April 23, 2001

Dr. Claire Kruger, Ph.D, D.A.B.T.
Environ Corporation
4350 North Fairfax Drive
Suite 300
Arlington, VA 22203

Re: GRAS Notice No. GRN 000042

Dear Dr. Kruger:

We received your letter of April 6, 2001, concerning the notice (GRAS Notice No. GRN 000042) that you previously submitted to the Food and Drug Administration (FDA) on behalf of DMV International (DMV). In GRN 000042, DMV informed FDA of its view that the use of milk-derived lactoferrin is generally recognized as safe (GRAS) for use as an ingredient in sports and functional foods. FDA had responded to this notice by letter of March 26, 2001 (Ref. 1). We have added your April 6 letter to the administrative file for GRAS Notice No. GRN 000042.

Your April 6 letter outlines a plan to address two issues that were not addressed in GRAS Notice No. GRN 000042 - i.e., the potential that the increased level and overall exposure to milk-derived lactoferrin would sensitize individuals who are not already allergic (to milk) and the potential that this immunologically active food component is correlated with autoimmune disorders. Environ Corporation intends to convene a panel of scientists qualified by scientific training and experience to evaluate these issues. After this panel meets, Environ Corporation would send a summary of the panel's conclusions to FDA to supplement information already provided to FDA.

Your April 6 letter includes an initial opinion from Dr. Steven Taylor concerning the potential allergenicity of milk-derived lactoferrin and its potential role in the onset of autoimmune disease. The initial opinion from Dr. Taylor urges FDA to keep GRAS Notice No. GRN 000042 open while awaiting this additional information.

Your April 6 letter raises the issue of the appropriate mechanism to "supplement" a GRAS notice after FDA has responded to the notice. FDA previously addressed this issue in our response to GRAS Notice No. GRN 000001, submitted by Archer Daniels Midland Company (ADM) for the use of soy isoflavones in performance bars, mature adult meal replacements, and "healthy" beverages. In a letter of November 2, 1998, ADM requested that FDA commit no further resources to the review of GRN 000001 while the company was "in the process of incorporating additional information to update the file." In our response to GRAS Notice No. GRN 000001 (Ref. 2), FDA advised ADM that if they wished to have FDA consider additional information that they submit regarding soy isoflavones, the appropriate mechanism would be for ADM to submit, in accordance with proposed 21 CFR 170.36, a complete GRAS notice. FDA would assign a new file number to any new notice regarding soy isoflavones.

FDA has not altered its view regarding the appropriate mechanism to have FDA consider additional information that a notifier submits to a GRAS notice that has come to closure, regardless of whether the notice comes to closure at the request of the notifier. For your information, FDA has received several GRAS notices as "resubmissions" since our response to ADM regarding GRAS Notice No. GRN 000001.⁽¹⁾ In at least one case, the notifier incorporated its first notice into its second notice by referring FDA to the first notice.⁽²⁾ Thus, if DMV wishes to have FDA consider any new information that DMV develops to address the issues that FDA raised in our letter dated March 26, DMV may incorporate by reference any or all of GRAS Notice No. GRN 000042 into a new notice. FDA would assign a new file number to any new notice that we receive.

In accordance with proposed 21 CFR 170.36(f)(iii), a copy of the text of this letter is available for public review and copying on the Office of Premarket Approval's homepage on the Internet (http://www.cfsan.fda.gov/~lrd/foodadd.html).

References

1. Letter dated March 26, 2001, from Alan Rulis of FDA to Claire Kruger. Available at http://www.cfsan.fda.gov/~lrd/foodadd.html.

2. Letter dated November 25, 1998, from Linda Kahl of FDA to Mark Empie. Available at http://www.cfsan.fda.gov/~lrd/foodadd.html.

3. Letter dated June 6, 2000, from Alan Rulis of FDA to Lee Dexter. Available at http://www.cfsan.fda.gov/~lrd/foodadd.html.

⁽¹⁾See the "Summary of all GRAS Notices "on the Office of Premarket Approval's homepage on the Internet, available at http://www.cfsan.fda.gov/~lrd/foodadd.html. GRNs 000005, 000012, 000017, 000031, and 000040 were resubmitted as GRNs 000015, 000018, 000047, 000038, and 000071, respectively.

⁽²⁾E.g., Larex Inc. submitted GRAS Notice No. GRN 000047 for arabinogalactan from Larix occidentalis for general use in food. This notice incorporated by reference a notice (i.e., GRAS Notice No. GRN 000017) that had previously been submitted by Larex Inc. (Ref. 3).

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