FDA food recalls grew 21.4% from 2021 to 2025, climbing from 505 to 613 annual events. In Q3 2025 alone, undeclared allergens drove 48 recall events — the single leading cause — responsible for 45.2% of all food recalls that quarter.
The majority of those recalls weren't the result of intentional mislabeling. They were the result of process gaps: a sub-ingredient that slipped through ingredient review, a reformulation that didn't trigger a label update, a claim that made sense to the marketing team but crossed a regulatory line. FDA compliance for CPG brands is a systems problem as much as a knowledge problem.
Why FDA Compliance Is Getting Harder for CPG Brands
The regulatory surface area for food and supplement brands has expanded significantly in the past few years. Three developments have raised the stakes:
Sesame became the ninth major allergen. Under the FASTER Act of 2021, sesame joined the eight major allergens already covered by FALCPA, with mandatory labeling required as of January 1, 2023. Many brands discovered, after the deadline, that sesame was buried in their natural flavors or spice blends — undisclosed because it had never needed to be called out before. Sesame in a flavoring system doesn't exempt you from declaration; it requires you to trace it.
The "healthy" claim definition changed. FDA's final rule updating the definition of "healthy" as a nutrient content claim took effect February 25, 2025. The prior definition, unchanged since 1994, disqualified avocados, salmon, and nuts from a "healthy" label because they were too high in total fat. The new definition scraps the fat-focused approach entirely and replaces it with food group contribution requirements and limits on added sugars, sodium, and saturated fat. Brands that have used "healthy" on the label for years may now be out of compliance — or may now qualify when they didn't before.
A proposed front-of-package labeling rule is in play. In January 2025, FDA issued a proposed rule requiring most packaged foods to carry a compact nutrition summary box on the principal display panel — rating saturated fat, sodium, and added sugars as Low, Med, or High. The rule isn't final, but FDA estimated implementation costs at $3.2 billion industry-wide over ten years. CPG brands that track regulatory developments early have time to plan. Those that don't will face abrupt redesign timelines.
The Most Common FDA Labeling Violations in CPG
Most FDA warning letters and recall events trace back to one of a short list of recurring compliance failures. These are the gaps that show up most often.
Undeclared Allergens
Allergen declarations are the most frequently cited cause of FDA food recalls — and the most preventable. The common failure points:
A supplier reformulates a seasoning blend and introduces a new allergen not reflected in the specification sheet
A "natural flavors" declaration covers a shellfish-derived flavor enhancer without a parenthetical disclosure
A contract manufacturer runs product on shared equipment with allergen-containing lines without adequate changeover controls, and the "may contain" advisory is missing
The practical requirement: every ingredient in your product, including sub-ingredients in compound ingredients, needs to be reviewed for the nine major allergens (milk, eggs, fish, shellfish, tree nuts, wheat, peanuts, soy, sesame). A single allergen-containing sub-ingredient that's not declared is a misbranding violation under 21 U.S.C. 343(w).
Unsupported Nutrient Content Claims
Under 21 CFR 101.13, nutrient content claims must meet specific, quantitative thresholds. "High protein" means ≥20% of the Daily Value per reference amount — not just "a good amount of protein." "Good source of fiber" means 10–19% DV. "Low sodium" means ≤140 mg per reference amount customarily consumed.
The problem: nutrient content claims are frequently added to packaging or marketing copy by brand or marketing teams who understand the spirit of the claim but not the threshold. A product might contain 8g of protein per serving and get labeled "high protein" — but 8g of protein is only 16% DV, which qualifies for "good source" but not "high." That's a misbranding violation.
The required disclosures that accompany claims are also routinely missed. A "light in sodium" claim, for example, must be followed by "not a low sodium food" if the product doesn't meet the low sodium threshold.
Structure/Function Claims That Cross Into Disease Claim Territory
This is where supplement brands and functional food brands most frequently draw FDA attention. A structure/function claim describes an effect on normal body structure or function — "supports healthy immune function," "promotes joint comfort." A disease claim characterizes the product as diagnosing, curing, treating, or preventing a specific disease — and that requires FDA pre-market approval that supplements and most foods cannot obtain.
The line isn't always obvious. "Supports healthy blood sugar levels already within the normal range" is a structure/function claim. "Helps control blood sugar" is a disease claim. "Reduces inflammation" is a disease claim. "Supports a healthy inflammatory response" may or may not be, depending on context.
FDA's enforcement position — and FTC's — is evaluated against the net impression of all the language, imagery, and context on the label and in advertising. A technically safe structure/function statement can be converted into a disease claim by the surrounding context.
Missing or Incorrect Required Disclosures
Every structure/function claim on a dietary supplement requires the DSHEA disclaimer: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." Under 21 CFR 101.93, that language must be exact, must appear on the label, and must not be obscured or minimized.
Other frequently missing required elements:
The iron warning required on all iron-containing dietary supplements in solid oral dosage form under 21 CFR 101.17(e)
The phenylalanine notice required on all aspartame-containing products under 21 CFR 101.17(f)
The "not a low calorie food" or equivalent disclosure required when "sugar free" claims appear on products that aren't low calorie
Serving Size Manipulation
Serving sizes must be based on the Reference Amount Customarily Consumed (RACC) for the product's food category under 21 CFR 101.12 — not on whatever amount makes the Nutrition Facts look most favorable. A brand cannot declare a 15g serving for a product category with a 30g RACC just because the per-serving nutrient numbers look better. FDA evaluates nutrient content claim eligibility against the RACC, not the declared serving size, which means a manipulated serving size doesn't just mislead consumers — it may not even succeed at making a claim eligible.
How to Build a Compliant Labeling Process
Compliance failures that lead to recalls almost always have a process root cause, not just a knowledge gap. The brands that stay out of trouble have a few things in common.
Every claim is verified against a specific threshold before it goes on packaging
"High protein," "low sodium," "no sugar added," "natural" — each of these terms has a specific regulatory definition or a set of requirements that must be satisfied. The verification step should happen before the label is designed, not during the legal review after it's ready to print.
Ingredient changes trigger a compliance review
A reformulation, a supplier change, or a new manufacturing facility can introduce an allergen, change a nutrient level enough to affect a claim, or introduce an ingredient that was never reviewed for regulatory status. The process should treat ingredient changes as compliance triggers — not just quality events.
Claims are tracked as structured data, not as copy in a document
Most compliance teams manage claims in spreadsheets or shared folders. The result: claims that were approved for one channel get copied to another, outdated language persists on old assets, and there's no system of record for which claims have been reviewed, by whom, and under what regulatory standard. A claims library — tracking proposed text, approved language, regulatory reference, and review history for every claim — is the operational infrastructure that prevents the entropy.
Marketing copy gets the same review as label copy
FDA and FTC enforcement does not distinguish between the label and the website. A disease claim on your product detail page is the same violation as a disease claim on the package. Social posts and influencer content are subject to the same rules. The compliance review process needs to include every channel where product claims appear.
What Changed in 2025 and 2026 That Affects Your Labels
Beyond the allergen and "healthy" claim updates, there are a few additional regulatory developments CPG brands should have on their radar:
"Healthy" safe harbor through February 2028. Products that qualified under the prior "healthy" criteria can continue using the claim during the safe harbor period. But brands should plan their label transition now — the safe harbor doesn't mean the old criteria still apply indefinitely, and new products launched after February 25, 2025 need to meet the updated standard.
Front-of-package labeling is proposed, not final. FDA's proposed Nutrition Info box rule (January 2025) is still in rulemaking. A final rule would require a mandatory Low/Med/High rating for saturated fat, sodium, and added sugars to appear on the principal display panel of most packaged foods. CPG brands with products that would rate "High" on any of those nutrients should start understanding what that means for consumer perception and potential reformulation timelines.
FDA enforcement continues. FDA's recall authority under FSMA and its warning letter program are ongoing. Brands in supplement categories — weight management, women's health, sports nutrition — continue to receive the highest concentration of warning letters for disease claims and unsubstantiated structure/function claims.
Get Ahead of FDA Compliance — Not Behind It
FDA compliance for CPG brands isn't a one-time review. It's a continuous process that runs across every label, every channel, every reformulation, and every new claim. Truli's AI compliance platform audits food and supplement labels against FDA regulations in real time — flagging undeclared allergens, unsupported claims, missing disclosures, and serving size issues before they reach shelves. Book a demo to see how Truli handles compliance for your product catalog.
