
USDA), the food label offers complete, useful and
accurate nutrition information about almost every
food in the grocery store, in easy-to-read formats to
help consumers make healthful food choices.
0052 Among other features, the regulations define cer-
tain nutrient claims (such as light and good source)
and list acceptable health claims about relationships
between a nutrient or food and the risk of a disease or
health-related condition. Some acceptable relation-
ships are: calcium and osteoporosis, fat and cancer,
saturated fat and cholesterol and coronary heart
disease, sodium and hypertension, and folic acid and
neural tube defects.
0053 For dietary supplements, the framework for FDA
regulation is set forth in the 1994 Dietary Supplement
Health and Education Act (DSHEA). (Under
DSHEA’s definition, the term ‘dietary supplement’
includes, with some exceptions, products intended
for ingestion as supplements to the diet. This includes
vitamins; minerals; herbs, botanicals, and other
plant-derived substances; and amino acids and con-
centrates, metabolites, constituents and extracts of
these substances.)
0054 Under DSHEA, FDA approval of supplement
ingredients and products is not required before
marketing, a feature that clearly distinguishes supple-
ment regulation from the agency’s regulation of other
products such as drugs and many additives used in
conventional foods. Manufacturers are responsible
for ensuring that the ingredients are safe and that
the ingredient list is accurate.
0055 Dietary supplements may carry certain claims on
their labels – for example, certain nutrient content
claims like ‘good source’ or ‘high’ are allowed if the
product meets the definition, as are FDA-approved
health claims.
0056 Under DSHEA, too, once a dietary supplement
is marketed, FDA has the responsibility to prove
that the supplement is unsafe before it can take
action to restrict the product’s use. FDA focuses its
resources based on risk, so food products associated
with public health emergencies are assigned the
highest priority, followed by products that may have
caused injury or illness. Then, products thought to be
fraudulent or otherwise in violation of the law are
analyzed.
Information Exchange: Stakeholder Input,
Education
0057 FDA strives to get broad input into its decisions,
through public meetings, advisory committees, and
other sources. By providing the opportunity for ex-
change of ideas and opinions between FDA and
the public, including consumers, patients, health
professionals, and the regulated industry, the agency
is aided in reaching the best policy decisions.
0058Chartered advisory committees, such as the Na-
tional Advisory Committee on Microbiological Cri-
teria for Foods, the FDA Science Board, and CFSAN’s
Food Advisory Committee, play an important role in
providing scientific advice. Internationally, FDA par-
ticipates in Codex Alimentarius, in expert consult-
ations, and on committees of the World Health
Organization and Food and Agricultural Organiza-
tion, to name a few.
0059In addition to the agency’s notice-and-comment
rulemaking process, supplementary outreach efforts
are sometimes necessary to achieve optimal industry
compliance. The following examples illustrate the
types of outreach the agency engages in to inform
audiences.
0060FDA’s response to several sprout-associated food-
borne illness outbreaks can serve as an example of
how the agency reaches out to educate different
groups on their respective food safety roles. Following
the outbreaks in the late 1990s, FDA issued two
guidance documents advising sprout growers and
seed suppliers of steps to reduce microbial contamin-
ation: Reducing Microbial Food Safety Hazards for
Sprouted Seeds and Sampling and Microbial Testing
of Spent Irrigation Water During Sprout Production.
In addition, FDA and the California Department of
Health Services produced an educational video on
good agricultural and manufacturing practices for
sprout producers. Also, to educate the general public
on ways to protect themselves from falling ill from
sprouts, FDA issued advisories directly to consumers
on the potential hazards associated with eating raw
sprouts.
0061To disseminate food-safety messages effectively to
various audiences, including consumers and food
producers and preparers, FDA participates in the
Partnership for Food Safety Education, which
includes representatives from several government
agencies as well as from industry and consumer
organizations.
0062For several years, the Partnership has been under-
taking a Fight Bac (Fight Bacteria) campaign to edu-
cate consumers on four simple principles of preventing
food contamination while preparing food at home:
clean, chill, cook, and combat cross-contamination.
Major corporations have included the ‘Bac’ character
and the food-safety messages in their national con-
sumer-education initiatives.
0063To improve outbreak detection and response when
outbreaks do occur, FDA has developed training
courses. For example, FDA’s satellite courses on
food microbiology, foodborne disease epidemiology,
and traceback in outbreak investigations have been
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