June 2, 1999

Janet M. Pang
R&D Manager
Vitasoy (U.S.A) Inc.
400 Oyser Point Blvd., Suite 201
South San Francisco, CA 94080

Re: GRAS Notice No. GRN 000013

Dear Ms. Pang:

The Food and Drug Administration (FDA) is responding to your notice, dated December 30, 1998, 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 11, 1999, and designated it as GRAS Notice No. GRN 000013.

Your notice informs FDA of your view that nine herbs are GRAS for use as flavoring agents in herbal tea beverages. The basis for your GRAS determinations is through experience based on common use in food (§§ 170.30(c) and 170.3(f)).

For each of the listed herbs, your notice includes usage information, botanical information and other related information. In addition, in response to our telephone request on January 22, 1999, you provided five published articles, referenced in the GRAS notice, that relate to the human use of these herbs. FDA received these five publications on March 3, 1999.

Based on the information provided by your notice, as well as other information available to FDA, the agency has no questions at this time regarding your conclusion that Dendranthema morifolium (chrysanthemum), Glycyrrhiza uralensis (licorice), and Mesona chinensis (jellywort) are GRAS under the proposed conditions of use. However, your notice does not provide a sufficient basis for a determination that Lonicera japonica (honeysuckle), Lophatherum gracile, Morus alba (mulberry leave), Plumeria rubra, Prunella vulgaris (self-heal), and Sophora japonica (pagoda tree blossom) are GRAS under the proposed conditions of use.

Data and information that Vitasoy presents to support Vitasoy's GRAS determinations

Because the GRAS determinations are based on common use in food, the information that is relevant to the human use of each herb is summarized below.

FDA's evaluation of the data and information regarding your GRAS determinations

FDA has evaluated the information that you discuss in your GRAS notice as well as other data and information that are available to the agency.

Under § 184.1408, licorice is affirmed as GRAS for use, among other things, as a flavoring agent or flavor enhancer in nonalcoholic beverages, including tea. This regulation covers the use of licorice described in your notice.

Section 170.3(f) defines "common use in food" as a substantial history of consumption for food use by a significant number of consumers. In FDA's view, your notice provides evidence of a history of consumption for food use for only two of the remaining eight herbs that are the subject of your notice (i.e., chrysanthemum and jellywort). We are aware that both chrysanthemum tea and the product "Grass Jelly" made from jellywort have been broadly consumed in China for at least one hundred years.

However, your published references ("Pharmacopoeia of the Peoples Republic of China", 1995; and Hu, 1997) provide evidence of historical use of the remaining six herbs only in relation to herbal teas and medicinal uses. The PRC Pharmacopoeia provides multiple disease-related medicinal claims for four of the herbs: Lonicera japonica, Lophatherum gracile, Prunella vulgaris, and Sophora japonica. Hu reviews 21 varieties of herbal teas that are popular in the province of Guangdong and are also marketed in Hong Kong, Macao, and Boston (Chinese stores). Hu identifies 127 species of plants used in those herbal teas, including the herbs Lonicera japonica, Lophatherum gracile, Morus alba, Plumeria rubra, Prunella vulgaris, and Sophora japonica. Importantly, the Hu article states that these herbal teas should be consumed occasionally rather than daily.

In FDA's view, the evidence that you submitted regarding medicinal use does not constitute the evidence of food use that is required under § 170.3(f). In addition, Hu's recommendation that consumption of herbal teas that contain the herbs Lonicera japonica, Lophatherum gracile, Morus alba, Plumeria rubra, Prunella vulgaris, and Sophora japonica be limited to occasional use undermines your position that the use of these herbs as flavoring agents in herbal tea beverages is GRAS.

Conclusions

Based on the information provided by your notice, as well as other information available to FDA, the agency has no questions at this time regarding your conclusion that Dendranthema morifolium (chrysanthemum), Glycyrrhiza uralensis (licorice), and Mesona chinensis (jellywort), are GRAS under the proposed conditions of use. The agency has not, however, made its own determination regarding the GRAS status of the subject use of chrysanthemum and jellywort. As always, it is the continuing responsibility of Vitasoy to ensure that food ingredients that the firm markets are safe, and are otherwise in compliance with all applicable legal and regulatory requirements.

Your notice does not provide a sufficient basis for a determination that the six herbs Lonicera japonica (honeysuckle), Lophatherum gracile, Morus alba (mulberry leave), Plumeria rubra, Prunella vulgaris (self-heal), and Sophora japonica (pagoda tree blossom) are GRAS under the proposed conditions of use.

In accordance with proposed 21 CFR 170.36(f), we have placed a copy of this letter, as well as a copy of the information in your notice that conforms to the information in proposed § 170.36(c)(1), in a file that is available for public review and copying in the public reading room of the agency's Freedom of Information Staff. A copy of this letter is also available for public review on the Office of Premarket Approval's homepage on the World Wide Web.

References

1. Hu, S.Y., "Herbal Teas and Populace Health Care in Tropical China," American Journal of Chinese Medicine, 25:103-134, 1997.

2. The Pharmacopoeia Commission of the Peoples Republic of China (PRC), "Pharmacopoeia of the Peoples Republic of China (1995 edition)," Guangdong Technology Press and Chemical Industry Press, Guangdong, China.

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