BILL ANALYSIS Ó
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Ed Hernandez, O.D., Chair
BILL NO: AB 688
A
AUTHOR: Pan
B
AMENDED: June 23, 2011
HEARING DATE: July 6, 2011
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CONSULTANT:
8
Trueworthy
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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 over-the-counter (OTC)
drugs, as defined, after the "use by," "use before," or
"expiration" date provided on the product's packaging
pursuant to federal law.
CHANGES TO EXISTING LAW
Existing federal law:
Provides for the regulation of food, drugs, and cosmetics
by the U.S. Food and Drug Administration (FDA) under the
Food, Drug and Cosmetic Act.
Requires expiration dates to be placed on drugs, as
defined, and requires a "use by" date to be included on the
product label of infant formula.
Existing state law:
Establishes the Sherman Food, Drug, and Cosmetic Law
(Sherman Act), which is administered by the Department of
Continued---
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Public Health (DPH), to regulate the contents, packaging,
labeling, and advertising of food, drugs, and cosmetics in
California.
Provides that it is unlawful to manufacture, sell, deliver,
hold, or offer for sale any drug or device that is
adulterated, as defined.
Establishes that a drug is adulterated if its quality or
purity falls below the standards set forth in the drug
compendia.
Requires infant formulas to bear a "use by," "use before,"
or "expiration" date on their product labels.
Requires drug products, including OTC drugs, to have
expiration dates on their label.
Establishes that any person who violates any provision of
the Sherman Act is 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).
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 the Sherman Act 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.
This bill:
Prohibits a retailer from selling or permitting to be sold
infant formula or baby food after the "use by," "use
before," or "expiration" date on its packaging as required
pursuant to federal law.
Prohibits a retailer from selling or permitting to be sold
OTC drugs, as defined, after the expiration date on its
packaging as required by federal law.
Defines infant formula and baby food consistent with the
definition under federal regulations.
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Defines an OTC drug as a nonprescription drug regulated by
the FDA that is required to have an expiration date on its
packaging pursuant to federal regulations.
Provides 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," "use
by," or "use before" date.
Requires the date of sale to be established by evidence of
the proof of purchase, including, but not limited to, a
sales receipt. Further directs any fines collected to be
deposited as specified.
FISCAL IMPACT
According to the Assembly Appropriations committee
analysis, AB 688 would result in potential minor,
absorbable costs to DPH to respond to complaints related to
the sale of expired food items and OTC drugs.
BACKGROUND AND DISCUSSION
According to the author, this bill will protect consumers
and the most vulnerable from the risk of serious illness
resulting from the consumption of expired baby food and
over-the-counter drugs that may be spoiled or that no
longer retain potency. The author argues that the "use
by," "use before," and "expiration" dates on these products
indicate the time at which they will lose their potency as
intended and could become dangerous to consume yet there is
no prohibition on selling these items after their "use by,"
"use before," or "expiration" dates.
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 meet
"open dating" requirements, which includes a pack date,
expiration date, or quality assurance/freshness date.
Infant formula and baby foods are required to bear an
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expiration date to ensure full nutritional value.
Federal regulations, which California adopts, require
infant formula to bear a "use by" date on their product
labels. Baby foods are not required to declare a "use by"
date on their product labels although most food processors
voluntarily list a "use by" date on their baby food labels
to assist with stock rotation. The "use by" date on the
label of infant formula is set by manufacturers based on
their tests or other information showing that, until the
date and under the normal conditions of handling, storage,
preparation, and use, the formula will contain the
quantities of each nutrient declared on the label and is
otherwise of acceptable quality.
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.
Attorney General investigation
In response to consumer reports about expired products on
store shelves in Southern California, the Attorney General
(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. 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' practice of stocking expired items
on its stores' shelves falsely implied that the products
met federal standards, and the AG called on the pharmacy to
change its policies to ensure that sales of expired
products would not occur in the future.
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Under the AG settlement agreement between the AG and CVS,
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. CVS has agreed to
comply with several terms and requirements, including:
implementation, review, or revision of written policies
regarding appropriate practices to provide that infant
formula, baby food, eggs, dairy products, and
over-the-counter drugs are not sold past their used by or
expiration dates; review and /or revise its expired
products policies and training materials, including
policies and contracts with third-party providers;
dissemination of its expired products policies to
designated store employees, as specified; require the
completion and repetition of training regarding such
policies; require stores to check expiration or best-by
dates of various categories of specified products at least
twice a month; implement a consumer coupon program related
to finding expired products in a store; and require
prominent posting of notices in the aisles where specified
products are offered for sale.
California Retail Food Code
SB 144 (Runner), Chapter 23, Statutes of 2006, repealed the
California Uniform Retail Food Facilities Law and
established the California Retail Food Code (CalCode) in
order to create uniformity between California's retail food
safety laws and those of other states, as well as to
enhance food safety laws based on the best available
science. CalCode is modeled on the federal Model Food
Code, which was drafted by the United States Food and Drug
Administration and is updated every two years. CalCode is
substantially similar to the Model Food Code in terms of
its substantive food safety and sanitation content.
Violations of CalCode are considered misdemeanors, unless
otherwise specified, and can be punishable by a fine of not
less than $25 or more than $1000, by imprisonment in the
count jail for up to 6 months, or by both fine and
imprisonment. Local enforcement agencies can also charge
re-inspection fees and impose administrative penalties.
Additionally, local enforcement agencies can require that
retail food facilities establish a corrective action plan
with timelines to correct violations noted during
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inspections.
Prior legislation
AB 1512 (Lieu and Jones) of 2009 had similar provisions to
those contained in AB 688. AB 1512 was vetoed by Governor
Schwarzenegger. The veto message stated the bill was
unnecessary since current law already had strong provisions
and accompanying penalties for adulterated food and drug
products.
SB 550 (Florez) of 2009 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. SB 550 was amended to delete these
provisions in the Assembly.
Arguments in support
The Consumer Federation of California, the sponsor of AB
688 write, expired products may be dangerous to consume and
could be potentially fatal. Digesting expired products
deprives the consumer of the intended benefit of the
product. For example, infants who do not consume adequate
amounts of nutrients such as DHA and ARA may suffer
lessened brain development. Despite this, the sponsor
argues, current law allows for the sale of expired infant
formula and non-prescription drugs.
The Consumer Attorneys of California write that AB 688
ensures product safety and effectiveness by making it a
crime for retailers to sell drugs, baby food, and baby
formula beyond the printed "use by" date. The California
Teamsters Public Affairs Council writes that investigations
conducted by the Attorney General of New York and
California discovered many retailers covered the "use by"
date with stickers. The California Nurses Association
writes, California consumers deserve to purchase safe and
effective baby food and OTC drugs.
Supporters argue AB 688 will bring meaning to the federal
government's efforts to protect consumers regarding items
that have the most risk of causing potentially dangerous
health complications.
Arguments in opposition
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The California Retailers Association writes that AB 688 is
unnecessary and that mechanisms to police the sale of
expired baby food, infant formula, and OTC drugs already
exist as retailers are currently subject to a host of
federal and state food safety inspection regulations.
Standard business practices dictate that when a customer
purchases an expired product and brings it to the attention
of the store, they will either receive an exchange or a
full refund. The California Retailers Association argues
the recent investigations and settlement by the Attorney
General's office against retailers who were found to have
expired products on their shelves shows that current
enforcement policies work.
The California Grocers Association (CGA) writes that
grocers work diligently to ensure that all food products
sold to customers are safe and of the highest quality,
utilizing written stock rotation policies that often call
for products to be removed from shelves a full thirty days
prior to expiration. CGA is unaware of any grocer that
currently refuses to exchange items or offer a full refund
should a product be found out-of-date. CGA writes they are
concerned AB 688's strict liability approach does not
require a consumer to substantiate when or where an
"expired" product was purchased nor does it require intent
on the part of a grocer. The bill sets up a scenario where
individuals with unscrupulous motives could steal or
purchase product, wait until the expiration date passes and
then pursue remedies against any grocer in California,
without ever substantiating when or where the product was
purchased or that it was in fact expired upon purchase.
CGA further argues that efforts should be spent targeting
the bad actors, such as organized retail crime rings who
steal quantities of infant formula, drugs, and a variety of
other products from grocers and then re-sell them.
PRIOR ACTIONS
Assembly Health: 12- 5
Assembly Appropriations:12- 5
Assembly Floor: 50- 26
COMMENTS
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1. Enforcement. Under current law, retailers, including
grocery stores, supermarkets and drug stores, selling any
food products are under the jurisdiction of local health
departments for these food products. Because AB 688 amends
the Sherman Act, the provisions of this bill would be
enforceable by DPH. Committee staff recommends amending
the bill to give enforcement authority to both DPH and the
local health departments.
2. Suggested clarifying amendment. AB 688 prohibits a
retailer from "selling" or "permitting to be sold" infant
formula, baby food, or OTC drugs. The term "permit to be
sold" does not appear to be consistent with the Sherman Act
or CalCode. Committee staff recommends replacing the term
"permit to be sold" with "offered for sale" which is
consistent with the Sherman Act and CalCode.
POSITIONS
Support: Consumer Federation of California (sponsor)
Abbott Laboratories
California Nurses Association
California Teamsters Public Affairs Council
CALPIRG
Consumer Attorneys of California
International Formula Council
Mead Johnson
United Food and Commercial Workers - Western
States Conference
Oppose:California Grocers Association
California Retailers Association
CVS Pharmacy
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