It’s Time: New Prop 65 Warnings are Required August 30, 2018

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In November 2017, we advised readers of Conkle, Kremer & Engel’s blog that products sold in California would become subject to new Proposition 65 warning requirements beginning August 30, 2018.  The new “Clear and Reasonable Warning Regulations” from California Office of Health Hazard Assessment (OEHHA) significantly changed warning requirements for affected products that are manufactured on or after August 30, 2018.  Among other changes, the new regulations affect the safe-harbor warning requirements that govern the language, text, and format of such warnings, and also impose downstream warning mandates through retail, online and catalog sales channels. Generally, some of the major changes that companies selling consumer products should be aware of include:

  • The “warning symbol” :  A graphic “warning symbol” is now required on consumer products, other than food products. The “warning symbol” must be printed in a size no smaller than the height of the bolded word “WARNING,” and should be in black and yellow, but can be in black and white if the sign, label, or shelf tag for the product is not printed using the color yellow. The entire warning must be in a type size no smaller than the largest type size used for other “consumer information” on the product, and in no case should be smaller than 6-point type.
  • Listing of a specific chemical:  Warnings must now specifically identify at least one listed ingredient chemical for each toxicological endpoint (cancer and reproductive toxicology) and include a link to OEHHA’s new website P65Warnings.ca.gov. Certain special categories of products, such as food and alcoholic beverages, have a specialized URL that must be used instead.
  • New warning language:  Warning language must now warn of an exposure to a chemical or chemicals from the product, rather than just warn that the product contains the chemical or chemical. For example, “ WARNING: This product can expose you to diethanolamine, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.”
  • Internet and catalog requirements:  For internet sales, warnings must be provided with a clearly marked hyperlink on the product display page, or otherwise prominently displayed to the purchaser before completion of the transaction. It will not be sufficient if the product sold on the internet bears the required label, but the internet point of purchase listing does not. For catalog sales, a warning must be provided in a manner that clearly associates it with the item being purchased.
  • Short-form warnings:  The regulations allow the use of certain abbreviated “short-form” warnings, which may omit the identity of any specific chemical, only if the warning is printed on the immediate container, box or wrapper of the consumer product or is affixed to the product.  For example, “ WARNING: Cancer – www.P65Warnings.ca.gov.”  If a short-form warning is used on the product, the same short-form warning may be used for internet and catalog sales.

The regulations seek to minimize the burden on retail sellers of consumer products, but there are some obligations affecting resellers. Manufacturers, producers, distributors, and other upstream businesses comply with warning requirements if they affix a clear and reasonable warning to the product, or provide written notice and warning materials to an authorized agent of a retailer, among other requirements.  Retailers who receive products with a Proposition 65 warning on the label, or who receive proper notice that a warning is required, are responsible for placement and maintenance of internet warnings for those products before selling to consumers in California.  Retailers should only be liable for Proposition 65 violations under limited circumstances, such as if they cover, obscure, or alter a product’s warning label, or if they receive notice and warning materials but fail to display a warning, including catalog and internet warnings preceding consumer sales into California.

The particular requirements for each specific product can vary, so manufacturers and resellers are well-advised to seek qualified counsel to review their circumstances before committing to potentially costly label and website changes that may not comply with the new requirements.  Conkle, Kremer & Engel attorneys stay up to date on important regulatory developments affecting their clients in the manufacturing and resale industries, and are ready to help clients navigate the changing regulatory landscape in California and elsewhere.

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October 2018 Update

H. Kim Sim of CK&E was interviewed and quoted extensively in ChemicalWatch about the difficulties manufacturers face in implementing the “very confusing and very complex” requirements of the new warning label requirements of Prop 65.  For example, as Kim said, “The requirement that manufacturers name at least one substance for which they are providing warning has proven particularly challenging. Determining which one to include ‘can be tricky for companies to decide’, she said. ‘Is one more scary to the public than another?'”

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WARNING: Are Your Products and Websites Ready for the New Prop 65 Requirements?

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California’s Office of Health Hazard Assessment (OEHHA) has issued new Proposition 65 Warning Regulations that will go into effect on August 30, 2018. It is important for companies to understand the changed regulations and be proactive in adapting their product labels and even internet marketing to adapt to the new regulations.  The coming changes have introduced a variety of new concepts, imposing additional burdens on businesses selling their products in California, and making it easier for plaintiff Prop 65 attorneys and groups to bring costly private enforcement actions.

The OEHHA has made significant changes to the safe-harbor language requirements that govern the language, text, and format of such warnings. The new regulations introduce the concept of a “warning symbol,” which must be used on consumer products, though not on food products. The “warning symbol” must be printed in a size no smaller than the height of the word “WARNING,” and should be in black and yellow, but can be in black and white if the sign, label, or shelf tag for the product is not printed using the color yellow.

Warnings must now also specifically state at least one listed chemical found in the product and include a link to OEHHA’s new website www.P65Warnings.ca.gov.  These are examples of the new format for more specific warnings:

  • For exposure to carcinogens: “ WARNING: This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov.”
  • For exposure to reproductive toxins: “ WARNING: This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause birth defects or other reproductive harm. For more information, go to www.P65Warnings.ca.gov.”
  • For exposure to both carcinogens and reproductive toxins: “ WARNING: This product can expose you to chemicals including [name of one or more listed chemicals], which is [are] known to the State of California to cause cancer, and [name of one or more chemicals], which is [are] known to the State of California to cause birth defects or other reproductive harm. For more information, go to www.P65Warnings.ca.gov.”

Certain special categories of products, such as food and alcoholic beverages, have a specialized URL that must be used. For example, warnings on food products must display the URL www.P65Warnings.ca.gov/food.

Recognizing that many consumer products have limited space “on-product” to fit the long-form warnings, the OEHHA has enacted new regulations allowing abbreviated “on-product” warnings. This short warning is permissible only if printed on the immediate container, box or wrapper of the consumer product. An example of the required format for the abbreviated warnings is:

  • WARNING: Cancer and Reproductive Harm – www.P65Warnings.ca.gov

The new regulations also specifically address internet sales for the first time. Warnings must be provided with a clearly marked hyperlink on the product display page, or otherwise prominently displayed to the purchaser before completion of the transaction.  It will not be sufficient if the product sold on the internet bears the required label, but the internet point of purchase listing does not.

The particular requirements for each specific product can vary, so manufacturers and resellers are well-advised to seek qualified counsel to review their situation before committing to potentially costly label and website changes that may not comply with the new requirements.  Conkle, Kremer & Engel attorneys stay up to date on important regulatory developments affecting their clients in the manufacturing and resale industries, and are ready to help clients navigate the changing regulatory landscape in California and elsewhere.

Although the new regulations take effect August 30, 2018, and the new warning labels are required for products manufactured after that date, companies can begin using the changed labels now. It is definitely not advisable to wait until August 2018 to begin making the required changes.

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California Proposition 65 Warnings for DINP Exposure are Required Soon

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Starting December 20, 2014, products sold in California that contain diisononyl phthalate (DINP) will require a Proposition 65 warning.

DINP is found is many soft plastic and vinyl products.  DINP is used as a plasticizer in a wide variety of products including apparel, footwear, sporting goods, gloves, fashion accessories, school supplies, shower curtains, bath mats and other home accessories, garden hoses, toys, vinyl flooring, and electrical wire and cables.

DINP was added to the Proposition 65 list of chemicals on December 20, 2013 as a chemical known to the State of California to cause cancer.  By law, the warning requirements go into effect one year after the listing.  Accordingly, the Proposition 65 warning requirement for products causing an exposure to DINP will start on December 20, 2014.

Businesses that manufacture, sell, or distribute products in California containing DINP are required to provide a warning to consumers that the product contains a chemical known to the State of California to cause cancer.  The warning is required unless the exposure is so low as to pose no significant risk to cancer.  The Office of Environmental Health Hazard Assessment (OEHHA) has not established a safe harbor level for DINP.

The phthalate DINP is presently banned in certain children’s toys and products in concentrations of greater than 0.1 percent under the Consumer Product Safety Improvement Act (CPSIA) of 2008.  Other phthalates that are already on the Proposition 65 chemical list include di (2-ethylhexyl) phthalate (DEHP), di-n-butyl phthalate (DBP), di-n-hexyl phthalate (DnHP), butyl benzyl phthalate (BBP) and di-isodecyl phthalate (DIDP).

Companies that have not reformulated their products to remove DINP, or that fail to provide a Proposition 65 warning on products containing DINP, by December 20, 2014 are at risk of receiving a “Notice of Violation” from private enforcers seeking tens of thousands of dollars in penalties and attorneys’ fees.  A Notice of Violation typically precedes a lawsuit for violation of Proposition 65.

Conkle, Kremer & Engel has extensive experience in the area of Proposition 65.  CK&E provides businesses with legal counseling and guidance on compliance with Proposition 65.  CK&E also regularly assists businesses in responding to Notices of Violation and defending claims for violation of Proposition 65 in litigation.

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Chemical Peel Ingredient Trichloroacetic Acid (TCA) Requires a Proposition 65 Warning

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Trichloroacetic acid (TCA), a chemical that is commonly used in cosmetic treatments such as chemical peels and for the removal of tattoos and treatment of skin tags, warts and moles, is now subject to Proposition 65’s warning requirement.  This means that any exposure to the chemical in California requires a warning that the chemical is “known to the State of California to cause cancer.”  The penalties for failing to provide the warning as required by Proposition 65 can be substantial:  The law authorizes civil penalties of up to $2,500 per day per violation.  In addition, attorney fees are authorized by California’s private attorney general statute – creating incentive for private Proposition 65 “bounty hunters” and their lawyers to target businesses who fail to comply.

Under Proposition 65, no legal action is authorized by the Attorney General, district attorneys or private enforcers until 12 months after the listing of that chemical.  TCA (CAS No. 76-03-9) was added to the list of chemicals known to the state of California to cause cancer on September 13, 2013.  As a result, Proposition 65 private enforcers were allowed to start sending out Notices of Violation over alleged exposure to TCA without a warning beginning on September 14, 2014.  The law permits such private enforcers to file a lawsuit 60 days after the Notice of Violation is served.

In addition to TCA, the following chemicals became subject to Prop 65 enforcement action on September 14, 2014:  chloral (CAS No. 75-87-6), chloral hydrate (CAS No. 302-17-0) and 1,1,1,2-tetrachloroethane (CAS No. 630-20-6).

Conkle, Kremer & Engel has significant experience in helping businesses understand and comply with the requirements of Proposition 65 and other regulations to avoid exposure to liability.  In addition to working with businesses to develop an effective compliance strategy, CK&E handles all aspects of Proposition 65 defense, including responding efficiently if a Notice of Violation is received.

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Prop 65 Notices and Lawsuits Target Cocamide DEA

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Cocamide DEA (coconut oil diethanolamine condensate) is a common ingredient in personal care products.  It is a viscous liquid used as a foaming agent in shampoo and soap products and as an emulsifying agent in cosmetics.  It can be found in shampoos, liquid soaps, body washes and bubble baths, among other products.  In June 2012 Cocamide DEA was added to the list of Proposition 65 chemicals, and warning requirements took effect one year later, on June 22, 2013.  To date, Notices of Violation concerning cocamide DEA exposure have been served on more than 350 businesses, and public enforcers have filed at least 16 lawsuits, most of them naming numerous defendants.  Lawsuits have been filed in both Los Angeles and Alameda Counties.

Proposition 65 is California’s right-to-know statute that requires businesses to provide clear and reasonable warnings before exposing Californians to a wide range of chemicals known to cause cancer or reproductive harm or both.  Proposition 65 requires a 60-day Notice of Violation to be served before public enforcers may file a lawsuit for alleged violation of the law.  The public enforcers who have served Proposition 65 Notices of Violation with respect to exposure to cocamide DEA include Center for Environmental Health, Shefa LMV LLC and ProtectConsumers LLC.  In addition, a number of individuals have become involved in Proposition 65 enforcement actions concerning cocamide DEA.  These individuals – Mark Lewis, Crystal Gerard, Mark Bates, Natisha Meloncon and Latonia Edge – are all represented by The Law Offices of Morse Mehrban.

2013 has been a particularly difficult year for manufacturers, distributors and sellers of personal care products.  In addition to cocamide DEA, other chemicals commonly found in personal care products and cosmetics became subject to Proposition 65 enforcement in 2013, including benzophenone and diethanolamine.

Businesses should carefully review the contents of the products they manufacture or distribute to determine whether those products may contain cocamide DEA.  Notices of Violation followed by prompt lawsuits have become the norm for alleged exposure to cocamide DEA.  Businesses must be proactive in protecting themselves from Prop 65 bountyhunters.  CK&E regularly helps clients with Prop 65 compliance issues.  If a Notice of Violation is received, CK&E handles responses to Notices of Violation and defense of businesses in Prop 65 actions to help resolve claims as efficiently and economically as possible.

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Navigating Civil Regulatory Issues: CK&E Presentation Highlights Key Regulations for Beauty Companies Doing Business in California

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Conkle, Kremer & Engel attorneys were featured speakers at the Beauty Industry West presentation “Navigating in Challenging Regulatory Waters:  Updates on California and Federal Compliance.”  About 150 entrepreneurs, consultants, executives and beauty industry professionals attended the event at the Crowne Plaza Hotel LAX in Los Angeles on October 15, 2013, which included a valuable networking session and a post-presentation Q&A.

CK&E’s presentation about legal regulatory issues for personal care product companies doing business in California included an overview of the California Organic Products Act (COPA), Proposition 65 (California’s Safe Drinking Water and Toxic Enforcement Act) and California’s Green Chemistry Initiative including the new Safer Consumer Products Regulations.  Conkle, Kremer & Engel’s materials from the BIW event, including the “Navigating Civil Regulatory Issues” presentation and its “Resource Guide for Regulatory Compliance,” are available for download on CK&E’s Regulatory Compliance web page.

Co-presenter Donald Frey, an industry veteran, regulatory expert and product development and innovation consultant, presented on key regulatory issues from the business perspective, including how to effectively deal with regulators. Mr. Frey has generously agreed to share his presentation, available for download here.

Among the questions and answers covered after the presentation were the addition of titanium dioxide (airborne, unbound particles of respirable size) to the Proposition 65 list of chemicals, responsible entities for purposes of compliance with the Safer Consumer Products Regulations, and the determination of organic ingredients under the National Organic Program standards.

Conkle, Kremer & Engel attorneys are frequent speakers at events of interest to the beauty industry due to their expertise in representing manufacturers, distributors, suppliers, retailers and salons in all aspects of their business, including the challenges of regulatory compliance.

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Five Additions to Prop 65 List of Regulated Chemicals

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The Proposition 65 list identifying chemicals known to the State of California to cause cancer or reproductive harm got a little longer in September 2013, with the addition of five new chemicals by the Office of Environmental Health Hazard Assessment (OEHHA).

Effective September 13, 2013, chloral, chloral hydrate, 1,1,1,2-tetrachloroethane, and trichloroacetic acid are chemicals known to the State of California to cause cancer for purposes of Proposition 65.  1,1,1,2- tetrachloroethane is commonly used as a solvent and in the production of wood stains and varnishes.  Trichloroacetic acid is commonly used in cosmetic treatments such as chemical peels and for the removal of tattoos and treatment of skin tags, warts and moles.

Effective September 27, 2013, chloramphenicol sodium succinate became a chemical known to the State of California to cause cancer for purposes of Proposition 65.

The effect of the listings is that anyone doing business in California must provide a clear and reasonable warning before they expose consumers to any of these chemicals.  None of the five chemicals has an established safe harbor level for exposure, although Proposition 65 generally provides that there is no warning requirement if the exposures caused are so low as to create no significant risk of cancer.

Businesses have some breathing room to comply with the listings under Proposition 65’s safe harbor provision: No action can be taken by the Attorney General, district attorneys or private enforcers until 12 months after the listing of that chemical.  Thus, businesses will have until September 13, 2014 (for chloral, chloral hydrate, 1,1,1,2-tetrachloroethane, and trichloroacetic acid) and September 27, 2014 (for chloramphenicol sodium succinate) before any alleged failure to comply is legally actionable.

Proposition 65 applies to everyone in the supply chain.  Manufacturers, distributors, suppliers, retailers and other entities doing business in California should take advantage of the safe harbor period and review the products they sell to determine whether chloral, chloral hydrate, 1,1,1,2-tetrachloroethane, trichloroacetic acid or chloramphenicol sodium succinate is present in any of their products.  If so, they should consider scientific testing to determine exposure levels.  Possible action that can be taken to proactively handle the new listings include reformulation or providing a clear and reasonable warning to California consumers.  Conkle, Kremer & Engel has substantial experience in helping businesses understand and comply with the requirements of Proposition 65 and other regulations to avoid exposure to liability, and to respond efficiently and effectively if a Notice of Violation is received.

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A Proposition 65 Reform Bill Becomes Law: California Health & Safety Code Section 25249.7 Amended by AB 227

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On October 5, 2013, Governor Brown signed into law a bill that makes immediate changes to Proposition 65.  The amendments, which passed the California Legislature last month, impose a number of restrictions on private enforcers seeking to enforce Prop 65 against businesses that allegedly fail to provide a warning as required by Prop 65.  The bill that became law is Assembly Bill 227 (AB 227), introduced by Assemblymember Mike Gatto (Forty-Third District of California) in February 2013, and discussed in our March 13, 2013 blog post.

However, as AB 227 was enacted, only limited types of businesses are likely to benefit.  The amendments are very narrow, covering only certain exposures to alcohol or food-related chemicals, vehicle exhaust and tobacco smoke.  Thus, the only businesses that are likely to benefit from the amendments are bars, restaurants, parking garages, and those who own or operate premises where smoking is permitted.

In general, the amendments establish a new “safe harbor”:  AB 227 prohibits a Prop 65 lawsuit from being filed by a private enforcer over an alleged failure to provide a warning concerning one of the specified exposures, if the business takes specified action within 14 days of receipt of the notice of violation.   The targeted business can escape a Prop 65 action if, within 14 days, the business:  (1) actually corrects the alleged violation; (2) agrees to pay a civil penalty of $500 per facility or premises within 30 days; and (3) submits a “Proof of Compliance” notifying the private enforcer that the violation has been corrected.  If the business takes the so-called “safe harbor” action in response to the notice of violation alleging failure to warn about exposure to alcohol or food-related chemicals, vehicle exhaust or tobacco smoke, the private enforcer is precluded from filing a lawsuit or collect additional civil penalties or attorneys’ fees from the business.

These types of piecemeal amendments to Prop 65 may increase public demand and political pressure for additional reform.  In May 2013, Governor Brown proposed sweeping, substantive reform to Prop 65, intended to end decades of “frivolous ‘shake-down’ lawsuits” by Prop 65 bounty hunters and their lawyers.  But by September 2013, those efforts stalled as stakeholders involved in the reform effort were unable to reach the consensus needed to generate the two-thirds majority approval that is required for any amendment of Prop 65 in the Legislature.

Conkle, Kremer & Engel constantly tracks the latest developments in Prop 65 in order to provide expert guidance and counseling to clients.  This latest amendment is a demonstration that businesses who receive a Prop 65 warning should immediately seek qualified legal counsel to help them avoid liability and unnecessary payments to Prop 65 claimants and their lawyers.  In fact, businesses are well advised to consult qualified legal counsel to review their compliance with Prop 65 before an immediate response becomes necessary.

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2012: A Bountiful Year for Prop 65 Plaintiffs and Their Lawyers

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Proposition 65 requires that businesses warn about the presence of chemicals believed by the State of California to cause cancer or reproductive harm.  Private citizens may file lawsuits “in the public interest” against businesses alleging a failure to provide the required warning.  Such lawsuits are often filed by private law firms (sometimes called “bounty hunters”), in the names of repeat-plaintiffs like “Center for Environmental Health,”  after sending Notices of Violation. The apparent primary purpose is to obtain quick cash settlements from bewildered, unsuspecting businesses.

2012 Prop 65 Settlements Bar Chart by Year2012 was a particularly “bountiful” year for Prop 65 private plaintiffs, according to data recently released by the California Attorney General’s Office. In 2012, private plaintiffs settled 397 cases.  The settlements totaled nearly $20.5 million. When combined with the additional settlements by District Attorneys and the Attorney General’s Office, there were 437 Prop 65 settlements during 2012, totaling over $22.5 million.  2012 was the second-highest annual dollar total for Prop 65 settlements since 2000, and shows a clear upward trend in the settlements extracted from businesses that receive Prop 65 Notices of Violation.

It should surprise no one who studies Prop 65 issues that the bulk of the $22.5 million paid in Prop 65 settlements during 2012 went to the plaintiffs’ attorneys:  Attorneys’ fees made up more than $14.5 million, or 71.34% of all private settlements.  Private plaintiffs can also take 25% of any civil penalty assessed as a “bounty”.  In 2012, the civil penalties retained by plaintiffs represented an additional $755,000 or 3.7% of all private settlements.

2012 Prop 65 Settlement Pie ChartA lesser-known fact is that private plaintiffs and their attorneys can and do make even more money from Prop 65 settlements.  A portion of each Prop. 65 settlement is supposed to go toward causes or activities that further the purpose of Prop 65, so Prop 65 allows parties to structure some of their civil penalty allocation as a “Payment in Lieu of Penalties” (aka “PILP”).  Some Prop 65 plaintiffs have kept such PILP recoveries to support vaguely stated causes; some Prop 65 plaintiffs have even argued that funding more private litigation itself is activity that furthers the purpose of Prop 65, justifying PILP recoveries from settlements.  In 2012, PILP money made up 13.88% of all private settlements.  That means almost $3 million landed in the hands of private plaintiffs and their attorneys, in addition to the attorneys’ fees and civil penalty bounties they received.

Statewide, there are only a few active Prop 65 plaintiffs.  Aggregated settlement data can be useful in achieving cost-effective resolutions of Prop 65 claims.  CK&E routinely defends businesses who have received Prop 65 Notices of Violation.  CK&E also works with businesses to develop compliance strategies to minimize the risk that they will be future targets of Prop 65 plaintiffs.

This Blog Post was Co-Authored by Jackson McNeill, Law Clerk, UCLA School of Law, Class of 2014

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Lead in Baby Food? Failure to Warn Leads to Unusual Prop 65 Trial

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Proposition 65 actions are notoriously expensive and difficult to defend.  For that reason, most Prop 65 cases settle.  But a rare case involving allegedly high levels of lead in baby food, packaged fruits and juices is in trial in the Alameda Superior Court.

In September 2011, the Environmental Law Foundation (one of a handful of organizations in California that files Prop 65 actions in the name of the public interest) brought a lawsuit against food companies Beech-Nut Nutrition, Dole, Gerber, Del Monte Foods, and many others.  ELF claimed that the manufacturers made and sold baby and children’s food containing lead, without a warning as required by Prop 65, California’s Safe Drinking Water and Toxic Enforcement Act.

What is at stake in the Prop 65 action is whether baby food and children’s food such as carrot and potato baby food, grape juice and fruit cocktail must include a warning that the foods contain a chemical known to the state of California to cause cancer or reproductive harm.  Naturally, the food manufacturers do not wish to be forced to warn potential consumers that their foods contain harmful chemicals.

The food companies’ defenses are being tried to Superior Court Judge Steven A. Brick.  The food companies claim that their products contain only trace levels of lead that are below the level required for a Prop 65 warning.  They also claim that the lead is “naturally occurring” in the foods and therefore no duty to warn is required under the “naturally occurring” exposure defense to Prop 65.  Finally, the food companies have argued that Prop 65’s warning requirements are preempted by the Food, Drug and Cosmetic Act and the Nutrition Labeling and Education Act.  They contend that the FDA has determined that the baby food and children’s food in question do not pose unacceptable risks to health, so a Prop 65 warning requirement would create a conflict between federal and state law.

This will be a closely-watched case, because the Court’s ruling on these defenses is likely to have a significant impact on the defenses available to businesses faced with Prop 65 actions in the future.  Regardless of the outcome, CK&E’s lawyers will continue to work with businesses to help them develop a plan of compliance so that they can achieve their goal of minimizing the risk of being named as a defendant in a Prop 65 lawsuit.  If a lawsuit is threatened or filed, CK&E’s lawyers apply can create and implement effective and cost-efficient defense strategies to minimize its impact.

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