BILL ANALYSIS Ó
AB 237
Page 1
Date of Hearing: May 3, 2011
ASSEMBLY COMMITTEE ON HEALTH
William W. Monning, Chair
AB 237 (Galgiani) - As Introduced: February 3, 2011
SUBJECT : Cosmetics: misbranding.
SUMMARY : Permits the Department of Public Health (DPH) to,
within existing resources, require any manufacturer of cosmetic
products that does not currently comply with the applicable
parts of the federal Food and Drug Administration (FDA)
Voluntary Cosmetic Reporting Program (VCRP), to provide to the
department information of the same kind disclosed through the
federal program.
EXISTING LAW :
1)Regulates, under the Sherman Food, Drug, and Cosmetic Law, the
packaging, labeling, and advertising of food, drugs, and
cosmetics.
2)Prohibits a person from manufacturing, selling, delivering,
holding, offering for sale, or receiving in commerce any
cosmetic that is adulterated and prohibits a person from
adulterating any cosmetic.
3)Requires the manufacturer of any cosmetic product subject to
regulation by the FDA that is sold in this state to, on a
schedule, and in electronic or other format, as determined by
the Division of Environmental and Occupational Disease Control
(DEODC) of the DPH, provide DEODC with a complete and accurate
list of its cosmetic products that, as of the date of
submission, are sold in the state and contain any ingredient
that is a chemical identified as causing cancer or
reproductive toxicity, as specified.
4)Creates, under federal regulation, a program for voluntary
registration of cosmetic product establishments and cosmetic
product ingredients, called the VCRP.
FISCAL EFFECT : This bill has not been analyzed by a fiscal
committee.
COMMENTS :
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1)PURPOSE OF THIS BILL . According to the author, this bill
provides new accountability and transparency for cosmetic
products sold in California, without adding new costs to state
government. The author states that based upon recent health
concerns related to other FDA regulated products, this
proposal, if enacted, would provide a new level of protection
for consumers, and cosmetic manufacturers.
2)VCRP . According to the FDA, the VCRP is a post-market
reporting system for use by manufacturers, packers, and
distributors of cosmetic products. The VCRP applies only to
cosmetic products being sold to consumers in the United States
and not to cosmetic products for professional use only, such
as products used in beauty salons, spas, or skin care clinics.
It also does not apply to hotel samples. The federal
regulation for the VCRP (Title 21, Part 720: Voluntary Filing
of Cosmetic Product Ingredient and Cosmetic Raw Material
Composition Statements) also exempts fragrance and/or flavor
from the reporting requirements. The information received by
the FDA from the VCRP is entered into a computer database. If
it is determined that a cosmetic ingredient presently being
used is harmful and should be removed from product use, the
FDA can notify the manufacturers and distributors of affected
products by using a mailing list (or email list for those who
participate via Internet) generated from the VCRP database.
Those whose products are not in the registration database are
not on the notification mailing list. According to the FDA,
information from the VCRP database assists the Cosmetic
Ingredient Review (CIR) Expert Panel in determining its
priorities for ingredient safety review.
3)CIR Expert Panel . According to the CIR Website, it was
established in 1976 by the Cosmetic, Toiletry, and Fragrance
Association (CTFA) with support of the FDA and the Consumer
Federation of America. Although funded by CTFA, CIR and the
review process are independent from CTFA and the cosmetics
industry. According to the CIR, it reviews and assesses the
safety of ingredients used in cosmetics in an open, unbiased,
and expert manner, and publishes the results in open,
peer-reviewed scientific literature. The seven voting members
of the CIR Expert Panel include physicians and scientists who
have been publicly nominated by consumer, scientific and
medical groups, government agencies, and the industry. After
completion of a development process that includes multiple
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opportunities for public comment and open, public discussion
of the report, a final report is issued, which is available
from CIR and published in the International Journal of
Toxicology. A May 1992 article in the FDA's consumer magazine
called CIR the "most well-known of industry-sponsored
self-regulation . . . sponsored by the CTFA." The article
went on to say that a "finding of safety by the CIR provides a
degree of confidence that the ingredient can safely be used in
cosmetics," and that in the absence of CIR, there would be no
systematic examination of the safety of individual cosmetic
ingredients.
4)Existing DPH authority . DPH currently must access the VCRP
data through the federal Freedom of Information Act process.
According to the CTFA, the FDA has indicated that DPH could
bypass the Freedom of Information Act process and request the
information through the FDA Federal-State relations division.
However, if DPH chooses to bypass the Freedom of Information
Act process altogether and request the information through the
FDA Federal-State relations division, there are no mandates
that require the information be provided; therefore no
guarantee that DPH would receive the information requested.
In addition, DPH has enforcement authority to inspect and have
access to any record, file, paper, process, control, and
facility that has a bearing on whether the cosmetic is
adulterated, misbranded or falsely advertised.
5)Previous legislation . AB 1879 (Feuer and Huffman), Chapter
559, Statutes of 2008, requires the Department of Toxic
Substances Control (DTSC), by January 1, 2011, to establish a
process to identify, evaluate, and prioritize chemicals and
chemical ingredients in products that may be considered a
"chemical of concern." AB 1879 also authorizes DTSC to take a
range of regulatory actions to limit exposure to chemicals of
concern. Additionally, AB 1879 requires DTSC to establish a
Green Ribbon Science Panel to advise them on technical and
scientific matters and establish a procedure for the
protection of information that is claimed to be a trade
secret. The proposed regulations from November 2010 have been
withheld from submission to the Office of Administrative Law
and are being reconsidered.
SB 509 (Simitian), Chapter 560, Statutes of 2008, requires DTSC,
by January 1, 2011, to establish a Toxics Information
Clearinghouse, a decentralized, Web-based system for the
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collection, maintenance, and distribution of information on
chemicals used in daily life. SB 509 also requires the Office
of Health Hazard Assessment (OEHHA), by January 1, 2011, to
evaluate and specify hazard traits and environmental and
toxicological end-points for the Clearinghouse. DTSC is
required to evaluate and prioritize the chemicals using the
criteria provided by OEHHA.
AB 595 (Dymally) of 2007 contained substantially similar
provisions to this bill and was held on suspense in the Senate
Appropriations Committee.
SB 484 (Migden), Chapter 729, Statutes of 2006, the California
Safe Cosmetics Act, requires cosmetic manufacturers to provide
DPH with a complete and accurate list of its cosmetic products
that, as of the date of submission, are sold in the state and
contain any ingredient that is a chemical identified as
causing cancer or reproductive toxicity, as specified. DPH
launched an online reporting system on June 15, 2009.
Companies subject to reporting under the Safe Cosmetics Act
were initially required to submit all reportable cosmetic
products by December 15, 2009, however compliance with the law
has not been completed by all companies. As of December 2010,
DPH had identified 791 chemicals that meet the burden of proof
required for mandatory reporting under the California Safe
Cosmetic Act.
AB 2025 (Chu) of 2004 would have required the manufacturer of
any cosmetic or personal care product sold in California to
submit to OEHHA a list of ingredients contained in the
product, including the name of each ingredient for purposes of
fragrance or flavoring and the name of each ingredient
identified by the phrase "and other ingredients." AB 2025
would also have required the manufacturer to identify any
ingredient that is a chemical identified as causing cancer or
reproductive toxicity or to declare in writing to the OEHHA
that its products do not contain any chemical identified as
causing cancer or reproductive toxicity. Finally, the bill
would have prohibited any person from manufacturing,
processing, or distributing in a cosmetic or personal care
product that contains a chemical identified as causing cancer
or reproductive toxicity. AB 2025 was set to be heard in the
Assembly Committee on Health, but the hearing was cancelled at
the request of the author.
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6)SUPPORT . The Personal Care Products Council states that this
bill is important as it will provide DPH with additional tools
necessary to protect consumers. The American Congress of
Obstetricians and Gynecologists, District IX - California
(ACOG) writes in support that this bill will provide
accountability and transparency for cosmetic products sold in
California. ACOG states that the National Institute of
Occupational Safety and Health found 884 chemicals used in
personal care products and cosmetics known to be toxic and
that this bill will give DPH new authority to request
ingredient data from cosmetic manufacturers who fail to
voluntarily report under the VCRP. Estée Lauder Companies and
the Professional Beauty Federation of California, also in
support, write that this bill will help ensure the safety of
products sold in California by cosmetic manufacturers.
7)OPPOSITION . The Breast Cancer Fund writes that should
California adopt this bill, fragrances and flavorings will be
exempt from disclosure due to the federal law, which will
reverse the positive precedent set by the California Safe
Cosmetics Act and represents a step backward on the road to
full ingredient transparency.
8)POLICY CONCERNS .
a) The author and the sponsor write that this bill is a
consumer protection measure. Specifically the background
material provided by the author states that this bill will
provide "new accountability and transparency for cosmetics
products." However, it is unclear how this bill, as
currently drafted, would accomplish this. As stated above,
the VCRP is a program meant to notify companies if it is
determined that a cosmetic ingredient is harmful and should
be removed from product use. This bill places no such
requirement on DPH, nor does it require DPH to publically
report the information. It is unclear what DPH would use
the information for.
b) This bill would permit DPH to require cosmetic companies
who have not reported ingredients under the VCRP to report
that information. However, DPH states that they have no
mechanism, regulatory or otherwise, to identify all
cosmetic manufacturers in California. Therefore, while DPH
can determine which companies have voluntarily reported
under the VCRP, they could not compare that to a list of
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all companies to determine which were not reporting.
Additionally, this bill would apply to any cosmetic
manufacturer, regardless of whether or not it sells
products in California.
If the author's intent is to simply compile a list of
cosmetic ingredients from companies not already reporting
to the VCRP, this bill should be amended to require
cosmetic companies who do not participate in the VCRP to
report ingredient information as follows:
111821. The State Department of Public Health may, within
existing resources, require any manufacturer of cosmetic
products is sold in this state that does not currently
comply with the applicable parts of the federal Food and
Drug Administration Voluntary Cosmetic Reporting
Registration Program, set forth in Parts 710 and 720 of
Title 21 of the Code of Federal Regulations , to shall
provide to the department with information of the same kind
disclose disclosed through the federal Food and Drug
Administration Voluntary Cosmetic Reporting Registration
Program.
REGISTERED SUPPORT / OPPOSITION :
Support
Personal Care Products Council (sponsor)
American Congress of Obstetricians and Gynecologists, District
IX - California
Estée Lauder Companies
Professional Beauty Federation of California
Opposition
Breast Cancer Fund
Analysis Prepared by : Melanie Moreno / HEALTH / (916)
319-2097