The Zarbee’s melatonin lawsuit is a proposed class action alleging that Zarbee’s children’s melatonin gummies contained far more melatonin than their labels stated, in some cases more than double the advertised 1 mg dose. Filed in California federal court in August 2022, the case survived Zarbee’s motion to dismiss in January 2023 and is continuing with additional plaintiffs. No settlement has been announced.
What the Lawsuit Alleges
California consumer Krystal Lopez sued Zarbee’s, Inc. on August 2, 2022 in the U.S. District Court for the Northern District of California. The case, Lopez v. Zarbee’s Inc. (No. 5:22-cv-04465), claims the company systematically misrepresented how much melatonin was actually in its Children’s Sleep with Melatonin Gummies.1ClassAction.org. Bottles of Zarbee’s Children’s Melatonin Are Overdosed, Class Action Alleges
A university lab used liquid chromatography-mass spectrometry to test multiple bottles labeled as containing 1 mg of melatonin per gummy. According to the complaint, actual melatonin content ranged from 128% to 216% of the labeled amount. Lopez’s own bottle averaged 2.13 mg per gummy. A second bottle from a different lot averaged 1.29 mg.2Business Insider. Melatonin Overdose Warning: Gummies Contain Double Advertised Amount, Lawsuit Says
The complaint alleges Zarbee’s tests its melatonin content before distribution and therefore knew its labels were “false and misleading.” Lopez brought claims under the California Unfair Competition Law, the California False Advertising Law, breach of express warranty, negligent and intentional misrepresentation, and unjust enrichment.3ClassAction.org. Lopez v. Zarbee’s Inc., Complaint
How Zarbee’s Responded
Represented by Lafayette & Kumagai LLP and Patterson Belknap Webb & Tyler LLP, Zarbee’s moved to dismiss. Its central argument was that the company “did nothing wrong” because the FDA sets no upper limit on how much a supplement’s active ingredient can exceed the amount declared on the label.4Law Street Media. Plaintiffs Receive Favorable Ruling in Melatonin Supplement Mislabeling Suit
Zarbee’s also argued that the state-law claims were preempted by federal regulation because Lopez had not followed the FDA’s own testing protocols, that she lacked standing to represent consumers in other states, and that she could not claim injury from products she had not personally purchased.4Law Street Media. Plaintiffs Receive Favorable Ruling in Melatonin Supplement Mislabeling Suit
The January 2023 Ruling
U.S. District Judge Charles Breyer largely denied the motion. The court rejected Zarbee’s preemption argument and found that the consumer-protection claims were adequately pleaded. It also rejected the arguments that Lopez failed to state a claim or lacked standing to sue.5Bloomberg Law. Olly, Zarbee’s Melatonin Mislabeling Suits Withstand Dismissal
Zarbee’s did win one point. The judge narrowed the case to the specific gummy product Lopez actually bought, dismissing claims tied to other Zarbee’s melatonin products she had not purchased. Lopez was given leave to amend.4Law Street Media. Plaintiffs Receive Favorable Ruling in Melatonin Supplement Mislabeling Suit
Where the Case Stands Now
On May 5, 2023, a second amended complaint was filed in Lopez v. Zarbee’s adding two more plaintiffs, Kemberly Phillips-Jones and Damany Browne. Phillips-Jones had briefly filed her own parallel case in the Northern District of Illinois in October 2022, alleging her bottle tested at 222% of the labeled melatonin amount, but voluntarily dismissed it in November 2022 before joining the California action.6ClassAction.org. Phillips-Jones v. Zarbee’s Inc., Complaint7CourtListener. Lopez v. Zarbee’s Inc., Docket
No settlement has been announced or approved. The case continues in the Northern District of California with the expanded plaintiff group.7CourtListener. Lopez v. Zarbee’s Inc., Docket Zarbee’s was acquired by Johnson & Johnson’s consumer health division in 2018 and is now part of Kenvue, the consumer health company J&J spun off in 2023.8Johnson & Johnson. Johnson & Johnson Consumer Inc. Announces Agreement to Acquire Zarbee’s Inc.
Why the Dosage Numbers Matter for Parents
Melatonin is regulated in the United States as a dietary supplement, not a drug. The FDA does not test or approve it for safety, effectiveness, or label accuracy before it reaches store shelves, and it is not required to verify that the amount of an active ingredient matches the label.9CNN. Melatonin Safety Standards10National Library of Medicine. Melatonin Use in Children
The overdosing allegations against Zarbee’s carry particular weight because the products are marketed for children. A 2022 CDC study found that U.S. poison control centers received 260,435 reports of pediatric melatonin ingestions between 2012 and 2021, a 530% increase over the decade. Of those, 4,097 children were hospitalized, 287 required intensive care, five needed mechanical ventilation, and two died. The vast majority of cases involved children under five who got into supplements unintentionally.11CDC. Pediatric Melatonin Ingestions — United States, 2012–2021
Common symptoms of melatonin overconsumption in children include sleepiness, nausea, vomiting, stomach pain, headache, and dizziness.12Poison Help. Study Shows a 530 Percent Increase in Melatonin Overdose in Children More serious cases can involve changes in blood pressure and elevated body temperature.13UK HealthCare. Melatonin Overdoses in Children Are on the Rise Federal regulations do not currently require child-resistant packaging for melatonin products, though the Council for Responsible Nutrition has asked manufacturers to voluntarily adopt it.9CNN. Melatonin Safety Standards