[Federal Register Volume 63, Number 68 (Thursday, April 9, 1998)]
[Rules and Regulations]
[Pages 17327-17329]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-9427]


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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                          
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                                                                       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: 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: 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: -   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: -  HDL-C: No sig dif   
                d)                         C 59                    foods: no PSY         PSY 2- 181; PSY 3-    5% (PSY 3)            (grps)             
                                                                  PSY 1:                 169                                                            
                                                                   2.3 g    C- 145 mg                                                       
                                                                   SF,                                                                                  
                                                                  PSY 2:                                                                                
                                                                   4.6 g;                                                                   
                                                                  PSY 3: 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: 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: 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: 7 g  CHOL: PSY- 166 mg; C- LDL-C: -13 mg/dL      HDL-C:              
                                                                   SF                     135 mg               (8.6%)                +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-                           8 g SF;   (Grp 2)               (6%)                                     
                Pla                                                Wheat cereal:        Wheat: 4.5% (Grp 1)                                             
                                                                   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-                           8 g SF;   (Grp 2)               (6%)                                     
                Pla                                                Wheat cereal:        Wheat: 4.7% (Grp 1)                                             
                                                                   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: 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                                          (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\         
                                                                   (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