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FDA Revokes 52 SOI’s

In 1939, food standards were vital in safeguarding families against mysterious foods and artificial fruit cocktails. Shortly after the 1938 Federal Food, Drug, and Cosmetic (FDC) Act was enacted, the FDA introduced its first standards covering canned tomatoes and tomato products. These standards marked a significant advancement in U.S. food safety, establishing standards of identity (SOI) and inspection practices. Think of SOIs as Grandma’s recipe cards—precise and reassuring for consistency.  

Today’s food industry, however, is more like a modern test kitchen: constantly evolving, experimenting with ingredients, and responding to diverse consumer demands. Over time, these standards have shielded families from uncertain foods. The standards of identity specify ingredient requirements for labeling products as specific foods. The latest proposed regulations do more than legal updates; they shape how the industry views food safety, innovation, and consumer trust. The FDA’s move suggests a shift away from rigid, uniform formulas toward a system that prioritizes transparent labeling and informed consumers. 

The News: What Did the FDA Announce? 

On July 16, 2025, the FDA announced plans to revoke 52 standards of identity for various food products. These include standards for canned fruits and vegetables, dairy products, baked goods, macaroni products, and other foods. The plan consists of three main parts: 

  • A direct final rule for 11 types of canned fruits and vegetables not currently available in U.S. grocery stores, along with a companion proposed rule. This proposed rule would be used if the final rule is withdrawn due to adverse comments, allowing the FDA to proceed with regulatory changes. 
  • A proposed rule to revoke standards for 18 types of dairy products. 
  • A proposed rule to revoke standards for 23 food categories, including bakery items, macaroni and noodle products, canned fruit juices, fish and shellfish, and food dressings and flavorings. 

Vanilla-Vanillin Extract is listed in the proposed rule under the category of “food dressings and flavorings.” This is a traditional standard that includes products combining real vanilla with artificial vanillin. The Statement of Identity (SOI) for Vanilla-Vanillin describes a product that contains real vanilla extract along with added artificial vanilla flavor or vanillin. Currently, industry regulations require that any product containing vanillin must clearly indicate this on the label. The proposed rule notes that this specific form is rarely sold today. This suggests that iconic ingredients like vanilla might be subject to different regulations in the future. 

The FDA notes that many of these standards are outdated, predating modern consumer protections such as ingredient safety, labeling, packaging, production practices, manufacturing standards, and nutrition labeling. 

This announcement marks a significant step following the HHS and FDA’s Request for Information on May 13, 2025, aimed at identifying and removing unnecessary or outdated regulations. This effort supports the broader federal goal of reducing regulatory burdens and increasing transparency, aligning with President Trump’s Executive Order 14192, “Unleashing Prosperity Through Deregulation.” 

Why It Matters: Beyond Bureaucracy 

This update should not be overlooked. While it may seem like bureaucratic housekeeping, it has broader implications that can impact your daily work. SOIs influence how food is formulated, labeled, and marketed, extending their impact beyond just legal definitions. Outdated SOIs can hinder product innovation, research, and development goals, leading to the use of alternative ingredients. Removing SOIs could offer more flexibility in sourcing, formulation, and labeling.  

However, this change will create a ripple effect across the industry. Many quality assurance and regulatory teams rely on SOIs in SOPs, training documents, and specifications. For these teams, the update involves more than just paperwork; they must: 

  • Reevaluate labeling checklists 
  • Update internal documentation related to SOIs 
  • Modify communication strategies 

Compliance and product development professionals will need to adjust procedures to remain compliant with regulations proactively 

Referring to the vanilla-vanillin extract example, removing the SOIs would eliminate the label claim that it contains vanillin, an artificial flavor. Instead, current labeling regulations would cover this information. The rationale is that consumers are familiar with modern product labels, allowing for updates that better reflect current consumer expectations. 

What’s Not Being Said: Innovation vs. Clarity 

At first glance, this update seems to prioritize modern innovation. However, a deeper examination prompts important questions regarding the future of food regulation and who will hold responsibility.  

What Replaces Definitions? 

The primary concern is: if definitions are eliminated, what will take their place? The FDA explains that “advances in food science, agriculture, and production practices, along with added consumer protections, have rendered many of these old, inflexible “recipe standards” obsolete.” This raises questions about how processors will ensure consistency, safety, and consumer confidence without SOIs.  

Are FSMA and Labeling Enough? 

This signals the start of a regulatory transition, shifting from detailed guidelines to a framework akin to FSMA and GMPs. While this could offer greater flexibility, it may also create some policy uncertainty. For example, if a blended vanilla product isn’t required to have a specific identity, is it sufficient to rely on a label listing “vanillin” to set consumer expectations? Food producers must act proactively now and engage in shaping the future regulatory environment.  

“The FDA’s Standards of Identity efforts have helped ensure uniformity, boost consumer confidence and prevent food fraud. But many of these standards have outlived their usefulness and may even stifle innovation in making food easier to produce or providing consumers healthier choices.”  

— FDA Commissioner Marty Makary, M.D., M.P.H.

What You Can Do Now 

Now is the time to review the proposed rules and understand their larger impact. Check the specific SOIs to see if they apply to your product. Some of the listed SOIs are no longer in use. This isn’t the moment to panic or overhaul your entire operation, but you should examine the rules more closely. Collaborate with your QA team to identify any references to the SOIs in your SOPs, QA manuals, or training materials. Pay particular attention to any changes in labeling or formulation that could be affected. Stay informed about these proposed rules, as the comment period is currently open. You can submit public comments at Regulations.gov.  

Conclusion: The Bigger Shift to Watch 

The FDA’s proposal to revoke 52 SOI exemplifies a broader industry trend toward adopting more modern, risk-based frameworks, moving away from overly specific definitions. As both the food system and its regulations evolve, this represents a significant step for the HHS in reallocating resources and shaping policies related to food safety, innovation, and consumer confidence. Since 1939, consumer trust has shifted from strict recipe adherence to confidence in proper labeling, safe production, and transparency. As the FDA transitions from prescriptive to flexible, risk-based models, the industry has a unique opportunity: to innovate boldly while maintaining trust and transparency. Safe Food Alliance will keep a close watch on these developments. Let’s stay ahead of the curve—together.