Sunscreen Ingredient Restrictions in Maui, Hawaii?

Posted by:

Sunscreen manufacturers and distributors should take note:  Maui County in the state of Hawaii could become the first county in the United States to ban the sale and use of sunscreen products containing oxybenzone and octinoxate, two active ingredients approved by the U.S. Food and Drug Administration (FDA) for use in sunscreens.

In November, a Maui Hawaii County Council committee introduced and recommended for approval a bill for an ordinance that would prohibit the sale and use of sunscreen containing the ingredients oxybenzone and octinoxate. These ingredients are commonly used in commercial chemical sunscreens as protection against ultraviolet (UV) light radiation.  The county-level move came after Senate Bill 1150 – introduced in 2017 by Hawaii Senator Will Espero to ban the use and application of sunscreens containing oxybenzone throughout the state of Hawaii – stalled at the end of the legislative session.

The FDA currently approves of only 16 active ingredients for use in over-the-counter (OTC) sunscreens, generally recognizing them as safe and effective.  Among the ingredients are oxybenzone and octinoxate, which are commonly found in commercial sunscreen products, including from major sunscreen brands such as L’Oreal, Neutrogena and Supergoop.  The European Union already imposes strict limits on the use of oxybenzone in sunscreen products as well as warning requirements.

The Maui County proposal was prompted by environmental concerns and intended to promote the health and welfare of Maui’s coral reefs and marine life. The bill’s supporters claim that oxybenzone and octinoxate have a significant impact on the marine environment, noting that both ingredients have been detected in the ocean surrounding Maui at levels that well exceed the toxicity range for coral reefs.  Opponents of the ban, on the other hand, contend that the ingredients are safe for use, as they have been approved for use by the FDA.

The proposal to ban sunscreen products containing oxybenzone and oxtinoxate, other than prescription products, is now before the full Maui County Council. If approved, manufacturers, retailers and distributors of sunscreen products containing oxybenzone and oxtinoxate would have a year to ensure that their products no longer contain the banned ingredients. Businesses or persons found in violation of the law would be subject to civil penalties and administrative enforcement procedures. As of now, the bill does not contain a private right of action to allow consumers to bring actions for violations.  If passed, Maui’s outright ban could still face enforcement and legal challenges – including state preemption and federal Commerce Clause challenges.

While this is a unique development, local efforts to protect against health and environmental concerns are nothing new, but they do not always remain confined to their original purpose.  For example, California’s Safe Drinking Water and Toxic Enforcement Act of 1986, commonly known as Proposition 65, was originally passed to protect the state’s drinking water sources from being contaminated with chemicals known to cause cancer or reproductive harm.  However, Proposition 65 does not act to ban the use of any chemicals; instead, it imposes warning requirements prior to consumer exposure to certain chemicals known to the state to cause cancer or reproductive harm.  The 2012 listing of benzophenone to the state’s list of regulated chemicals has already caused many sunscreen manufacturers using octocrylene, another FDA-approved active ingredient that may contain small amounts of benzophenone, to reformulate or use a more purified form of the ingredient.

Conkle, Kremer & Engel has many years of experience representing clients in the beauty and skin care industry address challenging regulatory compliance issues.  CK&E attorneys help clients stay out of legal crosshairs by working with them to ensure their products continue to meet all legal requirements, and helping them plan for foreseeable changes in the law.

Print Friendly, PDF & Email
0

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

Posted by:

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.

Print Friendly, PDF & Email
0

The Conkle Firm Featured Panel of 2017 PCPC Legal & Regulatory Conference

Posted by:

Conkle, Kremer & Engel attorney H. Kim Sim was on the featured panel of this year’s Legal & Regulatory Conference sponsored by the Personal Care Product Council.  The featured panel, called “California: The Wild, Wild West,” explored the changes and challenges of the new business landscape in California, which boasts an economy that would place it sixth among the world’s nations.  The panel discussion was held on May 10, 2017 at Hilton La Jolla Torrey Pines in San Diego, California.   John Conkle, the CK&E attorney originally scheduled to speak on this panel, was unable to appear due to a federal court trial conflict.

 

Print Friendly, PDF & Email
0

CK&E Sponsors 2016 PCPC Emerging Issues Conference

Posted by:

Conkle, Kremer & Engel is proud to once again sponsor the Personal Care Products Council Emerging Issues Conference on November 10, 2016 at the Ritz Carlton Hotel in Marina Del Rey, California.

John Conkle will attend the conference on behalf of CK&E to address current legal trends and developments in the cosmetic and personal care products industry.  This annual event by the PCPC – the leading national trade association for the cosmetic and personal care products industry – is a must-attend for beauty companies across the country, with its unique focus on the many challenges that are on the horizon for the beauty industry.  The presentation this year will include a particularly timely focus on international trade issues affecting the cosmetics industry, including appearances by industry representatives from Canada and Mexico.

This year’s conference is particularly topical panel discussion entitled “2016 Elections: What happened and what it means for you!”   The panel included Dan Schnur, a leading political strategist and Director of Jesse Unruh Institute of Politics at University of Southern California, which runs the USC-Los Angeles Times Daybreak Poll that was one of the few polls to correctly predict Donald Trump’s election.  In comments during their PCPC presentation, the panel noted that if President Trump follows through with pledges such as environmental regulation rollbacks, it is likely that California will respond by enacting its own additional rules and regulations.

2016-11-10-pcpc-mike-thompson-dan-schnur-darius-anderson-edited

Michael Thompson, Senior VP, PCPC Government Affairs; Dan Schnur Director, Jesse Unruh Institute of Politics, USC; Darius Anderson, CEO, Platinum Advisors

CK&E is pleased to once again participate in this annual event and to offer its experience and insight into legal issues affecting the industry to the PCPC and its members.

2016-emerging-issues-conference-cke-sponsor

Print Friendly, PDF & Email
0

The Conkle Firm Advises BIMA Participants on IP and Regulatory Issues

Posted by:

Once again, Conkle, Kremer & Engel attorneys Mark Kremer and Kim Sim have been honored to participate in and contribute to the revolutionary Beauty Industry Market Access (BIMA) program, led by beauty industry guru Patty Schmucker of American Made Beauty.  BIMA is a multi-day intensive domestic and international trade and business education program taught by leading health and beauty industry experts. BIMA participants focus on key principles essential to expand their personal care products businesses both in the U.S. and overseas.

Mark contributes to the BIMA educational program by teaching modules on domestic and foreign intellectual property protection and international distribution agreements.   Participants are particularly advised about cost-effective methods of protecting their intellectual property internationally, such as international trademark registrations through the Madrid System, which can offer a centralized application process for trademark registration in over 90 countries based on a brand owner’s domestic application or registration.  Kim adds her expertise in domestic regulatory compliance, including Prop 65, California Organic Products Act (COPA), Safe Cosmetics Act, California Air Resources Board (CARB) regulations and survey requirements, and federal and state Made in the USA regulations.

BIMA is sponsored by Universal Companies, which has been in the beauty industry for over 18 years and is an important distributor of more than 300 brands in the spa, salon, esthetics and massage market, as well as their own proprietary brands.

In partnership with the California Trade Alliance (CTA), access to international trade shows are available to companies that participate in the BIMA programs. BIMA participants can exhibit in the popular California Pavilion regularly sponsored by CTA at Cosmoprof Bologna and Cosmoprof Hong Kong, among the world’s largest and most important beauty industry trade shows.

Print Friendly, PDF & Email
0

PCPC’s California Lobby Day was a Great Success

Posted by:

On April 12, 2016, Conkle, Kremer & Engel attorney John Conkle flew to Sacramento to be part of Personal Care Products Council’s delegation for California Lobby Day. The Personal Care Products Council (PCPC) advocates for the personal care products, beauty and cosmetics industry at federal, state and local levels on legislative priorities and regulatory issues.

Conferences held in the Governor’s Council Room featured presentations by Nancy McFadden (Executive Secretary to Governor Edmund G. Brown), Graciela Castillo-Krings (Deputy Legislative Secretary to Governor Edmund G. Brown, Jr.), Dr. Meredith Williams (Deputy Director of Safer Products and Workplaces Program Director, Department of Toxics & Substance Control), and Elise Rothschild (Deputy Director of the Hazardous Waste Management Program, Department of Toxics & Substance Control).  John joined teams of PCPC staff and member companies who met with legislative offices to discuss the economic impact of the industry and legislation pending before the California legislature. The day’s events were capped with a reception at which PCPC staff and members were joined by California State Legislators.

Conkle, Kremer & Engel is a proud and active member of the Personal Care Products Council.  CK&E attorneys are glad to lend their legal expertise to the PCPC and its member companies by participating in PCPC conferences and industry advocacy efforts..

Print Friendly, PDF & Email
0

The Conkle Firm Joins PCPC California Lobby Day 2016

Posted by:

Conkle, Kremer & Engel attorney John Conkle is proud to have again been invited to join the Personal Care Products Council’s delegation for California Lobby Day, an annual PCPC event held at the Capitol in Sacramento, California.  The Personal Care Products Council (PCPC) represents the personal care products, beauty and cosmetics industry at the federal, state and local level on issues of interest to the industry.

California Lobby Day represents a unique opportunity for industry leaders to meet with legislators including Leadership, key Committee Chairs and members of the Legislative Women’s Caucus, state officials, and their staff members and to engage in open discussions about legislative and regulatory issues affecting the personal care products industry.  The day is expected to include briefings in the Governor’s Office by the executive department personnel and meetings with staff in the offices of members of the State Legislature, as well as a reception for members of the California Legislature, personnel from the Office of Governor Brown, and PCPC members and staff.  Among those with whom John is expecting to meet are Nancy McFadden (Executive Secretary to Governor Brown); Carol Monahan-Cummings (Office of Environmental Health Hazard Assessment); Meredith Williams (Deputy Director of Safer Consumer Products and Workplaces Program, Department of Toxic Substances Control); and Panorea Advis (Director of the Governor’s Office of Business and Economic Development).

Conkle, Kremer & Engel is proud to be an active member of the Personal Care Products Council.  Over the years, CK&E has provided legal expertise to the PCPC and its member companies by presenting at conferences organized by the PCPC on legal and regulatory matters, as well as representing many PCPC member companies.  CK&E has also been a frequent sponsor of conferences organized by the PCPC and has participated in numerous events hosted by the PCPC.

Print Friendly, PDF & Email
0

The Conkle Firm Participates in ICMAD Regulatory Forum

Posted by:

Conkle, Kremer & Engel attorney Eric S. Engel attended the ICMAD Regulatory Forum in Newport Beach, California on February 17, 2016.  The Forum has been an annual event for more than a decade, and offers CK&E an opportunity to meet with professionals in the personal care products industry to discuss important legislative and regulatory issues affecting the industry.  Among the topics of concern to the beauty industry, on which CK&E stays current through participation in the Forum and otherwise, include labeling and advertising claims, EU labeling and regulatory compliance, and California regulatory compliance, including Prop 65 issues, California Safe Cosmetics Act and California Air Resources Board (CARB), California Safer Consumer Products regulations, and the potential for class action liability.  One topic that generated particular industry interest was the pending “Personal Care Products Safety Act” introduced by Senators Feinstein and Collins.

Print Friendly, PDF & Email
0

CK&E to Present on Emerging Legal Issues at PCPC Emerging Issues Conference

Posted by:

Conkle, Kremer & Engel attorneys John Conkle and Kim Sim will once address current legal trends and developments in the cosmetic and personal care products industry at the Personal Care Products Council (PCPC)’s Emerging Issues Conference on November 18, 2015 at the Ritz Carlton Hotel in Marina Del Rey, California.

John and Kim will present on “Emerging Legal Issues in the Cosmetic and Personal Care Products Industry.”  The topics to be discussed include recent developments involving enforcement of prohibitions on container slack fill, trends in lawsuits and agency action concerning advertising, an update on the California Air Resources Board’s ongoing Consumer and Commercial Products Survey, as well as a discussion about protecting companies from counterfeiting and cybersquatting in the digital age.

CK&E’s presentation from last year’s Emerging Issues Conference can be found here.

The annual event by the PCPC – the leading national trade association for the cosmetic and personal care products industry – is a must-attend for beauty companies across the country, with its unique focus on the many challenges that are on the horizon for the beauty industry.

This year’s agenda will also include updates from the PCPC on key issues for the industry and from the California Department of Toxic Substances Control on the California Safer Consumer Products and Workplaces regulations, as well as presentations on emerging issues in the Americas, safety standards for cosmetics, current and future challenges for Proposition 65.  In addition, Deputy Attorney General Robert Sumner is slated to speak at the conference.

CK&E is pleased to once again participate in this annual event and to offer its experience and insight into legal issues affecting the industry to the PCPC and its members.

 

Print Friendly, PDF & Email
0

Seriously – Aloe Vera Whole Leaf Extract May be a Prop 65 Chemical

Posted by:

We’ve recently written a series of articles about “natural” personal care products that may inadvertently run afoul of Prop 65 regulations.  You may be surprised to learn that such “natural” products may include ingredients that have been identified as “chemicals known to the State of California to cause cancer” under Proposition 65.

One of the more surprising of the proposed Prop 65 ingredients is Aloe Vera Whole Leaf Extract.  On April 23, 2015, California’s Office of Environmental Health Hazard Assessment (“OEHHA”) issued its notice of intent to list Aloe Vera Whole Leaf Extract as a chemical known to cause cancer. Although more than 420 species of Aloe plant exist, the specific form that is the subject of the proposed listing is: “Aloe Vera whole leaf extract” which “consists of the liquid portion of the Aloe Vera leaf and is a natural constituent of the Aloe barbadensis Miller plant.”  Fortunately, OEHHA specifically excludes Aloe Vera decolorized whole leaf extract, Aloe Vera gel, Aloe Vera gel extract and Aloe Vera latex, which are the more common forms used in personal care products.

When it issued the notice of intent to list Aloe Vera Whole Leaf Extract, OEHHA also issued a notice of intent to list Goldenseal Root Powder as a chemical known to cause cancer. OEHHA identified goldenseal root powder in the proposed listing as “the powdered dried roots and underground stems of goldenseal plants” and declared it to be “a natural constituent of the goldenseal plant.” OEHHA further specifies that Goldenseal is also known as Hydrastis Canadensis, orangeroot, Indian turmeric, and curcuma. Fortunately, OEHHA further specifies that the spice turmeric (Curcuma longa Linn.), frequently found in personal care products such as face and body lotions and cleansers, is not proposed for listing. The form of goldenseal root extract that is contemplated for addition to the Prop 65 list is most often used in the form of nutritional supplements.

Even when manufacturing or distributing “natural” products, beauty companies should take care to review the products’ current formulations to determine whether they contain an ingredient that is or may be on the Proposition 65 list, or whether any of their products contain an ingredient that may cause an exposure to a Prop 65 chemical.  It may be vital to work closely with manufacturers or suppliers, and have strong contracts to protect against Proposition 65 liability. Companies should be pro-active and consider reformulation if a proposed or actual Prop 65 chemical is being used.  And if a Proposition 65 Notice of Violation is received, affected companies should promptly contact counsel with experience in successfully resolving Prop 65 claims.

Print Friendly, PDF & Email
0
Page 1 of 4 1234