[Federal Register: April 9, 1998 (Volume 63, Number 68)]
[Rules and Regulations]
[Page 17327-17329]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09ap98-11]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 96P-0338]
Food Labeling: Health Claims; Soluble Fiber From Certain Foods
and Coronary Heart Disease; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; correction.
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SUMMARY: The Food and Drug Administration (FDA) is correcting a final
rule that appeared in the Federal Register of February 18, 1998 (63 FR
8103). The document authorizes the use, on food labels and in food
labeling, of health claims on the association between soluble fiber
from psyllium seed husk and reduced risk of coronary heart disease
(CHD). The document was published with some errors. This document
corrects those errors.
EFFECTIVE DATE: February 18, 1998.
FOR FURTHER INFORMATION CONTACT: Virginia L. Wilkening, Center for Food
Safety and Applied Nutrition (HFS-165), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-5483.
In FR Doc. 98-4074, beginning on page 8103 in the Federal Register
of Wednesday, February 18, 1998, the following corrections are made:
1. On page 8104, in the first column, in the first full paragraph,
in the eighth line, the Federal Register citation ``(62 FR 3684''
should read ``(62 FR 3584''.
2. On page 8106, in the second column, in the second full
paragraph, in the tenth line, ``(mg/dL)'' should read ``(mg/dL))''.
3. On page 8107, in the first column, in the second full paragraph,
in the 32d line, ``24, and 26)'' should read ``24, 26, and 27)''.
4. On page 8109, in the first column, under the section ``E. Nature
of the Food Eligible to Bear the Claim'', in the first paragraph, in
the ninth and tenth lines, ``(7 g/d was'' should read ``(7 g/d) was''.
7. On page 8114, in the second column, in the first full paragraph,
in the 18th line, ``201(m)'' should read ``201(n)''.
8. On page 8118, in the first column, in Reference number 15, in
the third and forth lines, ``LDL-Synthesis'' should read ``LDL-
Cholesterol''.
9. On pages 8120 and 8121, under Table 1.--Summary of Clinical
Trials with Hypercholesterolemics: Psyllium and Coronary Heart Disease,
the reference numbers used to identify the study references are
incorrect. Table 1 is being republished in its entirety to read as
follows:
Table 1.--Summary of Clinical Trials with Hypercholesterolemics: Psyllium and Coronary Heart Disease
--------------------------------------------------------------------------------------------------------------------------------------------------------
Supplements Diet Intake of
Study Duration Treatment Number of Subjects (Psyllium, Placebo) groups: Sat fat % E; Magnitude of PSY Magnitude of Placebo
Soluble Fiber g/d CHOL mg/d Effect\1\ Effect
--------------------------------------------------------------------------------------------------------------------------------------------------------
Anderson et Base: 8 wk Step 1; Tx: 26 PSY: 131 10.2 g/d bulk Sat fat: PSY- 8.3%; CHOL: -5 mg/dL CHOL: +5 (2.6%)
al. wk Step 1+supplement C: 28 laxative, cellulose C- 7.7% (2.1%)\1\ LDL-C: +6 (3.9%)
(Ref. 12) PSY: <difference>7 g CHOL: PSY- 164 mg; C- LDL-C: -5 mg/dL HDL-C: no sig dif
SF 146 mg (2.9%)\1\ (grps)
Bell et al. Base: 12-wk Step 1; Tx: 8- PSY: 40 (20 men) 10.2 g/d bulk Sat fat: PSY- 8-10%; CHOL: -9 mg/dL CHOL: 0
(Ref. 13) wk Step 1+supplement Pla: 35 (18 men) laxative, cellulose C- 7.7-8.6% (4.2%) LDL-C: -0.2%
PSY: <difference>7 g CHOL: PSY- 168 mg; C- LDL-C: -12 mg/dL HDL-C: no sig dif
SF 206 mg (7.7%) (grps)
Davidson et Base: 8-wk Step 1; Tx: 24- PSY 1 56 (31 men) 3.4 g, 6.8 g, 10.2 g/ SAT fat: PSY- 7- CHOL: <difference>- CHOL: +1.7%; LDL-C:
al. wk Step 1 + PSY or PSY 2 40 (24 men) d; incorporated 8.6%; C- 7-8.6% 3% (PSY 3) +3%
(Ref. 14) control food (3 servings/ PSY 3 43 (28 men) into foods: C CHOL: PSY 1- 151 mg; LDL-C: <difference>- HDL-C: No sig dif
d) C 59 foods: no PSY PSY 2- 181; PSY 3- 5% (PSY 3) (grps)
PSY 1: 169
<difference>2.3 g C- 145 mg
SF,
PSY 2:
<difference>4.6 g;
PSY 3: <difference>7
g
[[Page 17328]]
Everson et Regular diet; 5-d Base; 2 20 men 15.3 g/d bulk SAT fat: PSY- 12%; C- CHOL: -14 mg/dL (- CHOL: -1.9%; LDL-C: -
al. 40-d periods; 11-d laxative, cellulose 13.2 % 5%) 2.7%
(Ref. 15) washout; crossover PSY: <difference>10 CHOL: PSY- 296 mg; C- LDL-C: -15 mg/dL HDL-C: No sig dif
g SF 274 mg (8%) (grps)
Keane et al. Base: 12 wk Step 1; Tx: 26 PSY: 40 (18m, 24f) 10.2 g/d bulk SAT fat: PSY- 5%; C- CHOL: -8.7 mg/dL CHOL: +2 (1%)
(Ref. 17) wk Step 1+supplement C: 39 (7m, 32f) laxative, cellulose 5.3% (3%) LDL-C: 0
PSY: <difference>7 g CHOL: PSY- 145.2 mg; LDL-C: -11.5 mg/dL HDL-C: no sig dif
SF C- 151.1 mg (5.9%)\1\ (grps)
Levin et al. Base: 8-wk Step 1; Tx: 16- PSY: 30 (26 men) 10.2 g/d bulk SAT fat: PSY- 6.7%; CHOL: -13 mg/dL CHOL: 0; LDL-C -
(Ref. 18) wk Step 1+supplement Pla: 28 (23 men) laxative, cellulose C- 6.3% (5.6%) 2.2%;
PSY: <difference>7 g CHOL: PSY- 166 mg; C- LDL-C: -13 mg/dL HDL-C:
SF 135 mg (8.6%) <difference>+6%
(sig from PSY)
Stoy et al. 4-wk Step 1; Step 1 + 23 men Estimated 11.6 g/d SAT fat: PSY: 5.1% CHOL: -10 mg/dL (4%) HDL-C: No sig dif
(Ref. 22) (8x5x5 wks): Grp 1: PSY- PSY from cereal: (Grp 1) and 5.1% LDL-C: -11 mg/dL (grps)
Pla-PSY; Grp 2: Pla-PSY- <difference>8 g SF; (Grp 2) (6%)
Pla Wheat cereal: Wheat: 4.5% (Grp 1)
<difference>3 g SF and 5.0% (Grp 2)
CHOL: PSY 141-165 mg
Wheat: 164 mg (Grp
1), 117-170 (Grp 2)
Stoy et al. 4-wk Step 1; Step 1 + 22 men Estimated 11.6 g/d SAT fat: PSY: 4.8 CHOL: -10 mg/dL (4%) HDL-C: No sig dif
(Ref. 23) (8x5x5 wks): Grp 1: PSY- PSY from cereal: (Grp 1) and 5.2% LDL-C: -11 mg/dL (grps)
Pla-PSY; Grp 2: Pla-PSY- <difference>8 g SF; (Grp 2) (6%)
Pla Wheat cereal: Wheat: 4.7% (Grp 1)
<difference>3 g SF and 5.6% (Grp 2)
CHOL: PSY 155-163 mg
Wheat: 133 mg (Grp
1), 169-172 (Grp 2)
Weingand et Base: 12 wk Step 1; Tx: 8 23 (16m, 7f) 10.2 g/d bulk SAT fat: PSY- 8.7%; CHOL: -9 mg/dL HDL-C: sig higher in
al. wk Step 1+supplement, laxative, cellulose C- 9% (3.8%) PSY group
(Ref. 25) crossover PSY: <difference>7 g CHOL: PSY- 162 mg; C- LDL-C: -11 mg/dL
SF 203-261 mg (6.2%)\1\
Jenkins et Base: 2 mo controlled Step Study 1: Study 1: Study 1: Study 1: Study 1:
al. (Ref. 2 diets; Tx: 2- 1 mo Step 32 (15m, 17f) 11.4 g/d PSY in SAT fat: PSY- 4.6%; CHOL: -27 mg/dL\1\ CHOL: -13.6 (5%)\2\
28) 2 diets+ cereal, cereal C -4.6% (9.8%) LDL-C: -10 (5.5%)
crossover (<difference>7.8 g CHOL: PSY- 31 mg; C- LDL-C: -24 mg/dL\1\ HDL-C: -2 (3.3%)
SF), wheat bran 29 mg (12.6%)
MUFA: PSY- 6%; C- 6% HDL-C: -6.6 mg/dL
(11.3%)\1\
Study 2: Study 2: Study 2: Study 2: Study 2:
27 (12m, 15f) 12.4 g/d PSY in SAT fat: PSY- 6%; C- CHOL: -34 mg/dL\1\ CHOL: -29.5
cereal 6% (12.6%) (10.7%)\2\
(<difference>8.4 g CHOL: PSY- 22 mg; C- LDL-C: -27.9 mg/ LDL-C: -17 (9%)\2\
SF), wheat bran 22 mg dL\1\ (14.9%) HDL-C: -1.4 (2.6%)
MUFA: PSY- 12%; C- HDL-C: -4.3 mg/dL\1\
12% (8%)
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\1\ Significant differences between treatment and placebo groups unless otherwise indicated.
\2\ Significant change across the diet phase.
[[Page 17329]]
Dated: April 3, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-9427 Filed 4-8-98; 8:45 am]
BILLING CODE 4160-01-F
This document was published on April 9, 1998.
For more recent information on Food Labeling
See http://www.cfsan.fda.gov/label.html
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