Key takeaways:
- The FDA’s updated ‘healthy’ definition is driving a reformulation race that extends far beyond R&D into sourcing, compliance and commercial strategy.
- Early movers are locking in compliant ingredients, pricing and regulatory certainty, while late adopters risk higher costs and tighter supplier markets.
- For global food and beverage manufacturers, the 2028 deadline isn’t just a labelling shift – it’s a test of supply chain resilience and competitive leverage.
The US Food and Drug Administration’s (FDA) updated definition of ‘healthy’ came into force on 25 February 2025, with full compliance required by 2028. On paper, that sounds like a comfortable glide path. In reality, many manufacturers have already realised the runway’s shorter than it looks.
The rule applies to the US market, but its impact is far wider. Any company exporting into the US must comply, and multinationals rarely reformulate for one geography alone. Nutrient thresholds, ingredient swaps and on-pack claims often sit within global brand frameworks, shared supply chains and harmonised specifications. A change in Washington can quickly ripple through factories in Europe, Latin America or Asia.
What began as a regulatory update on a single word is now reshaping internal priorities. Reformulation teams are busy, yes, but so are procurement, regulatory affairs and legal departments. Ingredient demand is shifting towards compliant inputs. Supplier conversations are becoming more urgent. Pricing discussions are getting tougher. For some, this is a nutrition story. For others, it’s a leverage story.
David Lennarz, president of Registrar Corp, believes too many companies are focusing narrowly on the recipe itself. The more significant risks, he suggests, sit in the operational detail that follows.
Reformulation is only step one
“The biggest operational risk for companies is successfully navigating the shifting landscape,” Lennarz says.
He advises companies to start with a hard look at their existing portfolios rather than jumping straight into new product development. “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, nutritional content and any product that is or has been engaged in making a ‘healthy’ claim.”
That exercise can be sobering. Products that once comfortably met earlier criteria may now sit outside the revised thresholds. Claims that appear routine may require tighter substantiation. For global groups, the review often stretches across multiple business units and legacy SKUs.
The ingredient question follows quickly. “Another aspect that needs to be closely watched is the new ingredients and nutritional levels allowed and whether a reformulation is required,” Lennarz explains. “If reformulation is an option, supplier verification and new specifications must start early to prevent delays or issues in sourcing.”
In other words, reformulation can’t be separated from supply chain strategy. Once companies decide to adjust fat sources, increase whole grains or rebalance nutrients to meet the new definition, they enter a race for compliant raw materials. Production capacity for certain ingredients is finite, and qualification processes take time.
Reformulation also triggers a communications audit. “Another aspect that needs to be audited is the labels, packaging, website and marketing materials to ensure that claims are exactly in line with the new regulation,” Lennarz says.
That means cross-checking everything from front-of-pack statements to digital advertising copy. A product that technically meets the criteria but carries an outdated or overly broad claim could create enforcement risk or reputational damage. Compliance here is as much about wording as it is about formulation.
R&D under pressure
The new definition’s placing a noticeable strain on technical teams. “This new dynamic requires a substantial increase in the workload of the research and development departments of manufacturing companies,” Lennarz says.
R&D functions are being asked to revisit established recipes while maintaining innovation pipelines. “The R&D departments of these companies 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.”
That balancing act isn’t trivial. Reformulation can affect taste, texture, shelf life and cost of goods. Securing new ingredients involves specification reviews, validation runs and, in some cases, reformatted production processes. Meanwhile, commercial teams are still pushing for launches aligned with health and wellness trends.
Delays carry consequences. “The greater risk is in lack of ability to market new ‘healthy’ products to their customers as they face delays in developing the reformulated products,” Lennarz notes.
In highly competitive categories, the ability to make a ‘healthy’ claim can influence retailer listings and promotional plans. If reformulated products aren’t ready in time, brands may find themselves temporarily sidelined in a segment that continues to grow.
Yet Lennarz sees potential upside for those who move early and think strategically. “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.”
In that reading, the rule does more than tighten compliance. It accelerates differentiation between companies that treat regulatory change as a burden and those that treat it as a platform for repositioning.
Early movers and shifting power
The supply chain implications are where the debate becomes more pointed. “The first/early movers are going to be able to gain an edge in sourcing, pricing and regulatory certainty,” Lennarz says.
As more manufacturers reformulate in response to the FDA’s revised definition, demand for compliant ingredients is climbing. “With the acceleration of reformulation in response to the new definition of ‘healthy’ from the FDA, demand for compliant ingredients is accelerating rapidly. By taking action now, manufacturers can secure supply contracts earlier, better pricing and production capacity before shortages become more limited.”
Those who lock in supply agreements early may secure more favourable terms and greater certainty over volumes. Those who wait risk negotiating in a tighter market where suppliers have more leverage and lead times have stretched.
There’s also a documentation dividend for acting sooner rather than later. “The opportunity to reformulate and finalise documentation and labelling with confidence, minimising the risk of costly final-minute changes, is also available,” Lennarz says. “This opportunity is rapidly closing. As more manufacturers begin reformulation to meet the 2028 deadline, supplier power will shift, ingredient costs may increase and lead times will likely stretch for those manufacturers who delay.”
Private label manufacturers may have a marginal advantage in terms of agility. “Typically, private label manufacturers are more accustomed to changes in product recipes, so in that respect they are better situated to make wide changes, like these new label requirements,” Lennarz observes. Even so, they operate within the same ingredient markets and regulatory framework as branded players.
Registrar Corp’s advice is straightforward. “In Registrar Corp’s view, the time for the manufacturers to review their compliance is now, rather than in 2028,” Lennarz says. Companies should “take advantage of the allowed ingredients and levels of nutrients as set by the FDA regulations and make sure that their products’ labelling and advertising are in line with the FDA requirements.”
The updated definition of ‘healthy’ was designed to modernise a claim and align it with current nutrition thinking. But as implementation unfolds, it’s also reshaping procurement strategies, internal workloads and supplier relationships. For food and beverage companies worldwide, the real test may not be whether they can meet the new criteria, but whether they can do so without ceding margin or control in the process.