Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease

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