Industry review of cosmetic regs

[Guest guest]

Cosmetic Regulations in North America - USA & Canada: Update on Legal

Dr. Annelie Struessmann - Sep 9, 2009

After being nominated by the American President Barack Obama, on May 18, 2009

Margaret A. Hamburg, M.D., was confirmed to become the 21st Commissioner of the

US Food and Drug Administration (FDA) which is under the umbrella of the US

Department of Health & Human Services. The FDA is the federal agency responsible

for ensuring the safety of drugs, medical devices, food, cosmetics and many

other health-related products. The Agency regulates as such products which

represent a value in consumer goods of more than US-$1 trillion, and is

responsible for monitoring a third of all goods imported into the USA, items as

varied as 'eggplants, eyeliners, microwave ovens, monoclonal antibodies and

cellphones'1.

With regard to cosmetics marketed in the United States, the Agency has authority

over the two most important laws pertaining to cosmetics, the Federal Food,

Drug, and Cosmetic Act (FD & C Act)2 and the Fair Packaging and Labeling Act

(FPLA)3. The key legal concept of the FD & C Act is the prohibition of 'marketing

adulterated or misbranded cosmetics into interstate commerce'. Only these

principles constitute the wording of the law and it is the FDA to decide on

definitions and measures to fulfill the Act's requirement. Adulteration may

result from ingredients, contaminants, processing, packaging, or shipping and

handling. Improperly labeled or deceptively packaged products are considered

misbranded. Both is subject to regulatory action while the responsibility for

substantiating the safety of products and ingredients lies with the cosmetic

firms and all parties involved in the handling, manufacturing, packing,

distributing and retailing. Cosmetic products & ingredients are not subject to

premarket approval with the exception of color additives4. Additional

regulations prohibit or restrict the use of eleven specified ingredients5. An

FDA post-market reporting system for use by manufacturers, packers, and

distributors of cosmetic products marketed in the United States is a voluntary

program (Voluntary Cosmetic Registration Program -VCRP).

During the past years, the FDA had been under scrutiny by the American public

and its political representatives. The prestigious newspaper New York Times

repeatedly drew attention on criticism that medicines were approved too easily6

and on scandals involving tainted drugs and food, etc7. Discussions included

increasing shortness of time in office for commissioners, political appointments

and also budget considerations8,9,10. With the appointment of Dr. Hamburg as new

commissioner, the Obama Administration announced also a request for an FDA

funding boost of more than 19% to US-$3.2 billion11. On July 9, 2009, a US-$2.99

billion budget for the fiscal year 2010 was approved by Congress; it represents

the largest increase on the funding in FDA history12. A first official act of

the new commissioner was the launch of a new FDA website in June 200913. The

page design and the navigation were updated, the contents were reviewed and new

features were created.

Criticism towards the FDA in the field of cosmetic's legislation was derived

from consumer advocacy groups, amongst these the most prominent are the Breast

Cancer Fund14 and the Environmental Working Group15, which are addressing issues

of potential risks from cosmetic ingredients for consumers and that these are

not sufficiently controlled by the FDA. As well, there has been criticism since

long from governmental institutions. Already in 1978, the U.S. Government

Accountability Office (GAO), an independent, nonpartisan agency that works for

Congress, stated in a Report that the 'FDA does not have an effective program

for regulating cosmetics'16. Major points of criticism include that the FDA has

limited statutory authority, but has to rely on the voluntary initiatives of the

cosmetic industry. Until today, cosmetics ingredients in the US are not

evaluated by the FDA, but by an industry sponsored panel and the results are

published as Cosmetic Ingredient Review (CIR)17 reports. However, the CIR panel

has evaluated only a limited percentage of ingredients and also, the reports are

not readily accessible to the consumer as they need to be paid for. A fee

applies as well to the Cosmetic Ingredient Dictionary and Handbook18,19, which

provides a comprehensive listing of ingredients used in cosmetic and personal

care products. The controversy over cosmetic safety and the options for

legislative counteraction are extensively depicted in a paper from 2006 on

'Cosmetic Regulation: The Case for Reform', published by Nakia Elliott of

Harvard Law School20.

When researching the FDA website for publications from the past years, it

becomes obvious, that few legal actions were taken to address the various issues

on cosmetics safety brought forward. Longtime requested new standards on UVA

protection of sunscreen products had finally been proposed on August 27, 2007

but the entrance into force was delayed by the FDA for the review of comments

received on the proposal21,22 and is still open. Sunscreen products are

legislated in the US as 'Drug Products for Overthe- Counter Human Use' (OTC

drugs). One new publication found dating from 2009 is 'Guidance for Industry' on

cochineal extract and carmine and requiring their declaration by name on the

label of all food and cosmetic products23. Also to be found on the FDA website

are actual consumer updates on potentially harmful products or advices and

alerts on products and its usages.

The new website provides comprehensive information, however, elucidates the

FDA's limitations and as such the sources of the criticisms. The Agency explains

its position by stating that laws governing the United States are passed by the

Congress. Government agencies, as such the FDA, are authorized by the Congress

to put the laws into effect through creating and enforcing regulations based on

the law. These are published in the Code of Federal Regulations [CFR] under

Title 21 and subdivided in parts, paragraphs, etc. A change in FDA's statutory

authority, as such over cosmetics, would require Congress to change the law.

Meanwhile the State of California passed its own cosmetics legislation which

took effect in January 2007. The California Safe Cosmetics Act24 puts higher

requirements on the manufacturers of cosmetics. These have to report the use of

potentially hazardous ingredients to the California Department of Public Health

(CDPH)25. The primary purpose of the program is to collect information on

hazardous and potentially hazardous ingredients in cosmetic products sold in

California and to make it available to the public.

The federal department responsible for minimizing the risk associated with the

use of cosmetics marketed in Canada is 'Health Canada'. It controls a cosmetics

market with estimated sales of over four billion Canadian dollars annually. On

October 30, 2008, Leona Aglukkaq was named Minister of Health. She is the first

Inuk in Canadian history to be appointed to the Cabinet. The department's

'Cosmetics Program' defines and communicates requirements for the manufacture,

labeling, distribution and sale of cosmetics, and evaluates compliance26.

Enforcement is overseen by Product Safety Officers who manage inspections,

investigations, seizures, recalls and prosecutions out of six regional offices.

Health Canada's regulatory authority for its Cosmetics Program is based on the

Food and Drugs Act and Cosmetic Regulations27, the Consumer Packaging and

Labeling Act and Regulations28, the Consumer Chemicals and Containers

Regulations of the Hazardous Products Act29 and several other regulatory

frameworks30. The laws are defining all regulatory principles and provisions in

its wordings. Also applicable to cosmetics is the Canadian Environmental

Protection Act (CEPA)31 on new and existing substances of the federal department

Environment Canada.

It is the manufacturer's and importer's responsibility to ensure compliance with

all legal provisions. A post market notification form has to be filed for each

cosmetic product within 10 days after first sales providing information on the

manufacturer(s)/distributor, the application of the product, its physical form

and the formulation. Further basic requirements include product labeling in both

official languages of the country, French & English, including the ingredients

list in INCI acc. to the Cosmetic Ingredient Dictionary and Handbook18,19.

Labels for pressurized containers have to display additionally defined hazard

symbols32. Not mandatory are safety substantiation files or GMP requirements;

however, mandatory as well are proper claims that do not mislead the public. The

claims or ingredients of a product determine whether it is regarded as a

cosmetic versus another type of consumer good (e.g. drug, food, natural health

product, etc.). Any product that is a drug is subject to pre-market approval and

must have a Drug Identification Number (DIN). Some products, e.g.

fluoride-containing toothpastes, sunscreens, and antiperspirants are regulated

as drugs because they may help to prevent a disease (cavities), abnormal

physical state (sunburn), or modify an organic function (perspiration).

Health Canada maintains and publishes a list of prohibited and restricted

ingredients in cosmetics, the Cosmetic Ingredient 'Hotlist'33. It is a

science-based document that is reviewed and updated a few times per year based

on new scientific information, new regulatory decisions (domestic or

international), consumer complaints, media reports or industry requests. It

contains more then 500 ingredients, which are known to cause adverse health

effects or are limited to pharmaceutical applications. Unless otherwise stated,

substances on the 'Hotlist' are prohibited in cosmetic products or are

restricted when listed with specific condition(s). If a cosmetic contains a

restricted ingredient the company must indicate the exact concentration in the

notification form.

In 2008 the Health Canada website26 was redesigned. It provides comprehensive

information on all aspect of cosmetics regulation and its enforcement, as well

as notification forms, guidance documents and warning or advisory papers.

1 NYT, March 11, 2009

http://www.nytimes.com/2009/03/12/us/politics/12hamburg.html?_r=2 & em

2 FD & C Act:

www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAc\

t/default.htm

3 FPLAct : www.fda.gov/RegulatoryInformation/Legislation/ucm148722.htm

4 ColorAdd.:

www.fda.gov/ForIndustry/ColorAdditives/ColorAdditivesinSpecificProducts/InCosmet\

ics/ucm130125.htm

5 Spec.Ingr.:

www.fda.gov/Cosmetics/ProductandIngredientSafety/SelectedCosmeticIngredients/ucm\

127406.htm

6 NYT, Sept. 29, 2008:

www.nytimes.com/2008/09/30/health/policy/30fda.html?scp=9 & sq=FDA%20cosmetics%202\

009 & st=cse

7 NYT, May 14, 2008: www.nytimes.com/2008/05/14/washington/14fda.html

8 SKAPP: www.defendingscience.org/newsroom/Advancing-FDA-Conversation.cfm

9 SKAPP:

www.defendingscience.org/newsroom/upload/Commissioner_Quotes_By_Topic.pdf

10 NYT, Feb. 11, 2007: www.nytimes.com/2007/02/11/magazine/11wwlnQ4.t.html

11 President's 2010 Budget Request:

http://budget.house.gov/doc-library/FY2010/05.15.09_Presidents_Budget_Analysis.p\

df

12 Wall Street Journal, July 6, 2009:

http://online.wsj.com/article/SB124716092508118941.html

13 FDA: www.fda.gov/default.htm

14 Breast Cancer Fund: www.breastcancerfund.org/site/pp.asp?c=kwKXLdPaE & b=70918

15 Environmental Working Group: http://www.ewg.org/

16 U.S. Government Accountability Office (GAO): www.gao.gov/products/HRD-78-139

16 Cosmetic Ingredient Review (CIR): www.cir-safety.org/index.shtml

18 Personal Care Products Councll:

http://eservices.personalcarecouncil.org/site/vision_Bookstore_SplashPage2.htm

19 Cosmetics Info: www.cosmeticsinfo.org/fdapartner_cid.php

20 Cosm.Reg: The Case for Reform, Nakia Elliott, May 24, 2006:

http://leda.law.harvard.edu/leda/data/797/Elliot06.html

21 Sunscreen proposal, Aug. 27, 2007: www.fda.gov/OHRMS/DOCKETS/98fr/07-4131.pdf

22 Sunscreen rulemaking history:

www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Overthe-

CounterOTCDrugs/StatusofOTCRulemakings/ucm072134.htm

23 Cochineal:

www.fda.gov/ForIndustry/ColorAdditives/GuidanceComplianceRegulatoryInformation/u\

cm153038.htm

24 CA Safe Cosm. Act, 2005:

www.leginfo.ca.gov/pub/05-06/bill/sen/sb_0451-0500/sb_484_bill_20051007_chaptere\

d.pdf

25 California Department of Public Health:

www.cdph.ca.gov/programs/cosmetics/Pages/default.aspx

26 Health Canada:

www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hecs-dgsesc/psp-psp/cosmet-eng.php

27 Food & Drugs Act and Cosmetic Regulations:

http://laws.justice.gc.ca/en/F-27/C.R.C.-c.869/122960.html

28 Consumer Packaging and Labelling Act and Regulations:

http://laws.justice.gc.ca/en/C-38/

29 CCCR of the Hazard.Prod.Act:

www.hc-sc.gc.ca/cps-spc/pubs/indust/cccr-2001-rpccc/ref_man/index-eng.php

30 Other legislation:

www.hc-sc.gc.ca/cps-spc/person/cosmet/info-ind-prof/notification-declaration-eng\

..php

31 CEPA: www.ec.gc.ca/CEPARegistry/the_act/

32 Symbols for pressurized containers:

www.hc-sc.gc.ca/cps-spc/pubs/indust/person/cosmet/index-eng.php

33 Hotlist:

http://www.hc-sc.gc.ca/cps-spc/person/cosmet/info-ind-prof/_hot-list-critique/ho\

tlist-liste-eng.php