STATE OF THE STATESLegal & Regulatory Conference, May 9-11, 2018Legal & Regulatory Conference, May 9-11, 2018
John A. Conkle, Esq.
Conkle, Kremer & Engel, PLC
Santa Monica, California
310.998.9100
Gregory G. Sperla, Esq.
Scali Rasmussen
Sacramento, California
916.449.9534
Anthony J. Cortez
Greenberg Traurig
Sacramento, California
916.868.0679
• State Registration Requirements
• State Labeling Laws
• State Ingredient Disclosure Laws
• State Efforts to Phase Out/Ban Harmful
Let’s Take a Road Trip
• State Efforts to Phase Out/Ban HarmfulIngredients and Products
• Ban on Animal Testing
• State VOC Limits on Consumer Products
• Slack Fill Laws
NIST ‘17 on State Requirements
Source: NISTIR 8178, “A Guide to U.S. Cosmetic Products Compliance Requirements” (May ’17).
STATE REGISTRATION REQUIREMENTS
Louisiana
• Wholesale manufacturersor distributors of cosmeticproducts in Louisiana mustbe permitted by the Foodand Drug Unit of theDepartment of Health andDepartment of Health andHospitals
• All cosmetics distributed inLouisiana must beregistered under theDepartment of Health andHospitals’ ProductRegistration program
Florida
• Cosmeticmanufacturers that arelocated in Florida mustobtain a cosmeticmanufacturer permitmanufacturer permit
• But as of July 1, 2017,Florida cosmeticmanufacturers nolonger have to registercosmetic products
Compare to FDA Voluntary CosmeticRegistration Program
• Cosmetic manufacturers and packagingestablishments can voluntarily register withFDA
• Cosmetic manufacturers can voluntarily file• Cosmetic manufacturers can voluntarily filecosmetic product ingredient statements
• However, proposed federal legislation wouldmake these mandatory
• Compare OTC manufacturer requirements
STATE LABELING LAWS
Prop 65
• The Warning Requirement – That Sign You SeeEverywhere in California………..is About to Change
WARNING:WARNING:This product contains a chemical known to the State ofCalifornia to cause cancer, or birth defects or otherreproductive harm.
• Safe-Harbor Product Warning
Prop 65
WARNING: This product can expose you tobenzophenone, a chemical known to theState of California to cause cancer. For moreinformation go to www.P65Warnings.ca.gov/information go to www.P65Warnings.ca.gov/
Prop 65
• Liability Shifting Provision (Cal Code ofRegs. § 25600.2(b)) –How Does It Work
• Dealing With Retailers
• Lots of Misinformation
• New Online Warning Requirement
Prop 65
• 1,4 Dioxane
• DEA in TEA
• Benzophenone• Benzophenone
• TiO2
• BPA
Prop 65
Plaintiff Plaintiff’s Counsel
Evan Smith,Anthony Ferrerio
(et al)
Brodsky & Smith
? Greenfire Law, PC
Kim Embry Noam Glick
TamarKaloustian
KJT Law Group
EcologicalAlliance, LLC
Vineet Dubey
Center forAdvanced PublicAwareness, Inc
(“CAPA”)
Kawahito Law Group
Prop 65
• Rigid Application of Prop 65
• Policy of Providing Consumers Accurate InformationLargely Ignored
Available for purchase at www.zazzle.com
California Organic Products Act
• Multi-ingredientcosmetics that are“sold as organic” mustcontain at least 70%organically producedorganically producedingredients
Identifying Organic Content in Productsthat Do Not Qualify as “Organic”
• Cosmetics that are not “organic” under COPAmay only identify organic content:
• By identifying each organic ingredient in theingredient statement with the word “organic” oringredient statement with the word “organic” orwith an asterisk or other reference mark
• By displaying the product’s percentage of organiccontents on the information panel
From Organix to . . . OGX
New Labeling Requirements forProfessional Cosmetics?
• California bill would require professionalcosmetics sold in California to satisfy all federallabeling requirements
• Professional cosmetics are exempt from FPLA,• Professional cosmetics are exempt from FPLA,which requires ingredient statements on thepackaging of consumer products
• However, proposed federal legislation wouldmake ingredient statements mandatory onprofessional products
STATE INGREDIENT DISCLOSURE LAWS
Ingredient Disclosure Proposals
• RI-H7295: Full ingredient disclosure
• CA-AB2775: Professional cosmetics labels
• NY-A5117: NY Safe Cosmetics Act of 2017
• NY-S6034A: “high concern” chemicals inchildren’s cosmetics
• And on and on and on…
Children’s Products in OR & WA• Oregon Toxic-Free Kids Act and
Washington Children’s Safe ProductsAct require reporting for children’sproducts sold or offered for sale in thestate that contain high prioritychemicals that are of high concern forchildren
• Children’s products are products made• Children’s products are products madefor, marketed for use by or marketed tochildren under 12
• Oregon requires manufacturers toremove or make a substitution of anyreportable chemical on before the dateon which it submits the third biennialnotice if the chemical is present in achildren’s cosmetic
New Internet Ingredient DisclosureLaws for Cosmetics?
• Summary: Alaska and Minnesota proposals require amanufacturer of a cosmetic manufactured,distributed, or offered for retail sale in the state todisclose on the manufacturer’s website the full list ofingredients, including the component ingredients ofingredients, including the component ingredients offragrances, flavors, and color additives.
• Status:• Alaska HB 28
• Minnesota SF 2268
• Nationwide online ingredient disclosure requirement?
California Safe Cosmetics Act: PublicDisclosure of Harmful Ingredients
• Cosmetic manufacturers must disclose to CDPHall products they sell in California that contain aningredient known or suspected to cause cancer orreproductive harm• Includes fragrances and flavorings and chemicals• Includes fragrances and flavorings and chemicals
identified by the phrase “and other ingredients”
• Information collected is publicly available on theSafe Cosmetics Program Product Database athttps://safecosmetics.cdph.ca.gov/search/
Reportable Chemicals
• Reportable chemicals based on:• Prop 65
• US EPA
• International Agency for Research on Cancer• International Agency for Research on Cancer(IARC)
• National Toxicology Program (NTP)
• Guidance list of reportable ingredientsavailable at http://bit.ly/CSCPChemlist
Safe Cosmetics Act Requirements
• Manufacturer must identify the ingredient(s)
• Manufacturer must identify the ChemicalAbstract Service (CAS) number for theingredientingredient
• Manufacturer must continuously update uponany reformulation that adds or removes areportable ingredient
Who Must Comply?
• “Manufacturers” of anycosmetic product soldin California with atleast $1 million annualaggregate sales ofaggregate sales ofcosmetic productsworldwide
• “Manufacturer” meansany person whose nameappears on the label ofa cosmetic product
Safe Cosmetics Act: Welcome toNew York?
• The New York Safe Cosmetics Act would impose thesame requirements as the California Safe CosmeticsAct
STATE EFFORTS TO PHASE OUT/BANHARMFUL INGREDIENTS & PRODUCTS
Green Chemistry
Green Chemistry
Layers Upon Layers ofRegulation
Green Chemistry
• Connecticut
• Maine
• Minnesota
• Washington• Washington
At least seven other states actively considering someform of green chemistry regulation
Green Chemistry
(b) This article does not authorize the department to supersede theregulatory authority of any other department or agency.
(c) The department shall not duplicate or adopt conflicting regulations forproduct categories already regulated or subject to pending regulationconsistent with the purposes of this article.
Cal. Health & Safety Code § 25257.1
Green Chemistry
Four-Step Process:
1. List of Candidates Chemicals – Issued (Thelist of lists)
2. Proposed Priority Products2. Proposed Priority Products
3. Alternative Analysis
4. Regulatory Response
Green Chemistry
1. Beauty, Personal Care and Hygiene Products
2. Cleaning Products
3. Household, School, and Workplace Furnishings andDécorDécor
4. Building Products and Materials Used inConstruction and Renovation
5. Consumable Office, School, and Business Supplies
Green Chemistry
Green Chemistry
Green Chemistry
Green Chemistry
Green Chemistry
• Women of Childbearing Age
• Volatile Chemicals, Vapors, Mists- InhalationExposures
• Health of Workers• Health of Workers
• Aquatic Environment
Green Chemistry
• DTSC has Invited Industry Input
• Take Advantage of That
• We have had success in working with DTSC tomake sure it has up-to-date information aboutmake sure it has up-to-date information aboutindustry practices
• Be Proactive and Monitor Your ProductPortfolio
2018 Potpourri
• VT-S.251 (Lyons) would prohibit…• manufacture, sale, and
professional use of cosmeticscontaining formaldehyde,formaldehyde equivalent, orformaldehyde releaser (>0.05%)
• replacement chemicals that are• replacement chemicals that are“toxic,” i.e. IARC 2B, NTP ROC,etc.
• NY-A5581 (Schimminger) wouldban the sale of cosmetics and OTCsfrom flea markets
• NY-A07374 (Englebright) wouldprohibit the sale of cosmetics with1,4-Dioxane
Sunscreen Ingredient Ban
• Hawaii
• SB 2571 (1/19/2018) enacted
• Bans oxybenzone and octinoxate containingsunscreens without Rxsunscreens without Rx
• Reminder: Prop. 65 listing of benzophenone
• More coming?
PROPOSED STATE BAN ON ANIMALTESTING
Animal Testing
• EU:
• REACH Article 25.1 – “testing on vertebrate animals for thepurposes of this Regulation shall be undertaken only as alast resort.”
• EU Directive 2010/63/EU (non-binding): three “Rs”
• US: Animal Welfare Act, USDA APHIS, NIH Public Health• US: Animal Welfare Act, USDA APHIS, NIH Public HealthService Policy of Humane Care and Use of Laboratory Animals
• State Testing Bans: New York, California, New Jersey
• Virginia HB 1087
• FDA’s Alternative Animal Testing Requirement
• China: mandatory testing to continue?
Cruelty-Free Cosmetics – Current
• EU Cosmetics Regulation (EC) No 1223/2009:marketing ban in EU since 3/13.
• ENVI: Worldwide ban on animal testing forcosmetics by 2023?cosmetics by 2023?
• EU, Norway, Switzerland, India, Israel, SouthKorea, New Zealand, Australia, and Taiwan
• Humane Cosmetics Act (HR 2790) (2017)
Cruelty-Free Cosmetics – Proposed
• California SB 1249 (Galgiani)• Prohibits “[import, sale,] or offer for []promotional
purposes at retail . . . any cosmetic if the final productor any component thereof was tested on animals forany purpose after January 1, 2020.”any purpose after January 1, 2020.”
• CA Sen. Judiciary 5 to 2 vote. Hearing 5/14.
• Updates?
• Hawaii SB 2115 (Gabbard, Inouye)
• New York A05145A (Rosenthal)
STATE VOC LIMITS ONCONSUMER PRODUCTS
California ARB VOC Limits• Examples of Consumer Product VOC Limits (by weight)
Product California VOC Limit
Hair Mousse 6%
Hair Shine 55%
Hair Spray 55%
Hair Styling Gel 6%
Hair Styling Product (aerosol and pumpspray)
6%spray)
Hair Styling Product (all other forms) 2%
Nail Polish Remover 2%
Personal Fragrance Product (with 20% orless fragrance)
75%
Personal Fragrance Product (with morethan 20% fragrance)
65%
Shaving Cream 5%
Shaving Gel 4%
Temporary Hair Color (aerosol) 55%
US EPA VOC LimitsProduct California VOC Limit US EPA VOC Limit
Hair Mousse 6% 16%
Hair Shine 55% N/A
Hair Spray 55% 80%
Hair Styling Gel 6% 6% (same)
Hair Styling Product (aerosol and pumpspray)
6% N/A
Hair Styling Product (all other forms) 2% N/AHair Styling Product (all other forms) 2% N/A
Nail Polish Remover 2% 85%
Personal Fragrance Product (with 20%or less fragrance)
75% N/A
Personal Fragrance Product (with morethan 20% fragrance)
65% N/A
Shaving Cream 5% 5% (same)
Shaving Gel 4% N/A
Temporary Hair Color (aerosol) 55% N/A
Date Product CategoryExcess VOCEmissions
SettlementAmount
01/2017Personal Fragrance Product (20% or less
fragrance) 0.826 tons $12,39001/2017 Hair Styling Products 0.350 tons $6,30003/2017 Nail Polish Remover 1.830 tons $33,00003/2017 Hair Styling Products 0.820 tons $12,300
06/2017
General Purpose Cleaning WipesGlass Cleaning WipesTemporary Hair Color 0.850 tons $31,143
2017 ARB Enforcement Actions
06/2017 Temporary Hair Color 0.850 tons $31,143
06/2017 Hair Styling Product: Aerosol and Pump Spray 1.340 tons $13,40009/2017 Hair Styling Products 3.600 pounds $3,000
10/2017
Hair Styling Product: Aerosol and Pump Spray&
Hair Finishing SprayHair Shine 0.480 tons $13,500
11/2017 Hair Styling Products 7.630 tons $100,00011/2017 Hair Styling Product 11.110 tons $110,00011/2017 Hair Styling Products 3.360 tons $50,374
Date Product CategoryExcess VOCEmissions
SettlementAmount
01/2018
Shaving GelHair Styling Product: Aerosol and Pump Spray
Personal Fragrance Product (20% or lessfragrance) 0.078 tons $10,000
2018 ARB Enforcement Actions(so far)
Other States with VOC Regulations
• Connecticut
• Delaware
• District ofColumbia
• Illinois
• Indiana
• New Jersey
• New York
• Ohio
• Pennsylvania
• Rhode Island• Indiana
• Maine
• Maryland
• Massachusetts
• Michigan
• NewHampshire
• Utah
• Vermont
• Virginia
SLACK FILL LAWS
What is Slack Fill?
• Empty space in packaging that implies that there is moreproduct than actually contained in the packaging
• Under-filling
• Indented bottoms• Indented bottoms
• Extra walls, etc.
California’s Slack Fill Laws
• “No container . . . shall have a false bottom, falsesidewalls, false lid or covering, or be otherwiseso constructed or filled . . . as to facilitate theperpetration of deception or fraud.”
• “No container shall be made, formed, or filled as• “No container shall be made, formed, or filled asto be misleading. A container that does notallow the consumer to fully view its contentsshall be considered to be filled as to bemisleading if it contains non-functional slack fill.”
“Nonfunctional Slack Fill”
• Slack fill in a package shall not be used asgrounds to allege a violation of the slack filllaw unless it is “nonfunctional slack fill.”
• “Nonfunctional slack fill” is the empty spacein a package that is filled to substantially lessthan its capacity and does not fall within oneof the statute’s 15 safe harbor exemptions
Safe Harbors• Actual size of the product is clearly depicted
• Necessary “headspace” for mixing
• Product delivery or dosing device
• Kit that consists of multiple components• Kit that consists of multiple components
• Routinely displayed using demonstrations
• Holiday or gift packages
• Purchased product and a free sample or gift
• Computer hardware or software
Safe Harbors (cont’d)
• Protection of the contents
• Requirements of packaging machines
• Unavoidable product settling
• Space for necessary and mandatory labeling information• Space for necessary and mandatory labeling information
• Container itself has value
• Facilitate handling or deter shoplifting
• “Reasonable relationship” to the product inside
More Safe Harbors on the Way?
• AB 2632 would add three additional safe harbors:
• Exterior packaging states the number of product itemscontained in the packaging, contains a full-scale depictionof the items and the statement “actual size”
• Exterior packaging indicates the amount of product in thecontainer by means of a “fill line” or silhouette thatrepresents the actual product or level of product with thestatement “fill line”
• The mode of commerce does not involve consumerinteraction with the container before purchase
Public Enforcement Case Example:Tropicana (2017)
• California AG filed a lawsuit against Tropicanafor slack fill in cardboard orange juicecontainers
• Tropicana agreed to pay $700,000 in civilpenalties and $65,050 in investigative costs
Peter Thomas Roth Face Mask
Clean Reserve Perfume
Blistex Medicated Lip Ointment
What’s the Matter with Missouri?• No “reliance” requirement under
Missouri’s Merchandising PracticeAct (MMPA), which prohibitsdeceptive, fraudulent, misleading andunfair conduct in connection with thesale or advertisement of anymerchandise
• “Puffery” may be actionable
• Plaintiffs’ lawyers can determine thevalue of the cases in their pleadingsin order to stay in state court andavoid jurisdictional amountrequirements that would kick thecase to federal court
Cases Often Survive the Pleading Stage
White v. Just BornHawkins v. Nestle USA Bratton v. Hershey Company
Ending on a high note…• Monsanto Federal Case (Prop. 65 listing of glyphosate)
• District Court: First Amendment bars mandatory disclosure ofmisleading information (ruling on preliminary injunction)
• APPLIES TO MORE THAN PROP. 65 WARNINGS?
Questions?
John A. Conkle, Esq.
Conkle, Kremer & Engel, PLC
Santa Monica, California
310.998.9100
Gregory G. Sperla, Esq.
Scali Rasmussen
Sacramento, California
916.449.9534
Anthony J. Cortez
Greenberg Traurig
Sacramento, California
916.868.0679
