rules enable the public to make informed
choices. They will not restrict access."
Health claims made for the products will have to be
scientifically valid, and a nutrition information panel on the
label will declare the nutrient content per serving. Health
claims will be authorized under the new rules if there is
significant scientific agreement among qualified experts that
these claims are valid.
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Page 2, P93-46, Supplement
"This is the standard Congress established for health claims
on labeling of conventional foods," said Kessler. "It's a
flexible standard that will keep unsubstantiated claims out of
the marketplace."
The health claim standard is scheduled to take effect in
July 1994. The additional rules on nutrition labeling and
nutrient content claims ("high," "low," etc.) become effective in
July 1995.
FDA is one of eight Public Health Service agencies in HHS.
FACT SHEET ON FDA'S DIETARY SUPPLEMENT LABELING REGULATIONS
The Food and Drug Administration (FDA) is required by law to
publish final dietary supplement labeling regulations by December
31, 1993. FDA is publishing 7 regulations that will help ensure
that consumers have access to dietary supplements that bear
truthful and scientifically valid nutritional and health claim
information on product labels.
o The label changes do not become effective immediately.
The new health claims standard becomes effective in
July 1994. Other changes do not become mandatory until
July 1995.
o Consumer access to dietary supplements will not change
nor will consumers need prescriptions for dietary
supplements after these regulations are published and
become effective.
o Effective immediately, dietary supplement manufacturers
may market folic acid products with a health claim
stating that folic acid may reduce the risk of certain
birth defects.
WHAT ARE THE 7 DOCUMENTS?
1. GENERAL REQUIREMENTS FOR HEALTH CLAIMS FOR DIETARY
SUPPLEMENTS - Final rule
o Dietary supplements of vitamins, minerals, herbs, or
other similar nutritional substances will be subject to
the general requirements for health claims that already
apply to conventional food.
o A health claim touting the relationship between a
substance and a disease or health-related condition
must be supported by significant scientific agreement
among qualified experts.
o This rule becomes effective in July 1994.
2. GENERAL REQUIREMENTS FOR NUTRITION LABELING FOR DIETARY
SUPPLEMENTS - Final rule
o Requires nutrition labeling for dietary supplements.
o This rule becomes effective in July 1995.
o Permits 7 additional nutrients to be included in the
"Nutrition Facts" portion of the label.
o Permits reduced type size on smaller labels.
3. REQUIREMENTS FOR NUTRIENT CONTENT CLAIMS FOR DIETARY
SUPPLEMENTS - Final rule
o Provides for the use of nutrient content claims on
labels or in labeling of dietary supplements (e.g.
"high," "low," "less").
o This rule becomes effective in July 1995.
4. FOLIC ACID HEALTH CLAIM - Notice
o Announces that the October 14, 1993, proposal to
authorize a health claim about the relationship between
folate and the risk of neural tube defects is now a
final regulation for dietary supplements.
5. SPECIFIC HEALTH CLAIMS - Notice
o Announces that the October 14, 1993, proposal not to
authorize health claims relating an association between
dietary fiber and cancer; dietary fiber and
cardiovascular disease; antioxidant vitamins and
cancer; omega-3 fatty acids and coronary heart disease;
and zinc and immune deficiency in the elderly on the
labels and in the labeling of dietary supplements is
now a final regulation.
o Separately, FDA recently convened a symposium on the
possible health benefits of antioxidant vitamins and is
awaiting the publication of a major study in early
1994. FDA stands ready to approve antioxidant vitamin
claims that are supported by significant scientific
agreement.
6. DAILY INTAKE LEVELS - Proposed rule
o Establishes Reference Daily Intakes for vitamin K,
selenium, chloride, manganese, fluoride, chromium, and
molybdenum for use in declaring the nutrient content of
a food on its label or labeling.
7. DELAY OF APPLICATION - Final rule
o FDA is invoking provisions that permit up to a 1 year
delay in the effective date of the nutrition labeling
and nutrient content claims regulations to minimize the
cost of compliance with the new regulations.
o These regulations become effective in July 1995, 18
months after publication of the final rules.
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