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Question and Answer About NYA's Citizen Petition

1. Why did NYA submit a Citizen Petition to the Food and Drug Administration (“FDA”)?

NYA recognized that the existing yogurt standards of identity were not useful to manufacturers or consumers.  FDA finalized these standards in 1981, and due to comments that objected to certain provisions and requested hearings, FDA amended some provisions and stayed numerous others.  Since 1982, the yogurt standards of identity have been a combination of stayed and amended provisions with multiple gaps for which no regulatory guidance exists.  Also, the existing standards do not reflect current industry practice or consumers’ expectation that yogurt will contain a minimum level of live and active cultures.  Finally, unlike other dairy products, yogurt does not conform to the requirements of the Nutrition Labeling and Education Act of 1990 (“NLEA”).  For example, a yogurt product may be declared “nonfat” if the milkfat content is less than 0.5%, even if chocolate is added to create a much higher fat content in the entire product. 

2. What is NYA requesting FDA to do in its Citizen Petition?

Generally, NYA is requesting FDA to:

• Require a minimum level of the live and active cultures at the time of manufacture;
• Resolve labeling issues by ensuring that product claims such as “lowfat” and “nonfat” are consistent with the provisions of NLEA; and
• Provide flexibility in the ingredients that may be included in yogurt without compromising the integrity of yogurt as a dairy product.
• The NYA Citizen Petition details technical aspects about the manufacture of yogurt, which will be discussed in the next section.

3. How will NYA's Citizen Petition benefit consumers?

NYA's Citizen Petition will provide consumers with yogurt products that will meet their expectations.  Products that use the term “yogurt” will be required to contain a minimum level of live and active cultures, which is a unique characteristic of yogurt products and are associated with health benefits.  Also, the inconsistencies of yogurt product labels and the requirements of NLEA will be resolved.  Yogurt products that declare “lowfat” and “nonfat” will represent the fat content of the entire product.  Finally, NYA’s proposed yogurt standard allows greater flexibility in the manufacturing process, which will provide consumers with a wider variety of great tasting yogurt products. 

4. Will NYA's Citizen Petition impact the products available to consumers?

No.  NYA’s Citizen Petition will not prevent the marketing of any products.  It will continue to allow “yogurt-style” products that do not contain live and active cultures to be marketed, but under the name of “fermented milk.”  The term “yogurt” is reserved for products that contain, among other things, a minimum level of live and active cultures, which is consistent with consumers’ expectation for these products.

Technical Aspects of NYA’s Citizen Petition

1. What would the requirement for live and active cultures be for yogurt products?

NYA’s Citizen Petition proposes that yogurt contain at least 107 cfu/g of active cultures of Lactobacillus delbrueckii subspecies bulgaricus and Streptococcus thermophilus at the time of manufacture.  Under normal refrigerated conditions, the cultures would remain present in the product at a level of at least 106 cfu/g at the end of the code life of the product. 

2. Should acidity be measured in pH or titratable acidity?

NYA has reevaluated its position regarding the measure and level of acidity for yogurt products.  NYA believes that titratable acidity, expressed as lactic acid should be the standard for yogurt products.  The acidity when measured in pH can be altered by different buffering solutions and still maintain the same titratable acidity.  A standard that addresses titratable acidity instead of pH is more flexible.  Therefore, in its comments to the Advanced Notice of Proposed Rulemaking (“ANPR”), NYA will revise its previous statement and recommend a standard of 0.7% titratable acidity.

3. Is a pH of 4.6 (or 0.7% titratable acidity) too low for some yogurt products that use novel flavoring such as chocolate yogurt?

There may be a misunderstanding about this requirement.  The acidity level applies to the “white mass” before the addition of the optional ingredients.  The acidity level after the addition of optional ingredients should not bear on whether the product is compliant with the yogurt standard of identity.  Therefore, the “white mass” is required to meet the 0.7% titratable acidity level and the raising or lowering of acidity through the addition of optional ingredients should not result in noncompliant product.

4. How does NYA’s proposed standard of identity allow for advancements in technology or the inclusion of novel ingredients in yogurt products?

The standard proposed by NYA allows for flexibility by including the provision “the addition of any safe and suitable ingredients added for nutritional or functional purposes.”  Under this provision, new ingredients such as soy could be added to yogurt products.  However, contrary to the current standard, the proposed standard would require that dairy ingredients (including standard dairy ingredients and optional dairy ingredients) comprise a minimum of 51% of the finished food.  Therefore, soy or another non-dairy ingredient could not be added to yogurt in a concentration greater than 49% of the finished product.  This provision ensures that the integrity of the yogurt product is not comprised and its primary constituents are dairy components. 

5. How will the yogurt standard of identity proposed by NYA in its Citizen Petition effect products such as “soy yogurt”?

All standards of identity are intended to place requirements on foods that declare that identity. NYA’s proposed yogurt standard maintains the integrity of “yogurt” as a dairy product by requiring dairy ingredients (including standard dairy ingredients and optional dairy ingredients) to comprise a minimum of 51% of the finished yogurt product.  Therefore, if a product such as “soy yogurt” does not contain at least 51% dairy ingredients and meet the other requirements of the standard, it cannot declare “yogurt” on its label. 

6. Will yogurt manufacturers be required to reformulate or relabel their yogurt products?

Because NYA’s proposed yogurt standard harmonizes the labeling requirements of yogurt products with NLEA, some manufactures may need to reformulate or relabel their products.  As previously mentioned, under the existing yogurt standards of identity, the “lowfat” or “nonfat” nomenclature refers to the amount of milkfat found in the “white mass,” not the overall fat content of the product, which is inconsistent with NLEA. 

The proposed standard brings the lowfat and nonfat nomenclature into compliance with the NLEA, which is based on the quantity of fat per reference amount customarily consumed.  Therefore, if a yogurt product currently complies with the NLEA labeling provision such as the lowfat requirement of 3 grams or less of fat per reference amount customarily consumed, relabeling or reformulation would not be required.

7. What is the economic impact of these changes if relabeling or reformulation is necessary?

It is not likely that significant relabeling or reformulation would be necessary as the proposed standard would merely bring the standard into compliance with the NLEA requirement applied to other foods.  To the extent a company opts to relabel or reformulate a product, the company would likely have until the next uniform compliance date, which should allow for ample time to come into compliance.