The Compliance Issue No-one is talking about (but will be in 6 Months)

While most food manufacturers are focused on existing FDA and CFIA requirements, there’s a massive regulatory change brewing that could force you to redesign every single product label in your portfolio. And based on the compliance timeline, you have less time to prepare than you think.

The FDA’s proposed Front-of-Package (FOP) nutrition labeling rule, published January 16, 2025, represents the most significant change to food labeling in over 30 years. If finalized as proposed, this mandatory requirement will affect nearly every packaged food product sold in the United States—and could reshape how consumers perceive your entire product line.

What Is Front-of-Package Nutrition Labeling?

The FDA’s proposed “Nutrition Info” box would be required on the principal display panel of most packaged foods—the front of your package where consumers make split-second purchasing decisions. Unlike the current Nutrition Facts panel on the back or side of packages, this new label would provide immediate, interpretive information about three specific nutrients:

• Saturated Fat
• Sodium
• Added Sugars

Each nutrient would be displayed with its percent Daily Value (%DV) and an interpretive descriptor: “Low” (5% DV or less), “Med” (6-19% DV), or “High” (20% DV or more).

The black-and-white box would appear in the upper third of your principal display panel, using a format similar to the existing Nutrition Facts label. It would also include an attribution to “FDA.gov” to increase consumer trust and credibility.

Why This Changes Everything for Food Manufacturers

It’s Not Voluntary—It’s Mandatory

Unlike previous FOP labeling initiatives (remember “Facts Up Front”?), this isn’t a voluntary program. The FDA is proposing to require the Nutrition Info box on virtually all foods that currently must bear a Nutrition Facts label and are marketed to people ages 4 and older.

The Timeline Is Shorter Than You Think

The proposed compliance timeline gives manufacturers:

• 3 years after the final rule’s effective date for businesses with $10 million or more in annual food sales
• 4 years for businesses with less than $10 million in annual sales

But here’s the catch: the comment period was recently extended to July 15, 2025. Assuming the rule is finalized by late 2025 or early 2026, larger manufacturers could be looking at a compliance date as early as 2028-2029. That’s why you need to start planning now.

Reformulation May Be Your Only Option

The FDA estimates that the rule will generate $2.2 billion in reformulation costs over ten years—because many manufacturers will have no choice but to change their recipes to avoid “High” designations that could kill product sales.

Consider what a “High” in added sugars or sodium means for consumer perception. Research shows that interpretive FOP labels significantly influence purchasing decisions, particularly among consumers with lower nutrition literacy. A prominent “High” designation on your breakfast cereal or frozen meal could send customers straight to your competitor’s product.

What Products Are Affected?

The rule would apply to most foods currently required to bear a Nutrition Facts label, including:

• Packaged foods marketed for people ages 4 and older
• Foods sold from bulk containers to consumers
• Imported products entering the U.S. market

Exemptions and Special Requirements

The proposed rule includes exemptions for:

• Raw fruits and vegetables
• Foods marketed for children under 4 years old (though FDA is seeking comments on this)
• Most dietary supplements
• Packages with total surface area less than 12 square inches
• Foods exempt from nutrition labeling under 21 CFR 101.9(j)

Modified requirements apply to packages between 12-40 square inches, variety packs, and foods with multiple Nutrition Facts panels (such as “as packaged” vs. “as prepared”).

The Hidden Complication: Nutrient Content Claims

The proposed rule also amends existing nutrient content claim regulations to prevent “within-label inconsistencies.” This creates a double impact:

Changes to “Low Sodium” Claims

The threshold for “low sodium” claims would drop from 140 mg or less per RACC to 115 mg or less. Additionally, products making “low sodium” claims must also display “Low” for sodium in the Nutrition Info box.

New Requirements for “Low Saturated Fat” Claims

Foods bearing “low saturated fat” claims would need to meet stricter criteria and display “Low” in the Nutrition Info box for saturated fat.

If your products currently make these nutrient content claims, you may need both reformulation and label redesign to maintain those claims under the new rule.

What International Manufacturers Need to Know

This rule applies to both domestic and imported foods. If you’re a Canadian manufacturer exporting to the U.S. market, or a U.S. importer bringing products across the border, every product will need to comply.

The challenge? You’ll need to navigate different labeling systems:

• Canada’s Front-of-Package nutrition symbol (implemented 2026) focuses on different criteria
• The FDA’s proposed U.S. system uses a High/Med/Low interpretation
• Different thresholds and formatting requirements apply

Products manufactured for both markets may need entirely different label designs—multiplying your compliance costs and complexity.

The Business Impact: Beyond Label Redesign

Brand Positioning and Product Mix

Smart manufacturers are already running scenario analyses:

• Which products in your portfolio would receive “High” designations?
• Can you reformulate cost-effectively, or do these products need to be discontinued?
• Should you launch reformulated versions now, ahead of the requirement?
• How will “Med” and “High” designations affect your premium positioning?

Supply Chain and Inventory Management

The uniform compliance date of January 1, 2028 (for any FDA labeling rules published between January 2025-December 2026) adds another layer of complexity. You’ll need to:

• Plan for existing label inventory depletion
• Coordinate with co-packers and label printers
• Manage SKU transitions without supply chain disruptions
• Budget for both redesign costs and potential ingredient sourcing changes

Litigation Risk

Here’s what keeps food company lawyers up at night: the plaintiff’s bar is already monitoring for noncompliant labels. Class action lawsuits alleging false labeling typically claim consumers wouldn’t have purchased products if properly labeled—or would have paid less.

Given the high-profile nature of this rule, expect increased scrutiny once it takes effect.

What You Should Do Right Now

1. Conduct a Portfolio Audit

Analyze every SKU to determine:

• Saturated fat, sodium, and added sugar levels per serving
• Whether products would receive “High,” “Med,” or “Low” designations
• Which products make nutrient content claims that would be affected
• Package sizes and principal display panel layouts

2. Model Reformulation Options

For products likely to receive “High” designations:

• Identify reformulation strategies that maintain taste and functionality
• Calculate cost implications for ingredient changes
• Consider consumer acceptance testing for reformulated versions
• Evaluate whether reformulation is economically viable or if discontinuation makes more sense

3. Assess Package Redesign Requirements

Work with your design team to:

• Determine where the Nutrition Info box must be placed on each SKU
• Ensure adequate space in the upper third of the principal display panel
• Consider brand identity implications of the mandatory black-and-white box
• Plan for different box sizes based on package dimensions

4. Submit Comments to FDA

The comment period is open until July 15, 2025. This is your opportunity to:

• Raise concerns about implementation challenges specific to your product categories
• Provide data on economic impacts to your business
• Suggest alternative approaches or exemptions
• Request clarification on ambiguous requirements

Comments should be submitted to regulations.gov under Docket No. FDA-2024-N-2910.

5. Stay Informed on Political Developments

The FOP rule was proposed under the outgoing administration. With the regulatory freeze following the change in administration, the rule’s timeline and final form remain uncertain. However, given bipartisan interest in nutrition policy and alignment with “Make America Healthy Again” priorities, the rule is likely to move forward in some form.

Don’t count on the rule being withdrawn—plan as if it will be implemented.

Why Most Companies Are Unprepared

In our work with mid-size food manufacturers, we’ve found that most companies:

• Haven’t analyzed their products against the proposed High/Med/Low thresholds
• Underestimate the complexity of package redesign when space is limited
• Haven’t budgeted for potential reformulation costs
• Don’t realize the rule will affect their existing nutrient content claims
• Assume they’ll have more time than the timeline actually allows

The manufacturers who act now will have significant competitive advantages:

• More time for cost-effective reformulation
• Ability to launch improved products ahead of the mandate
• Better negotiating position with suppliers and co-packers
• Reduced risk of compliance failures and associated litigation

The Canadian Angle: Navigating Two Systems

For manufacturers serving both U.S. and Canadian markets, 2026-2029 will bring a perfect storm of FOP labeling requirements:

Canada’s Front-of-Package Nutrition Symbol:

• Focuses on high levels of saturated fat, sugars, and sodium
• Uses a simplified “high in” magnifying glass symbol
• Compliance required by January 1, 2026 for most products

U.S. FDA Nutrition Info Box:

• Interpretive High/Med/Low system for saturated fat, sodium, and added sugars
• Compliance likely required 2028-2029
• Different thresholds and formatting from Canadian requirements

Companies need integrated strategies that address both markets simultaneously rather than sequential compliance projects.

The Bottom Line

Front-of-package nutrition labeling represents a fundamental shift in how nutrition information is communicated to consumers. While the proposed rule is still under review, the momentum behind FOP labeling—both domestically and internationally—makes some form of implementation virtually certain.

The question isn’t whether this will happen, but how you’ll respond. Manufacturers who treat this as a strategic opportunity rather than just a compliance burden will be better positioned to maintain market share and consumer trust.

The compliance issue nobody’s talking about today will be the only thing the food industry discusses in 18 months. By then, companies that waited will be scrambling to catch up, facing compressed timelines, higher costs, and limited reformulation options.

Start your planning now, while you still have time to do it right.

How FTC International Can Help

As food regulatory specialists with 25+ years of experience in FDA and CFIA compliance, FTC International helps food manufacturers navigate complex labeling changes:

• Portfolio Audits: Complete analysis of your products against proposed FOP requirements
• Reformulation Strategy: Technical guidance on reducing sodium, saturated fat, and added sugars while maintaining product quality
• Label Compliance Review: Expert review to ensure your redesigned labels meet all FDA and CFIA requirements
• Regulatory Consultation: Strategic guidance on timing, implementation, and regulatory submissions

Contact us to discuss how the proposed FOP labeling rule will affect your specific products and what steps you should take now to prepare.

Phone: +1-604-288-2719
Email: contact@ftcinternational.com
Website: ftcinternational.com