SANTA ANA, Calif. – The Orange County District Attorney's Office (OCDA), as part of the California Food, Drug, and Medical Device Task Force, comprised of 10 district attorneys' offices including Alameda, Marin, Monterey, Napa, Santa Clara, Santa Cruz, Shasta, Solano, and Sonoma Counties, along with the California Attorney General's Office, filed a civil lawsuit today against Graceleigh Inc. and Nutraceutical Corporation, accused of selling toddler formulas with dangerously elevated levels of lead.

The action was filed today in Alameda County Superior Court. The complaint states the defendants' toddler formula products, Sammy's Milk Free-Range Goat Milk Toddler Formula (Sammy's Milk) and Peaceful Planet Toddler Supreme (Peaceful Planet), are adulterated under California and Federal standards and their sale constitutes an unfair business practice under California's Unfair Competition Law (UCL) and violates Proposition 65, the state law requiring businesses to warn consumers about exposure to harmful chemicals.

The prosecutors charged in their complaint that testing of the products revealed these formulas exceed the U.S. Food and Drug Administration (FDA) provisional daily intake levels for children under six, and cause lead exposures between 13 and 15 times the maximum allowable dose level under California law. The lawsuit further states the defendants' representation of the products as “pure” and “clean” was false and misleading.

District Attorney Tony Rackauckas remarked, “When parents give their toddlers formula, they need to have peace of mind that the product they are giving them is safe and free of lead. In fact, these formulas were targeted for sale to the most health conscious parents. By continuing to protect food safety, we hope to keep our citizens, especially vulnerable children, safe.”

Background

Graceleigh Inc., doing business as Sammy's Milk, is a California corporation with its principal headquarters in Newport Beach. Under California's UCL and Proposition 65, the OCDA has the right to bring this consumer protection action against Graceleigh on behalf of the People of Orange County. Sammy's Milk was being sold online and in specialty markets in Orange County.

Nutraceutical is a Utah corporation with its principal headquarters in Park City, Utah. Under California's UCL and Proposition 65, the OCDA has the right to bring this consumer protection action against Nutraceutical on behalf of the People of Orange County. Peaceful Planet toddler formula was available for sale online through various retailers.

Unlawful, Unfair, and Fraudulent Business Practices

The OCDA intends to prove the following in the litigation: Peaceful Planet and Sammy's Milk toddler formulas are adulterated and should not be sold in California because they expose toddlers to lead amounts exceeding the FDA's Provisional Total Tolerable Intake Level for children. Sales of these two products therefore constitute an unfair business practice under California's UCL.

In addition, Proposition 65, approved by California voters in 1986, protects public health by requiring businesses to warn consumers if they expose them to toxic chemicals, including lead. The lawsuit states the two products cause exposures that exceed the threshold warning levels for lead under Proposition 65, and the companies failed to adequately warn consumers these products would expose their children to lead.

According to the U.S. Centers for Disease Control and Prevention and the U.S. Department of Health and Human Services, lead exposure can lead to learning disabilities, behavior problems, malformed bones, and slow growth; high levels of lead can cause seizures, comas, and death. Parents who believe their child may have been exposed to lead should consult with their pediatrician immediately.

Relief Sought by the OCDA

The OCDA is seeking to permanently enjoin Graceleigh Inc., maker of Sammy's Milk, and Nutraceutical, maker of Peaceful Planet, from continued unlawful, unfair, deceptive, and fraudulent business practices as it pertains to consumers and competitors. The OCDA is seeking civil penalties of up to $2,500 per violation under UCL. The Plaintiff is also seeking recovery of attorneys' fees, investigation costs, and any other equitable relief as deemed just.

A copy of the complaint in this casecan be found here.

Prosecutor: Senior Deputy District Attorney Tracy Hughes, Consumer Protection Unit

Orange County District Attorney / Case # RG18907841/ June 7, 2018