From: Pascualdairy@aol.com Sent: Tuesday, September 30, 2003 11:11 AM To: fdadockets@oc.fda.gov Subject: 2000P-0685 "Milk and Cream Products and Yogurt Products"; Petition Please be advised that we were unabale to submit our comments electronically via the website using the FDA´s web site due to technical problems. Our company Information: PASCUAL DAIRY, INC 2100 SALZEDO STREET, SUITE 301-B CORAL GABLES, FLORIDA 33134 TEL: 305-444-5709 FAX: 305-444-0862 GABRIEL PASCUAL, VICE-PRESIDENT TYPE: FOOD INDUSTTY Docket´s Number: 2000P-0685 "Milk and Cream Products and Yogurt Products; Petition to Revoke Standards for Lowfat Yogurt and Nonfat Yogurt and to Amend Standards for Yogurt and Cultured Milk COMMENT: After a careful reading and consideration of NYA´s proposal we agree on the convenience of having a single standard of identity for yogurt including low fat and nonfat yogurts. We do not agree on and, therefore, we do not support the following provisions found in NYA´s proposed standard of identity for yogurt: 1. The requirement of at least 107 CFU/g active yogurt culture of Lactobacillus delbrueckii subsp. bulgaricus and Streptococcus thermophilus at the time of manufacture. In conclusion, based on the previous considerations, we defend that the presence after fermentation of live and active culture does not give any special value to finished yogurt. Therefore it should not neither be considered as an essential characteristics of yogurt nor subjected to regulation since it is irrelevant for yogurt identity. Any treatment after fermentation (freezing, drying or pasteurization) should not change product denomination. 2. The option for the manufacturers of keeping records to demonstrate that, under proper conditions of distribution and storage, the yogurt will contain at least 106 CFU/g live and active culture through manufacturer´s assigned code life for the product. The proposed standard does not adequately ensure the presence of sufficient number of living and active culture throughout the shelf life of the product and at the point of purchase or consumption. In short, NYA´s proposal insists on the requirement of an arbitrary level of living and active bacteria in finished yogurt but without further compromise once the product leaves the plant. CONCLUSION: We agree there is a need for updating and modernizing the current yogurt standards. Changes should bring advantages for either industry and consumers. Many of the provisions set forth in NYA´s proposal are positive and we agree on. However we consider yogurt benefits come only from the transformations suffered by milk and rest of ingredients during fermentation. After fermentation, the basic nature of yogurt is already developed and the presence of living and active bacteria is irrelevant for consumers benefit. Therefore we consider there is no a need for a regulation on this point. In our opinion, the standard proposed by the NYA does not give any rationality to establish what is an "adequate" number of live and active culture and does not ensure that products offered in the market actually contain this adequate number as consumers may expect or be induced to expect. The same is true for other optional cultures that may be used and labeled in the product. From this point of view, NYA´s proposal does not fulfill its own statement of grounds. Moreover, if the new standard has to promote the use of new technologies, there is no reason to limit the future use of technology for the production of long shelf life yogurt and restrict the sale of a product currently being sold in the US and which is heat treated after fermentation. The denomination "fermented milk" for a yogurt heat treated after fermentation will confuse to the consumer and mislead about the very nature of the product. We are in favor of an alternative approach to permit the labeling of yogurt with or without live and active culture. In this approach, manufacturers could claim on the package "live and active culture" if the product meets the required level of 107 CFU/g of live and active culture at the time of yogurt manufacture and at least 106 UFC/g at the purchasing point and at expiration time. Additionally, the claim "heat-treated after culturing" will be required for long shelf life yogurts. Consumers will decide their choice. Thank you, Gabriel Pascual VP Pascual Dairy, Inc