Society of Cosmetic ChemistsToronto ChapterToronto Chapter

Robert Ross-FichtnerSCC TorontoApril 6 2016April 6, 2016

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Let’s see what we will do in the next hour 

• Sessions BillThe Safe Cosmetics Modernization Act– The Safe Cosmetics Modernization Act

• Feinstein Collins Bill– The Personal Care Products Safety Act

C d C t t T i f L i l ti• Compare and Contrast: Two pieces of Legislation

• Regulatory News ‐ ICMADRegulatory News  ICMAD

Why do governments regulate things???Why do governments regulate things???

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How Much TRUST do we have in cosmetics and their How Much TRUST do we have in cosmetics and their i di t ???i di t ???ingredients???ingredients???

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GOOGLE:

“How to Ban Dangerous Chemicals”“How to Ban Dangerous Chemicals”( i i l l h d h h )(using simple tools you have around the house)

1 340 000 Hits1 340 000 Hits1,340,000 Hits1,340,000 Hits

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Leading NA authority on Cosmetic Safety?Leading NA authority on Cosmetic Safety?

CCTFA?FDA?

PCPC?ICMAD?

SCC?CIR?

State of California?????? State of California?????? State of California?????? State of California??????

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California Safe Cosmetics Act

“Given the presence of substances in cosmetic products that d d ti t i it th h f thcause cancer and reproductive toxicity, the heavy use of these 

products by women of childbearing age, the significant exposure to these products in occupational settings such as nail andto these products in occupational settings such as nail and beauty salons, the adverse impacts of these substances on human health, the inadequate information about the…..”

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Environmental Working GroupEnvironmental Working Group(EWG)(EWG)

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WHY???WHY???

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TWO BILLS

SESSIONS BILL

SESSIONS BILL

• The bill was proposed and named after the US• The bill was proposed and named after the US congressman Pete Sessions

– Introduced The Safe Cosmetics Modernization Act November 19th, 2015

– This act reforms and improves the FDA’s ability– This act reforms and improves the FDA s ability  to streamline and strengthen consumer safety requirements

SESSIONS BILL

• Took several years and meetings with the FDA cosmetic industry and• Took several years and meetings with the FDA, cosmetic industry and activists along with watching how other countries regulations are changing

• Takes current laws and modernizes them to create a strong federal regulatory program

Meaning there will be ONE regulatory authority in the US– Meaning there will be ONE regulatory authority in the US– Will enhance The Food and Drugs Administration’s authority

SESSIONS BILL

• This piece of legislation is supported by the Independent Cosmetic Manufacturers And Distributors (ICMAD)Manufacturers And Distributors (ICMAD)– “modernizes and improves the FDA’s ability to assure the safety of cosmetic products 

by examining ingredient safety, establishing manufacturing processes and tracking and quickly addressing adverse health impacts from potentially unsafe products andand quickly addressing adverse health impacts from potentially unsafe products and requir‐ing that all manufacturers be registered with the FDA”

• Bill will continue a system if cosmetic regulation that has kept the U.S. a leader in the world market by maintaining a record of safetyleader in the world market by maintaining a record of safety

SESSIONS BILL

• According to the Bill itself:“To amend the Federal Food Drug and Cosmetic Act to establish new procedures and– To amend the Federal Food, Drug, and Cosmetic Act to establish new procedures and requirements for the registration of cosmetic manufacturing establishments, the submission of cosmetic and ingredient statements, and the reporting of serious cosmetic adverse events, and for other purposes”

• This will be possible without affecting small businesses to allow entrepreneurs and innovators within the cosmetic industry to compete inentrepreneurs and innovators within the cosmetic industry to compete in both national and international marketplaces

SESSIONS BILL

Federal PreemptionFederal PreemptionADR ReportingGMPsIngredient SafetyCosmetic and facility Registration

SESSIONS BILL

• Sections 4 5: Registries of Cosmetics and Manufacturing Establishments• Sections 4,5: Registries of Cosmetics and Manufacturing Establishments– Creates mandatory registration of products and manufacturing facilities using current 

registration systems• The Secretary shall require that even domestic and foreign establishments engaged in the• The Secretary shall require that even domestic and foreign establishments engaged in the manufacture of a cosmetic must be registered with the Secretary within 60 business days after the first commercial sale in the US

– No cost to the government in setting up new reporting facilities

SESSIONS BILL

• Section 6: Serious and Unexpected Adverse Event Reporting for Cosmetics• Section 6: Serious and Unexpected Adverse Event Reporting for Cosmetics– Amends Chapter VI (21 U.S.C. 361 et seq.) by the addition if certain criteria to the end 

of this sectionIf a product is causing a serious safety problem the FDA will know immediately– If a product is causing a serious safety problem the FDA will know immediately

– Procedures will be part of the post marketing risk management program which is similar to those in place for dietary supplements and OTC drugs

SESSIONS BILL

• Section 7: Good Manufacturing Practises• Section 7: Good Manufacturing Practises– Amends Section 601 (21 U.S.C. 361) by including these at the end where presently 

they are not foundWill t bli h GMP f ti th t f d th i k i t d ith th– Will establish GMPs for cosmetics that are focused on the risk associated with these products

– There are currently few enforcement actions and it is apparent that the greatest risks are associated with either micro contamination or issues with the manufacturingare associated with either micro‐contamination or issues with the manufacturing process

SESSIONS BILL

• Section 8: Safety Substantiation for Cosmetic Ingredients and Non• Section 8: Safety Substantiation for Cosmetic Ingredients and Non‐Functional Constituents– Amends Chapter VI (21 U.S.C. 361 et seq.) by the addition if certain criteria to the end 

f thi tiof this section

• Session 9: National Cosmetic Regulatory Databankg y– Amends Chapter VI (21 U.S.C. 361 et seq.) by the addition if certain criteria to the end 

of this section

SESSIONS BILL

• Section 11: Prohibited Acts• Section 11: Prohibited Acts– Amends Section 301 (21 U.S.C. 331) by adding prohibited acts to the end of the current 

version

• Section 12: National UniformitySection 12: National Uniformity– Amends Section 752 (21 U.S.C. 379) by adding national uniformity for cosmetics at the 

end of the current legislation

SESSIONS BILL

Definition of a cosmetic:

• Allow:  “alter the appearance by temporarily affecting the Structure or Function of the human skin” 

SESSIONS BILL

• SummaryIt ill increase cons mer protection on cosmetics hile still allo in a– It will increase consumer protection on cosmetics while still allowing a continued growth of small businesses in the US

• Allow them to thrive due to a national uniformity of regulations• Will allow for an industry that is open for small business entrepreneurs to bring true innovation

• “Our goal was to improve transparency and safety while helping our country and our industry maintain its competitive edge. We believe we have accomplished this goal.” – Sharon Blinkoff

Feinstein Collins Bill

Senate

FEINSTEIN COLLINS BILL

• Bill was introduced and named after Senators Dianne Feinstein and Susan CollinsCollins– Titled the Personal Care Products Safety Act– Would require the FDA to investigate five potentially risky ingredients every year

FEINSTEIN COLLINS BILL

• When first introduced, the ICMAD immediately stated its opposition to the billbill

• The bill is being supported by the Personal Care Products Council (PCPC)– They represent over 600 companies within the cosmetic industry

• The bill is also supported by the majority of major companies such as:– Johnston & Johnston– Procter & Gamble– Estee Lauder– Unilever

FEINSTEIN COLLINS BILL

• The Senate has stated that many Americans are surprised to learn that the• The Senate has stated that many Americans are surprised to learn that the ingredients in their cosmetics are largely under regulated

• Under this bill, the FDA would have the ability to stop companies from selling unsafe products and would be able to recall any products it finds dangerousdangerous

FEINSTEIN COLLINS BILL

• First brought up due to Europe’s robust system which includes:Consumer protection with product registration– Consumer protection with product registration

– Ingredient reviews 

• As Feinstein has stated:

– “it will require FDA to review chemicals used in these products and provide clear q p pguidance on their safety. In addition, the legislation has broad support from companies and consumer groups alike.”

FEINSTEIN COLLINS BILL

• According to the Bill itself:According to the Bill itself:– “To amend the Federal Food, Drug, 

and Cosmetic Act to ensure the safety of cosmetics”

• It will protect consumers and create better industry ycompliance by strengthening the FDA’s authority to regulate ingredients

FEINSTEIN COLLINS BILL

• Once again, whenever in this Act an amendment is expressed to a section, the reference is considered to be made to a section or chapter of thethe reference is considered to be made to a section or chapter of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.301 et seq.)

• Section 101: Registration of cosmetic facilities and Cosmetic ingredient statements– Will add registration and Fees for existing manufacturing or processing of cosmetics– For each cosmetic product, a responsible person must submit to the FDA an ingredient 

statement

FEINSTEIN COLLINS BILL• Section 102: Review of ingredients and non‐functional constituents; safety 

of finished products– Amendment to Chapter VI (21 U.S.C. 361 et seq.) by further adding to the end– Would require the FDA to evaluate a minimum of five ingredients per year to 

determine their safety and appropriate use– The first set of chemicals for review includes:The first set of chemicals for review includes: 

1. Diazolidyl Urea2. Lead Acetate3. Methylene Glycol/formaldehyde4 Propyl paraben4. Propyl paraben5. Quaternium‐15

• Would provide companies with clearer guidance about ingredients– Ex: A chemical may be deemed inappropriate for use in children’s products or appropriate for 

f i l li ti lprofessional application only

FEINSTEIN COLLINS BILL

• Section 103: Good manufacturing practices for cosmeticsAmend Chapter VI (21 U S C 361 et seq ) by adding this to the end– Amend Chapter VI (21 U.S.C. 361 et seq.) by adding this to the end

– Will direct the FDA to issue regulations on GMPs for personal care products

• Section 104: Adverse event reports– Amend Chapter VI (21 U.S.C. 361 et seq.) by adding this to the end– With any cosmetic distributed in the US, the responsible person shall submit to the y p p

FDA a report of any serious adverse events associated with the product– This bill will require companies to provide contact information on their products for 

consumers and report serious adverse events to the FDA within 15 days

FEINSTEIN COLLINS BILL

• Section 105: Records Inspection; mandatory recall authorityAmend Chapter VI (21 U S C 361 et seq ) by adding this to the end– Amend Chapter VI (21 U.S.C. 361 et seq.) by adding this to the end

– Require manufacturers to register annually with the FDA and provide the agency with information on the ingredients used in their personal care products.Would provide the FDA with the authority to order recalls of certain cosmetics that– Would provide the FDA with the authority to order recalls of certain cosmetics that threaten consumer safety

i b lli• Section 106: Labelling– Amend Chapter VI (21 U.S.C. 361 et seq.) by adding this to the end– The FDA requires labelling of products that includes ingredients that are no 

appropriate for children and those that should be professionally administered

FEINSTEIN COLLINS BILL

• Section 107: Coal tar chemicalsAmend Chapter VI (21 U S C 361 et seq ) by adding this to the end– Amend Chapter VI (21 U.S.C. 361 et seq.) by adding this to the end

– The FDA may review any ingredient to determine it is safe for cosmetic products

S i 108 A i l i Al i• Section 108: Animal Testing Alternatives– Amend Chapter VI (21 U.S.C. 361 et seq.) by adding this to the end– This will minimize the use of animal testing for the safety of cosmetic ingredients and 

the FDA will encourage the use of alternative testing

FEINSTEN COLLINS BILL

• SUMMARYIn order to f nd these acti ities the bill a thori es the FDA to collect ser fees– In order to fund these activities, the bill authorizes the FDA to collect user‐fees from cosmetic manufacturers 

– The bill would provide federal standards so that this industry knows what to t d i l f th f t ith t i texpect and companies can plan for the future with certainty

Compare and Contrast:

Two Pieces of o eces oLegislation

COMPARE AND CONTRASTSessions Bill Feinstein – Collins Bill

FDA Oversight FDA Oversight

Allow cosmetics to make structure function claims which are therapeutic claims

n/a

GMPs GMPs

ADR Reporting ADR Reporting

N/A FEES

Ingredient Safety‐Precedent Massive ingredient safety provisions

l d d l d dFacility and ingredient registration Facility and ingredient registration

Minimal work for FDA Huge work for FDA

Regulatory News

ICMAD

REGULATORY NEWS

• In November 2015, lawmakers in the House and Senate introduced the bill H 4061which directs the HHS secretary to develop a final rule for the useH. 4061 which directs the HHS secretary to develop a  final rule for the use of “natural” ingredients

• The cosmetic industry groups are still monitoring the legislation and the FDA’s efforts, to control the labelling of theses claims

REGULATORY NEWS

• The FDA’s Office of International Programs is realigning its interaction enforcement activities:enforcement activities:– “In order to strategically focus its resources to monitor counterfeiting, diversion and 

other criminal activities”

• Attorneys and stakeholders believe the new federal legislation banning the use of plastic microbeads is light on details and fails to define some key terms– Companies producing biodegradable microbeads from plant materials are unsure if 

the ban applies to their products– An FDA rulemaking or guidance may be required to clarify several points

REFERENCES

• http://www.feinstein.senate.gov/public/index.cfm/files/serve/?Fil id 445 9268 4964 4d 0 89f9 4 f577099f2?File_id=445a9268‐4964‐4de0‐89f9‐4caf577099f2

Thank you!Thank you!

R b t R Fi htRobert Ross-Fichtner@RobRossFichtner

robrf@focalpointresearch.neté  p905-271-2709 ext 222

© 2016 Focal Point Research Inc. No copies without permission.

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