November 2, 2000

Judith A. Weinstein
Novartis Consumer Health, Inc.
560 Morris Avenue
Building F
Summit, NJ 07901-1312

Re: GRAS Notice No. GRN 000039

Dear Ms. Weinstein:

The Food and Drug Administration (FDA) is clarifying our letter dated April 24, 2000, regarding a notice that you submitted in accordance with the agency's proposed regulation, proposed 21 CFR 170.36 (62 FR 18938; April 17, 1997; Substances Generally Recognized as Safe (GRAS)). FDA received your notice on January 28, 2000 and designated it as GRAS Notice No. GRN 000039.

The subject of GRN 000039 is tall oil phytosterols. The notice informs FDA of the view of Novartis Consumer Health, Inc. (Novartis) that tall oil phytosterols are GRAS, through scientific procedures, for use in vegetable oil spread at a level up to 12 per cent free phytosterols.

In our April 24, 2000, letter regarding GRN 000039, we characterized the intended use of tall oil phytosterols as "nutrient in vegetable oil spread to reduce the absorption of cholesterol from the gastrointestinal tract" because this was how you described it. Consistent with our April 24 letter, we characterized the intended use of tall oil phytosterols in this same way in the Inventory of GRAS Notices (available on the Internet at http://vm.cfsan.fda.gov/~lrd/foodadd.html). We believe that our description of the intended use in both our April 24 letter and in the Inventory of GRAS notices inadvertently implies that the Office of Premarket Approval evaluated, and concurs with, two potential label claims. One potential claim is that the role of tall oil phytosterols is as a nutrient. Another potential claim is that tall oil phytosterols will reduce the absorption of cholesterol from the gastrointestinal tract. To clarify that we did not evaluate such potential label claims, we are changing the description of your intended use of tall oil phytosterols in the Inventory of GRAS Notices to "ingredient."

Consistent with our April 24 letter, based on the information provided by Novartis, as well as other information available to FDA, FDA has no questions at this time regarding Novartis' conclusion that tall oil phytosterols are GRAS for use as an ingredient in vegetable oil spread at a level up to 12 per cent free phytosterols.

In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter, as well as a copy of the information in your notice that conforms to the information in proposed 21 CFR 170.36(c)(1), is available for public review and copying on the Office of Premarket Approval's homepage on the Internet (at http://vm.cfsan.fda.gov/~lrd/foodadd.html).

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