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<p>The past year has brought a seismic shift in how the federal government, and states, regulate what goes into our food and how it is packaged. From the FDA's aggressive phase-out of petroleum-based dyes to the elimination of PFAS grease-proofers and potential overhauls to the GRAS framework, food companies are facing an entirely new regulatory environment. These changes don't just affect product formulations and supply chains, they create urgent new demands on how companies manage their intellectual property.</p><h3><u>The New Regulatory Landscape: A Snapshot</u></h3><p>The FDA is moving rapidly to eliminate petroleum-based synthetic food dyes. In January 2025, the agency revoked authorization for Red No. 3 (erythrosine), giving manufacturers until 2027 to reformulate food products. By April 2025, HHS and FDA announced a plan to phase out all remaining petroleum-based dyes, including Red No. 40, Yellow No. 5 and 6, Blue No. 1 and 2, and Green No. 3, by the end of 2027. Major manufacturers from General Mills to Kraft Heinz have already committed to these transitions. The FDA is simultaneously fast-tracking approval of natural color alternatives like butterfly pea flower extract and gardenia blue.</p><p>On the packaging side, PFAS-based grease-proofers have been effectively eliminated from food contact materials. In January 2025, the FDA declared that 35 food contact notifications for PFAS-containing grease-proofers are no longer effective. Meanwhile, fourteen states have enacted laws prohibiting intentionally added PFAS in food packaging, and more legislation is pending.</p><p>At the ingredient level, the FDA has announced plans to reform the GRAS (Generally Recognized as Safe) system by requiring mandatory notice submissions, a dramatic departure from the current voluntary approach. States including Texas and West Virginia are enacting their own ingredient-restriction regimes, and former FDA Commissioner David Kessler has petitioned the agency to revoke GRAS status for certain ultra-processed food ingredients.</p><p>The message is clear: what was permissible yesterday may be prohibited tomorrow.</p><h3><u>Trade Secret Practices: New Formulations Mean New Risks</u></h3><p>For food companies, reformulation creates both opportunity and exposure. Developing new recipes using natural color alternatives, non-PFAS packaging solutions, or reformulated ingredient profiles generates valuable intellectual property. These proprietary formulations and processes often qualify for trade secret protection, but only if they are treated as such.</p><p>Trade secret law requires that companies take "reasonable measures" to maintain secrecy. In a period of rapid reformulation, many companies are bringing in external consultants, collaborating with ingredient suppliers, and working with contract manufacturers who gain access to confidential information. Each of these relationships creates a potential leak point.</p><p>Companies should take this moment to audit their trade secret hygiene. Key questions include: Are confidentiality agreements in place with all parties who have access to reformulation data? Do those agreements adequately define what constitutes confidential information under the new regulatory context (e.g., natural dye sourcing, alternative grease-proofing technologies)? Are internal access controls sufficient to limit exposure to only those employees with a legitimate need to know?</p><p>Equally important is documentation. When the FDA revokes an ingredient authorization or a state bans a substance, the process by which a company developed its alternative formulation becomes commercially significant. Maintaining detailed records of R&amp;D efforts, testing protocols, supplier evaluations, and internal decision-making can be critical—not only for defending trade secret claims but also for establishing priority in any subsequent patent filings or disputes.</p><h3><u>Vendor Agreements: Time to Reexamine Your Supply Chain</u></h3><p>As companies scramble to source natural colorants, alternative grease-proofers, and reformulated ingredients, vendor relationships are under new stress. The supplier of a proprietary natural dye extract or a PFAS-free packaging film may be providing a key input to your reformulation, and may also be selling similar products to your competitors.</p><p>This creates risk on multiple fronts. First, companies must ensure that vendor agreements clearly allocate ownership of any jointly developed IP. If a supplier works with your R&amp;D team to customize a natural color additive for your product, who owns the resulting formulation? Who owns the data generated from stability testing or consumer trials? Absent clear contractual language, these questions may be resolved in favor of the supplier or, worse, through litigation.</p><p>Second, companies should consider whether vendor agreements include adequate confidentiality protections and non-disclosure obligations. The regulatory pressure to find compliant alternatives creates a seller's market for specialized ingredients and packaging materials. Suppliers may be simultaneously working with multiple food companies on similar problems. Robust confidentiality provisions, combined with clear definitions of what information is proprietary to each party, are essential.</p><p>Third, food companies should review whether their agreements contain representations and warranties regarding regulatory compliance. A supplier's assurance that a natural color additive is FDA-authorized, or that a packaging material is PFAS-free, needs to be backed by indemnification obligations if those representations prove false. Given the patchwork of state laws, particularly in the PFAS space, where fourteen states have enacted their own restrictions, companies should also require suppliers to warrant compliance with all applicable state-level requirements, not just federal regulations.</p><p>Finally, consider audit rights. As companies transition away from restricted substances, the ability to verify supplier compliance becomes critical. Including contractual audit rights, and exercising them, can provide assurance that the reformulated supply chain is as clean as promised.</p><h3><u>Beyond Trade Secrets and Vendors: Other IP Considerations</u></h3><p>The regulatory upheaval extends beyond trade secrets and supply chain agreements. Companies with existing patents on formulations that include now-banned or disfavored ingredients may find those patents losing value. Conversely, companies that develop innovative natural alternatives or novel packaging solutions may find new patenting opportunities, provided they move quickly to secure protection before competitors or suppliers do the same.</p><p>Trademark considerations also arise. Companies that have built brand identity around the color profile of their products (think: iconic candy colors) face the challenge of maintaining brand continuity while transitioning to natural alternatives. Consumer-facing communications about reformulation, and any associated "natural" or "clean label" claims, should be carefully reviewed for compliance with FDA and FTC guidelines to avoid false advertising exposure.</p><h3><u>The Bottom Line</u></h3><p>The past year's regulatory changes are not incremental adjustments. They represent a fundamental reordering of the rules governing food ingredients and packaging, one that will force many food companies to reformulate products, requalify suppliers, and repackage goods. For companies that treat these challenges as purely operational or regulatory compliance issues, the risks are significant: lost IP, unprotected innovations, supplier disputes, and exposure to competitor claims.</p><p>The companies that will thrive in this environment are those that treat the regulatory transition as an IP opportunity. That means revisiting trade secret protocols, strengthening vendor agreements, and building IP considerations into every reformulation decision.&nbsp;</p><div class="passle-featured-image passle-featured-image-position-bottom"><img src="https://images.passle.net/fit-in/400x400/filters:crop(0,220,2121,1187)/Passle/5f6edd8e8cb62a0bec3e5fd2/SearchServiceImages/2026-03-09-14-20-51-771-69aed743bc4870c9b9016a81.jpg" alt="Featured Image" /></div>

When Food Regulation Changes, IP Strategy Must Change Too

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