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. w ‘o /’---=. ii”~ “’ d Pfocc’ssm St ~“c);) j ‘~;j Ifhij 17 P2 :29 February 15,2000 —-_.”-”_.6ETv_E. D “-—-—-—.-m,, ~ik The Office of S,,pecial Nutritiorials ~FS-450] Center for Food Safety and Applied Nutrition Food and Drug Administration 200 C. Street S.W. Washington, DC 20204 .—...~ MAR -2 ZO()(j ]! “’m’”’’-$,”,m,n,,,, ““m!! !m,,,,,,q Dear Sir/Madam: This is a notification pursuant to 21 U.S.C. 343(r)(6) that Standard Process Inc., Pahnyra, Wisconsin 53156-0904, is making the following statements: * # (1) Cholacol II contains bentonite, bile salts, iron, and collinsonia root to promote natural intestinal cleansing. (~) The bentonite in Cholacol H works like a magnet to help carry waste materials through the intestines for proper elimination. Bile salts contribute further to intestinal cleansing through their role in helping to breakdown fats. Collinsonia root has been used for centuries by the Chinese as a “bowel tonic” to hel;p keep the intestines clean and functioning properly. “ (3) Promotes intestinal health. (4) The ingred imts found in Cholacol H work together to hehp cleanse the intestines. Collinsonia root helps to keep mucous membranes th~t line the GI tract in good working order. (5) Encourages regularity. (6) The combined cleansing and emulsifying properties of the ingredients in Cholacol H help keep the intestines free of debris that can cause some types of irregularity. (7) This exclusive formula combines the’idsorbcnt properties of bentonite, the astringent properties of coHinsonia, and purgative effects of bile salts stimulating peristalsis to make Cholacol H an effective cleansiW..~product for the bowel. ~1~ STANDARD PROCESS INC.*1200WEST ROYAL LEE DRIVE ~PALMYRA, WI 53156 ”414.495.21 22* FAX 414.495.2512*1 fft b~ ~~~b , .800.848 =5061 $ ‘@ ‘7 Stcmdad I@?_,)Pfocess@ These statements are made for a dietary supplement containing a proprietary blend of bentonite (montmorillinite), collinsonia (root), and purified bovine bile salts. Other ingredients include honey and calcium stearate. The name of the product is Cholacol@ II. The information contained herein is accurate and Standard Process Inc. has substantiation the statements are truthfu! and not misleading. that Sincerely yours, Ann Holden Standard Process Inc. * %$ STANDARD PROCESS INC. *1200 WEST HOYAL LEE DRIVE *PALMYRA, Wi 53156 *414* 495.2122* FAX 414.495 .2512* I .800.848 .5061 + $