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3980 ‘02 WR -5 PI :42

November 28,200l

Office of Special Nutritionals (HFS-450)

Center for Food Safety and Applied Nutrition
Food and Drug Administration
200 C Street, S.W.
Washington, D.C. 20204


This notification is filed pursuant to section 403(r)(6) of the Federal Food, Drug,
and Cosmetic Act (FDC Act), 21 U.S.C. 6 343(r)(6).

Dietary ingredient(s) Statement(s) of nutritional

Protease, Amylase, Lipase, A multi-enzyme
Cellulase, Lactase, combination which supports
Glucoarnylase, Invertase, the digestion of proteins,
Delayed Release Protective carbohydrates, fiber and
Coating: cellulose, coconut fat.* Replenishes enzymes
oil, oleic acid lost from foods during
processing and cooking .*
Delayed release for optimal
enzyme action. *

97s 0162 LET 9yga

15 Argonaut lAliso Viejo lCA 92656
949/770-2610 l Fax: 9491837-8415 .
Name of dietary Dietary ingredient(s) Statement(s) of nutritional
supplement support
Herbal Colon Cleanse Cascara Sagrada Bark, Promotes a healthy colon by
Senna Leaf, Aloe Vera safely and naturally helping
Leaf, Rhubarb Root, to eliminate potentially
Buckthom Bark, harmful toxins.* Delivers
Meadowsweet Herb, and supports the growth of
Marshmallow Root, beneficial microflora
Slippery Elm, Psyllium naturally found in the
Husk, Lactospore@ colon. *
(Lactobacillus sporogenes),

I certify that the information contained in this notice is complete and accurate, and that
we have substantiation that the statements are truthful and not misleading.

Candace R. Keefe
Senior Vice President Marketing and Product Development