The attached article includes links to topical blog posts and websites referenced in the interview. CK&E wishes to thank BIR’s Mike Nave for taking the initiative to disseminate information about these important industry issues. BIR proved again that working in the beauty industry without reading BIR is like working in finance without reading The Wall Street Journal.
Amy and Mark contribute to the BIMA educational program by teaching modules on domestic and foreign intellectual property protection, domestic regulatory compliance, and international distribution agreements. Participants are particularly interested in cost-effective methods of protecting their intellectual property internationally, such as international trademark registrations through the Madrid System. The Madrid System offers a centralized application process for trademark registration in over 90 countries based on a brand owner’s domestic application or registration. Participants are also interested in CK&E’s practical approach to domestic regulatory compliance, including California’s evolving green chemistry initiative, Safe Cosmetics Act and Proposition 65. Participants have also benefited from CK&E’s tips for forging fruitful business relationships with distributors, based on decades of experience representing clients in the personal care products industry.
Amy will accompany Patty Schmucker and several graduates of the BIMA educational program to Cosmoprof Worldwide in Bologna in April 2014. Amy and Mark look forward to the next BIMA session, which begins on June 26, 2014. Click for further information about joining the BIMA program: BIMA_Summer-Fall_2014
The presentation, entitled “Are Your Products California-Bound? Dealing With California’s Unique Regulatory Schemes,” provided valuable information about and insight into such California regulatory laws and initiatives as:
- Proposition 65 (California’s Safe Drinking Water and Toxic Enforcement Act of 1986)
- California Safe Cosmetics Act
- California Green Chemistry Initiative (the Safer Consumer Products Regulations)
- California Volatile Organic Compounds (VOC) Regulations
- California Organic Products Act (COPA)
- California Consumer Legal Remedies Act (CLRA)
California’s vast and ever-changing regulations pose a challenge for businesses no matter where they may be located. Any business manufacturing, distributing or selling products into California needs to comply with California’s regulatory schemes to stay out of difficulty with the California Attorney General, regulatory agencies, non-governmental organizations (NGOs), bounty hunters, putative class action plaintiffs and even competitors.
CK&E was honored to team with the New York-based law firm Gottlieb, Rackman & Reisman, P.C., which specializes in intellectual property, to provide this presentation. CK&E has worked with the Gottlieb firm for nearly 25 years on matters of common intrest to our clients. CK&E’s active regulatory compliance practice has helped clients in numerous industries – including such diverse areas as personal care products, alcoholic beverages, construction and recreational equipment.
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.
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.
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.