[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]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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