[Federal Register Volume 68, Number 150 (Tuesday, August 5, 2003)]
[Rules and Regulations]
[Pages 46403-46410]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-19509]



[[Page 46403]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. 1987F-0179]


Food Additives Permitted for Direct Addition to Food for Human 
Consumption; Olestra

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; denial of requests for a hearing and response to 
objections.

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SUMMARY: The Food and Drug Administration (FDA) is denying the requests 
for a hearing it has received on the final rule that amended the food 
additive regulations to provide for the safe use of sucrose esterified 
with medium and long chain fatty acids (olestra) as a replacement for 
fats and oils in savory snacks. After reviewing the objections to the 
final rule and the requests for a hearing, FDA has concluded that the 
objections do not raise any issue of material fact that justifies a 
hearing or otherwise provides a basis for revoking the regulation.

FOR FURTHER INFORMATION CONTACT: Mary Ditto, Center for Food Safety and 
Applied Nutrition (HFS-255), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, 202-418-3102.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background and Procedural History
II. Standard for Granting a Hearing
III. Objections and Supporting Documents Submitted by Center for 
Science in the Public Interest (CSPI)
IV. Analysis of Objections and Response to Hearing Requests
    A. Carotenoids
    1. Are Carotenoids Beneficial to Health?
    2. Does Consumption of Olestra Cause a Harmful Depletion of 
Carotenoids?
    B. Vitamin K
    C. Gastrointestinal (GI) Effects
    1. Are the Observed GI Symptoms Adverse Health Effects?
    2. Did FDA Err in Pooling Certain GI Data for Analysis?
    D. Adequacy of Olestra's Label Statement
    1. Label Statement Regarding GI Effects
    2. Label Statement Regarding Absorption of Nutrients
    E. Alleged Procedural Problems in the Olestra Proceeding
    F. Alleged Absence of Reasonable Certainty of No Harm
V. Summary and Conclusion

I. Background and Procedural History

    In a notice published in the Federal Register of June 23, 1987 (52 
FR 23606), FDA announced that a food additive petition (FAP 7A3997) had 
been filed by the Procter & Gamble Co., 6071 Center Hill Rd., 
Cincinnati, OH 45224-1703 (P&G, the petitioner), proposing the issuance 
of a food additive regulation providing for the safe use of sucrose 
esterified with medium and long chain fatty acids as a replacement for 
fats and oils. The common name for this additive is olestra. 
Subsequently, the petitioner amended the petition to limit the intended 
use of the additive to a 100 percent replacement for conventional fats 
in the preparation of savory snacks (i.e., snacks that are salty or 
piquant but not sweet, such as potato chips, cheese puffs, and 
crackers).
    FDA reviewed the data and information in the olestra food additive 
petition to determine whether the additive is safe (see section 
409(c)(3) of the Federal Food, Drug, and Cosmetic Act (the act) (21 
U.S.C. 348(c)(3)), for use in savory snacks. As part of this review 
process, FDA held public meetings of the agency's Food Advisory 
Committee (the FAC) and a working group of the FAC, the Olestra Working 
Group (the OWG) to provide for a scientific discussion of FDA's 
evaluation of the safety data in the petition.
    On January 30, 1996, FDA issued a final rule in the Federal 
Register authorizing the use of olestra in place of fats and oils in 
prepackaged ready-to-eat savory snacks (61 FR 3118, January 30, 1996) 
(Sec.  172.867 (21 CFR 172.867)). In the preamble to the final rule, 
FDA concluded that all safety issues regarding olestra had been 
addressed adequately and that there is a reasonable certainty that no 
harm will result from the use of olestra in savory snacks. The 1996 
olestra regulation requires that the fat-soluble vitamins A, D, E, and 
K be added to olestra-containing foods to compensate for any inhibition 
of absorption of these vitamins caused by olestra. The 1996 regulation 
also requires that foods containing olestra be labeled with the 
following information statement:
    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.
(Sec.  172.867(e)(1)).
    Consistent with section 409(f) of the act (21 U.S.C. 348(f)), the 
preamble to the final rule advised that objections to the final rule 
and requests for a hearing were due within 30 days of the publication 
date (i.e., by February 29, 1996)\1\ (Sec.  171.110 (21 CFR 171.110) 
and 21 CFR 12.22(a).) On February 29, 1996, CSPI filed six objections 
to the final rule and requested a hearing on all six objections.\2\ 
CSPI had substantially participated in the November 1995 OWG/FAC 
meeting and had also filed multiple sets of comments with FDA prior to 
issuance of the final rule.
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    \1\ In addition to notifying the public of the opportunity to 
submit objections and hearing requests, FDA requested comments on 
the olestra label requirement on such issues as the need for such a 
label, the adequacy of its content, the agency's word choice, and 
the configuration of the label. In the Federal Register of March 3, 
2000 (65 FR 11585), FDA announced that a food additive petition (FAP 
0A4708) had been filed by P&G proposing to amend Sec.  172.867 by 
removing the requirement for the label statement prescribed in Sec.  
172.867(e). Elsewhere in this issue of the Federal Register, FDA is 
issuing a final rule that responds to FAP 0A4708. In that final 
rule, the agency responds to comments received regarding the label 
statement.
    \2\ In addition, FDA received several letters within the 30 day 
objection period, all of which expressed general opposition to 
olestra, identified no substantive question to which the agency can 
respond, and did not request a hearing. These letters will not be 
discussed further.
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    In the preamble to the 1996 final rule (61 FR 3118 at 3169), FDA 
advised that it would publish in the Federal Register notice of the 
objections that it received or lack thereof.\3\ This document fulfills 
the agency's obligation to publish such a notice. The only timely, 
substantive objections FDA received were from CSPI.
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    \3\ The January 30, 1996, final rule includes a more detailed 
background statement.
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II. Standard for Granting a Hearing

    Under Sec.  171.110 of the food additive regulations, objections 
and requests for a hearing are governed by part 12 (21 CFR part 12) of 
FDA's regulations. Specific criteria for determining whether a hearing 
has been justified are set forth in Sec.  12.24(b). Under the 
regulation, a hearing will be granted if the material submitted by the 
requester shows, among other things, that: (1) There is a genuine and 
substantial issue of fact for resolution at a hearing; a hearing will 
not be granted on issues of policy or law; (2) the factual issue can be 
resolved by available and specifically identified reliable evidence; a 
hearing will not be granted on the basis of mere allegations or denials 
or general descriptions of positions and contentions; (3) the data and 
information submitted, if established at a hearing, would be adequate 
to justify resolution of the factual issue in the way sought by the 
requestor; a hearing will be denied if the data and information

[[Page 46404]]

submitted are insufficient to justify the factual determination urged, 
even if accurate; and (4) resolution of the factual issue in the way 
sought by the requestor is adequate to justify the action requested; a 
hearing will not be granted on factual issues that are not 
determinative with respect to the action requested, (e.g., if the 
action would be the same even if the factual issue were resolved in the 
way sought).
    A party seeking a hearing is required to meet a ``threshold burden 
of tendering evidence suggesting the need for a hearing.'' (See Costle 
v. Pacific Legal Foundation, 445 U.S. 198, 214-215 (1980), reh. den., 
446 U.S. 947 (1980), citing Weinberger v. Hynson, Westcott & Dunning, 
Inc., 412 U.S. 609, 620-621 (1973).) An allegation that a hearing is 
necessary to ``sharpen the issues'' or to ``fully develop the facts'' 
does not meet this test. (See Georgia-Pacific Corp. v. U.S. EPA, 671 
F.2d 1235, 1241 (9th Cir. 1982).) If a hearing request fails to 
identify any evidence that would be the subject of a hearing, there is 
no point in holding one. In judicial proceedings, a court is authorized 
to issue summary judgment without an evidentiary hearing whenever it 
finds that there is no genuine issue of material fact, and a party is 
entitled to judgment as a matter of law (see Rule 56, Federal Rules of 
Civil Procedure). The same principle applies in administrative 
proceedings (Sec.  12.28).
    A hearing request must not only contain evidence, but that evidence 
must raise a material issue of fact concerning which a meaningful 
hearing might be held. (See Pineapple Growers Association v. FDA, 673 
F.2d 1083, 1085 (9th Cir. 1982).) Where the issues raised in the 
objection are, even if true, legally insufficient to alter the 
decision, the agency need not grant a hearing. (See Dyestuffs and 
Chemicals, Inc. v. Flemming, 271 F.2d 281 (8th Cir. 1959), cert. 
denied, 362 U.S. 911 (1960).) FDA need not grant a hearing in each case 
where an objector submits additional information or posits a novel 
interpretation of existing information. (See United States v. 
Consolidated Mines & Smelting Co., 455 F.2d 432 (9th Cir. 1971).) In 
other words, a hearing is justified only if the objections are made in 
good faith, and if they ``draw in question in a material way the 
underpinnings of the regulation at issue.'' (See Pactra Industries v. 
CPSC, 555 F.2d 677 (9th Cir. 1977).) Finally, courts have uniformly 
recognized that a hearing need not be held to resolve questions of law 
or policy. (See Citizens for Allegan County, Inc. v. FPC, 414 F.2d 1125 
(D.C. Cir. 1969); Sun Oil Co. v. FPC, 256 F.2d 233, 240 (5th Cir.), 
cert. denied, 358 U.S. 872 (1958).)
    Even if the objections raise material issues of fact, FDA need not 
grant a hearing if those same issues were adequately raised and 
considered in an earlier proceeding. Once an issue has been so raised 
and considered, a party is estopped from raising that same issue in a 
later proceeding without new evidence. The various judicial doctrines 
dealing with finality can be validly applied to the administrative 
process. In explaining why these principles ``self-evidently'' ought to 
apply to an agency proceeding, the D.C. Circuit wrote:
    The underlying concept is as simple as this: justice requires 
that a party have a fair chance to present his position. But overall 
interests of administration do not require or generally contemplate 
that he will be given more than a fair opportunity.
(Retail Clerks Union, Local 1401, RCIA v. NLRB, 463 F.2d 316, 322 (D.C. 
Cir. 1972).) (See also Costle v. Pacific Legal Foundation, supra at 
1106, and Pacific Seafarers, Inc. v. Pacific Far East Line, Inc. 404 
F.2d 804 (D.C. Cir. 1968).)
    In summary, a hearing request must present sufficient credible 
evidence to raise a material issue of fact and the evidence presented 
must be adequate to resolve the issue as requested and to justify the 
action requested.

III. Objections and Supporting Documents Submitted by CSPI

    In a document dated February 29, 1996, entitled ``Objections and 
Request for Hearing'' (CSPI obj.), CSPI submitted to the Division of 
Dockets Management, its objections to the approval of the use of 
olestra as a food additive in savory snacks. CSPI submitted six 
objections to the 1996 final rule, and requested a hearing on issues 
raised by each objection. CSPI raised one general objection to the 1996 
final rule, asserting that FDA improperly concluded that the use of 
olestra in savory snacks meets the safety standard of reasonable 
certainty of no harm. CSPI also raised five specific objections, 
asserting that: (1) Olestra's potential to deplete carotenoids may 
present a risk of harm to health, which precludes a finding of 
reasonable certainty of no harm; (2) FDA's decision to require 
compensation with vitamin K may not solve health problems that 
depletion of vitamin K may cause; (3) the potential GI disturbances 
that olestra may cause are adverse health effects that preclude a 
finding of reasonable certainty of no harm; (4) the label statement 
required on an interim basis by the 1996 final rule is insufficient to 
protect the public against adverse effects associated with consumption 
of olestra; and (5) problems with procedure and process tainted FDA's 
review of, and decision-making process for, the food additive petition 
for olestra to the detriment of FDA's consideration of the public 
health concerns raised by CSPI and others. In support of its objections 
and hearing requests, CSPI filed 18 exhibits (CSPI exh. 1 through 
18.)\4\
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    \4\ In a letter dated August 26, 1996 (Docket No. 1987F-0179), 
CSPI requested that certain documents submitted to the agency after 
February 29, 1996, be considered part of their objections. As noted 
previously, February 29, 1996, was the final day allowed under 
section 409(f)(1) of the act for submission of objections and 
hearing requests, including supporting material. Accordingly, the 
material submitted in August 1996 was not timely filed and thus, has 
not been considered in evaluating the CSPI objections and hearing 
requests.
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IV. Analysis of Objections and Response to Hearing Requests

    As noted in section III of this document, CSPI raised one general 
objection and five specific objections to the 1996 final rule. In this 
document, FDA addresses each of CSPI's objections, as well as the data 
and information filed in support of each, comparing each to the 
standards for granting a hearing in Sec.  12.24(b). Because several of 
the issues in the general objection overlap with the five more specific 
objections, FDA addresses CSPI's five specific objections first (CSPI 
obj. 2 through 6), followed by the general objection (CSPI obj. 1).

A. Carotenoids

    In its second objection and request for a hearing, CSPI states that 
there are two questions central to a discussion of the depletion of 
carotenoids by consumption of olestra. First, are carotenoids 
beneficial to health? Second, if carotenoids are beneficial to health, 
does consumption of olestra cause depletion of carotenoids such that 
there would be an absence of a reasonable certainty of no harm? CSPI 
claims that FDA did not answer either of these questions accurately and 
requests a hearing on both factual issues.
1. Are Carotenoids Beneficial to Health?
    In its objection and request for a hearing, CSPI asserts that FDA 
erroneously concluded that there is no demonstrated health benefit of 
carotenoids except the provitamin A function of beta-carotene.
    In analyzing this objection, it is important to recognize that 
FDA's position on carotenoids (as articulated in the 1996 final rule) 
has two parts. First, although FDA concluded that there is no 
demonstrated association between carotenoids per se and health

[[Page 46405]]

benefits, the agency agrees that epidemiological studies show an 
association between diets rich in fruits and vegetables and decreased 
cancer risk (61 FR 3118 at 3149).\5\ As shown in this section, all of 
the evidence and opinions cited by CSPI to support this objection is 
consistent with an association between fruit and vegetable consumption 
and health benefits. Second, FDA concluded that the variation in serum 
levels of carotenoids associated with olestra consumption is within the 
normal range, given diet variations and the bioavailability of 
carotenoids. CSPI's objection does not directly address this second 
issue.\6\
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    \5\ Indeed, CSPI itself concedes that there may be ``substances 
in fruits and vegetables for which carotenoids are markers'' that 
are beneficial to health (CSPI obj. at 19).
    \6\ Although not strictly relevant to the objections lodged by 
CSPI, it is important to note that in its 1996 final rule, FDA 
acknowledged the growing body of data and information regarding 
carotenoids and committed to reviewing such information within 30 
months of olestra's initial approval (61 FR 3118 at 3168 and 
footnote 94). In June 1998, FDA presented the accumulated data and 
information to the FAC.
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    CSPI offers essentially two arguments to support its view that FDA 
erroneously concluded that there is no demonstrated health benefit of 
carotenoids except the provitamin A function of beta-carotene. First, 
CSPI asserts that FDA's position on carotenoids is a minority view.\7\ 
To support this challenge, CSPI relies on statements of Drs. Regina 
Ziegler (CSPI exh. 10), Walter Willet (CSPI exh. 13), and Jerianne 
Heimendinger (CSPI exh. 8) to demonstrate that FDA's position is not 
well-founded. Importantly, Drs. Ziegler and Willet both state that 
fruits and vegetables, not carotenoids per se, are associated with 
reduction of the risk of cancer. (CSPI exh. 13, p. 1; CSPI exh. 10, 
letter dated October 23, 1995, p. 1, and letter dated January 21, 1996, 
p. 2.) Similarly, Dr. Heimendinger asserts merely that evidence is 
``increasing that * * * carotenoids may play important roles'' in 
reducing cancer risk (emphasis added). (CSPI exh. 8, Heimendinger 
letter, p. 2). Thus, none of these statements support CSPI's claim that 
carotenoids have been demonstrated to have a significant beneficial 
health role.\8\ Accordingly, FDA is denying CSPI's request for a 
hearing on this issue because the information identified in the 
objection is insufficient to justify the factual determination urged by 
CSPI (Sec.  12.24(b)(3)).\9\
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    \7\ Although CSPI asserts that FDA's view is a minority view, 
the final rule noted that five different conferences or reviewing 
groups have examined the relationship between carotenoids and 
disease and concluded that there was insufficient evidence to 
recommend specifically the consumption of carotenoids, except to 
encourage the consumption of fruits and vegetables (61 FR 3118 at 
3148). CSPI does not challenge this fact..
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    CSPI also relies on the dietary guidelines issued by the Department 
of Health and Human Services (DHHS), 4th edition, to support its 
assertion that FDA's position on carotenoids is a minority view. 
Careful reading of the guidelines establishes that, once again, the 
evidence identified in the objection does not support the position 
urged by CSPI because the guidelines do not identify carotenoids per se 
as beneficial to human health.
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    \8\ CSPI's objection and hearing request on this point also 
refer to an article published by Dr. Edward Giovannucci addressing 
the association between high intake of tomato products and reduced 
incidence of prostate cancer and claims that Dr. Giovannucci opposes 
the approval of olestra because of the additive's potential to 
deplete carotenoids, citing CSPI exh. 8. Although CSPI exh. 8 
contains numerous letters from individuals opposing olestra's 
approval, there is no identifiable communication from Dr. 
Giovannucci in that exhibit. In the absence of specifically 
identified evidence demonstrating Dr. Giovannucci's position, FDA is 
denying CSPI's objection and hearing on this point (Sec.  12.24 
(b)(2)). In addition, CSPI's reliance on the Giovannucci article is 
misplaced because, even as described by CSPI, the paper does not 
support CSPI's claim that carotenoids themselves have been shown to 
have distinct health benefits. Accordingly, FDA is denying CSPI's 
claim on this point (Sec.  12.24(b)(2) and (b)(4)).
    \9\ CSPI also relies on its White Paper (CSPI exh. 1) and 
exhibits 3 through 7 to the White Paper. Although this reference is 
quite lengthy (approximately 230 pages total), CSPI fails to specify 
the information or data in these documents that support its 
assertion that FDA's position on carotenoids is a minority view. In 
such circumstances, reliance on the White Paper (CSPI exh. 1) and 
exhibits 3 through 7 cannot justify a hearing because a hearing will 
not be granted in the absence of available and specifically 
identified reliable evidence to support the factual issue asserted 
(Sec.  12.24(b)(2)).
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    Consumption of these foods [fruits and vegetables] is associated 
with a substantially lower risk of many chronic diseases, including 
certain types of cancers. (CSPI exh. 11, p. 13.)\10\
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    \10\ CSPI's exh. 11 is a photocopy of the complete dietary 
guidelines pamphlet. However, at the time of olestra's approval, 
only an excerpt (the cover and pp. 22-23 of the pamphlet) was in the 
record.
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Elsewhere the guidelines describe the role of carotenoids in health as 
yet-to-be established.
    The antioxidant nutrients found in plant foods (e.g., vitamin C, 
carotenoids, vitamin E, and certain minerals) are presently of great 
interest to scientists and the public because of their potentially 
beneficial role in reducing the risk for cancer and certain other 
chronic diseases. Scientists are also trying to determine if other 
substances in plant foods protect against cancer. (CSPI exh. 11, p. 
13, emphasis added.)
Because the information regarding the DHHS dietary guidelines is 
insufficient to establish CSPI's claim regarding the role of 
carotenoids in human health, FDA is denying a hearing on this issue 
(Sec.  12.24(b)(3)).
    As a third basis to show that FDA's position regarding carotenoids 
is a minority view, CSPI cites correspondence between FDA and two 
different institutes of the National Institutes of Health (NIH).\11\ 
CSPI challenges FDA's reliance on the letter from the NEI because it 
only addresses the role of beta-carotene, not lutein or lycopene. Even 
if CSPI's claims on this issue are correct, FDA is denying its request 
for a hearing because the assertion that lutein and lycopene have a 
beneficial role in eye health is not supported by specifically 
identified factual evidence. Accordingly, CSPI's allegations are mere 
speculation, which is not an adequate basis for a hearing request 
(Sec.  12.24(b)(2)).
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    \11\ Following the November 1995 meeting of the FAC, FDA 
exchanged letters with experts at the National Eye Institute (NEI) 
and the National Cancer Institute (NCI). CSPI claims that the fact 
FDA consulted with experts at NCI and NEI demonstrates that FDA was 
uncertain of its position on carotenoids, an assertion unsupported 
in the record.
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    With respect to the NCI, CSPI claims that there are conflicting 
views in the record from NCI and that FDA should determine, on the 
record, the ``official'' NIH position. Specifically, CSPI believes that 
Dr. Ziegler's views are significantly different from the views 
expressed by the then Director of the Division of Cancer Prevention and 
Control, NCI, NIH, Dr. Peter Greenwald.\12\ CSPI does not demonstrate 
why such a determination is necessary, the authority under which it 
would be done, or how it would alter the outcome of this proceeding. 
Accordingly, FDA is denying CSPI's request for a hearing on this issue 
(Sec.  12.24(b)(2) and (b)(4)).
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    \12\ In fact, CSPI's own documents demonstrate that there is no 
conflict as to the official statements of the NCI regarding 
carotenoids because Dr. Ziegler acknowledges that she does not speak 
on behalf of the NCI (even though her two letters are written on NCI 
letterhead). (CSPI exh. 10, letter dated January 21, 1996, p. 1).
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    Finally, CSPI asserts that FDA staff, the OWG, and the FAC failed 
to acknowledge and accept data from in vitro, animal, and epidemiologic 
studies that all point to a protective role for carotenoids. In support 
of this portion of its second objection, CSPI cites two articles (CSPI 
obj. at p. 20, footnote 19).\13\ This portion of CSPI's objection is 
without foundation because the information specifically cited is not 
adequate to establish the factual issue urged by CSPI\14\ (Sec.  
12.24(b)(3)). In particular, the first article cited (Garewal, H., 
``Antioxidants in Oral Cancer Prevention,'' American Journal of 
Clinical Nutrition, 62:1410S-1416S, 1995, at 1413S.) concludes that the 
reported results do not themselves demonstrate a reduction in human

[[Page 46406]]

cancer risk,\15\ and CSPI does not identify any other potential health 
benefit of carotenoids established by this article. Similarly, the 
second publication (Bertram, J. S. and H. Bortkiewicz, ``Dietary 
Carotenoids Inhibit Neoplastic Transformation and Modulate Gene 
Expression in Mouse and Human Cells,'' American Journal of Clinical 
Nutrition, 62:1327S-1336S, 1995, at 1328S.), notes that the 
investigators' results simply provide ``a possible mechanistic basis 
for the activity of carotenoids as chemopreventive agents (emphasis 
added).'' Moreover, citing this second publication, CSPI asserts that 
``carotenoids affect intercellular communications'' (CSPI obj. at p. 
20, footnote 19). However, CSPI does not demonstrate how the effect of 
carotenoids on intercellular communications supports its assertion that 
carotenoids are beneficial to health.\16\ Accordingly, FDA is denying 
CSPI's hearing request on this issue (Sec.  12.24(b)(3)).\17\
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    \13\ These articles are the only specific data identified by 
CSPI to support its second objection.
    \14\ CSPI claims that FDA, the OWG, and the FAC ignored certain 
data on carotenoids. Importantly, however, the two journal articles 
cited by CSPI were published in a supplement to the December 1, 
1995, issue of the American Journal of Clinical Nutrition. The FAC/
OWG meeting was held November 14 through 17, 1995, and CSPI presents 
no evidence that these articles were even available at the time of 
the meeting. In fact, these two articles were not submitted to FDA 
until December 22, 1995.
    \15\ CSPI states that ``carotenoids reverse oral leukoplakia in 
rats.'' (CSPI obj. at p. 20, footnote 19.) However, the Garewal 
article cited by CSPI in support of this statement presents no data 
on the reversal of oral leukoplakia in rats.
    \16\ As noted previously, in the 1996 final rule, FDA concluded 
that the variation in serum levels of carotenoids associated with 
olestra consumption is within the normal range, given diet 
variations and the bioavailability of carotenoids, a conclusion not 
addressed directly by CSPI. In view of this unchallenged conclusion, 
the Bertram and Bortkiewicz paper, id. at 1333S-1334S, appears to 
support a finding of no harm from olestra's effects on carotenoid 
levels of consumers of olestra-containing food. ``Our demonstration 
that dietary carotenoids can inhibit neoplastic transformation and 
modulate the expression of gene products in both human and mouse 
cells implies that these ubiquitous compounds have hitherto unknown 
properties. Moreover, these effects were produced at micromolar 
concentrations that are within the physiologic range * * * ''
    \17\ Indeed, the paper by Bertram and Bortkiewicz is consistent 
with FDA's conclusion that the available evidence demonstrates an 
association between a diet rich in fruits and vegetables and 
reduction in the risk of certain diseases. ``Many epidemiologic 
studies have shown a consistent inverse correlation between 
consumption of foods rich in carotenoids * * * and future risk of 
cancer.'' (Id. at 1327S.)
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    CSPI's second argument to support its position that FDA erroneously 
concluded that there is no demonstrated health benefit of carotenoids, 
except the provitamin A function of beta-carotene, is that the agency 
wrongly insisted on randomized trials to establish the role of 
carotenoids in health. CSPI bases this allegation on the fact that FDA 
quoted Dr. Alvan Feinstein in the preamble to the 1996 final rule. CSPI 
implies that FDA relied on Dr. Feinstein and thus, ignored evidence in 
the record that establishes a beneficial role of carotenoids in human 
health. In addition, CSPI claims that Dr. Feinstein is a ``debunker'' 
and he, and his views, lack credibility.
    These allegations are not adequate to justify a hearing on this 
issue for three reasons. First, CSPI quotes Dr. Feinstein out of 
context. Contrary to CSPI's claim, Dr. Feinstein did not ``insist'' on 
randomized trials. Instead, Dr. Feinstein described certain limitations 
of epidemiologic studies (studies such as those cited by another 
witness, Dr. Meir Stampfer), including the fact that it is difficult to 
draw conclusions about cause and effect relationships from such studies 
(61 FR 3118 at 3147 to 3148), a conclusion not directly challenged by 
CSPI. Thus, FDA is denying CSPI's hearing request on this point because 
a hearing will not be granted where the information to support the 
factual conclusion urged is unreliable (Sec.  12.24(b)(2)). Second, 
CSPI asserts that Dr. Feinstein failed to acknowledge that the test 
methods he advocated might not be meaningful for dietary carotenoids. 
Because CSPI offers no evidence to suggest that these methods are not 
appropriate and does not show how, if at all, prevailing on this 
factual issue would change the outcome of the rulemaking, FDA is 
denying a hearing on this issue (Sec.  12.24(b)(2) and (b)(4)). 
Finally, in reaching its position on carotenoids, FDA considered all 
the comments, data, and information that the agency had received on 
carotenoids, including information from epidemiological studies (61 FR 
3118 at 3149). FDA's position on the carotenoids issue is not 
inconsistent with the findings of the epidemiological studies relied 
upon by CSPI (61 FR 3118 at 3149). Thus, even if Dr. Feinstein's views 
were shown to be incorrect and CSPI prevailed on this issue, the 
outcome of the ruling would not be altered. Therefore, FDA is denying 
CSPI's request for a hearing on this issue (Sec.  12.24(b)(4)).
2. Does Consumption of Olestra Cause a Harmful Depletion of 
Carotenoids?
    In its second objection and request for a hearing, CSPI asserts 
that consumption of olestra likely would cause major depletions of 
serum levels of carotenoids and that this depletion could be harmful 
because carotenoids have beneficial properties.\18\ CSPI also asserts 
that even a 5 to 10 percent reduction in serum levels of carotenoids 
could be harmful. CSPI offers several arguments to support this portion 
of its objection.\19\
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    \18\ To the extent that CSPI contends that there is a lack of 
reasonable certainty of no harm from olestra's depletion effect on 
carotenoids, CSPI's hearing request is denied because whether a food 
additive is safe for its intended use (i.e., whether there is a 
reasonable certainty of no harm) is a question of law to be decided 
based on the facts established in the record. Under Sec.  
12.24(b)(1), a hearing will not be granted on issues of policy or 
law.
    \19\ It is important to note that depletion of serum carotenoid 
levels is relevant only if carotenoids themselves are shown to have 
human health benefits. As discussed in the previous section, CSPI's 
objection and hearing request fails to establish any genuine issue 
of material fact regarding FDA's conclusion that there is no 
demonstrated health benefit of any carotenoid except the provitamin 
A function of beta-carotene. Thus, this portion of CSPI's objection 
and hearing request is also denied because resolution of this issue 
in CSPI's favor would not alter the outcome of this proceeding 
(Sec.  12.24(b)(4)).
---------------------------------------------------------------------------

    First, CSPI asserts generally that the amounts of olestra consumed 
are sufficient to cause major depletions of carotenoids, referring to 
``the section [above] on consumption estimates.'' (CSPI obj. at p. 24.) 
However, there is no such section in CSPI's submission.\20\ Moreover, 
CSPI's objection did not offer any facts to contradict FDA's conclusion 
in the final rule that the magnitude of olestra's effects on carotenoid 
absorption are likely to be within the range of normal variation (61 FR 
3118 at 3149). Accordingly, FDA is denying CSPI's challenge to the 
agency's determination that any depletion of carotenoids by olestra 
consumption would be minor because a hearing on a factual issue will 
not be granted in the absence of specifically identified, available 
evidence to support the requestor's position (Sec.  12.24(b)(2)).
---------------------------------------------------------------------------

    \20\ It is possible that CSPI intended to reference the 
discussion in its White Paper (CSPI exh. 1) on consumption 
estimates, but no such reference was given (Sec.  12.24(b)(2)).
---------------------------------------------------------------------------

    CSPI also challenges FDA's conclusion on the magnitude of 
carotenoid depletion by asserting that patterns of consumption of 
olestra will not prevent such depletion. In particular, CSPI asserts 
that P&G's depletion studies only measured the status of beta-carotene 
and thus, the full impact of olestra consumption on carotenoids was not 
assessed. However, CSPI did not submit or otherwise specifically 
identify evidence to establish that olestra's effect on beta-carotene 
was not representative of the additive's effect on carotenoids 
generally. Moreover, CSPI does not demonstrate how resolving this 
particular issue in its favor will alter the outcome of this 
proceeding. Accordingly, FDA is denying CSPI's objection and hearing 
request (Sec.  12.24(b)(2) and (b)(4)).
    CSPI also claims that FDA erroneously relied on data presented by 
P&G on patterns of consumption when the agency concluded that olestra's 
effects on carotenoid absorption would not be harmful. CSPI did not 
present

[[Page 46407]]

any specific information to dispute P&G's consumption pattern data; 
instead, CSPI simply asserted that other consumption patterns were 
likely.\21\ Mere allegations of this type do not require that a hearing 
request be granted (Sec.  12.24(b)(2)). Moreover, although the 
petitioner did present information on snack consumption patterns and 
their effects on carotenoid depletion, FDA did not rely on this 
information in its safety determination (61 FR 3118 at 3149 at footnote 
51). Accordingly, even if CSPI were to prevail on this factual issue, 
the outcome of this rulemaking would not be altered and thus, FDA is 
denying this portion of CSPI's objection and hearing request (Sec.  
12.24(b)(4)).\22\
---------------------------------------------------------------------------

    \21\ For example, CSPI claims that the ``great popularity of 
tomato-based salsa in recent years suggests that many consumers 
would consume tortilla, corn, or potato chips with this carotenoid-
rich dip, with or between meals.'' (CSPI obj. at p. 24.) Similarly, 
CSPI asserts that ``consumption of savory snacks is likely to 
increase if olestra snacks become generally available.'' (CSPI obj. 
at p. 25.) CSPI does not identify any particular information or 
evidence in the record to support either assertion (Sec.  
12.24(b)(2)).
    \22\ In questioning the petitioner's evidence on consumption 
patterns, CSPI also challenges the hypothesis of Dr. Penny Kris-
Etherton, a P&G consultant, that consumption of olestra-containing 
foods between meals has no effect on carotenoid depletion. 
Importantly, however, CSPI fails to identify any credible data or 
information to support its assertion that this hypothesis is 
``unproven and doubtful.'' (CSPI obj. at p. 25.) Thus, FDA is 
denying CSPI's request for a hearing on this point (Sec.  
12.24(b)(2)).
---------------------------------------------------------------------------

    Finally, CSPI relies on the proceedings of a January 1996 workshop 
at the Harvard School of Public Health to support its view that 
olestra's depletion of carotenoids will be harmful.\23\ In particular, 
CSPI cites estimates of the possible impact on the public health that 
would allegedly result from the wide-spread use of olestra in snack 
foods, which estimates were presented at the Harvard meeting (CSPI exh. 
13). CSPI contends that if FDA had correctly understood the Harvard 
meeting estimates regarding carotenoid depletion, it is doubtful that 
olestra would have been approved\24\ (CSPI obj. at 28).
---------------------------------------------------------------------------

    \23\ CSPI raises two spurious arguments regarding carotenoids, 
neither of which is adequate to justify a hearing on this issue. 
Specifically, CSPI criticizes the agency because no one from FDA's 
``senior level'' attended the meeting, and faults the summary 
prepared by the FDA staffer who did attend the meeting. In addition, 
CSPI claims that Dr. Stampfer was given only a limited period to 
speak during the November 1995 FAC meeting and that his schedule 
precluded him from staying for the afternoon session when he could 
have expanded his comments. Neither of these arguments raises a 
material question of fact that requires a hearing (Sec.  
12.24(b)(1)).
    \24\ CSPI also asserts that at the Harvard meeting, P&G employee 
Dr. Keith Triebwasser ``stated that he could not assume that 
depletion of carotenoids was harmless,'' citing a letter from Dr. 
Alberto Ascherio (CSPI exh. 15). Importantly, however, Dr. Ascherio 
does not directly quote or even paraphrase Dr. Triebwasser; instead, 
the letter contains Dr. Ascherio's characterization of what Dr. 
Triebwasser said. (Dr. Ascherio stated: ``The responses of the 
gentleman from Procter & Gamble made it clear that there is no 
scientific evidence to support [a conclusion that depletion of 
carotenoids will not harm people's health.]'' Again, the information 
tendered by CSPI is insufficient to justify the factual conclusion 
urged and thus, FDA is denying CSPI's request for a hearing on this 
issue (Sec.  12.24(b)(3)).
---------------------------------------------------------------------------

    FDA is denying CSPI's request for a hearing on this point because 
the data and information submitted are insufficient to establish that 
olestra's depletion of carotenoids will be harmful (Sec.  12.24(b)(3)). 
First, the comments of those preparing the estimates undermine their 
validity. In particular, in their letter transmitting the estimates, 
Drs. Willett and Stampfer readily acknowledge that the estimates are 
not based on an established cause and effect relationship and are 
speculative in that they are based on a number of assumptions (CSPI 
exh. 13, pp. 1, 3, and 4). Moreover, in the preamble to the final rule, 
FDA outlined several considerations to be addressed in determining 
whether olestra's effect on carotenoids will be harmful, including the 
other factors that influence carotenoid utilization (carotenoid 
stability, bioavailability, and absorption) and whether serum 
carotenoid levels are an adequate indicator of carotenoid availability 
(61 FR 3118 at 3148 to 3149). Neither CSPI nor the scientists who 
prepared the Harvard estimates addressed these considerations. 
Accordingly, the Harvard estimates in and of themselves are not 
adequate to demonstrate that olestra's effect on carotenoid levels will 
be harmful.

B. Vitamin K

    In its third objection and request for a hearing, CSPI challenges 
FDA's conclusion that supplementation of olestra with vitamin K will 
offset the additive's effect on vitamin K and thereby prevent adverse 
health effects associated with vitamin K depletion in olestra 
consumers. CSPI claims that FDA's decision on this point is erroneous 
for two reasons. First, CSPI asserts that a decision on olestra's 
safety should not have been made in the absence of a study of the 
interaction between Coumadin (a widely used anti-coagulant) and 
olestra. Importantly, however, CSPI did not specifically identify any 
available data or information in the record to demonstrate why data 
from a study of olestra's effects on Coumadin therapy are 
necessary.\25\ Accordingly, FDA is denying CSPI's request for a hearing 
on this question because it is merely an unsupported allegation (Sec.  
12.24(b)(2)). Second, CSPI asserts that olestra supplemented with 
vitamin K may have adverse effects on bone formation. Once again, CSPI 
fails to specifically identify any data or information that could be 
used to resolve this question. Accordingly, FDA is denying CSPI's 
objection and hearing request on this point (Sec.  12.24(b)(2)).
---------------------------------------------------------------------------

    \25\ In fact, this concern was raised at the November 1995 FAC 
meeting and addressed in the preamble to the final rule. One 
witness, Dr. John Suttie, testified that vitamin K intake can vary 
from day-to-day by three or four-fold and that diet is not usually a 
primary factor of concern with anti-coagulation therapy. 
Accordingly, he concluded that changes due to consumption of 
vitamin-K compensated olestra would likely be within the normal 
range of dietary variation (61 FR 3118 at 3147).
---------------------------------------------------------------------------

C. GI Effects

    In its fourth objection and request for a hearing, CSPI asserts 
that in a significant proportion of individuals olestra causes GI 
disturbances, including diarrhea, that these disturbances are adverse 
health effects, and that these GI disturbances are of sufficient 
concern to warrant a finding that there is no ``reasonable certainty of 
no harm.'' CSPI also asserts that FDA's analysis of the data from two 
8-week studies obscured the detection of trends between olestra 
consumption and GI symptoms reported.
1. Are the Observed GI Symptoms Adverse Health Effects?
    In its objection and request for a hearing, CSPI asserts that FDA 
erred by concluding that certain GI effects of olestra (such as anal 
leakage, underwear staining, and oil-in-the-toilet) are not relevant to 
the question of the safety of olestra.\26\ In particular, CSPI asserts 
that these olestra-related effects can have an ``adverse effect on 
people's lives and interfere with their daily activities'' and thus 
implies that FDA should have considered them in determining olestra's 
safety. In support of this objection, CSPI relies heavily on the 
proceedings before the OWG and the FAC (such as the testimony of Dr. 
Ian Greaves and Ms. Rosie Schwartz.)\27\
---------------------------------------------------------------------------

    \26\ In its fourth objection, CSPI also claims that consumption 
of olestra causes diarrhea, which CSPI claims is an adverse health 
effect. However, CSPI does not further address diarrhea in this 
objection.
    \27\ As part of their objections, CSPI criticizes a P&G market 
research study, and the OWG's alleged reliance on it. FDA told the 
OWG that the agency had not used data from the market research study 
in its analysis. Moreover, FDA did not rely on the study in 
determining that olestra is safe. CSPI concedes as much (CSPI obj. 
at p. 33).
---------------------------------------------------------------------------

    At its core, CSPI's fourth objection concerns the meaning of the 
statutory standard of ``safe,'' section 409(c)(3)(A) of the act, and, 
specifically, what is

[[Page 46408]]

``harm'' for purposes of that standard.\28\ CSPI has not demonstrated 
that FDA wrongly decided any genuine and substantial issue of fact 
concerning the GI effects of olestra. Rather, CSPI disagrees with FDA's 
application of the statutory safety standard, alleging that FDA ignored 
certain effects of olestra consumption that CSPI claims preclude a 
finding of safety.\29\ In the absence of a genuine and substantial 
issue of fact, a hearing need not be granted because a hearing is not 
needed to settle issues of law (Sec.  12.24(b)(1)).
---------------------------------------------------------------------------

    \28\ As noted in the preamble to the final rule, ``safe'' means 
``proof of a reasonable certainty of no harm,'' a standard drawn 
from the legislative history of section 409 of the act; harm in this 
context means ``hazardous to the health of man or animal.'' (61 FR 
3118 at 3119 to 3120.) FDA concluded that ``an effect is harmful if 
it affects health, not if it is simply an undesirable or unexpected 
effect that has no adverse health consequences.'' (61 FR 3118 at 
3120.)
    \29\ Contrary to CSPI's assertions, FDA's evaluation of the 
evidence in the record did address a broad range of GI symptoms, 
including loose stools, cramping and bloating, fecal urgency, oil-
in-the toilet, and anal leakage (61 FR 3118 at 3152 to 3159). In 
applying the statutory standard of ``safe,'' FDA concluded that none 
of these effects is harmful to health (61 FR 3118 at 3159). CSPI's 
objection identifies no factual evidence to contradict this 
conclusion.
---------------------------------------------------------------------------

2. Did FDA Err in Pooling Certain GI Data for Analysis?
    In its objection and request for a hearing, CSPI asserts that FDA's 
analysis of two 8-week studies was inappropriate because the analysis 
pooled the data from both studies.\30\ CSPI asserts that pooling these 
data was inappropriate because different formulations of olestra were 
used in the two studies. CSPI also objects to pooling the data because 
it would allegedly diminish the ability to detect trends in one 
study.\31\
---------------------------------------------------------------------------

    \30\ FDA explained that pooling the data from the two studies 
increased the number of study subjects, thereby increasing the power 
of the data to detect trends (61 FR 3118 at 3153).
---------------------------------------------------------------------------

    FDA is denying CSPI's request for a hearing on this issue because 
the organization failed to identify specifically any reliable evidence 
to support either of its factual allegations. That is, CSPI did not 
identify any data or information to support its claim that different 
olestra formulations precluded the pooling of the data from the two 8-
week studies\32\ (Sec.  12.24(b)(2)). Moreover, even if the data from 
the two studies should have been analyzed separately, as asserted by 
CSPI, that analysis would not have changed the outcome of this 
proceeding because the results would be the same whether analyzed 
separately or pooled (61 FR 3118 at 3153 to 3154). Accordingly, FDA is 
denying CSPI's hearing request on this point (Sec.  12.24(b)(4)).
---------------------------------------------------------------------------

    \31\ In its first objection, CSPI alludes to the pooling issue 
but does not elaborate on or support its challenge to pooling data 
(CSPI obj. 1 at p. 16).
    \32\ In fact, although the two formulations of olestra differed 
in the degree of stiffness, each was within the range of stiffness 
permitted by the 1996 final rule (Sec.  172.867(b)(14)).
---------------------------------------------------------------------------

D. Adequacy of Olestra's Label Statement\33\
---------------------------------------------------------------------------

    \33\ Elsewhere in this issue of the Federal Register, FDA has 
concluded, based upon a subsequent food additive petition submitted 
by P&G containing new data and information, that olestra-containing 
foods need not bear the information statement required by the 
original final rule. FDA has concluded that most of the information 
statement is no longer required to ensure that olestra-containing 
products are not misbranded. The olestra regulation, Sec.  172.867, 
as revised in response to P&G's petition, requires that an asterisk 
appear in the ingredient list beside the added vitamins A, D, E, and 
K. The asterisk will reference the statement, ``Dietarily 
insignificant.'' The purpose of such labeling is to inform consumers 
that their vitamin status will not change as a result of consuming 
olestra-containing products. Accordingly, CSPI's objections to the 
olestra label statement imposed by the 1996 final rule are arguably 
moot.
---------------------------------------------------------------------------

    In its fourth objection and request for a hearing, CSPI challenges 
the label statement required by the 1996 final rule, claiming that it 
is not sufficient to protect the public from adverse effects associated 
with consumption of olestra. CSPI also claims that the portion of the 
label statement regarding the nutritional effects of olestra 
consumption is inadequate. CSPI offers several specific criticisms in 
support of these general allegations. As shown in the following 
sections D.1 and D.2, none of CSPI's specific allegations raises a 
question of material fact that requires a hearing. In analyzing CSPI's 
objection regarding the olestra label statement, it is critical to 
recognize that FDA did not require the statement to ensure olestra's 
safe use (61 FR 3118 at 3160). Instead, the label statement was 
designed to prevent olestra-containing foods from being misbranded.
1. Label Statement Regarding GI Effects
    CSPI alleges that the GI effects portion of the olestra label 
statement is not adequate for three reasons. First, CSPI claims that 
the word ``laxative'' should be used to describe olestra's GI effects. 
Second, CSPI asserts that all GI effects of olestra should be 
disclosed, including diarrhea, underwear staining, oil-in-toilet, and 
anal leakage because they ``might distress'' consumers of olestra-
containing snacks. Third, CSPI claims that the GI portion of the 
olestra label statement ought to advise consumers to seek medical 
treatment if the effects of olestra consumption do not subside within 
48 hours of consumption. Importantly, CSPI does not dispute any facts 
that underlie FDA's decision regarding the label statement. 
Fundamentally, CSPI's allegation in this instance is that olestra-
containing foods are misbranded in the absence of these three pieces of 
information. Whether foods that bear the olestra label statement set 
out in Sec.  172.867 are misbranded is a question of law. Thus, FDA is 
denying CSPI's hearing request on this point because a hearing will not 
be granted on issues of law (Sec.  12.24(b)(1)). Moreover, even if such 
questions are questions of fact, CSPI did not specifically identify any 
data or other information to support its position. Thus, on this basis, 
FDA is denying this hearing request (Sec.  12.24(b)(2)).
2. Label Statement Regarding Absorption of Nutrients
    CSPI also challenges that portion of the olestra label statement 
that relates to absorption of nutrients. CSPI asserts that this portion 
of the olestra label statement has several deficiencies. Specifically, 
CSPI claims that the word ``compensation'' should be substituted for 
``added,'' that carotenoid depletion resulting from olestra consumption 
should be disclosed, that consumers should be advised that there are 
``no data'' about the vitamin K repletion, and that the statement 
should begin with the word ``warning'' and appear on the front of the 
package. Again, in presenting this portion of the fifth objection, CSPI 
fails to identify specifically any underlying factual dispute that 
could be resolved by a hearing. The question of whether olestra-
containing foods that bear the required label statement are misbranded 
is a question of law. Accordingly, FDA is denying CSPI's request for a 
hearing on this point because a hearing will not be granted on issues 
of law (Sec.  12.24(b)(1)).

E. Alleged Procedural Problems in the Olestra Proceeding

    In its fifth objection and hearing request, CSPI claims that there 
were a number of problems with the procedures utilized by FDA to reach 
a decision about the safety of olestra. CSPI raises the following six 
complaints: (1) Its White Paper was not provided promptly enough to the 
members of OWG and FAC, (2) the presentation by FDA's staff to OWG did 
not adequately address carotenoids, (3) the 1996 final rule unfairly 
described support for olestra and discounted letters from CSPI members 
opposing olestra's approval, (4) the petitioner engaged in a letter 
writing campaign to gain olestra's approval, (5) FDA discounted the 
opinions of CSPI's experts and ignored the ``scientific information'' 
in the letters from these experts, and (6) members of OWG and FAC were 
biased. As is the case with its fourth objection and hearing request, 
CSPI specifically identifies no factual issue underlying any of its six 
procedural complaints. In such circumstances, a hearing is not

[[Page 46409]]

required (Sec.  12.24(b)(1)). Accordingly, FDA is denying CSPI's fifth 
objection.\34\
---------------------------------------------------------------------------

    \34\ In fact, CSPI raised most of these complaints in comments 
to FDA prior to olestra's approval, and the agency addressed each 
such complaint in the preamble to the final rule (61 FR 3118 at 3163 
to 3165). CSPI's fifth objection and hearing request does not 
dispute FDA's resolution of these challenges in the final rule.
---------------------------------------------------------------------------

F. Alleged Absence of Reasonable Certainty of No Harm

    As noted, CSPI filed six objections to FDA's decision to approve 
olestra, including a general objection (CSPI obj. 1) that asserts that 
the additive does not meet the statutory standard of ``reasonable 
certainty of no harm.''\35\ Many of the assertions of CSPI's general 
objection mirror the allegations of the more specific objections (CSPI 
obj. 2 through 5), which FDA has considered previously and denied.\36\ 
Even standing alone, however, CSPI's first objection must be denied for 
several reasons.
---------------------------------------------------------------------------

    \35\ The act prohibits FDA from approving a food additive if it 
has not been shown to be ``safe'' for its intended use, section 
409(c)(3) of the act; FDA's regulation, relying on the legislative 
history of the Food Additives Amendment of 1958, defines ``safe'' as 
``a reasonable certainty in the minds of competent scientists that 
the substance is not harmful under the intended conditions of use. 
It is impossible in the present state of scientific knowledge to 
establish with complete certainty the absolute harmlessness of the 
use of any substance.'' (Sec.  170.3(i) (21 CFR 170.3(i)).)
    First, CSPI's first objection challenges FDA's finding that 
olestra is safe for use in savory snacks.\37\As noted, resolving the 
question of olestra's safety requires the application of the legal 
standard (``safe'') as defined by FDA's regulations (``reasonable 
certainty of no harm'') to a set of facts. As such, the question of 
whether olestra is safe for its intended use is a question of law, 
not fact. Accordingly, FDA is denying CSPI's first objection because 
a hearing will not be granted on issues of policy or law (Sec.  
12.24(b)(1)).
    \36\ In these circumstances and for reasons of economy, FDA does 
not restate its analysis and basis for denial of the specific 
objections.
    \37\ CSPI asserts that FDA's approval of olestra is ``artibrary 
and capricious'' and thus erroneous (CSPI obj. at p. 12). In fact, 
the standard of review for a food additive approval is ``a fair 
evaluation of the entire record * * *'' (section 409(g)(2) of the 
act). CSPI provides no evidence that FDA did not conduct a fair 
evaluation of the entire record.
---------------------------------------------------------------------------

    Second, although CSPI's first objection is the longest of the six, 
it is almost exclusively a series of allegations\38\ without any 
specifically identified and available evidence to support them.\39\  
That is, CSPI did not cite specific data or other factual information 
in the record to demonstrate the validity of its challenges to FDA's 
conclusions (CSPI obj. at pp. 8 through 18). Thus, CSPI's first 
objection is denied for a second, separate reason because a hearing 
will not be granted on the basis of mere allegations (Sec.  
12.24(b)(2)).\40\
---------------------------------------------------------------------------

    \38\ For example, in its discussion of the ``Inadequate Safety 
Base'' for olestra, CSPI notes Dr. Klish, a witness at OWG, 
testified that at 1 year, children's GI tracts are the same as 
adults and therefore, data from adults can be extrapolated to 
children. On this subject CSPI simply asserts, ``Life experience, 
however, does not support that view. After all, why do one- and two-
year-olds experience `toddlers' diarrhea' * * * ?'' (CSPI obj. at p. 
8.)
    \39\ In the carotenoids portion of its first objection, for 
example, CSPI refers to a ``selection of letters from noted 
scientists opposing the approval of olestra'' (CSPI exh. 8.) 
Notably, however, CSPI does no more to identify the specific facts 
these experts dispute or to specify the data and other information 
on which these experts rely (Sec.  12.24(b)(2)).
    \40\ It is not surprising that CSPI's allegations are 
unsupported because, in some cases, the allegations are clearly 
false. For example, CSPI claims that ``the FDA staff declined to 
consider'' certain data regarding carontenoids (CSPI obj. at p. 6). 
In fact, FDA devoted a significant amount of attention to the 
carotenoids issue (61 FR 3118 at 3147 to 3149 and 3161), but 
ultimately reached a different conclusion than that urged by CSPI.
---------------------------------------------------------------------------

    Third, CSPI asserts that the quality of certain studies relied upon 
by FDA is ``spotty at best,'' and claims that these tests were 
``critical'' to the safety evaluation of olestra (CSPI obj. at p. 13). 
In support of this claim, CSPI cites parts of the 1996 final rule and 
supporting memoranda discussing the limitations of certain studies.\41\ 
(CSPI obj. at p. 12, footnote 8). Importantly, however, CSPI does not 
demonstrate how the outcome of this proceeding would have been 
different if, due to these alleged quality problems, FDA had not been 
able to rely on these ``certain studies'' in determining the safety of 
olestra. Thus, FDA is denying CSPI's first objection because a hearing 
will not be granted on factual issues that are not determinative of the 
action requested\42\ (Sec.  12.24(b)(4)).
---------------------------------------------------------------------------

    \41\ In particular, CSPI quotes excerpts from the 1996 final 
rule in which FDA identified certain limitations of these studies of 
olestra. Identifying such limitations is consistent with FDA's 
obligation to make a ``fair evaluation of the data'' in the record 
when determining olestra's safety (section 409(c)(4) of the act).
    \42\ For example, CSPI offers several criticisms of a P&G 
marketing study which the company presented to illustrate 
consumption patterns for savory snacks (CSPI obj. at p. 13, footnote 
10). In fact, as CSPI noted (CSPI obj. at p. 33), FDA told OWG that 
FDA had not relied on data from this study in its safety evaluation 
(Transcript of the FAC meeting, November 16, 1995, at p. 55).
---------------------------------------------------------------------------

    Fourth, CSPI challenges FDA's conclusion that the GI effects seen 
in P&G's 8-week studies are not harmful health effects. As part of this 
challenge, CSPI criticizes the size of the two 8-week studies and 
asserts that a larger study would likely have shown statistical 
significance at the 8 grams/day (g/d) dose, citing the comments of 
David Allison, Ph.D., a statistician and consultant to FAC (CSPI obj. 
at pp. 13 through 14 and footnote 11). CSPI fails to note that Dr. 
Allison concluded his statement by saying that whether ``to make a 
great deal of argument on is there or isn't there an effect at the 8 g 
dose is really a misleading kind of argument because it seems almost 
certain that there is but, rather, is it an important effect, an effect 
that is clinically meaningful * * *'' (transcript of FAC meeting, 
November 16, 1995, at p. 52). In the same footnote, CSPI claims that 
Dr. Marvin Schneiderman performed a trend test which demonstrated an 
increase in incidence of ``gastrointestinal disturbances above the 
placebo level at 8 g/day.'' In fact, Dr. Schneiderman's analysis 
concerned only anal leakage, not all GI effects (CSPI exh. 14 at p. 2). 
FDA found that anal leakage is not a health hazard (61 FR 3118 at 
3154), a fact not disputed by CSPI in its objections and hearing 
requests. Accordingly, FDA is denying CSPI's objection on this point 
because a hearing will be denied where the data and information 
submitted are insufficient to justify the factual determination urged 
(Sec.  12.24(b)(3)).
    Finally, CSPI disputes FDA's conclusion that the ``diarrhea'' 
experienced by olestra consumers is not clinical diarrhea and thus, not 
an adverse health effect.\43\ In particular, CSPI asserts that ``weight 
and water content of diarrheal stools was increased over those of loose 
and normal stools in subjects eating 20 g/day of olestra.'' (CSPI obj. 
at p. 16). Importantly, however, CSPI does not cite a reference to 
support this conclusion. In the absence of specifically identified and 
available evidence to support a disputed fact, a hearing must be denied 
(Sec.  12.24(b)(2)). Moreover, CSPI does not explain how a finding of 
increased stool weight among olestra consumers would alter FDA's 
conclusion that olestra's GI effects are not harmful to health.\44\ 
Thus, FDA is denying a hearing on this issue because it is not 
determinative of the question at issue (Sec.  12.24(b)(4)). Likewise, 
although FDA concluded that increased water content of stools could be 
an indicator of true diarrhea (61 FR 3118 at 3158), FDA concluded that 
in the study in question, the data ``regarding stool water 
concentration--expressed as a percent of stools by weight--suggests 
that the stool water concentration of subjects having diarrhea during 
the olestra 20 g/d period did not differ from that of their 
nondiarrheal stools during the placebo period'' (61 FR 3118 at 3171; 
Ref. 88). Thus, even if CSPI intended to rely on Ref. 88 to support 
this allegation, the memorandum does not establish that

[[Page 46410]]

the subjects' stool water content increased when they consumed olestra. 
Thus, FDA is denying CSPI's hearing on this point (Sec.  12.24(b)(3)).
---------------------------------------------------------------------------

    \43\ CSPI refers to a December 26, 1995, memorandum of Karl 
Klontz, M.D., erroneously describing it as Ref. 87 to the final rule 
(CSPI obj. at p. 16, footnote 14). In fact, Dr. Klontz's December 
26, 1995, memorandum is Ref. 88 of the final rule (61 FR 3118 at 
3171).
    \44\ Olestra is not digested and thus will add to the weight of 
the stools of olestra consumers (61 FR 3118 at 3158). Thus, mere 
increase in stool weight of olestra consumers is not itself evidence 
of harm.
---------------------------------------------------------------------------

V. Summary and Conclusion

    The act requires that a food additive be shown to be safe prior to 
marketing under section 409 of the act. Under Sec.  170.3(i), a food 
additive is ``safe'' if there is a reasonable certainty in the minds of 
competent scientists that the substance is not harmful under the 
intended conditions of use. In the agency's January 30, 1996, final 
rule approving olestra, FDA concluded that the studies conducted to 
establish the safety of this additive demonstrate that olestra is safe 
for its intended use in savory snacks.
    The petitioner has the burden to demonstrate the safety of the 
additive in order to gain FDA approval. Nevertheless, once FDA makes a 
finding of safety in an approval document, the burden shifts to an 
objector, who must come forward with evidence that calls into question 
FDA's conclusion (American Cyanamid Co. v. FDA, 606 F2d. 1307, 1314-
1315 (D.C. Cir. 1979)).
    Despite its many allegations, CSPI has not established that FDA 
overlooked significant information in the record in reaching its 
conclusion that olestra is safe. In such circumstances, FDA has 
determined that the objections do not raise any genuine and substantial 
issue of fact that would justify an evidentiary hearing on any of the 
objections raised (Sec.  12.24(b)). Accordingly, FDA is overruling 
CSPI's objections and is denying CSPI's requests for a hearing in their 
entirety.

    Dated: July 23, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-19509 Filed 8-1-03; 4:00 pm]
BILLING CODE 4160-01-S