BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | AB 688|
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THIRD READING
Bill No: AB 688
Author: Pan (D), et al.
Amended: 9/2/11 in Senate
Vote: 21
SENATE HEALTH COMMITTEE : 8-1, 7/6/11
AYES: Hernandez, Strickland, Alquist, Blakeslee, De León,
DeSaulnier, Rubio, Wolk
NOES: Anderson
SENATE APPROPRIATIONS COMMITTEE : Senate Rule 28.8
ASSEMBLY FLOOR : 50-26, 5/19/11 - See last page for vote
SUBJECT : Food and drugs: sale
SOURCE : Consumer Federation of California
DIGEST : This bill prohibits the selling or offering for
sale of over-the-counter drugs past the expiration date or
baby food and infant formula past the use by date.
Non-compliance would result in a $10 per item, per day
fine.
Senate Floor Amendments of 9/2/11 provide that the date of
sale be established by evidence of proof of purchase,
including, but not limited to, a sales receipt.
ANALYSIS :
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Existing federal law:
1. Provides for the regulation of food, drugs, and
cosmetics by the United States Food and Drug
Administration (FDA) under the Food, Drug and Cosmetic
Act.
2. 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:
1. Establishes the Sherman Food, Drug, and Cosmetic Law
(Sherman Act), which is administered by the Department
of Public Health (DPH), to regulate the contents,
packaging, labeling, and advertising of food, drugs, and
cosmetics in California.
2. Provides that it is unlawful to manufacture, sell,
deliver, hold, or offer for sale any drug or device that
is adulterated, as defined.
3. Establishes that a drug is adulterated if its quality or
purity falls below the standards set forth in the drug
compendia.
4. Requires infant formulas to bear a "use by," "use
before," or "expiration" date on their product labels.
5. Requires drug products, including over-the-counter (OTC)
drugs, to have expiration dates on their label.
6. 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 $1,000.
7. 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
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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 the selling or offering for sale of OTC
drugs past the expiration date or baby food and infant
formula past the use by date.
The OTC drugs provision is enforced by the DPH pursuant to
the Sherman Act.
The baby food and infant formula provision is enforced
primarily by local governments pursuant to the California
Retail Food Code.
Non-compliance would result in a $10 per item, per day
fine.
This bill provides that the date of sale be established by
evidence of proof of purchase, including, but not limited
to, a sales receipt.
Background
Product dating in California . According to the Food and
Drug Branch 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 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
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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.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: Yes
SUPPORT : (Verified 9/6/11)
Consumer Federation of California (source)
Abbott Laboratories
California Nurses Association
California Public Interest Research Group
California Teamsters Public Affairs Council
Consumer Attorneys of California
Mead Johnson
United Food and Commercial Workers - Western States
Conference
OPPOSITION : (Verified 9/6/11)
California Grocers Association
California Retailers Association
CVS Pharmacy
ARGUMENTS IN SUPPORT : The Consumer Federation of
California, the sponsor of this bill writes, 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 may suffer lessened brain development. Despite
this, the sponsor argues, current law allows for the sale
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of expired infant formula and non-prescription drugs.
The Consumer Attorneys of California write that this bill
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 this bill 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 : The California Retailers
Association writes that this bill 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 this bill's strict liability approach does not
require a consumer to substantiate when or where an
"expired" product was purchased nor does it require intent
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on the part of a grocer. This 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.
ASSEMBLY FLOOR : 50-26, 5/19/11
AYES: Allen, Ammiano, Atkins, Beall, Block, Blumenfield,
Bonilla, Bradford, Brownley, Buchanan, Butler, Charles
Calderon, Campos, Carter, Cedillo, Chesbro, Davis,
Dickinson, Eng, Feuer, Fong, Fuentes, Furutani, Galgiani,
Gatto, Gordon, Hall, Hayashi, Roger Hernández, Hill,
Huber, Hueso, Huffman, Lara, Bonnie Lowenthal, Mendoza,
Mitchell, Monning, Pan, Perea, V. Manuel Pérez,
Portantino, Skinner, Solorio, Swanson, Torres,
Wieckowski, Williams, Yamada, John A. Pérez
NOES: Achadjian, Bill Berryhill, Conway, Cook, Donnelly,
Fletcher, Beth Gaines, Garrick, Grove, Hagman, Halderman,
Harkey, Jeffries, Jones, Knight, Logue, Mansoor, Miller,
Morrell, Nestande, Nielsen, Norby, Silva, Smyth, Valadao,
Wagner
NO VOTE RECORDED: Alejo, Gorell, Ma, Olsen
CTW:kc 9/6/11 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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