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FDA Food and Supplement Labeling Enforcement, 2020–2026: What Warning Letters and Recalls Show

Nick Nullen
Illustration of sealed official letters, a magnifying glass and charts beside a supplement bottle and a food box

An original Compliance Naturally analysis of 3,779 FDA warning letters (January 2021 to October 2026) and 10,356 food recall records (January 2020 to October 2026). All the data and the method are below, so you can check every number.

Key findings

  • Labeling is a big part of FDA’s food enforcement, but only part of it. 834 of the 3,779 warning letters FDA posted for January 4, 2021 to October 23, 2026 went to food or dietary supplement firms. 225 of those 834 (27%) charged a labeling or claims violation.
  • Supplements get labeling letters far more often than regular food. 126 of 164 warning letters to supplement firms (77%) cited labeling or claims, compared with 99 of 670 letters to conventional food firms (15%). Supplement firms received 20% of food and supplement letters, but 56% of the labeling ones.
  • Disease claims are the top problem. 143 of the 225 labeling letters (64%) said a food or supplement was being sold with claims that made it an unapproved drug, such as claims that it treats, cures or prevents a disease. For supplement letters it was 103 of 126 (82%).
  • What FDA objects to has changed. Disease-claim letters dropped from 53 in 2021 to 7 in 2024. Over the same years, letters charging label-content violations under the food misbranding law (21 U.S.C. 343 or 21 CFR 101) went from 10 to 27.
  • Undeclared allergens are the most common reason for food recalls when you count recall actions. 1,187 of 3,228 FDA food recall events from January 2020 to October 21, 2026 (37%) involved an undeclared major allergen. Microbial contamination was the main reason in 848 events.
  • Milk is the allergen most often missing from labels. It was named in 398 undeclared-allergen recall events, a third of the total, followed by soy (275), tree nuts (246) and wheat (244).
  • Sesame recalls jumped after the labeling law changed. In 2020 through 2022 there were 11 undeclared-sesame recall events in total. Sesame label declaration became mandatory on January 1, 2023, and from then through October 21, 2026 there were 79.
  • Many allergen recalls are high-risk. 503 of the 1,187 allergen recall events (42%) included a Class I recall, FDA’s most serious category: a reasonable probability of serious health effects or death.

Why we looked at this

Most people find out a label was wrong only when a recall makes the news. FDA has two public records that show the pattern behind those stories. Warning letters are formal notices telling a company it broke the law. Recalls pull products off shelves. We wanted to know how often the problem is the label itself (what has to be on a food label and what the company says about the product) and not contamination or how the product was made.

Part 1: FDA warning letters, 2021–2026

FDA’s public warning-letter table listed 3,779 letters issued from January 4, 2021 to October 23, 2026 when we downloaded it on November 1, 2026. The table does not list letters from 2020, so this part of the study starts in 2021. Tobacco letters were the largest group (1,211). We read the full text of every letter that could involve a food or supplement and sorted them by product type and violation.

FDA warning letters to food and supplement firms by year, 2021–2026Stacked columns by letter issue year. Supplement labeling letters 38, 28, 24, 6, 16, 14; conventional-food labeling letters 20, 25, 13, 25, 9, 7; food or supplement letters with no labeling charge 85, 142, 98, 124, 70, 90 for 2021 through 2026 (2026 through October 23).Supplement labelingFood labelingNo labeling charge050100150200Warning letters2021: Supplement labeling 38382021: Food labeling 20202021: No labeling charge 858514320212022: Supplement labeling 28282022: Food labeling 25252022: No labeling charge 14214219520222023: Supplement labeling 24242023: Food labeling 132023: No labeling charge 989813520232024: Supplement labeling 62024: Food labeling 25252024: No labeling charge 12412415520242025: Supplement labeling 16162025: Food labeling 92025: No labeling charge 70709520252026: Supplement labeling 14142026: Food labeling 72026: No labeling charge 90901112026Jan–Oct 23
Warning letters to food and supplement firms, by year. “Labeling” means the letter charged food misbranding (21 U.S.C. 343 or 21 CFR 101) or said the product’s claims made it an unapproved drug. 2026 runs through October 23. Source: FDA warning letters; Compliance Naturally analysis.

Labeling letters to food and supplement firms fell every year, from 58 in 2021 to 25 in 2025 (2026 had 21 through October 23). Much of the 2021–2022 total came from letters about disease claims, including 17 about COVID-19 products. Supplement firms were the main targets: 77% of supplement letters cited labeling or claims. For conventional food, most letters were about food safety systems instead. 337 of the 834 food and supplement letters (40%) were about the Foreign Supplier Verification Program (FSVP) for importers, which is not a labeling rule.

What the labeling letters cited

What FDA cited in food and supplement labeling warning letters, 2021–2026Horizontal bars. Number of the 225 labeling-related warning letters (January 2021 to October 2026) that cite each issue: Disease or drug claims 143; Ingredients & other required info 71; Nutrition or Supplement Facts panel 68; Allergen labeling 49; False or misleading labeling 45; CBD / cannabis products 21; Structure/function claim rules 15; Nutrient content or health claims 13. A letter can cite several issues.Disease or drug claimsDisease or drug claims: 143143Ingredients & other required infoIngredients & other required info: 7171Nutrition or Supplement Facts panelNutrition or Supplement Facts panel: 6868Allergen labelingAllergen labeling: 4949False or misleading labelingFalse or misleading labeling: 4545CBD / cannabis productsCBD / cannabis products: 2121Structure/function claim rulesStructure/function claim rules: 1515Nutrient content or health claimsNutrient content or health claims: 1313
Issues cited in the 225 labeling-related warning letters, January 2021 to October 2026. A letter can cite several issues, so the bars add up to more than 225. Source: FDA warning letters; Compliance Naturally analysis.
  • Disease or drug claims (143 letters). These were mostly supplements (103) whose websites, social media or labels said the product treats, cures or prevents a disease (17 of these letters were about COVID-19 products). Products sold with those claims are legally drugs. See the difference between food and supplements.
  • Ingredient list, identity and other required information (71) and the Nutrition or Supplement Facts panel (68). These are the basic label requirements. Our guide to reading a Nutrition Facts label explains what the panel must show.
  • Allergen labeling (49). These letters cited section 403(w), the allergen labeling requirement. 41 of them went to conventional food firms.
  • False or misleading labeling (45), CBD products (21), and supplement structure/function claim rules (15). All 15 structure/function letters went to supplement firms. They cover rules like the required disclaimer and notifying FDA about the claim.

Who issues them, and where they go

FDA’s field food divisions issued 111 of the 225 labeling letters (49%). FDA’s food center issued 81: 44 as CFSAN and 37 under its new name, the Human Foods Program. The drug center (CDER) issued 27, 22 of them to supplement sellers. By location, California firms got the most (51), followed by Florida (27), Texas (17) and New York (12). Only 4 labeling letters went to firms outside the United States.

Part 2: Food recalls, 2020–2026

For recalls we used FDA’s food enforcement data through the openFDA API. It covers 10,356 product records in 3,228 recall events reported from January 1, 2020 to October 21, 2026. One recall event can include many products, so we report events (recall actions) unless we say otherwise.

FDA food recall events by year, 2020–2026, by reasonStacked columns. Recall events per year (openFDA food enforcement, by report date): undeclared allergen events 158, 178, 167, 206, 157, 189, 132; other labeling or misbranding events 40, 39, 41, 51, 50, 56, 52; all other reasons 222, 231, 230, 223, 254, 330, 222 for 2020 through 2026 (2026 through October 21).Undeclared allergenOther labeling / misbrandingAll other reasons0100200300400500600Recall events2020: Undeclared allergen 1581582020: Other labeling / misbranding 40402020: All other reasons 22222242020202021: Undeclared allergen 1781782021: Other labeling / misbranding 392021: All other reasons 23123144820212022: Undeclared allergen 1671672022: Other labeling / misbranding 41412022: All other reasons 23023043820222023: Undeclared allergen 2062062023: Other labeling / misbranding 51512023: All other reasons 22322348020232024: Undeclared allergen 1571572024: Other labeling / misbranding 50502024: All other reasons 25425446120242025: Undeclared allergen 1891892025: Other labeling / misbranding 56562025: All other reasons 33033057520252026: Undeclared allergen 1321322026: Other labeling / misbranding 52522026: All other reasons 2222224062026Jan–Oct 21
FDA food recall events by year and reason. Year is the year FDA reported the recall. “Other labeling” includes undeclared colors or sulfites, false gluten-free claims, missing labels and similar problems. 2026 runs through October 21. Source: openFDA food enforcement API; Compliance Naturally analysis.

Labeling problems of any kind were behind 1,516 of the 3,228 recall events (47%). Undeclared allergens alone accounted for 1,187 events. If you count individual products instead, microbial contamination leads (4,600 product records, against 2,772 for allergens). That is because contamination recalls cover more products each: about 5.4 product records per microbial recall event, against 2.3 per allergen event. Allergen recall events peaked at 206 in 2023.

Undeclared-allergen recall events by allergen, 2020–2026Horizontal bars. Number of FDA food recall events naming each undeclared major allergen, Jan 2020 to Oct 21 2026: Milk 398; Soy 275; Tree nuts (incl. coconut) 246; Wheat 244; Egg 172; Peanut 130; Sesame 90; Fish 77; Crustacean shellfish 35. One event can name several allergens.MilkMilk: 398398SoySoy: 275275Tree nuts (incl. coconut)Tree nuts (incl. coconut): 246246WheatWheat: 244244EggEgg: 172172PeanutPeanut: 130130SesameSesame: 9090FishFish: 7777Crustacean shellfishCrustacean shellfish: 3535
Undeclared-allergen recall events by allergen, January 2020 to October 21, 2026. 284 events named more than one allergen. Until January 2025 FDA counted coconut as a tree nut, so coconut is included under tree nuts. Source: openFDA; Compliance Naturally analysis.

Milk was the allergen most often missing from labels (398 events), well ahead of every other allergen. California firms had the most allergen recall events (185), followed by Texas (102) and New York (84). If you want to understand the labels these recalls are about, see can food companies lie about ingredients?

Undeclared-sesame recall events by year, 2020–2026Columns. FDA food recall events naming undeclared sesame: 2020: 5, 2021: 3, 2022: 3, 2023: 26, 2024: 17, 2025: 23, 2026: 13. Sesame became the ninth major food allergen requiring label declaration on January 1, 2023 (FASTER Act).Sesame recall events0102030Recall events2020: Sesame recall events 55520202021: Sesame recall events 33320212022: Sesame recall events 33320222023: Sesame recall events 2626262023Labeling required2024: Sesame recall events 17171720242025: Sesame recall events 23232320252026: Sesame recall events 1313132026Jan–Oct 21
Undeclared-sesame recall events by year. The FASTER Act made sesame the ninth major food allergen, and label declaration became required on January 1, 2023. 2026 runs through October 21. Source: openFDA; Compliance Naturally analysis.

Sesame shows what happens when a labeling rule changes. Before 2023, sesame was not one of the major food allergens that labels must call out, and recalls for it were rare (5, 3 and 3 events in 2020, 2021 and 2022). Once declaration became mandatory, there were 26 sesame recall events in 2023, 17 in 2024, 23 in 2025 and 13 through October 21, 2026.

Methodology

Warning letters. We downloaded the full list of letters behind FDA’s warning-letter table (3,779 letters) on November 1, 2026. We set aside letters that could not involve food or supplements: tobacco, medical devices, biologics, veterinary products, and drug-manufacturing or telehealth subjects. We then downloaded the full text of the remaining 1,221 letters. A letter counts as a food or supplement letter if FDA’s “Product” field says Food & Beverages or Dietary Supplements, or if the text describes the product as a dietary supplement or an adulterated food. That gave 834 letters. A letter counts as labeling-related if, outside FSVP template language, it charges misbranding under section 403 of the FD&C Act (21 U.S.C. 343) or cites 21 CFR Part 101, or if it says the product’s claims make it an unapproved drug. Violation topics were assigned by specific citations, for example 403(w) for allergens and 403(q) for Nutrition or Supplement Facts.

Recalls. We downloaded every openFDA food enforcement record with a report date from January 1, 2020 to October 21, 2026. We classified each record by keyword rules applied to FDA’s “reason for recall” text, in this order: undeclared major allergen, undeclared drug ingredient, other labeling or misbranding, microbial contamination, foreign material, chemical hazard, other. A recall event counts in a category if any of its products does.

Accuracy check. We checked random samples by hand. In 30 food and supplement warning letters, the labeling yes/no decision was right in 30 of 30 and the product type in 29 of 30. In 30 recall records, the main category was right in 27 of 30 on our first rules, and the labeling yes/no in 30 of 30. All three recall errors were rule problems; we fixed them and re-ran the analysis. A second check of 15 labeling letters found topic errors in 2, which we also fixed. The full keyword rules, scripts and hand-check files are in the download below.

Limitations

  • FDA’s warning-letter table starts in January 2021, so we could not count 2020 letters. FDA also posts letters weeks or months after it issues them, so the 2026 count is incomplete twice over: it is a partial year, and recent letters may not be posted yet.
  • Warning letters show FDA enforcement priorities and staffing, not how common violations are in the market.
  • Keyword and citation rules can miss unusual wording. Product type depends partly on FDA’s own “Product” field.
  • openFDA data is not validated by FDA. A recall’s year is the year FDA reported it, which can be later than when the recall started. Firm location is the recalling firm’s address, not where the product was made.

Download the data

The cleaned files are free to use with credit (CSV, UTF-8):

How to cite this study

Compliance Naturally. “FDA Food and Supplement Labeling Enforcement, 2020–2026: What Warning Letters and Recalls Show.” November 2026. https://compliancenaturally.com/fda-labeling-enforcement-data

Journalists and researchers are welcome to use the charts and figures with a link to this page. Please cite the date ranges along with the numbers: warning letters issued January 4, 2021 to October 23, 2026; recalls reported January 1, 2020 to October 21, 2026.

Related reading: FDA’s Nutrition Facts label changes and how nutrition labels can be misleading.

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