Tag: proposition 65

California AG Leads Attack on Lead in Infant Formula

Fresh off a victory in the CA primary, California Attorney General Xavier Bacerra filed suit on June 7, 2018 against Nutraceutical Corporation of Park City, Utah and Graceleigh, Inc. dba Sammy’s Milk of Newport Beach, CA, alleging violations of California’s Proposition 65 and California’s consumer protection laws.

At issue are Sammy’s Milk Free-Range Goat Milk Toddler Formula, made by Graceleigh, and Peaceful Planet Toddler Supreme Formula, a rice formula made by Nutraceutical. The 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 advised that both companies have voluntarily agreed to stop selling the products at issue in California.

Prop 65 Claims

Lead was placed on the Prop 65 list on two occasions: on February 27, 1987 for reproductive toxicity and on October 1, 1992 for cancer.

Nutraceutical said it intends to vigorously contest the suit, which it said lacks merit. The company has reported 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. An issue will be if the levels meet the safe harbor provisions for lead, which would preclude the requirements for a Prop 65 warning. Prop 65 safe harbors do not always align with FDA standards.  The no significant risk level (“safe harbor”) for a cancer warning regarding lead is 15 ug/day (oral exposure). The maximum allowable dose level (“safe harbor”) for a reproductive toxicity warning regarding lead is 0.5 ug/day.

Claims Under CA Consumer Protection Laws

The complaint further alleges that due to the excess levels of lead, the products are adulterated within the meaning of the California Sherman Food, Drug and Cosmetic laws and therefore violates the unlawful prong of CA Bus. & Prof. Code section 17200. The false and misleading statements  of the two companies are alleged to also violate  CA Bus. & Prof. Code sections 17200 and 17500 in the following ways:

  • With respect to Graceleigh, by asserting that its ingredients in Sammy’s milk are “selected for purity” and provide “clean nutrition.”
  • With respect to Nutraceutical, by asserting that its Peaceful Planet product is “CLEAN” and “PURE.”

The State has requested that the court award both injunctive relief and civil penalties (Prop 65 statute calls for $2500 per violation).

We will continue to follow this case and other actions in California related to the continued assault on lead contamination of consumer and children’s products.

 

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California Proposition 65: Beep Beep, BPA Labeling

California proposition 65California proposes to amend Prop 65 warning requirements for BPA in canned and bottled foods and beverages.

  • In May 2015, California’s Office of Environmental Health Hazard Assessment (OEHHA) added bisphenol A (BPA) to the California proposition 65 list as a reproductive toxicant. On April 18, 2016, OEHHA implemented an emergency regulation for BPA, providing a safe harbor warning strategy to address exposures to this chemical from packaged foods and beverages sold at retail.  The emergency rulemaking allowed the use of point-of-sale (POS) signage to indicate exposures from BPA present in cans, lids, and caps of packaged foods and beverages at retail stores until October 17, 2016.

  • On July 22, 2016, OEHHA issued a proposed rule that would permit POS signage for BPA until December 30, 2017. The proposed rule is substantially similar to the emergency regulations promulgated earlier this year.  However, there is a significant difference in the proposal for foods that: (1) are covered under the POS signage requirement (i.e., BPA present in the can coating, lid, or cap); and (2) do not bear an on-label BPA warning. The proposal would require manufacturers, producers, packagers, importers, or distributors of foods in BPA-containing packages to send OEHHA specific information about the products to post on the “lead agency website” (in addition to sending similar information to retailers).  The proposal focuses on BPA that is intentionally used in food packaging.  OEHHA does not want manufacturers sending in information for posting on the lead agency website where BPA is unintentionally present.

  • OEHHA anticipates that by December 30, 2017, manufacturers either will have eliminated BPA from product packaging, labeled their products with a BPA warning, or provided retailers with shelf tags and signs. The final compliance option produces some confusion, as OEHHA has stated that part of the rationale for the emergency rulemaking was to avoid there being hundreds of shelf tags on retail shelves.  A public hearing on the proposal is scheduled for September 12 and comments are due by September 26.

ARTICLE BY Food and Drug Law at Keller and Heckman of Keller and Heckman LLP

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