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For decades, the Food and Drug
Administration regulated dietary supplements as foods, in most
circumstances, to ensure that they were safe and wholesome, and that
their labeling was truthful and not misleading. An important facet of
ensuring safety was FDA's evaluation of the safety of all new
ingredients, including those used in dietary supplements, under the 1958
Food Additive Amendments to the Federal Food, Drug, and Cosmetic Act
(FD&C Act). However, with passage of the Dietary Supplements Health and
Education Act of 1994 (DSHEA), Congress amended the FD&C Act to include
several provisions that apply only to dietary supplements and dietary
ingredients of dietary supplements. As a result of these provisions,
dietary ingredients used in dietary supplements are no longer subject to
the premarket safety evaluations required of other new food ingredients
or for new uses of old food ingredients. They must, however, meet the
requirements of other safety provisions. Signed by President Clinton on October
25, 1994, the DSHEA acknowledges that millions of consumers believe
dietary supplements may help to augment daily diets and provide health
benefits. Congress's intent in enacting the DSHEA was to meet the
concerns of consumers and manufacturers to help ensure that safe and
appropriately labeled products remain available to those who want to use
them. In the findings associated with the DSHEA, Congress stated that
there may be a positive relationship between sound dietary practice and
good health, and that, although further scientific research is needed,
there may be a connection between dietary supplement use, reduced
health-care expenses, and disease prevention. The provisions of DSHEA define dietary
supplements and dietary ingredients; establish a new framework for
assuring safety; outline guidelines for literature displayed where
supplements are sold; provide for use of claims and nutritional support
statements; require ingredient and nutrition labeling; and grant FDA the
authority to establish good manufacturing practice (GMP) regulations.
The law also requires formation of an executive level Commission on
Dietary Supplement Labels and an Office of Dietary Supplements within
the National Institutes of Health. These specific provisions of the DSHEA
are synopsized below. FDA traditionally considered dietary
supplements to be composed only of essential nutrients, such as
vitamins, minerals, and proteins. The Nutrition Labeling and Education
Act of 1990 added "herbs, or similar nutritional substances," to the
term "dietary supplement." Through the DSHEA, Congress expanded the
meaning of the term "dietary supplements" beyond essential nutrients to
include such substances as ginseng, garlic, fish oils, psyllium,
enzymes, glandulars, and mixtures of these. The DSHEA established a formal definition
of "dietary supplement" using several criteria. A dietary supplement:
The DSHEA amends the adulteration
provisions of the FD&C Act. Under DSHEA a dietary supplement is
adulterated if it or one of its ingredients presents "a significant or
unreasonable risk of illness or injury" when used as directed on the
label, or under normal conditions of use (if there are no directions). A
dietary supplement that contains a new dietary ingredient (i.e., an
ingredient not marketed for dietary supplement use in the U.S. prior to
October 15, 1994) may be adulterated when there is inadequate
information to provide reasonable assurance that the ingredient will not
present a significant or unreasonable risk of illness or injury. The
Secretary of HHS may also declare that a dietary supplement or dietary
ingredient poses an imminent hazard to public health or safety. However,
like any other foods, it is a manufacturer's responsibility to ensure
that its products are safe and properly labeled prior to marketing.
The DSHEA provides that retail outlets
may make available "third-party" material s to help inform consumers
about any health-related benefits of dietary supplements. These
materials include articles, book chapters, scientific abstracts, or
other third-party publications. These provisions stipulate that the
information must not be false or misleading; cannot promote a specific
supplement brand; must be displayed with other similar materials to
present a balanced view; must be displayed separate from supplements;
and may not have other information attached (product promotional
literature, for example). The DSHEA provides for the use of various
types of statements on the label of dietary supplements, although claims
may not be made about the use of a dietary supplement to diagnose,
prevent, mitigate, treat, or cure a specific disease (unless approved
under the new drug provisions of the FD&C Act). For example, a product
may not carry the claim "cures cancer" or "treats arthritis."
Appropriate health claims authorized by FDA--such as the claim linking
folic acid and reduce risk of neural tube birth defects and the claim
that calcium may reduce the risk of osteoporosis--may be made in
supplement labeling if the product qualifies to bear the claim. Under
DSHEA, firms can make statements about classical nutrient deficiency
diseases--as long as these statements disclose the prevalence of the
disease in the United States. In addition, manufacturers may describe
the supplement's effects on "structure or function" of the body or the
"well-being" achieved by consuming the dietary ingredient. To use these
claims, manufacturers must have substantiation that the statements are
truthful and not misleading and the product label must bear the
statement "This statement has not been evaluated by the Food and Drug
Administration. This product is not intended to diagnose, treat, cure,
or prevent any disease." Unlike health claims, nutritional support
statements need not be approved by FDA before manufacturers market
products bearing the statements, however, the agency must be notified no
later than 30 days after a product that bears the claim is first
marketed. Like other foods, dietary supplement
products must bear ingredient labeling. This information must include
the name and quantity of each dietary ingredient or, for proprietary
blends, the total quantity of all dietary ingredients (excluding inert
ingredients) in the blend. The label must also identify the product as a
"dietary supplement" (e.g., "Vitamin C Dietary Supplement"). Labeling of
products containing herbal and botanical ingredients must state the part
of the plant from which the ingredient is derived. If a supplement is
covered by specifications in an official compendium and is represented
as conforming, it is misbranded if it does not conform to those
specifications. Official compendia include the U.S. Pharmacopeia, the
Homeopathic Pharmacopeia of the United States, or the National
Formulary. If not covered by a compendium, a dietary supplement must be
the product identified on the label and have the strength it is
represented as having. Labels also must provide nutrition
labeling. This labeling must first list dietary ingredients present in
"significant amounts" for which FDA has established daily consumption
recommendations, followed by dietary ingredients with no daily intake
recommendations. Dietary ingredients that are not present in significant
amounts need not be listed. The nutrition labeling must include the
quantity per serving for each dietary ingredient (or proprietary blend)
and may include the source of a dietary ingredient (for example,
"calcium from calcium gluconate"). If an ingredient is listed in the
nutrition labeling, it need not appear in the statement of ingredients.
Nutrition information must precede ingredient statements on the product
label. Supplements may contain new dietary
ingredients--those not marketed in the United States before October 15,
1994--only if those ingredients have been present in the food supply as
an article used for food in a form in which the food has not been
chemically altered or there is a history of use, or some other evidence
of safety exists that establishes that there is a reasonable expectation
of safety when the product is used according to recommended conditions
of use. Supplement manufacturers must notify FDA at least 75 days before
marketing products containing new dietary ingredients, providing the
agency with the information on which the conclusion that a dietary
supplement containing the new dietary ingredient "will reasonably be
expected to be safe" was based. Any interested party, including a
manufacturer of a dietary supplement, may petition FDA to issue an order
prescribing the conditions of use under which a new dietary ingredient
will reasonably be expected to be safe. DSHEA grants FDA the authority to
establish GMP regulations governing the preparation, packing, and
holding of dietary supplements under conditions that ensure their
safety. These regulations are to be modeled after current good
manufacturing practice regulations in effect for the rest of the food
industry. FDA intends to work with the supplement industry and other
interested persons to develop GMPs and, in doing so, will seek public
comment as to their scope. The DSHEA requires the formation of a
Commission to conduct a study and make recommendations on the regulation
of label claims and statements for dietary supplements and procedures
for the evaluation of the claims. The members of the Commission will
evaluate how best to provide truthful, scientifically valid, and not
misleading information to consumers so that they can make informed and
appropriate health care choices. The Commission will be composed of
seven members, appointed by the President, with experience in dietary
supplements and in the manufacture, regulation, distribution, and use of
supplements. Three members must be qualified by scientific training and
experience to evaluate supplements' health benefits, and one of these
must be trained in pharmacognosy, medical botany, traditional herbal
medicine, or other related sciences. All Commission members and staff
should be unbiased about supplement use. On October 2, 1995, the White House
announced the names of the seven individuals the President intends to
appoint to the Commission. The members include nutritionists, industry
representatives, a pharmacognosist, and attorneys. The Commission will submit a final report
including recommendations and legislation related to label claims for
dietary supplements to the President and Congress within two years of
convening. The HHS Secretary will establish an
office within the National Institutes of Health to explore the potential
role of supplements to improve health care in the U.S. The office will
also promote scientific study of supplements and their value in
preventing chronic diseases; collect and compile scientific research,
including data from foreign sources and the NIH Office of Alternative
Medicine; serve as a scientific adviser to HHS and FDA; and compile a
database of scientific research on supplements and individual nutrients.
DSHEA's provisions for use of nutritional
support statements and third-party literature became effective when the
law was signed. The effective date for other labeling provisions and any
FDA implementing regulations is after December 31, 1996, although
manufacturers may label their products consistent with provisions of
DSHEA until that date
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