Dr. Joseph Scimeca, Senior Vice President of Regulatory and Scientific Affairs for the International Dairy Foods Association (IDFA), issued the following statement on IDFA’s formal objection to the U.S. Food and Drug Administration final rule to amend and modernize the standard of identity for yogurt:
“After 40 years of waiting since FDA first issued standards for yogurt, the FDA dropped a new final rule on the standard of identity for yogurt in late June, underscoring a lack of transparency in the FDA rulemaking process. Because the rulemaking process has been so severely delayed and because the agency has consulted very little with yogurt makers, the final rule is already out of date before it takes effect. For the most part, FDA relied on comments submitted 12 or more years ago to formulate its final rule—as if technology has not progressed or as if the yogurt making process itself has been trapped in amber like a prehistoric fossil.
“Although the International Dairy Foods Association (IDFA), which represents the nation’s yogurt makers, has been offering feedback or assistance to the FDA since it released its initial proposed rule in 2009, the agency has largely ignored our comments and suggested revisions to ensure a modernized standard. The result is a yogurt standard that is woefully behind the times and doesn’t match the reality of today’s food processing environment or the expectations of consumers. Unfortunately, IDFA has been left with no reasonable options except filing a formal objection to this final rule and imploring the agency to revisit the final rule to amend and truly modernize the standard of identity for yogurt.”
Background on Rulemaking for Standard of Identity for Yogurt
In June, FDA announced the issuance of the long-awaited final rule to amend and modernize the standard of identity for yogurt. Updates to the yogurt standard of identity have been pending at the FDA since 1982 when FDA stayed several major provisions of its 1981 final rule first establishing standards for yogurt. These stays were in response to objections filed at the time also by the industry. Dairy foods makers then began petitioning FDA to update the standard in 2000—more than 20 years ago. Finalization of this rule has been a priority for the IDFA for many years. While there has been very little outreach by FDA over these 20 years, IDFA has submitted comments, offered revisions and technical assistance, and made our dairy foods experts available. IDFA has continued to request updates on the status of the rule and stressed the importance of modernizing and finalizing the standard in a timely way.
The compliance date of this final rule is January 1, 2024, which is the uniform compliance date for final food labeling regulations issued in 2021 and 2022.
FDA says that publishing this final rule is a part of the FDA’s Nutrition Innovation Strategy, one of the goals of which is to modernize food standards to maintain the basic nature and nutritional integrity of products while allowing food makers more flexibility for innovation. The final rule hits the mark in some areas and misses badly in others. For example, the final rule consolidates three separate standards—for yogurt, lowfat yogurt and nonfat yogurt—into one standard of identity for yogurt, allowing food makers to nutritionally modify traditional standardized yogurt and then to communicate those modifications to consumers via label descriptions, product names and appropriate claims, such as “lowfat yogurt”. This seems reasonable. However, the final rule also expands the allowable ingredients in yogurt in some instances and adds confusing restrictions in others. FDA accepted industry suggestions and establishes a minimum amount of live and active cultures for yogurt containers to bear the labeling statement “contains live and active cultures” or a similar statement. The final rule also allows manufacturers to fortify yogurts, such as by adding vitamins A and D, provided they meet minimum fortification requirements, which also aligns with IDFA’s requests; however, the minimum fortification requirements are two to three times higher than standards for most dairy products and conflict with FDA’s own vitamin D regulations.
There is a wide range of yogurts of different flavors, protein levels, sugar and sweetener content, and milkfat content on grocery store shelves today, underscoring the variety that consumers want. IDFA and its members have long advocated for having a standard that reflects what consumers are eating today and flexible enough to allow for reasonable innovation tomorrow.
IDFA made several attempts to convey and explain recommended revisions to a 2009 proposed rule, but several of these, which would have aligned with current industry practices and allowed room for innovation, were not included in this revised standard.
To protect the products in the marketplace that consumers want and recognize as yogurt, IDFA has submitted a formal objection to specific provisions of FDA’s final rule, including the following:
- Baseless and overly prescriptive limitations around what ingredients can be added after fermentation, such as cream, which fail to recognize that milk fat in cream contributes the same general properties to yogurt regardless of whether added before or after fermentation.
- Restrictions related to the required acidity and pH of the yogurt that, as written, could result in popular and traditional “cup-set” style yogurt products to be discontinued along with other styles.
- Conflicting new requirements that would deter yogurt makers from voluntarily adding vitamin D to yogurts, which companies have done for decades and hope to continue.
- IDFA supports clear disclosure of non-nutritive sweeteners on labels where consumers are used to looking for this information in the ingredient declaration. However, the final rule doesn’t allow the use of non-nutritive sweeteners unless nutrient content claims, such as “reduced calories,” are used on the label. IDFA believes this requirement will drive innovation in the yogurt industry away from the manufacture of standard of identity yogurt towards non-standardized products. Further, the requirement runs counter to recommendations made in the 2020-2025 Dietary Guidelines for Americans (DGAs), when the agency should be incentivizing yogurt makers toward nutritionally-enhanced products consistent with the DGAs.
Additionally, regarding FDA’s general rulemaking process used to develop this new standard for yogurt, IDFA has the following strong concerns:
- There has been a clear lack of urgency and transparency in the regulatory process, as well as a lack of outreach by FDA to dairy foods makers to ensure the agency has up-to-date information thus resulting in standards that don’t reflect current industry practice.
- FDA staff and managers must be more responsive and accountable to the pressing needs of the food industry that depend on timely guidance and promulgation of regulations that reflect long-established and traditional yogurt-making processes and enable the adoption of technologies and innovations needed to meet rapidly changing consumer needs.
- FDA’s lack of transparency in the creation of guidance and regulations can and often does result in requirements that are inconsistent with industry practices and that limit or prevent the ability to produce food products that satisfy consumer expectations yet still meet the basic and essential characteristics of the food.
- Closer collaboration between the FDA and the industry is essential for the development of guidance and regulations that are pragmatic yet sufficiently flexible to allow for expanded consumer choice and the implementation of new innovations that may arise in the years to come.
The International Dairy Foods Association (IDFA), Washington, D.C., represents the nation’s dairy manufacturing and marketing industry, which supports more than 3.3 million jobs that generate $41.6 billion in direct wages and $753 billion in overall economic impact. IDFA’s diverse membership ranges from multinational organizations to single-plant companies, from dairy companies and cooperatives to food retailers and suppliers, all on the cutting edge of innovation and sustainable business practices. Together, they represent 90 percent of the milk, cheese, ice cream, yogurt and cultured products, and dairy ingredients produced and marketed in the United States and sold throughout the world. Delicious, safe and nutritious, dairy foods offer unparalleled health and consumer benefits to people of all ages.