Blog By: McKinley Pitts
Despite toxic heavy metals found present at substantial levels in both organic and conventional baby food products, there is no industry-wide federal standard or warning to parents on the issue.[i] In April 2021, the U.S. Food and Drug Administration established its Closer to Zero action plan in response to pressure from Congress and various interest groups.[ii] This plan aimed to reduce environmental contaminant exposure by implementing guidelines for toxic metals in foods consumed by babies and young children.[iii] The FDA’s goal was to provide action levels and guidance on four major environmental contaminants: arsenic, lead, cadmium, and mercury, within a one-to-two-year timeframe.[iv] However, rather than proposing finalized action levels or creating binding regulations for manufacturers, FDA action under Closer to Zero has been limited to a mere draft guidance proposal in April 2022.[v] In March of this year, the FDA updated its website, quietly removing any proposed deadlines for setting limit guidelines and eliminating existing timelines for further action under Closer to Zero.[vi]
Arsenic, lead, cadmium, and mercury are classified as heavy metals that, in significant amounts, may build up in biological systems and become toxic, posing significant long-term and irreversible health hazards.[vii] Oral consumption may adversely affect the cardiovascular, neurological, reproductive, and musculoskeletal systems, to name a few.[viii] Low levels of exposure in infants and children up to six years old have been linked to behavior and learning problems, lowered IQ, hyperactivity, slowed growth, hearing problems, and anemia.[ix] Babies are particularly sensitive to heavy metal exposure since their bodies are rapidly developing, they have a less varied diet, and they eat more food relative to their body weight.[x]
A Consumer Reports study from June 2023 revealed that heavy metals remain present in many popular baby food brands at unacceptably high levels despite pressure on industries and manufacturers to create safer products.[xi] Reducing heavy metals in baby foods can be challenging because these toxins already exist within foods prior to processing, either by naturally occurring means or, most often, through widespread use of industrial pollutants, fertilizers, and pesticides.[xii] Agriculture experts suggest that various techniques can and should be implemented by farmers in the industry to reduce toxin levels in crops and soil.[xiii] Researchers are continuing to develop potential solutions through new technology.[xiv] Many baby food brands currently involved in litigation on this issue argue that the metals in question occur naturally in soil and water, only presenting themselves in trace amounts.[xv] But, without thorough limit regulations in place, how do we know what constitutes a “trace amount?”
Although the FDA imposes broad mandates to ensure safe food products, there are few actual, enforceable limits in place for specific toxins. The FDA’s proposed “action limits” under Closer to Zero operate as nothing more than mere guidelines for manufacturers to follow voluntarily; not legally enforceable.[xvi] Recent government action has demonstrated a policy priority for resolution through stricter food safety initiatives. In March 2021, the Baby Food Safety Act was introduced to the 117th Congress but never received a hearing or vote.[xvii] The Act, which aimed to set limits on specified toxin amounts and impose stringent regulations for manufacturers, would have bypassed the FDA’s process of establishing action levels under Closer to Zero.[xviii] Still, it has yet to pass over two years later.[xix] Additionally, the proposed fiscal 2024 budget included a funding boost of $87 million for food safety initiatives, including the Closer to Zero plan.[xx] This funding exceeds the fiscal 2023 enacted level by $64 million and could provide adequate means and support for more aggressive FDA action moving forward.[xxi]
Multiple class action lawsuits regarding failure to disclose heavy metal presence in baby food products have been dismissed or put on pause due to pending further regulatory activity from the FDA.[xxii] Until the agency makes serious progress under Closer to Zero and prioritizes strict regulation and industry compliance, courts cannot determine whether various baby food products are mislabeled.[xxiii]
Many food safety advocates argue that the FDA isn’t “serious about continuous improvement” and has “missed opportunities to force the industry to more diligently work to lower early childhood exposure to toxic heavy metals.”[xxiv] The FDA should take more initiative through its capacity and authority to strengthen and expand its guidance, and it must be held accountable for providing goal deadlines for the public.[xxv] FDA resources should be expended toward an increased focus on ensuring industry compliance with these stricter limits once they are established.[xxvi] Taken together, scientific research, expert opinions, government efforts and funding, and delayed class action litigation all point toward and depend upon further regulatory action to resolve this critical and preventable health crisis. Moving forward, the FDA must make considerable efforts to protect current and future generations of children from the potential detrimental harms of extensive heavy metal exposure from baby food products.
[i] U.S. House of Rep. Subcomm. on Econ. and Consumer Pol’y, Comm. on Oversight and Reform, H.R., Baby Foods Are Tainted with Dangerous Levels of Arsenic, Lead, Cadmium, and Mercury (2021), https://oversightdemocrats.house.gov/sites/democrats.oversight.house.gov/files/2021-02-04%20ECP%20Baby%20Food%20Staff%20Report.pdf [https://perma.cc/99F4-2M5T].
[ii] Celine Castronuovo et al., Deadlines for Baby Food Metal Policy Vanish as Lawmakers Object, Bloomberg L. (Mar. 23, 2023, 5:00 AM), https://www.bloomberglaw.com/product/blaw/bloomberglawnews/environment-and-energy/BNA%200000018704aed9b5a5d735ee598d0001?bna_news_filter=environment-and-energy&bc=W1siU2VhcmNoICYgQnJvd3NlIiwiaHR0cHM6Ly93d3cuYmxvb21iZXJnbGF3LmNvbS9wcm9kdWN0L2JsYXcvc2VhcmNoL3Jlc3VsdHMvN2UyNzYxZmYwMTA3Y2E2MDRkMjhkZmRjZmFjOTg2NzQiXV0--7a89d0db043222bbb1d13c426c244a2571e15807&criteria_id=7e2761ff0107ca604d28dfdcfac98674 [https://perma.cc/CC4D-T4G5].
[iii] Id.
[iv] Id.; Closer to Zero: Reducing Childhood Exposure to Contaminants from Foods, Food and Drug Admin. (last updated Aug. 10, 2023), https://www.fda.gov/food/environmental-contaminants-food/closer-zero-reducing-childhood-exposure-contaminants-foods [https://perma.cc/69TF-X6D7].
[v] Gary Harki, Baby Foods With Toxic Metals Stay on US Market While FDA Dithers, Bloomberg L. (Jan. 5, 2023, 5:00 AM), https://www.bloomberglaw.com/product/blaw/bloomberglawnews/bloomberg-law-news/BNA%20000001857e1fd921abc57e3f1a960000?bna_news_filter=bloomberg-law-news&bc=W1siU2VhcmNoICYgQnJvd3NlIiwiaHR0cHM6Ly93d3cuYmxvb21iZXJnbGF3LmNvbS9wcm9kdWN0L2JsYXcvc2VhcmNoL3Jlc3VsdHMvYjY0ODU2NzVmMjdhODE4ZjM3NDQ4NTk1MDljNWYzZWQiXV0--a82d8f50ad63d74f13edbca79f9a7082df23a73e&criteria_id=b6485675f27a818f3744859509c5f3ed [https://perma.cc/JA2E-ZGVN].
[vi] Castronuovo et al., supra note ii.
[vii] Toxic Metals Overview, Occupational Safety and Health Admin., https://www.osha.gov/toxic-metals (last visited Oct. 1, 2023) [https://perma.cc/9KQM-DBDH].
[viii] Jill Rosenthal et al., 5 Actions the FDA Can Take to Reduce Heavy Metal Toxins in Baby Food, Ctr. for Am. Progress (Apr. 4, 2023), https://www.americanprogress.org/article/5-actions-the-fda-can-take-to-reduce-heavy-metal-toxins-in-baby-food/ [https://perma.cc/U4C3-VTFF].
[ix] Learn About Lead, U.S. Env’t Prot. Agency, https://www.epa.gov/lead/learn-about-lead (last visited Oct. 1, 2023) [https://perma.cc/YJ9P-JLGE].
[x] Colleen Wood, The Daunting Task of Cutting Heavy Metals from Baby Food, ASBMB Today (June 25, 2023), https://www.asbmb.org/asbmb-today/science/062523/the-daunting-task-of-cutting-heavy-metals-from-bab [https://perma.cc/UJH9-Q2AZ].
[xi] Nyah Phengsitthy, Heavy Metals Still Problem for Baby Food Brands Five Years Later, Bloomberg L. (June 27, 2023, 6:00 AM), https://www.bloomberglaw.com/product/blaw/bloomberglawnews/environment-and-energy/X2R27BOO000000?bc=W1siU2VhcmNoICYgQnJvd3NlIiwiaHR0cHM6Ly93d3cuYmxvb21iZXJnbGF3LmNvbS9wcm9kdWN0L2JsYXcvc2VhcmNoL3Jlc3VsdHMvN2UyNzYxZmYwMTA3Y2E2MDRkMjhkZmRjZmFjOTg2NzQiXV0--7a89d0db043222bbb1d13c426c244a2571e15807&bna_news_filter=environment-and-energy&criteria_id=7e2761ff0107ca604d28dfdcfac98674 [https://perma.cc/4EFA-CFAR].
[xii] Harki, supra note v.
[xiii] Wood, supra note x.
[xiv] Id.
[xv] Jenna Greene, Tainted Baby Food Claims Become Uphill Litigation Battle, reuters (Sept. 11, 2023, 6:41 PM), https://www.reuters.com/legal/litigation/column-tainted-baby-food-claims-become-uphill-litigation-battle-2023-09-11/ [https://perma.cc/U7LN-DQYX].
[xvi] Christina Jewett, How Do Heavy Metals like Lead Get in Baby Food, NY Times (Jan. 26, 2023), https://www.nytimes.com/2023/01/26/health/baby-food-metals-lead.html [https://perma.cc/8HER-5Z3X].
[xvii] Baby Food Safety Act, H.R. Res. 2229, 117th Cong. (2021), https://www.congress.gov/bill/117th-congress/house-bill/2229 [https://perma.cc/5UAH-ANL3].
[xviii] Harki, supra note v.
[xix] Id.
[xx] U.S. dep’t of Health & Hum. Serv., Fiscal Year 2024 Budget in Brief (2023).
[xxi] Id.; Celine Castronuovo, Baby Food, Formula Safety Get FDA Focus in Biden Budget Request (1), Bloomberg L. (Mar. 9, 2023, 2:22 PM), https://www.bloomberglaw.com/product/blaw/bloomberglawnews/environment-and-energy/BNA%2000000186bd0fde4da18efd2f648b0001?bna_news_filter=environment-and-energy&bc=W1siU2VhcmNoICYgQnJvd3NlIiwiaHR0cHM6Ly93d3cuYmxvb21iZXJnbGF3LmNvbS9wcm9kdWN0L2JsYXcvc2VhcmNoL3Jlc3VsdHMvN2UyNzYxZmYwMTA3Y2E2MDRkMjhkZmRjZmFjOTg2NzQiXV0--7a89d0db043222bbb1d13c426c244a2571e15807&criteria_id=7e2761ff0107ca604d28dfdcfac98674 [https://perma.cc/8MQX-63ER].
[xxii] Julie Steinberg, Kroger, Others Exit Suit Over Heavy Metals in Teething Wafers, Bloomberg L. (Sept. 11, 2023, 3:22 PM), https://www.bloomberglaw.com/product/blaw/bloomberglawnews/bloomberg-law-news/XFMBUK0S000000?bc=W1siU2VhcmNoICYgQnJvd3NlIiwiaHR0cHM6Ly93d3cuYmxvb21iZXJnbGF3LmNvbS9wcm9kdWN0L2JsYXcvc2VhcmNoL3Jlc3VsdHMvYjY0ODU2NzVmMjdhODE4ZjM3NDQ4NTk1MDljNWYzZWQiXV0--a82d8f50ad63d74f13edbca79f9a7082df23a73e&bna_news_filter=bloomberg-law-news&criteria_id=b6485675f27a818f3744859509c5f3ed [https://perma.cc/B4UR-V9DW].
[xxiii] Julie Steinberg, Beech-Nut Says Baby Food Heavy Metal Suits Properly Dismissed, Bloomberg L. (Sept. 5, 2023, 11:46 AM), https://www.bloomberglaw.com/product/blaw/bloomberglawnews/bloomberg-law-news/XBQ76588000000?bc=W1siU2VhcmNoICYgQnJvd3NlIiwiaHR0cHM6Ly93d3cuYmxvb21iZXJnbGF3LmNvbS9wcm9kdWN0L2JsYXcvc2VhcmNoL3Jlc3VsdHMvYjY0ODU2NzVmMjdhODE4ZjM3NDQ4NTk1MDljNWYzZWQiXV0--a82d8f50ad63d74f13edbca79f9a7082df23a73e&bna_news_filter=bloomberg-law-news&criteria_id=b6485675f27a818f3744859509c5f3ed [https://perma.cc/3PA3-9JLF].
[xxiv] Celine Castronuovo, Children Still at Risk With FDA’s Arsenic Limit for Apple Juice, Bloomberg L. (June 5, 2023, 2:23 PM), https://www.bloomberglaw.com/product/blaw/bloomberglawnews/bloomberg-law-news/X53OK6GK000000?bc=W1siU2VhcmNoICYgQnJvd3NlIiwiaHR0cHM6Ly93d3cuYmxvb21iZXJnbGF3LmNvbS9wcm9kdWN0L2JsYXcvc2VhcmNoL3Jlc3VsdHMvMTNkMDNhNDczNTFjZTNmMjAzNzY2ZmY0MDNjY2U4M2IiXV0--42a7f8c705826cab83db3b7b9a9ea8e74462cc1f&bna_news_filter=bloomberg-law-news&criteria_id=13d03a47351ce3f203766ff403cce83b&search32=D3pq4DlWA1BCS1_QTytDng%3D%3D27XVhqbWLzp2YItVk__Nk5M7RPD6fuwtT0VxoMhM1lLdNw2mUJBKDwSQ9LrcUL53FVjJZfOnj_3m-re77N4FUEKqP8Kf-0BWmjXumHXOOKY670W5A-97meZaVjsD9vU7YZOBGFtgUtOTTb7ttvTh3Q%3D%3D [https://perma.cc/5SJX-4TUK].
[xxv] Castronuovo et al., supra note ii.
[xxvi] Rosenthal et al., supra note viii.