BILL ANALYSIS
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Elaine K Alquist, Chair
BILL NO: AB 1512
A
AUTHOR: Lieu and Jones
B
AMENDED: May 5, 2009
HEARING DATE: July 8, 2009
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CONSULTANT:
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Park/
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SUBJECT
Food and drugs: sale
SUMMARY
Prohibits a retailer from selling, or permitting to be
sold, infant formula, baby food, and drugs, as defined,
beyond the expiration date indicated on the product's
packaging.
CHANGES TO EXISTING LAW
Existing federal law:
Existing federal law, under the Food, Drug and Cosmetic
Act, provides for the regulation of food, drugs, and
cosmetics by the U.S. Food and Drug Administration (FDA).
Existing federal law requires expiration dates on drugs, as
defined, and requires a "use-by" date on the product label
of infant formula and the varieties of baby food under
inspection by the FDA.
Existing state law:
Existing state law establishes the Sherman Food, Drug, and
Cosmetic Law (Sherman), administered by the Department of
Public Health (DPH), to regulate the contents, packaging,
Continued---
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labeling, and advertising of food, drugs, and cosmetics in
California.
Existing state law defines a drug as any article recognized
in an official compendium; or any article used or intended
for use in the diagnosis, cure, mitigation, treatment, or
prevention of disease in human beings or any other animal;
or any article other than food, that is used or intended to
affect the structure or any function of the body of human
beings or any other animal; or any article used or intended
for use as a component of any article in the first three.
Existing state law allows any authorized agent of DPH to,
upon presenting appropriate credentials and at a reasonable
time, enter any factory, warehouse, or establishment in
which any food, drug, device, or cosmetic is manufactured,
packed, or held.
Existing state law allows DPH, upon the request of a health
officer, to authorize the local health department of a
city, county, city and county, or local health district to
enforce the provisions of Sherman and its regulations that
pertain to retail food establishments, as defined, if DPH
determines that the local health department has sufficient
personnel with adequate training to do so, and requires
that the enforcement be limited to the area under the
jurisdiction of the local health department.
Existing state law provides that any person who violates
any provision of Sherman or its regulations shall, if
convicted, be subject to imprisonment for not more than one
year in the county jail or a fine of not more than one
thousand dollars ($1,000), or both the imprisonment and
fine. Existing law provides for higher penalties for other
specified violations of the Sherman Act.
This bill:
This bill would prohibit a retailer from selling, or
permitting to be sold, after the "use-by" date, infant
formula or baby food that is required to have this date on
its packaging pursuant to the federal Food, Drug, and
Cosmetic Act and its regulations.
This bill would prohibit a retailer from selling, or
permitting to be sold, after the expiration date, a drug
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that is required to have this expiration date on its
packaging pursuant to the federal Food, Drug, and Cosmetic
Act and its regulations.
The bill would provide that, in lieu of other penalties,
any person who violates these prohibitions is guilty of an
infraction, punishable by a maximum fine of $10 per day for
each item sold, or permitted to be sold, after the
expiration or "use-by" date.
FISCAL IMPACT
According to the Assembly Appropriations Committee, the
bill would result in minor absorbable workload to the
California Department of Public Health (DPH) to continue
oversight of state food and product labeling laws.
BACKGROUND AND DISCUSSION
The authors state that the measure builds on federal
regulations, which require a "use-by" date to be placed on
infant formula, baby food, or drugs, by prohibiting a
retailer from selling these products after their dates in
California. The authors point out that, at various retail
pharmacies through California, products such as
over-the-counter medicines, baby food and baby formula are
being sold beyond their expiration dates. The authors
assert that retailers that stock expired items not only
violate state laws against false advertising and unfair
business practices, they endanger the well-being of
California's consumers. The authors highlight that stores
may pledge to purge their stores' shelves of expired goods,
but they continue to sell expired products with no
accountability or oversight.
The authors believe that the measure will ensure that the
health and safety of California consumers are protected by
prohibiting and penalizing the sale of expired products.
Attorney General's investigation and settlement agreement
with CVS
In response to consumer reports about expired products on
store shelves in Southern California, the Attorney General
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(AG) launched an undercover shopping operation in March
2008, which found 48 expired products on the shelves of 26
CVS pharmacies in Los Angeles, Orange, and San Diego
Counties. The investigators found that some of the expired
products, which included baby formula, toddler food, and
over-the-counter medications, were between four and six
months old. (Expired dairy and eggs were also found.) The
investigation noted that some of the products' "sell by"
dates were hidden with price tags or other store stickers.
As a result of the investigation, the AG stated that CVS
Pharmacy's practice of stocking expired items on its
stores' shelves falsely implied that the products met
federal standards, and called on the pharmacy to change its
policies to ensure that sales of expired products would not
occur in the future.
On June 10th, the AG and CVS filed a settlement agreement,
under a stipulation for entry of final judgment, in
Superior Court. The judgment states that CVS is permanently
enjoined and restrained from selling or offering to sell
expired products to any person at a CVS store in
California, among other things. As a result, CVS agreed to
comply with several terms and requirements, including:
implementation, review, or revision of written policies
regarding appropriate practices to provide that specified
items [infant formula, baby food, eggs, dairy products, and
over-the-counter drugs] are not sold past their best-by or
expiration dates; reviewing and /or revising its expired
products policies and training materials, including
policies and contracts with third-party providers;
disseminating its expired products policies to designated
front-store employees, as specified, and requiring the
completion and repetition of training regarding such
policies; requiring certification of receipt of policies
and training; requiring stores to check expiration or
best-by dates of various categories of specified products
at least twice a month; implementing a consumer coupon
program related to finding expired products in a store;
requiring prominent posting of notices in the aisles where
specified products are offered for sale; among other
requirements.
As part of the agreement, CVS was ordered to pay $487,500
to the Unfair Competition Law Fund, and a similar amount in
attorney's fees and costs.
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Federal law and regulations - "use-by" dates
According to the Food Safety and Inspection Service (FSIS)
of the U.S. Department of Agriculture, except for infant
formula and some baby food, product dating is not generally
required by federal regulations. Federal regulations
require a "use-by" date on the product label of infant
formula and the varieties of baby food under inspection by
the FDA. If consumed by that date, the formula or food
must not contain less than the quantity of each nutrient as
described on the label. Formula must maintain an
acceptable quality to pass through an ordinary bottle
nipple. If stored too long, formula can separate and clog
the nipple. Dating of baby food is for quality as well as
for nutrient retention. The "use-by" date is selected by
the manufacturer, packer, or distributor of the product on
the basis of product analysis throughout its shelf life,
test, or other information. It is also based on the
conditions of handling, storage, preparation, and use
printed on the label. FSIS states that baby formula and
baby food should not be bought or used after its "use-by"
date.
The FDA began requiring expiration dates on drugs in 1979
in order to set uniform testing and reporting guidelines.
Federal regulations require a drug product to bear an
appropriate expiration date as determined by stability
testing that analyzes the capacity of the drug to maintain
its identity, strength, quality, and purity for the period
of shelf life that the manufacturer picks. Expiration
dates are also required to be related to any storage
conditions specified on the label. Homeopathic drug
products and new drug products for investigational use are
exempt from federal regulations governing expiration
dating.
Product dating in California
According to the Food and Drug Branch (FDB) of DPH, only a
few products require "sell by" dates or "expiration dates"
in California. State law requires dairy products to have
"open dating" (which includes a pack date, expiration date,
or quality assurance/freshness date) requirements. Infant
formula and baby foods are required to bear an expiration
date to ensure full nutritional value. Even though the
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majority of foods do not require expiration or "sell by"
dates, most consumers expect some way to determine the age
of a product.
Related legislation
SB 550 (Florez) would require a grocery store that uses a
point-of-sale system to ensure that when a recalled product
is scanned, the point-of-sale system will notify the
employee and customer that the product being purchased is
subject to a recall. Pending in the Assembly Business and
Professions Committee.
Arguments in support
The sponsor of this bill, Consumer Federation of California
(CFC), states that during tough economic times, consumers
deserve to purchase products that are safe and effective
for themselves and their families. CFC asserts that
requiring the removal of specific products that have
exceeded their nutritional or safety effectiveness is a
simple practice that retailers can employ to protect their
customers. The International Formula Council notes writes
that infant formula products sold past their "sell by" date
may experience nutrient and other losses that could impact
the product's safety and potentially threaten an infant's
health.
The Consumer Attorneys of California supports this bill
because it levies fines against retailers who sell products
that have already expired and serves to protect the
well-being of California consumers. Various labor groups
write in support that this bill will act as an incentive
for retailers to remove expired products from their shelves
and protect parents and other consumers from purchasing
useless or potentially harmful products in the future.
Arguments in opposition
The California Grocers Association (CGA) objects to the
punitive and arbitrary fines in this bill that would be
applied even when innocent mistakes are made, and opposes
this bill because it inappropriately targets responsible
businesses, rather than bad actors, such as organized
retail crime rings that steal quantities of infant formula,
drugs, and a variety of other products and make no effort
to ensure that products sold are safe.
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The California Retailers Association (CRA) objects to the
legislation, because it believes the bill does not require
any substantiation before a penalty can be assessed on a
retailer, such as a receipt. CRA believes the bill would
subject retailers to civil penalties without any evidence
that a consumer purchased the product at their store or
that the product was past the expiration date at the time
of sale. Additionally, CRA believes that the bill is silent
on whom the penalty would be assessed and when the per-day
penalty begins. Lastly, CRA has concerns that this measure
conflicts with federal prohibitions that prevent the
monetary compensation for Women, Infant and Children's
(WIC) Program participants who receive expired products.
CRA notes that federal regulations require retailers to
provide an exchange of the exact item to WIC participants
who receive expired or spoiled goods and expressly prohibit
retailers from providing WIC participants cash, credit, and
refunds.
PRIOR ACTIONS
Assembly Floor: 48-29
Assembly Appropriations:11-4
Assembly Health: 14-4
COMMENTS
1.Recommended clarifying amendments.
Staff recommends the following clarifying amendments
related to enforcement, collection of fines, and the type
of drugs that are subject to this section.
110286. (a) A retailer shall not sell or permit to be
sold after the "use by" date infant formula or baby food
that is required to have this date on its packaging
pursuant to the federal act and federal regulations
adopted pursuant to the federal act, including, but not
limited to, Section 107.20 of Title 21 of the Code of
Federal Regulations.
(b) A retailer shall not sell or permit to be sold after
the expiration date a drug an over-the-counter drug that
is required to have this expiration date on its packaging
pursuant to the federal act and federal regulations
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adopted pursuant to the federal act, including, but not
limited to, Section 211.37 211.137 of Title 21 of the
Code of Federal Regulations.
(c) Notwithstanding Section 111825, any person retailer
who violates this section is guilty of an infraction,
punishable by a fine of not more than ten dollars ($10)
per day for each item sold or permitted to be sold after
the expiration or "use by" date. Fines collected pursuant
to this section shall be deposited in the General Fund,
if enforced by the department, or with the local
jurisdiction that enforces this section, pursuant to
Section 111015 through 111065.
(d) Over-the-counter drug means any non-prescription drug
regulated by the federal Food and Drug Administration
that contain expiration dates.
POSITIONS
Support: Consumer Federation of California (sponsor)
Amalgamated Transit Union
American Federation of State, County and Municipal
Employees, AFL-CIO
California Conference of Machinists
California Teamsters Public Affairs Council
Consumer Attorneys of California
Engineers and Scientists of California, IFPTE L.20,
IFPTE L. 21
International Formula Council
International Longshore and Warehouse Union
UNITE HERE!
United Food and Commercial Workers Union, Western
States Council
Oppose: California Grocers Association
California Retailers Association
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