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Exploring the FDA Regulations on Lead in Food and Why Cinnamon is a Major Concern

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By: Bianca Ortalano, Senior Editor

Photo courtesy of Pixabay

You may have heard concerns about lead poisoning due to lead in water, in your household pipes, or even from bullets being lodged in the human body.1 However, the most common threat of lead poisoning might be right under your nose and within your kitchen. From baked goods and holiday festivities to applesauce and everyday cooking, cinnamon is quite the popular spice.2 As recently as October 2023, the FDA conducted an investigation after children were found to have elevated blood lead levels.3 This investigation revealed concerns about lead contamination in food, causing the FDA to issue a public health report.4 In response to this report, one company—WanaBana—began voluntarily recalling some of their products.5 WanaBana’s recall, and the FDA’s continuing lead testing, prompted other companies to enact their own voluntary recalls.6 On March 6, 2024, the U.S. Food and Drug Administration (“FDA”) sent a letter to cinnamon manufacturers, processors, distributors, and facility operators informing them of the FDA’s findings from lead concentration testing.7 Within this letter, the FDA recommended recalls of ground cinnamon from several brands whose products tested at over 2.0 parts per million (“ppm”).8 In addition to cinnamon products made in the United States, this threat of lead contamination has been so concerning that it has compelled the FDA to reject certain imported cinnamon products.9

So how does the FDA decide what level of lead is worth a recall? The brands and products listed in the FDA’s March 6 letter contain lead levels measuring between 2.03 to 3.4 ppm, which the FDA says may be unsafe for prolonged use.10 Symptoms of lead poisoning can differ based on age and exposure but can include developmental delays, abdominal pain, seizures, high blood pressure, and may even cause miscarriages during pregnancy.11 With the dangers of lead, one might think that any level of contamination is unacceptable and should be recalled. However, solving the problem of contamination is not as simple as keeping manufacturing facilities clean.12 Lead can occur naturally from the environment and “[t]race amounts can [still] infiltrate the food supply in various ways.”13 Keeping the unavoidable contamination in mind, the FDA has created a “Closer to Zero” initiative.14 This program works to reduce the level of various contaminants—arsenic, lead, mercury, and more—without limiting access to food.15 Closer to Zero also focuses its mission on food commonly eaten by babies and children, highlighting the importance of cinnamon recalls given its popularity in apple sauce and other fruit purees.16

Fraudulent and obscure production or economically motivated adulteration can also add to the frequency of lead contamination in food.17 There are several reasons why manufacturers add other materials to spices: to improve product color and the perception of quality, to increase product weight and cut costs, and more.18 Despite the existence of certain cinnamon manufacturers that add lead solely for aesthetic purposes, the FDA does not have any regulations “that authorize lead for use as a color additive or food additive.”19 These manufacturing techniques directly oppose current regulations.20 Cinnamon and other spices are not the first group of food products to be purposefully contaminated, and they are certainly not the last.21 However, not every brand is aware that they are engaging in fraudulent behavior.22 Product suppliers can employ these techniques before providing their products to other companies throughout the supply chain.23 This very deception resulted in one brand, Austrofood, having to recall their applesauce pouches which contained high levels of lead after their supplier sold them cinnamon containing lead chromate.24 Although certain brands may not be at fault for contaminating the cinnamon themselves, this issue begs the question of whether current food safety regulations are enough.

To determine whether the amount of lead in food is a potential health concern the FDA “considers the toxicity of lead and potential exposure based on” the amount of lead, as well as “estimated consumption” and “risks specific to vulnerable subpopulations.”25 The FDA is also researching methods to test for smaller and smaller amounts of contaminants.26 Utilizing testing methods to measure “concentrations as low as 3 parts per billion (ppb)”—as compared to the current parts per million testing—could open the door to new regulations.27 Since the FDA began attempting to eliminate lead in food in the 1970s, they claim that children ages one to three years old have had their dietary exposure to lead decreased by 97% as of 2016.28 In general, “food manufacturers have a responsibility to significantly minimize or prevent chemical hazards when needed.”29 In addition to lead-specific regulations, the FDA also performs routine inspections at facilities within the food supply chain.30 However, in 2020, during the COVID-19 pandemic, “the FDA announced that it would temporarily suspend routine domestic facility inspections.”31 According to food safety expert Bill Marler, this suspension would not have a significant impact on food safety as the inspections typically occur only every five to seven years.32 Thus, while consumers may see this suspension as absurd given the importance of health and safety, these inspections may not have actually been as effective as the public believed them to be; emphasizing the need for greater transparency in food safety regulations.33

Apart from the production and manufacturing side of food safety, the FDA often addresses consumers directly through press announcements.34 The purpose of these announcements and other media interactions is to inform and engage with the public about relevant health and safety issues that fall within the FDA’s jurisdiction.35 For example, searching “lead in cinnamon” on the press announcements page reveals numerous articles on the matter.36 Consumers can easily find information regarding FDA requests for recalls or updated statements on the status of recalls by using this search function.37 Due to the nature of these press announcements, the information is given in relatively simple and easy-to-understand language with links to other resources so that the public can understand each element of the issues at hand.38 While some specific information may be inaccessible to the public regarding current investigations, the FDA does provide brand names and product details and advises consumers of the steps the agency is taking to treat the issue.39 Often the general public receives important health and food information from news sources, instead of getting it directly from governmental agencies, because the public tends to hold greater trust in independent news sources.40 However, in the current age of media and technology, more distrust of the news is building.41 Whether you rely more on news or direct government announcements, drawing upon both resources can give consumers the best chance of staying informed and avoiding harmful products.42

Although regulations are imperative in keeping the general public safe, “by definition, regulation reduces choices and curtails autonomy. There may be good reasons for doing so, but those reasons need to be placed in the context of what is lost by the consumer.”43 Therefore, in publishing information directly to consumers, the FDA is not only informing them of important health information, it is also restoring some sense of autonomy and motivating the public to look further into the reasoning behind these regulations. Staying informed pushes food manufacturers and government regulators to raise their standards.44 And despite an inability to survey the public on each proposed idea, there are avenues for consumers to make their thoughts on food safety known.45 Filing petitions, making conscious shopping decisions, and informing those around you can have an impact.46 In response to a boom in online food ordering and delivery in 2021 due to the COVID-19 pandemic, the FDA reevaluated its regulatory framework for e-commerce models, confirming that consumer shopping behaviors are impactful.47 Consumers can decide whether the regulations are enough, and if they do not meet the standards that the public expects, a change may be necessary. The FDA may not be able to totally eliminate lead in cinnamon but the sheer abundance and popularity of cinnamon products urges food regulators to do everything possible to ensure the health and safety of all.48

  1. Mayo Clinic Staff, Lead poisoning, Mayo Clinic. (Jan. 21, 2022), https://www.mayoclinic.org/diseases-conditions/lead-poisoning/symptoms-causes/syc-20354717; Gerstner Garcés JB & Manotas Artuz RI, Lead poisoning due to bullets lodged in the human body, National Library of Medicine. (Sept. 30, 2012), https://pmc.ncbi.nlm.nih.gov/articles/PMC4001953/#:~:text=Lead%20intoxication%20(saturnism)%20caused%20by,to%20contact%20with%20synovial%20fluid.; Minnesota Department of Health, Let it run … and get the lead out!, Mn Department of Health(Feb. 27, 2024), https://www.health.state.mn.us/communities/environment/water/factsheet/letitrun_english.html#:~:text=Lead%20can%20cause%20serious%20health,all%20parts%20of%20your%20body. 
    ↩︎
  2. McCormick & Company, Incorporated, Cinnamon-Lovers Everywhere Have Reason to Celebrate as First-Ever National Cinnamon Day is Declared for November 1st to Officially Launch the Holidays, PR Newswire. (Oct. 30, 2019, 15:44 ET), https://www.prnewswire.com/news-releases/cinnamon-lovers-everywhere-have-reason-to-celebrate-as-first-ever-national-cinnamon-day-is-declared-for-november-1st-to-officially-launch-the-holidays-300948546.html 
    ↩︎
  3. U.S. Food and Drug Administration, Post-Incident Response Activities: Elevated Lead and Chromium Levels in Cinnamon Applesauce Pouches, U.S. Food and Drug Administration. (Nov. 4, 2024), https://www.fda.gov/food/outbreaks-foodborne-illness/post-incident-response-activities-elevated-lead-and-chromium-levels-cinnamon-applesauce-pouches ↩︎
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  5.  Id. ↩︎
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  7. U.S. Food and Drug Administration, Post-Incident Response Activities: Letter to Cinnamon Manufacturers, Processors, Distributors, and Facility Operators Recommending Recall of Certain Ground Cinnamon Products, U.S. Food and Drug Administration. (Mar. 6, 2024), https://www.fda.gov/media/176824/download  ↩︎
  8. Id.  ↩︎
  9. Id.  ↩︎
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  12. U.S. Food and Drug Administration, Closer to Zero: Reducing Childhood Exposure to Contaminants from Foods, U.S. Food and Drug Administration. (Sept. 16, 2024), https://www.fda.gov/food/environmental-contaminants-food/closer-zero-reducing-childhood-exposure-contaminants-foods ↩︎
  13.  Id.; Berkeley Lovelace Jr., Why there still aren’t limits on lead in baby food, NBC News. (Dec. 13, 2023, 6:04 PM EST), https://www.nbcnews.com/health/kids-health/still-arent-limits-lead-baby-food-rcna129013 ↩︎
  14. U.S. Food and Drug Administration, Closer to Zero: Reducing Childhood Exposure to Contaminants from Foods, U.S. Food and Drug Administration. (Sept. 16, 2024), https://www.fda.gov/food/environmental-contaminants-food/closer-zero-reducing-childhood-exposure-contaminants-foods ↩︎
  15. Id.  ↩︎
  16. Id.; U.S. Food and Drug Administration, FDA Issues Warning Letter to Austrofood and Continues Robust Activities to Ensure Safety of Cinnamon Products Sold in U.S., U.S. Food and Drug Administration. (Aug. 15, 2024), https://www.fda.gov/news-events/press-announcements/fda-issues-warning-letter-austrofood-and-continues-robust-activities-ensure-safety-cinnamon-products ↩︎
  17. Bill Chappell, Lead in cinnamon: Where do things stand, 1 year after a scary recall?, NPR. (Oct. 25, 2024, 6:00 AM ET), https://www.npr.org/2024/10/24/nx-s1-5119336/cinnamon-lead-fda-recall-what-we-know#:~:text=In%20last%20fall’s%20recall%2C%20%22lead,its%20ubiquity%20in%20the%20environment.; U.S. Food and Drug Administration, Economically Motivated Adulteration (Food Fraud), U.S. Food and Drug Administration. (Apr. 18, 2024), https://www.fda.gov/food/compliance-enforcement-food/economically-motivated-adulteration-food-fraud ↩︎
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  19. U.S. Food and Drug Administration, Lead in Food and Foodwares, U.S. Food and Drug Administration. (Aug. 16, 2024), https://www.fda.gov/food/environmental-contaminants-food/lead-food-and-foodwares ↩︎
  20. Id.  ↩︎
  21. U.S. Food and Drug Administration, Economically Motivated Adulteration (Food Fraud), U.S. Food and Drug Administration. (Apr. 18, 2024), https://www.fda.gov/food/compliance-enforcement-food/economically-motivated-adulteration-food-fraud ↩︎
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  23. Bill Chappell, Lead in cinnamon: Where do things stand, 1 year after a scary recall?, NPR. (Oct. 25, 2024, 6:00 AM ET), https://www.npr.org/2024/10/24/nx-s1-5119336/cinnamon-lead-fda-recall-what-we-know#:~:text=In%20last%20fall’s%20recall%2C%20%22lead,its%20ubiquity%20in%20the%20environment. ↩︎
  24. U.S. Food and Drug Administration, FDA Issues Warning Letter to Austrofood and Continues Robust Activities to Ensure Safety of Cinnamon Products Sold in U.S., U.S. Food and Drug Administration. (Aug. 15, 2024), https://www.fda.gov/news-events/press-announcements/fda-issues-warning-letter-austrofood-and-continues-robust-activities-ensure-safety-cinnamon-products ↩︎
  25. U.S. Food and Drug Administration, Lead in Food and Foodwares, U.S. Food and Drug Administration. (Aug. 16, 2024), https://www.fda.gov/food/environmental-contaminants-food/lead-food-and-foodwares ↩︎
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  27. Id. ↩︎
  28.  U.S. Food and Drug Administration, Closer to Zero: Reducing Childhood Exposure to Contaminants from Foods, U.S. Food and Drug Administration. (Sept. 16, 2024), https://www.fda.gov/media/147324/download ↩︎
  29. U.S. Food and Drug Administration, Lead in Food and Foodwares, U.S. Food and Drug Administration. (Aug. 16, 2024), https://www.fda.gov/food/environmental-contaminants-food/lead-food-and-foodwares ↩︎
  30. U.S. Food and Drug Administration, Inspections to Protect the Food Supply, U.S. Food and Drug Administration. (Mar. 5, 2024), https://www.fda.gov/food/compliance-enforcement-food/inspections-protect-food-supply#:~:text=Inspection%20Types,-The%20FDA%20and&text=Routine%20inspections%20of%20facilities%20and,non%2Dhigh%2Drisk%20facilities. ↩︎
  31. Gosia Wozniacka, Critical Food and Farm Rules Have Been Rolled Back Amid Pandemic, Civil Eats. (Apr. 14, 2020), https://civileats.com/2020/04/14/critical-food-and-farm-rules-have-been-rolled-back-amid-pandemic/ ↩︎
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