[Federal Register Volume 65, Number 43 (Friday, March 3, 2000)]
[Notices]
[Pages 11585-11586]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-5096]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00F-0792]


The Procter & Gamble Co.; Filing of Food Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
Procter & Gamble Co. (P&G) has filed a petition proposing that the food 
additive regulations regarding olestra be amended by removing the 
requirement for the label statement.

FOR FURTHER INFORMATION CONTACT: Mary D. Ditto, Center for Food Safety 
and Applied Nutrition (HFS-206), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3102.

SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic 
Act (the act) (sec. 409(b)(5) (21 U.S.C. 348(b)(5))), notice is given 
that a food additive petition (FAP 0A4708) has been filed by P&G, 
Winton Hill Technical Center, 6071 Center Hill Ave., Cincinnati, OH 
45224. The petition proposes to amend the food additive regulations in 
Sec. 172.867 Olestra (21 CFR 172.867) by removing the requirement for 
the label statement prescribed in Sec. 172.867(e).
    Olestra is a food additive that is approved for use in place of 
fats and oils in prepackaged ready-to-eat savory snacks (Sec. 172.867). 
Olestra is not digested to any appreciable degree in the human gut and 
is not absorbed or metabolized by the body.
    In the Federal Register of June 23, 1987 (52 FR 23606), FDA 
announced that P&G had filed a petition (FAP 7A3997) proposing that the 
food additive regulations be amended to provide for the safe use of 
olestra. FDA subsequently published a final rule approving olestra for 
use in savory snacks(61 FR 3118, January 30, 1996) after completing its 
evaluation of the relevant data and information. Prior to the issuance 
of the final rule, FDA convened a public meeting of its Food Advisory 
Committee (FAC) on November 14 through 17, 1995, to undertake a 
scientific discussion of the agency's evaluation of the safety data in 
the petition. As a result of the 4-day FAC meeting, a substantial 
portion of the relevant safety data on olestra was publicly discussed 
in detail by both proponents and opponents of olestra's approval, as 
well as by members of the FAC.
    In issuing the olestra final rule, FDA carefully considered the 
proper labeling for foods containing the additive. This issue was also 
discussed in detail before the FAC. As noted, olestra is not absorbed, 
and it passes through the gastrointestinal (GI) tract intact. Data from 
clinical studies submitted by P&G in support of its original petition 
show that consumption of olestra with a meal can affect the absorption 
of certain fat-soluble vitamins and nutrients, which partition into the 
olestra. The petitioner and FDA agreed that these fat-soluble vitamins 
needed to be added to the snacks to compensate for any such effect, and 
that this addition of vitamins was not equivalent to fortification. 
These data also show that olestra has the potential to cause certain GI 
effects such as abdominal cramping and loose stools. FDA determined 
that consumers needed to know about any potential effects of olestra on 
the GI system.
    In view of the record before the agency, FDA concluded that 
olestra-containing products would need to carry an information 
statement in order for such products to avoid being misbranded within 
the meaning of 21 U.S.C. 343(a)(1) and 321(n). Therefore, the final 
rule (Sec. 172.867(e)) required that foods containing olestra be 
labeled with the following statement in a boxed

[[Page 11586]]

format: ``This Product Contains Olestra. Olestra may cause abdominal 
cramping and loose stools. Olestra inhibits the absorption of some 
vitamins and other nutrients. Vitamins A, D, E, and K have been 
added.'' This requirement was established under section 409(c)(3) of 
the act (61 FR 3118, 3160). As such, the requirement was immediately 
effective. Although immediately effective, FDA requested comments on 
the label from interested persons on such issues as the need for 
labeling, the adequacy of its content, and the agency's current word 
choices.
    At the time of olestra's approval, P&G informed FDA that the 
company intended to conduct certain post-marketing studies, which 
included establishing a system for monitoring complaints associated 
with the ingestion of olestra-containing products (passive 
surveillance), a program of active surveillance, and consumer 
evaluation studies of the required label statement. Since the approval 
of olestra in January 1996, olestra-containing snacks have been 
introduced into the marketplace, and P&G has carried out the studies 
and surveillance it committed to do. The company also sponsored new 
clinical studies, which provide additional data and information on 
possible GI effects from consuming olestra-containing snacks in ``real-
life'' situations. A substantial amount of additional data and 
information have been submitted to FDA since the January 1996 olestra 
approval. Specifically, the agency has received reports from four 
studies: An Acute Consumption Study (FAP 0A4708, exhibit 1, reference 
B), a 6-Week Consumption Facilitated Ad Lib Study (FAP 0A4708, exhibit 
1, reference C), a Rechallenge Study (FAP 0A4708, exhibit 1, reference 
D), and a Stool Composition Study (FAP 0A4708, exhibit 1, reference E). 
P&G has also submitted reports and analysis of data collected through 
passive surveillance, consumer focus group and perception studies, 
literature reviews on carotenoids and disease, and an analysis of the 
first year of data collected in the ongoing active surveillance study. 
In addition, the Center for Science in the Public Interest (CSPI) has 
submitted new data and information regarding olestra to the agency.
    Consistent with its responsibilities to monitor the safety of all 
food additives, and as set out in Sec. 172.867(f), FDA presented the 
new data and information concerning olestra, and the agency's 
evaluation of such new information, to the FAC at a meeting held on 
June 15 through 17, 1998. At this open public meeting, FDA, P&G, CSPI, 
and other interested members of the public made presentations to the 
Committee. At the meeting, there was considerable discussion of the 
label required by Sec. 172.867(e), with a range of views expressed. The 
complete set of transcripts of the June 1998 FAC meeting is publicly 
available through FDA's Internet site at http://www.fda.gov/ohrms/dockets/ac/cfsan98t.htm#Food Advisory Committee (choose June 15, 16, 
and 17).
    Since the June 1998 FAC meeting, P&G as well as other interested 
parties have submitted additional information and analyses of the 
required label statement to FDA. The recent submissions include a 
report from a multi-disciplinary panel assembled by P&G and charged 
with examining the scientific evidence, as well as the legal and policy 
precedents, in regard to the label statement. The panel report also 
includes information from the ongoing passive surveillance, and 
additional consumer perception studies regarding the olestra label.
    On December 2, 1999, P&G submitted the food additive petition that 
is the subject of this filing notice; the petition requests that the 
food additive regulations be amended to eliminate the requirement for 
the olestra label statement. P&G contends that the weight of the 
scientific evidence collected since the 1996 approval establishes that 
the label statement contains inaccurate information and is not 
understood by consumers. Accordingly, P&G claims that the olestra label 
misleads consumers and thus misbrands the products on which it appears. 
P&G also asserts that the label statement does not convey material 
information and, thus, is not authorized under sections 403(a)(1) and 
201(n) of the act (21 U.S.C. 343(a)(1) and 321(n)) The material that 
P&G relies on to support its contentions has been incorporated into its 
petition, FAP 0A4708. Much of that material has been publicly available 
since the June 1998 FAC meeting.
    In light of the substantial public interest in this matter and the 
previous public discussion and comment on the olestra label, FDA has 
determined that it is appropriate to make a copy of FAP 0A4708 
available at the agency's Dockets Management Branch, Docket No. 00F-
0792. Relevant information incorporated into FAP 0A4708 includes copies 
of various reports and published studies conducted or sponsored by the 
petitioner, as well as a report produced by the multi-disciplinary 
panel assembled by P&G to evaluate the label statement. Also referenced 
in the petition are consumer perception studies on the olestra label 
conducted by Frito-Lay, Inc., in 1996 and 1999, as well as a variety of 
other published scientific references, and various letters submitted to 
the agency regarding the labeling of olestra-containing snacks. The 
petition also discusses other information relevant to the olestra label 
which can be found in Docket No. 87F-0179. These include comments 
received in response to the agency's request for comments on the label 
statement in the olestra final rule (January 30, 1996), and reports 
submitted by CSPI.
    FDA often receives comments on food additive petitions, especially 
those for which there is a high level of public interest. Although 
section 409 of the act establishes no comment period for food additive 
petitions, and the agency does not solicit comments in notices 
announcing the filing of a food additive petition, it is FDA's 
customary practice to consider any relevant comments submitted 
regarding such petitions. In the case of olestra, much of the material 
relevant to the label issue raised by the petition was submitted to the 
agency since the final rule published, and the bulk of that material 
was available and discussed at the June 1998 FAC meeting. Consistent 
with section 409 of the act, FDA will, as part of the review of P&G's 
petition, fairly evaluate all the evidence of record, including 
relevant comments received by the agency that become part of the 
record.
    The agency has determined under 21 CFR 25.32(i) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

    Dated: February 15, 2000.
Alan M. Rulis,
Director, Office of Premarket Approval, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 00-5096 Filed 3-2-00; 8:45 am]
BILLING CODE 4160-01-F