US food and beverage manufacturers scramble to reformulate as FDA tightens “healthy” definition

F&B manufacturers in the US are facing a reformulation crunch as the country’s FDA updated its definition of “healthy” last year, with full compliance required by 2028. Ultimately, experts note that the biggest risks are not in R&D, as brands rushing to adapt to the new standards are running into ingredient shortages, volatile pricing, and increasingly complex quality testing and supplier validation requirements. 

Nutrition Insight speaks to David Lennarz, president of Registrar Corp, an FDA compliance and regulation agency offering guidance on the nutrition label update amid national supply chain tensions.

He pinpoints the main challenges delaying urgent reformulations, such as rising ingredient prices, the need for qualified suppliers, and compounding regulatory risks. While early movers are locking in alternative suppliers and gaining leverage, late adopters are facing higher costs and fewer compliant options.

Lennarz breaks down what this shift means for manufacturers, importers, and private-label brands, and why waiting to act may be an expensive decision in the lead-up to 2028.

Which categories are most exposed to compliance pressure?
Lennarz: The FDA’s new definition of “healthy” puts a lot of compliance work on categories that have traditionally used added sugars, sodium, and saturated fat as a means of improving palatability and shelf life. Many foods that were once considered healthy may no longer meet the new definition without a complete overhaul.

This poses a challenge for processed snacks, frozen and ready-to-eat meals, breakfast cereals, flavored yogurts, packaged baked goods, and certain beverages. The trick is not only to reduce the levels of nutrients of concern but to do so in a way that maintains product integrity.

Industry is beginning to see tightening supply conditions for replacement ingredients, particularly those tied to sodium reduction, sugar alternatives, and whole food positioning.From a compliance standpoint, manufacturers must now review their formulations, verify their nutrient information, and ensure that their packaging complies with the new definition.

Where are shortages or price spikes hitting the hardest?
Lennarz: We are beginning to see tightening supply conditions for certain replacement ingredients, particularly those tied to sodium reduction, added sugar reformulation, and whole food positioning. Many specialty fibers, potassium-based salt substitutes, alternative fats, and concentrated whole food ingredients are sourced internationally. With ongoing tariff pressures and global trade volatility, there is already baseline price inflation affecting these categories.

When you layer on top of that a surge in demand driven by manufacturers reformulating to comply with the updated “healthy” criteria from the FDA, the economics become more complex. Suppliers are fielding increased inquiries simultaneously, which can constrain availability and extend lead times.

From a compliance and risk management standpoint, companies should not assume ingredient access will remain stable. Early supplier engagement, diversified sourcing strategies, and proactive cost modeling are critical to avoiding margin compression and production disruptions as reformulation efforts accelerate.

What regulatory or supply chain risks increase if companies delay reformulation?
Lennarz: Currently, regulatory risks are relatively minimal, but this situation is likely to change as Congress and the FDA continue to refine and establish new requirements. It is important for manufacturers to be alert and ready to make the necessary changes quickly to avoid potential noncompliance issues, which could result in severe consequences, such as penalties or loss of market share.

This new dynamic requires a substantial increase in the workload of the R&D departments of manufacturing companies. The R&D departments are faced with the daunting task of reformulating existing products to comply with new regulations, while also providing a steady supply of the new ingredients required by consumers.

The innovative manufacturers will take advantage of this opportunity to innovate and produce healthier products that are in line with consumer trends. They will use these regulatory changes to capture a larger market share and position themselves as leaders in the industry.

What practical steps should manufacturers be taking now to avoid a last-minute compliance scramble?
Lennarz: As 2028 approaches, manufacturers cannot afford to “wait-and-see.” The initial step would be to perform a thorough portfolio analysis using the new “healthy” standards released by the FDA. This would involve assessing existing products, their nutritional content, and any products that are, or have been, engaged in making a “healthy” claim.

Another aspect that needs to be closely watched is the new ingredients and nutritional levels allowed and whether a reformulation is required. If reformulation is an option, supplier verification and new specifications must start early to prevent delays or issues in sourcing.

Another aspect that needs to be audited is the labels, packaging, website, and marketing materials to ensure that claims align with the new regulation.