[Federal Register Volume 64, Number 149 (Wednesday, August 4, 1999)]
[Proposed Rules]
[Pages 42315-42316]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-19979]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 98P-0683]
Food Labeling: Health Claims; Soy Protein and Coronary Heart
Disease
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; notice of extension of period for issuance of
final rule.
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SUMMARY: The Food and Drug Administration (FDA) is extending, for 80
days, the period for issuance of a final rule in response to its
proposal of November 10, 1998, entitled `Food Labeling: Health Claims;
Soy Protein and Coronary Heart Disease.'' FDA's regulations require the
agency to issue a notice of such extension if it finds, for cause, that
it is unable to issue a final rule within 270 days from the November
10, 1998, date of publication of the proposal. Comments to that
proposal have persuaded the agency of the need to propose an
alternative procedure to assess compliance with qualifying amounts of
soy protein in foods that may bear the proposed health claim. FDA will
publish a reproposal of the procedure for compliance assessment in the
Federal Register shortly. The agency then intends to issue one final
rule in response to both proposals on or before October 25, 1999.
FOR FURTHER INFORMATION CONTACT: Susan M. Pilch, Center for Food Safety
and Applied Nutrition (HFS-465), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-205-4500.
SUPPLEMENTARY INFORMATION: In the Federal Register of May 22, 1997 (62
FR 28229), FDA published a final rule to amend Sec. 101.70 (21 CFR
101.70) of its regulations to provide a timeframe in which it will
issue, in rulemakings on health claims, final rules announcing whether
it will authorize the use of the claim at issue and to provide for
extensions of that timeframe for cause. In that final rule, FDA adopted
Sec. 101.70(j)(4)(i), which provides that within 270 days of the date
of publication of a proposal to authorize a health claim, the agency
will publish a final rule that either authorizes the use of a health
claim or explains why the agency has decided not to authorize one. FDA
also adopted Sec. 101.70(j)(4)(ii), which provides that, for cause, the
agency may extend, no more than twice, the period in which it will
publish a final rule and that each such extension
[[Page 42316]]
will be for no more than 90 days. This regulation further requires that
FDA publish a notice of any such extension in the Federal Register, and
that it explain in that notice the basis for the extension, the length
of the extension, and the date by which the final rule will be
published (Sec. 101.70(j)(4)(ii)).
In the Federal Register of May 14, 1998 (63 FR 26717), FDA
published a final rule in part to amend Sec. 101.70 in response to
section 302 of the Food and Drug Administration Modernization Act of
1997 (FDAMA) . Section 302 of FDAMA amended section 403(r)(4)(A)(i) of
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C.
343(r)(4)(A)(i)) to provide, in part, that FDA must publish a final
rule on a health claim petition within 540 days of receipt of the
petition or FDA is required to provide the relevant House and Senate
legislative committees with the reason for failing to do so.
Accordingly, FDA amended Sec. 101.70(j)(4)(ii) to state that
rulemakings on health claim petitions shall be completed within 540
days of receipt of those petitions. FDA noted that, depending upon how
much time the agency uses to file a petition and publish a proposed
rule in response to it, the agency may be limited to only one extension
under Sec. 101.70(j)(4)(ii), and the extension may be limited to fewer
than 90 days (63 FR 26717 at 26718).
In the Federal Register of November 10, 1998 (63 FR 62977), FDA
proposed adding Sec. 101.82 to authorize the use, on food labels and in
food labeling, of health claims on the association between soy protein
and reduced risk of coronary heart disease (CHD) (the soy protein
proposed rule). In the soy protein proposed rule, the agency presented
the rationale for a health claim on this food-disease relationship as
provided for under the standard in section 403(r)(3)(B)(i) of the act
and 21 CFR 101.14(c) of FDA's regulations. The agency tentatively
concluded that, based on the totality of publicly available scientific
evidence, soy protein included in a diet low in saturated fat and
cholesterol may reduce the risk of CHD. The soy protein proposed rule
included qualifying criteria for the purpose of identifying soy
protein-containing foods eligible to bear the proposed health claim and
a proposed analytical method for assessing compliance with the
qualifying criteria. Comments received in response to the soy protein
proposed rule have persuaded FDA that the proposed method for
assessment of compliance is inadequate for many products. Accordingly,
FDA intends to publish, in a separate document, a reproposal for an
alternative procedure. This procedure would rely on measurement of
total protein and require manufacturers, in certain circumstances, to
maintain records that document the amount of soy protein in products
and to make these records available to appropriate regulatory officials
for inspection and copying upon request.
To publish a final rule regarding a health claim for soy protein
and CHD within 270 days of the date of publication of the proposed
rule, which was November 10, 1998, the agency should publish the final
rule on or before August 6, 1999. However, because of the need to
provide for public notice and comment on the reproposal, FDA hereby
gives notice that there is cause to extend the period for publication
of the final rule for a period of 80 days. FDA will, thus, publish a
single final rule in response to both proposals on or before October
25, 1999, which is within 540 days of the date of receipt of the
petition.
Dated: July 28, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning and Legislation.
[FR Doc. 99-19979 Filed 8-3-99; 8:45 am]
BILLING CODE 4160-01-F
