Could a Pending Federal Safe Cosmetics Act Preempt the California Safe Cosmetics Act?

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After nine years, the California Safe Cosmetics Act is suddenly in the news, now that the California Safe Cosmetics Program Product Database has been posted for the public.  The California Safe Cosmetics Act requires manufacturers of cosmetic products to be sold in California to report any ingredients in their products that have been identified to the California Department of Public Health as causing cancer or reproductive toxicity.

While no federal counterpart to the California Safe Cosmetics Act presently exists, legislation to amend Chapter VI of the Federal Food, Drug and Cosmetic Act (FD&C Act or FDCA, 21 U.S.C. § 361 et seq.) has been introduced in every session of Congress since 2010.  The latest version of the bill, the Safe Cosmetics and Personal Care Products Act of 2013, seeks to ensure the safe use of cosmetics by creating a uniform system of registration of cosmetic companies, set national safety standards for cosmetic ingredients, and provide recall authority.  The bill was proposed March 21, 2013 (H.R. 1385, sponsored by Rep. Janice D. Schakowsky (D. Ill.)), and remains pending during the 2013-2014 legislative session. It remains an open question whether any finally enacted federal law regulating cosmetics ingredient safety may preempt state authorities’ regulation in the same area.  That is an issue in which the Personal Care Products industry should be keenly interested.

Conkle, Kremer & Engel lawyers keep abreast of developments in regulatory compliance matters to help clients proactively create and execute plans to remain competitive while meeting their compliance requirements.

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Safe Cosmetics Act Database to Go Public in 2014: Watch for More Lawsuits

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In a previous blog post, we referred to the Safe Cosmetics Act as a “sleeper” because it has been in existence for several years but has been little noticed and seldom used.  That is likely to change in 2014.

The Safe Cosmetics Act was enacted in 2005 and became effective January 1, 2007.  Businesses manufacturing cosmetics sold in California were required to make their initial report to the California Department of Public Health by December 15, 2009.  Reporting must be made on a continuous basis, such as when formulation changes add a “suspect” chemical to an existing cosmetic product.  The Safe Cosmetics Act is so little-known that many manufacturers may have missed the reporting requirements, or complied as to some products but failed to update their reporting as product formulations changed.  So far, those omissions have rarely had any significant impact on manufacturers, but that is likely to start changing now.

The relative quietude may change in 2014 because by December 31, 2013 the CDPH must make a publicly accessible database available on its website containing all of the information collected pursuant to the Safe Cosmetics Act.  The information included in the database could be used by enterprising Prop 65 bounty hunters searching for products that contain chemicals that are subject to the warning requirements of Prop 65.  And the failure to report required information timely or accurately may be the basis for future unfair competition lawsuits by private parties, including consumers and competitors.

As a harbinger of the potential consequences for manufacturers, in January 2012 the California Attorney General’s Office announced the first law enforcement action taken under the Safe Cosmetics Act against a manufacturer of “Brazilian Blowout” products.  But the manufacturer’s failure comply with the Safe Cosmetics Act’s reporting requirement was only one of many business acts and practices alleged to violate California’s Unfair Competition Law.  The Attorney General also alleged violations of California’s False Advertising Law and Proposition 65.  The end result was a consent judgment that required the manufacturer to pay $300,000 in attorneys’ fees and costs and an additional $300,000 civil penalty for violation of Prop 65.  The manufacturer was also subject to numerous injunctions, including a requirement that it report in compliance with the Safe Cosmetics Act.  Private claimants such as Prop 65 bounty hunters are likely to take notice of the newly available information and any failures to comply.

Conkle, Kremer & Engel stays up to date on regulatory compliance matters to provide continued expert legal guidance to clients.  Conkle, Kremer & Engel has decades of experience representing clients in the personal care products and cosmetics industry, and understand the unique regulatory compliance concerns facing manufacturers, distributors and retailers.

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California Safe Cosmetics Act of 2005: A Sleeper That May Awake in 2014

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California has a well deserved reputation for extraordinary efforts to protect consumers.  While the goals behind the regulations may be laudable, California’s many requirements impose enormous burdens on companies doing business in the state, often with questionable public benefit.  Proposition 65 is a familiar example of a regulation that requires elaborate warnings, but does not actually regulate the use of any chemicals.

There are many other examples, including a “sleeper” called the Safe Cosmetics Act.  Enacted in 2005, the Safe Cosmetics Act was heralded by its supporters as a landmark law that would protect the health of millions of Californians who use cosmetics.  In reality, the Safe Cosmetics Act is just another glorified reporting statute, requiring manufacturers of cosmetic products sold in California to file with the California Department of Public Health (CDPH) reports of information that is already on product ingredient labels.

But the Safe Cosmetics Act takes the idea of the consumers’ “right to know” to an extreme by imposing a precautionary rather than risk-based approach.  Unlike Prop 65, the Safe Cosmetics Act requires manufacturers to report use of chemicals that are not just “known” to cause cancer or reproductive harm, but also chemicals that are “suspected” to cause cancer or reproductive harm.  In addition, the Safe Cosmetics Act does not recognize any “safe harbor” levels for reporting – any amount of a “suspect” chemical must be reported.  Finally, cosmetic products that contain a reportable chemical must be reported regardless of whether the likely mode of exposure to the chemical by use of the product differs from the route of exposure identified by the authoritative scientific body as a pathway likely to cause cancer or reproductive harm.  For example, a chemical that has only been identified as “suspected” of causing cancer or reproductive harm when ingested must be reported even if it is contained in a skincare product.

In future blog posts, we’ll address why the Safe Cosmetics Act could become much more significant to personal care products manufacturers beginning in 2014, the risks of liability to manufacturers posed by the Safe Cosmetics Act, and how manufacturers can know if their products contain the regulated  chemicals.  At Conkle, Kremer & Engel, we help our clients meet compliance requirements, despite constantly changing state and federal laws.  With proper counseling, clients can avoid potential liability and minimize disruption to their businesses.

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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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CK&E Attorneys to be Featured Speakers at Upcoming Beauty Industry Presentation on Legal Regulatory Issues

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Conkle, Kremer & Engel attorneys will be featured speakers at the Beauty Industry West presentation “Navigating in Challenging Regulatory Waters:  Updates on California and Federal Compliance.”  The presentation will take place on October 15, 2013 at the Crowne Plaza Hotel LAX in Los Angeles.

CK&E will be speaking on legal regulatory issues for personal care product companies doing business in California, including California Organic Products Act (COPA), Proposition 65 (California’s Safe Drinking Water and Toxic Enforcement Act) and California’s Green Chemistry Initiative.

Co-presenter Donald Frey is an industry veteran and a product development and innovation consultant of Frey Consulting.  Mr. Frey will present on key regulatory issues from the business perspective, including how to effectively deal with regulators.

Beauty Industry West is a non-profit industry trade organization that educates and provides resources and a networking platform for companies and entrepreneurs who want to develop their own personal care and beauty brands.

Conkle, Kremer & Engel has decades of experience in the personal care industry.  Our attorneys are pleased to participate in trade organizations like Beauty Industry West and to share their experience with members of the industry.

 

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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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Naked Juice Labels to be Stripped of "All Natural" and "Non-GMO" Claims in False Advertising Settlement

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PepsiCo has agreed to pay $9 million to settle a class action battle over its use of the words “All Natural” and “Non-GMO” (non-Genetically Modified Organism) on its Naked Juice drink products.  As part of the settlement, PepsiCo agreed to change its labeling.

If approved by the district court, the settlement would resolve five separate class action lawsuits, which were consolidated with the lead case Pappas v. Naked Juice Co. of Glendora, Inc., in March 2012.

The case against PepsiCo stems from allegations that statements on the Naked Juice labels constitute false advertising.  The plaintiffs sued for violation of a number of California statutes – the Consumer Legal Remedies Act (CLRA) and False Advertising and Unfair Competition Laws.

According to the plaintiffs, independent testing revealed genetically modified soy protein in some Naked Juice products.  The plaintiffs also alleged that several ingredients in the Naked Juice products are non-natural, including ingredients like beta carotene and biotin which do occur naturally but are produced synthetically when added as supplements to foods, and a fiber ingredient that is produced by chemically rearranging corn starch molecules.  All of these ingredients are listed in the ingredient panel, but according to the plaintiffs, a reasonable consumer wouldn’t scrutinize the ingredient list for information contradicting the plain, conspicuous statements “All Natural” and “Non-GMO.”

The settlement in the PepsiCo case is likely to lead to many more class action lawsuits against businesses that advertise their products as “natural” or “all natural.”  Unlike use of the word “organic,” use of the word “natural” is not explicitly regulated by federal or state law, leaving the door open for claims of false or misleading advertising by consumers.

What’s the moral of this story?  An ounce of prevention is worth a pound of cure.  It is important to scrutinize health-related language used in advertising, especially on food products, and ensure there is documentation to back up claims.  CK&E routinely works with clients to evaluate the language on product packaging and in advertising as part of a comprehensive risk analysis so they can make informed choices for their businesses.  CK&E also has extensive experience defending clients against consumer false advertising claims.

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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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