미국 FDA에서는 나트륨(sodium) 섭취를 하루 2,300 mg 미만으로 하도록 권고하고 있으며 Meal and main dish products 에 \"Healthy\" Claim을 사용하기 위해서는 나트륨(sodium)이 480mg 이하여야 한다고 규정한다.
101.9(c)(9)))) which was cited in the 2000 Dietary Guidelines.
The new USDA pyramid (http://www.mypyramid.gov) (Ref. 4) encourages
consumers to use the Nutrition Facts label to determine the amount of
sodium in processed foods, particularly meats and canned vegetables,
and to keep sodium consumption below 2,300 mg per day by looking for
lower sodium foods. (FDA has verified the Web site address, but we are
not responsible for subsequent changes to the Web site after this
document publishes in the Federal Register.)
(Comment 2) One comment argued that FDA should delay consideration
of the 2003 proposed rule until the NHLBI of NIH responds to a joint
request for correction filed by the Salt Institute and the U.S. Chamber
of Commerce under the Information Quality Act (IQA) (Public Law 106-
554, H.R. 5658, Sec. 515, 114 Stat. 2763, 2763A-153 to -154 (2000)),
and NIH Information Quality Guidelines, http://aspe.hhs.gov/infoquality/Guidelines/NIHinfo2.shtml.
(FDA has verified the Web site
address, but we are not responsible for subsequent changes to the Web
site after this document publishes in the Federal Register.) This
comment questioned the accuracy and objectivity of NHLBI\'s conclusion,
based on the DASH-Sodium study, that all segments of the population can
lower their blood pressure by reducing sodium intake. The comment
argued that because not all of the data from the DASH-Sodium study were
made available for review by interested parties and therefore could not
be evaluated and validated by others, FDA should defer consideration of
the study until the data are released and any necessary reexamination
of NHLBI\'s conclusions about sodium intake and blood pressure has been
accomplished. A second comment similarly argued that FDA should not
consider the DASH-Sodium study or any other studies ``until such time
that they are in accord with the [IQA].\'\'
(Response) Under the IQA, affected persons must be afforded an
administrative mechanism through which they may seek and obtain
correction of information disseminated by Federal agencies (Public Law
106-554, H.R. 5658, Sec. 515(b)(1)(B)). The joint Salt Institute--
Chamber of Commerce request for correction asked NIH to make publicly
available the DASH-Sodium data for all study subgroups, but did not ask
NIH to withdraw or correct any of its public statements recommending
that consumers reduce sodium intake to lower blood pressure, which
relied on the DASH-Sodium data. At the time the comments were filed,
NIH had not yet responded to the joint IQA request for correction. NIH
denied the request by letter on August 19, 2003 (Ref. 5). See http://aspe.hhs.gov/infoquality/request&response/reply_8b.shtml.
II. Summary of the Final Rule
As proposed, this final rule amends the ``healthy\'\' definition in
Sec. 101.65(d) by eliminating the second-tier, more restrictive sodium
requirement (480 mg) for meal and main dish products, which had been
stayed until January 1, 2006. The final rule also eliminates the
second-tier sodium requirement for individual foods instead of allowing
it to go into effect on January 1, 2006, as proposed. Consequently,
neither second-tier sodium requirement will take effect when the stay
expires on January 1, 2006, and the sodium requirements for products
labeled as ``healthy\'\' will remain at the current first-tier levels of
600 mg of sodium for meal and main dish products and 480 mg of sodium
for individual food products. As proposed, the final rule also revises
the regulatory text for the definition of ``healthy\'\' to clarify the
scope and meaning of the regulation and to convert the nutrient content
requirements for ``healthy\'\' to a more readable table-based format.
As discussed in section III of this document, this action is being
taken as a result of comments from a variety of stakeholders urging FDA
to eliminate the more restrictive sodium requirements for individual
foods as well as for meal and main dish products. The comments
documented substantial technical difficulties in finding suitable alternatives for sodium and demonstrated the lack of
consumer acceptance of certain ``healthy\'\' products made with salt
substitutes and/or lower sodium. Comments from both industry and
consumer advocates support the conclusion that implementing the second-
tier sodium requirements would risk substantially eliminating existing
``healthy\'\' products from the marketplace because of unattainable
nutrient requirements or undesirable and, thus, unmarketable flavor
profiles. As a result of these comments, FDA has concluded that it can
best serve the public health by continuing to permit products that meet
the first-tier sodium level to be labeled as ``healthy,\'\' and thereby
ensure the continued availability of foods that consumers can rely on
to help them follow dietary guidelines not only for controlling sodium
but also for limiting total fat, saturated fat, and cholesterol and
consuming adequate amounts of important nutrients such as fiber,
protein, and key vitamins and minerals.
발췌: U.S. Food and Drug Administration
