Every BFY Claim Is a Compliance Risk: What F&B Manufacturers Need to Know

Mar 20, 2026 5:49:14 PM | Product Lifecycle Management | Food & Beverage | Blogs
Posted By: Trace One

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TL;DR:
39% of consumers increasing diet effort are actively choosing products with BFY claims, and 58% rate claims as very or extremely important in purchase decisions, according to Mintel Better for you eating trends 2025 research. Claims drive purchase — but the regulatory landscape for BFY claims (“better for you”) is fragmented. What qualifies as “low sugar” in the US differs from the EU, which differs from the UK post-Brexit. A claim that drives purchase in one market can trigger enforcement action in another. For F&B manufacturers selling across jurisdictions, claim validation must be built into product development from day one.

Which BFY Claims Drive Consumer Purchase Decisions?

Not all “better for you” claims carry equal weight with consumers. Mintel’s 2025 data reveals a clear hierarchy of what health-active consumers actually look for on pack — and each claim at the top of that hierarchy carries specific regulatory requirements that vary by market.

53% of consumers define “better for you” as containing quality ingredients. This is the broadest and most powerful consumer expectation: ingredient quality is the foundation of every other BFY claim. But “quality ingredients” is not a regulated term — it is a consumer perception shaped by the specificity and recognizability of the ingredient list. Manufacturers who claim quality must deliver transparency.

47% define it as being naturally low in sugar, salt, and fat. This is where regulatory complexity begins. “Naturally low” is not a standardized claim across jurisdictions. The consumer expectation — as Blog 1 in this series establishes, where consumer demand for naturally low products is reshaping product development — is clear. But the regulatory definition of what “low” means differs across every major market.

40% define it as containing no additives or preservatives. “No additives” and “no preservatives” are claims with specific regulatory definitions that do not align across jurisdictions. An ingredient classified as a processing aid in one market may be classified as an additive in another. A “no artificial preservatives” claim that is compliant in the US may be misleading under EU standards if the product contains an ingredient that functions as a preservative regardless of its classification.

The bottom line: 39% of health-active consumers are choosing products specifically because of BFY claims. Claims are not decorative — they are purchase drivers. And every purchase-driving claim carries regulatory risk that scales with the number of markets where the product is sold.

How Do BFY Claim Requirements Differ Across US, EU, and UK Markets?

Take a single claim — “reduced sugar” — on a cereal bar sold in three markets. The same product, the same formulation, the same consumer promise. Three different regulatory frameworks.

United States (FDA): Under FDA nutrient content claim definitions, a “reduced sugar” claim requires at least 25% less sugar than the appropriate reference food. The reference food, the serving size definition, and the calculation methodology are all FDA-specific.

European Union: Under EU nutrition and health claims regulation (Regulation 1924/2006), a “reduced sugars” claim requires at least a 30% reduction compared to a similar product. The calculation basis, the comparison product definition, and the label language requirements differ from the FDA framework.

United Kingdom (post-Brexit): UK food claim regulations currently mirror much of the EU’s Regulation 1924/2006 framework, but the UK is actively developing independent guidance through the Food Standards Agency. A claim strategy built on EU compliance today may not remain UK-compliant as frameworks diverge.

One formulation, three claim strategies. And this is just “reduced sugar” — one of dozens of BFY claims a manufacturer might make. Multiply this by “low fat,” “high protein,” “no additives,” “source of fiber,” and every other claim in a manufacturer’s portfolio, across every market and every SKU, and the compliance surface area becomes enormous. The international food standards and guidelines established by Codex Alimentarius provide a global reference framework, but national implementations vary significantly — and it is the national implementation, not the Codex standard, that determines whether a claim is compliant on shelf.

What Happens When a BFY Claim Fails Regulatory Review?

A claim that fails regulatory review does not fail quietly. The cascade is predictable and expensive.

Stage 1: Product hold. The product cannot ship until the claim is corrected. For products already in the supply chain, this means warehouse holds, shipment recalls, and retailer notification. Every day of hold is a day of lost revenue and a day competitors are on shelf without you.

Stage 2: Label reprinting. A non-compliant claim requires label correction — which means new artwork, new print runs, and new packaging. For a multi-market product, this may mean different corrections in different markets, multiplying the cost and coordination burden.

Stage 3: Retailer consequences. Retailers operate under their own compliance standards and take non-compliant claims seriously. A retailer delisting — even a temporary one — can take months to reverse. In a market where 63% of consumers view private label as just as healthy as name brands, the shelf space vacated by a delisted product is immediately filled by the retailer’s own brand.

Stage 4: Consumer trust erosion. 28% of consumers are already wary of food safety due to recalls, and 37% wish the US had stricter food production regulations. A public claim correction or recall does not just damage the specific product — it damages the brand’s credibility on every health claim across every product in the portfolio. Consumers who have learned to read labels with skepticism do not give second chances easily.

How Can F&B Manufacturers Build Claim Compliance into Product Development?

The pattern in every claim failure is the same: compliance was checked after the product was developed, not during. The formulation was finalized, the label was designed, and then someone asked whether the claim was valid in every target market. By that point, a non-compliant claim means rework — back to formulation, back to labeling, back through the approval chain.

The alternative is compliance-by-design in food manufacturing: integrating claim validation into the product development workflow from the first formulation decision. When a manufacturer enters a “reduced sugar” claim as a product requirement, the system validates that claim against FDA, EU, and UK thresholds simultaneously — before R&D begins formulating. When the formulation changes, the claim validation updates automatically. When a regulation changes, the system flags affected products and claims proactively.

Comprehensive claim compliance requires coverage of 80+ horizontal regulations across national and confederation levels. It requires food regulatory compliance software that does not just store regulations but actively monitors them, validates formulations against them in real time, and traces the connection between every ingredient, every nutritional calculation, and every on-pack claim. This is not a spreadsheet exercise — it is an infrastructure requirement.

As PLM as a catalyst for brand integrity research from CIMdata confirms, the manufacturers who integrate regulatory compliance into integrated PLM and compliance for F&B are the ones who launch compliant products faster — because they never build a product that cannot pass regulatory review in the first place.

Key Takeaway

39% of health-active consumers choose products based on BFY claims, making claims a direct revenue driver. But every claim carries regulatory risk that varies by market. Claim validation must be built into product development from day one.

Frequently Asked Questions

What is food claim compliance software?

Food regulatory compliance software automates the validation of on-pack claims — such as “low sugar,” “high protein,” or “no additives” — against applicable regulations in each target market. Rather than manually checking claim thresholds across FDA, EU, and UK frameworks, the system validates claims in real time as formulations are developed, flags non-compliance before production, and updates validations automatically when regulations change. This eliminates the manual handoffs and post-development reviews that are the primary source of claim errors.

How do you validate BFY claims across multiple markets?

Validating BFY claims across multiple markets requires a system that maps each claim type to the specific regulatory thresholds in each target jurisdiction. For example, a “reduced sugar” claim requires a 25% reduction under FDA rules and a 30% reduction under EU Regulation 1924/2006. Compliance-integrated PLM validates the formulation against all applicable frameworks simultaneously, ensuring that a single product’s claims are compliant in every market before production begins. This approach replaces the sequential, market-by-market review process that causes delays and errors.

What regulations apply to BFY food claims?

The primary regulatory frameworks governing BFY food claims include: the FDA’s nutrient content claims regulations (21 CFR 101) and “healthy” labeling definitions in the United States; EU Regulation 1924/2006 on nutrition and health claims in the European Union; UK-specific guidance from the Food Standards Agency, which is diverging from EU standards post-Brexit; and the Codex Alimentarius guidelines from WHO/FAO, which provide an international reference framework. Each jurisdiction defines its own thresholds, approved claim language, and enforcement mechanisms, meaning a claim compliant in one market may be non-compliant in another.

Every BFY claim on your product is a compliance decision. Are you making it with the right data?
See how food regulatory compliance software validates claims across FDA, EU, and UK frameworks in real time — so your team launches compliant products faster, in every market.

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About Trace One

With more than 30 years of industry expertise, Trace One partners with over 9,000 brands across food and beverage, cosmetics, and chemicals to accelerate product development and turn regulatory complexity into a competitive advantage. Our AI-powered PLM platform, with regulatory intelligence spanning 170+ countries, supports the entire product manufacturing lifecycle — helping brands bring market-leading products to shelf faster and thrive in new markets. Learn more at traceone.com.