Agency Response Letter
GRAS Notice No. GRN 000177

William C. Franke, Ph.D.
President
Heart Blend Foods LLC
14 Silvers Lane
Cranbury, NJ 08512

Re: GRAS Notice No. GRN 000177

Dear Dr. Franke:

The Food and Drug Administration (FDA) is responding to the notice, dated July 15, 2005, that Heart Blend Foods LLC (Heart Blend) 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); the GRAS proposal). FDA received the notice on July 18, 2005, filed it on July 20, 2005, and designated it as GRAS Notice No. GRN 000177.

The subject of the notice is plant sterol esters. The notice informs FDA of the view of Heart Blend that plant sterol esters are GRAS, through scientific procedures, for use as an ingredient in ground roasted coffee at 1.0 gram (g) per 8 fluid (fl) ounce (oz) serving.

Heart Blend obtains the plant sterol esters from Archer Daniels Midland, who submitted GRAS notices for plant sterol esters in November 2000 (GRN 000061) and, more recently, in August 2005 (GRN 000176). Heart Blend's notice describes its intended conditions of use for plant sterol esters and the estimated daily intake that would result from that use. GRN 000177 incorporates by reference the information contained in GRNs 000048, 000053, 000061, and 000112; and in Food Master File (FMF) 000625.

As described in GRN 000061, the main sterol components of the ingredient plant sterol esters are beta-sitosterol, campesterol, and stigmasterol. The sterols are derived from oil seeds such as corn, palm, soy, rape, and sunflower. In the manufacturing process, the sterols are esterified with vegetable oil fatty acids. The fatty acids are preferentially derived from soy, sunflower, safflower, and canola. Corn, peanut, cottonseed, and palm may also be used as sources. Food grade specifications exist for plant sterol esters.

Heart Blend intends plant sterol esters for use as an ingredient in ground roasted coffee that, when brewed according to package directions, will yield 1.0 g plant sterol esters per 8 fl oz serving. Brand name, brand positioning, price, product information, and directions for preparation are intended to inform consumers about the presence of plant sterol esters in the roasted ground coffee. The requirement to use a wire mesh "permanent" filter will limit consumption predominantly to home brewed coffee because wire mesh filters are not commonly used in commercial food service operations. A typical paper filter will trap the plant sterol esters in the filter, resulting in little or no plant sterol esters in the filtered coffee beverage.

Heart Blend provides an estimate of the consumption of plant sterol esters in brewed coffee. Assuming that 1.0 g plant sterol esters is equivalent to 0.6 g plant sterols, Heart Blend estimates that its use of plant sterol esters would result in the consumption of 1.4 g/day (d) at the mean and 2.5 g/d at the 90th percentile.

The notifier notes that a panel of individuals who evaluated the data and information that are the basis for a determination that vegetable sterol esters are GRAS considered that an acceptable daily intake (ADI) of 130 milligrams per kilogram body weight per day, as the free sterol, was appropriate for vegetable sterol esters.⁽¹⁾ Heart Blend considers that plant sterol esters are similar to vegetable sterol esters and that for a 70 kilogram person, an ADI of 9.1 g/d is appropriate. Based on a review of literature from January 2000 to June 2005, Heart Blend concludes that the original safety assessment of these esters remains valid.

Based on the information provided by Heart Blend, as well as other information available to FDA, the agency has no questions at this time regarding Heart Blend's conclusion that plant sterol esters are GRAS under the intended conditions of use. The agency has not, however, made its own determination regarding the GRAS status of the subject use of plant sterol esters. As always, it is the continuing responsibility of Heart Blend to ensure that food ingredients that the firm markets are safe, and are otherwise in compliance with all applicable legal and regulatory requirements.

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 homepage of the Office of Food Additive Safety (on the Internet at http://www.cfsan.fda.gov/~lrd/foodadd.html).

Sincerely,

Laura M. Tarantino, Ph.D.
Director
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition

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⁽¹⁾Heart Blend references Lipton's GRAS panel, from FMF 000625, for the ADI for vegetable oil sterol esters.