[Federal Register Volume 66, Number 109 (Wednesday, June 6, 2001)]
[Rules and Regulations]
[Pages 30311-30313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-14285]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 21 CFR Part 101

[Docket Nos. 00P-1275 and 00P-1276]


Food Labeling: Health Claims; Plant Sterol/Stanol Esters and 
Coronary Heart Disease

AGENCY: Food and Drug Administration, HHS.

ACTION: Interim final rule; notice of extension of period for issuance 
of final rule.

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SUMMARY: The Food and Drug Administration (FDA) is extending to July 
25, 2001, the period for issuance of a final rule in response to its 
interim final rule of September 8, 2000, entitled ``Food Labeling: 
Health Claims; Plant Sterol/Stanol Esters 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 date of publication of the

[[Page 30312]]

interim final rule. The complexity of the issues raised by the comments 
to the interim final rule and the lack of agency resources to complete 
the final rule within the specified 270 days have persuaded the agency 
of the need to extend the deadline to publish the final rule.

FOR FURTHER INFORMATION CONTACT: James E. Hoadley, Center for Food 
Safety and Applied Nutrition (HFS-832), 200 C St. SW., Washington, DC 
20204, 202-205-5372.

SUPPLEMENTARY INFORMATION: In the Federal Register of May 22, 1997 (62 
FR 28230), FDA published a final rule amending 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 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 that, in part, amended 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 if FDA initiates rulemaking 
in response to a health claim petition, the agency must complete the 
rulemaking within 540 days of receipt of the petition. If FDA does not 
meet the 540-day deadline, FDAMA requires FDA to provide the relevant 
House and Senate legislative committees with the reasons for failing to 
do so. Accordingly, FDA amended Sec. 101.70(j)(4)(ii) to state that any 
extensions of the final rule deadline in health claim rulemakings shall 
not cause the deadline to exceed 540 days from receipt of the petition. 
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 September 8, 2000 (65 FR 54686), FDA 
published an interim final rule adding 21 CFR 101.83 to authorize the 
use, on food labels and in food labeling, of health claims on the 
association between plant sterol/stanol esters and reduced risk of 
coronary heart disease (CHD) (plant sterol/stanol esters interim final 
rule). The act, as amended by FDAMA, authorizes FDA to make proposed 
health claim regulations effective upon publication pending 
consideration of public comment and publication of a final regulation, 
if the agency determines that such action is necessary for public 
health reasons (see section 403(r)(7) of the act). The legislative 
history of FDAMA indicates that such proposed regulations should be 
issued as interim final rules (H. Conf. Rept. 105-399, at 98 (1997)). 
Because the plant sterol/stanol esters interim final rule was issued 
under FDA's authority to make a proposed rule effective upon 
publication (see 65 FR 54685 at 54713), it was subject to the deadline 
for proposed rules in Sec. 101.70(j)(3). Likewise, the final rule 
deadline in Sec. 101.70(j)(4) applies to this rulemaking.
    In the plant sterol/stanol esters interim final rule, the agency 
presented the rationale for a health claim on this food-disease 
relationship 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 concluded that, 
based on the totality of the publicly available scientific evidence, 
plant sterol/stanol esters may reduce the risk of CHD. The interim 
final rule specified the daily intake levels of plant sterol and stanol 
esters associated with reduced risk of CHD, the categories of foods 
eligible to bear the plant sterol/stanol esters health claim, and 
analytical methods for assessing compliance with qualifying criteria 
for the claim.
    The comments received in response to the plant sterol/stanol esters 
interim final rule raised numerous complex issues. For example, we 
received many comments urging the agency to broaden the categories of 
foods eligible to bear the plant sterol/stanol esters health claim. 
Many comments also argued that the daily intake level for plant stanol 
esters should be the same as for plant sterol esters. Another group of 
comments requested that FDA allow foods containing the nonesterified 
form of plant sterols/stanols to bear the health claim.
    The complex issues raised by these comments warrant significant 
attention and the expenditure of significant staff resources. 
Unfortunately, the Office of Nutritional Products, Labeling, and 
Dietary Supplements (ONPLDS) within FDA's Center for Food Safety and 
Applied Nutrition has had to focus a large part of its health claim 
review resources on litigation-related work since the issuance of the 
plant sterol/stanol esters interim final rule. (ONPLDS is also the 
office responsible for reviewing all health claim petitions.) FDA's 
review of these comments, therefore, has been hampered by a lack of 
staff available to examine the scientific evidence pertaining to these 
complex issues. Accordingly, an extension of time to complete the plant 
sterol/stanol esters final rule is needed.
    To publish a final rule regarding a health claim for plant sterol/
stanol esters and CHD within 270 days of the date of publication of the 
interim final rule, which was on September 8, 2000, the agency would 
have to publish the final rule on or before June 5, 2001. However, 
because of the need to provide for additional time for agency staff to 
evaluate the issues raised by the comments on the plant sterol/stanol 
esters interim final rule, FDA hereby gives notice that there is cause 
to extend the deadline for publication of the final rule by 50 days. 
FDA will, therefore, publish a final rule in response to the interim 
final rule on or before July 25, 2001.
    The new deadline of July 25, 2001, falls within the 540-day limit 
set by the statute. As noted above, section 403(r)(4)(A)(i) of the act 
requires FDA to complete health claim rulemakings within 540 days of 
the receipt of the petition. Since the current rulemaking involves two 
separate health claim petitions, submitted by Lipton and McNeil 
Consumer Healthcare, that have been combined into one rulemaking, the 
agency will consider the date of receipt of the earlier petition for 
purposes of calculating the deadline. Lipton submitted its health claim 
petition on February 1, 2000; McNeil submitted its petition on February 
15, 2000. Publication of a final rule on or before July 25, 2001, will 
allow the agency to complete this rulemaking within 540 days of the 
receipt of the earlier (Lipton's) petition.


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    Dated: May 31, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-14285 Filed 6-5-01; 8:45 am]
BILLING CODE 4160-01-S