California Attorney General Xavier Bacerra has filed Proposition 65 enforcement actions against two makers of baby formula whose products that allegedly contain elevated levels of lead in violation of the Proposition 65 Safe Harbor Level, and the provisional Total Tolerable Intake level for lead of 6 micrograms per day applicable to children 6 years of age and younger, as mandated by the U.S. Food and Drug Administration.
The baby formula makers, Nutraceutical Corporation of Park City, Utah and Graceleigh, Inc. dba Sammy’s Milk of Newport Beach, CA, are alleged to have violated California’s Proposition 65 and related California’s consumer protection laws according to the Attorney General’s complaint.
The Attorney General alleges that , made by Graceleigh, and Peaceful Planet Toddler Supreme Formula, a rice formula made by Nutraceutical. The Attorney General’s complaint, filed in Alameda County, CA, alleges that the levels of lead in both products result in exposures above the Provisional Total Tolerable Intake level for lead of 6 micrograms per day (“ug/day”) applicable to children 6 years of age and younger, as set by the U.S. Food and Drug Administration. A statement issued by the AG asserts that State testing showed that the products actually cause lead exposure between 13 and 15 times the maximum allowable dose under California law. The AG’s office also announced that both companies have voluntarily agreed to stop selling the products at issue in California.
Nutraceutical Corporation said it intends to vigorously contest the AG’s suit, which it said lacks merit. The company reports that its Toddler Supreme protein supplement’s ingredient levels comply with applicable laws and regulations and don’t pose any safety risk to consumers, based on an opinion from a former FDA toxicologist.
For the products to pose no significant risk the products must not exceed two Safe Harbor levels adopted for lead.
The reason that there are two distinct Safe Harbor Levels for lead under Proposition 65, is that lead was listed twice, first as a reproductive toxicant in February 1987 and later as a carcinogen in October 1992. It is one of a handful of substances that have the distinction of causing cancer and reproductive toxicity.
The Safe Harbor oral exposure level for lead as a carcinogen is 15 micrograms per day (15/ug/day).
But the Maximum Allowable Dose Level (MADL) Safe Harbor level for lead as a reproductive toxicant is a mere 0.5 micrograms per day–making it the strictest lead standard in the world.
The Attorney General’s complaint also alleges that the excessive levels of lead, contained in the baby formula products render them adulterated under the California Sherman Food, Drug and Cosmetic laws and, which then triggers violations of the unlawful prong of CA Bus. & Prof. Code section 17200 and The complaint also alleges that false and misleading statements made by the the two companies are alleged to also violate CA Bus. & Prof. Code sections 17200 and 17500.
While Nutraceutical Corporation intends to vigorously contest the Attorney General’s lawsuit, bluster and swagger only goes so far. company’s sued by the Attorney General eventually settle. A company with big pockets and a very skillful attorney managed to prevail against the Attorney General once, and it has not been done since.