BILL ANALYSIS Ó
AB 688
Page 1
Date of Hearing: April 12, 2011
ASSEMBLY COMMITTEE ON HEALTH
William W. Monning, Chair
AB 688 (Pan) - As Introduced: February 17, 2011
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" or expiration date
provided on the product's packaging. Specifically, this bill :
1)Prohibits 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
federal regulations.
2)Prohibits a retailer from selling or permitting to be sold
after the expiration date an OTC drug.
3)Prohibits the provisions of this bill from being construed to
preclude any other action relating to expiration and "use by"
dates authorized by law.
4)Defines specified terms for purposes of this bill.
EXISTING LAW :
1)Establishes the Sherman Food, Drug, and Cosmetic Law,
administered by the Department of Public Health (DPH), to
regulate the contents, packaging, labeling, and advertising of
food, drugs, and cosmetics in California.
2)Prohibits, under the Sherman Food, Drug, and Cosmetic Law, a
dealer from being prosecuted for a violation of any food,
drug, device, or cosmetic contained in an original, unbroken,
and undamaged package that bears the original labeling if all
of the following conditions are met:
a) The dealer has used reasonable care in the storage and
handling of the item;
b) The dealer has received the item in first-class
merchantable stock, as specified; and,
AB 688
Page 2
c) The dealer can produce a guarantee that the item is not
adulterated, misbranded, or falsely advertised, as
specified.
FISCAL EFFECT : This bill has not yet been analyzed by a fiscal
committee.
COMMENTS :
1)PURPOSE OF THIS BILL . The author states that this bill is
needed to address a discrepancy between current law that does
not prohibit the sale of infant formula, baby food, and OTC
medications beyond the "use by" or expiration dates indicated
on their packaging, and federal law that requires these dates
to be disclosed on their labels. The sponsor, Consumer
Federation of California (CFC), notes that expired products
may be dangerous to consume and potentially fatal, and
digesting them deprives the consumer of the intended benefit
of the product. CFC asserts that the state's weak law
allowing for the sale of expired infant formula and
nonprescription drugs has resulted in far too many expired
products being sold to pregnant women, seniors, and other
vulnerable consumers. CFC states that this bill will ensure
product safety and effectiveness by halting expired baby food
and OTC drugs from even reaching the shelves of California's
stores.
2)BACKGROUND . According to information provided by the author,
this bill arises from a March 2008 undercover shopping
operation in which state investigators with the Attorney
General's (AG) office found 48 different types of expired
products on the shelves of 26 CVS Pharmacies in Los Angeles,
Orange, and San Diego counties. Some of the expired products,
which included baby formula, toddler food, and OTC
medications, were between two and 11 months old.
Investigators also discovered expired food products including
milk and eggs. Some of the products' dating information was
hidden with price tags or other store stickers. The
investigation was launched after the AG's office received
consumer reports about expired products on store shelves in
Southern California. 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 the AG called on CVS Pharmacy to change
AB 688
Page 3
its policies to ensure that sales of expired products would
not occur in the future.
In June 2008, the AG's office and CVS reached a settlement
agreement. As part of the settlement, CVS agreed to: stop the
sale of expired products in its stores in California;
implement a first-of-its-kind coupon program to entitle
consumers who find an expired item on store shelves to a
coupon that can be used toward any future purchase for any
product at a CVS store in California; require employees to
check at least twice a month that expiration dates have not
passed on infant formula, baby food, eggs, dairy products, and
OTC drugs; perform random audits in its California stores
twice a year to make certain that expired products are not
being sold; require each store to submit bi-monthly reports to
its corporate headquarters regarding incidents involving
expired products; and, designate a toll-free number for
employees and customers to report expired products.
3)FEDERAL DATING REGULATIONS . 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; tests; or, other information. It is also based on the
conditions of handling, storage, preparation, and use printed
on the label. Federal regulations require a "use-by" date on
the product label of infant formula and the varieties of baby
food under inspection by the federal Food and Drug
Administration (FDA). If stored too long, formula can
separate and clog the nipple. Formula must maintain an
acceptable quality to pass through an ordinary bottle nipple.
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.
AB 688
Page 4
4)PRODUCT DATING IN CALIFORNIA . According to the Food and Drug
Branch (FDB) of DPH, there are only a few products that
require "sell by" or "expiration dates" in California. Dairy
products have open dating requirements enforced by the U.S.
Department of Agriculture and the California Department of
Agriculture. Infant formula and baby foods are required to
bear an expiration date to ensure full nutritional value.
Even though the majority of foods do not require expiration or
"sell by" dates, most consumers expect some way to determine
the age of a product.
FDB indicates that there are two types of dating on food
packaging, open dating and code dating. In open dating, dates
are provided alphabetically, such as "July 10" or numerically,
such as "7-10." Open dating includes "pull date," "quality
assurance or freshness date," "pack date," and "expiration
date." Manufacturers have the pull date, quality assurance
date, or pack date on labels to inform retailers and consumers
when the product was made, how long the product should be
offered for sale, or how long the products will be of optimum
quality. The expiration date is the date before which a
product should be eaten. Open dating is recommended for all
foods that are readily perishable, such as meat, poultry,
eggs, and dairy products. In code dating, the information is
coded in letters, numbers, and symbols known only to the
manufacturer. Code dating enables the manufacturer to convey
a relatively large amount of information, such as production
code and date and location of production or packaging, with a
few small letters, numbers, and symbols. In the case of a
recall, it makes it easier to quickly identify and track down
the product and remove it from the market. Code dating
typically appears on shelf-stable products such as cans and
boxes of food.
5)SUPPORT . Consumer Attorneys of California supports this bill
because it serves to protect California consumers by making it
a crime for retailers to sell OTC drugs and baby food and
formula beyond the printed "use by" or expiration dates and
keeps dangerous products off store shelves. The California
Teamsters Public Affairs Council and United Food and
Commercial Workers add in support that use of these products
after a "use by" date risks public health and defrauds
consumers. Mead Johnson Nutrition, a manufacturer of infant
formula, states in support that, for infants to receive the
maximum benefits of formula feeding, instructions and proper
AB 688
Page 5
handling must be followed and expired formula must not be sold
and should be discarded.
6)OPPOSITION . The California Retailers Association (CRA), the
California Grocers Association (CGA), and CVS oppose this
bill, asserting that it will not provide any additional level
of consumer protection for these products, given that
mechanisms to police the sale of expired baby food, infant
formula, and OTC drugs already exist through a host of
federal, state, and local food safety inspection regulations.
CRA believes this bill is unnecessary and will result in
additional enforcement action and lawsuits against retailers
at a time when they are just beginning to rebound from the
economic downtown. CGA adds that grocers already employ a
number of policies and procedures, including proper stock
rotation, to ensure that all food products sold to customers
are safe and of the highest quality and consumers are already
well-equipped to handle the situation by either bringing an
expired product to the attention of store employees or simply
bringing it back to the store for an exchange or refund.
Opponents also remain concerned that the definition of "baby
food" in this bill is legally ambiguous and the "permit to be
sold" language in this bill would subject them to an
enforcement action or lawsuit without having sold a single
expired product.
7)PRIOR LEGISLATION . AB 1512 (Lieu) of 2009, which was
substantively identical to this bill, was vetoed by Governor
Schwarzenegger who stated that it was unnecessary because
current law already has strong provisions and accompanying
penalties for adulterated food and drug products.
REGISTERED SUPPORT / OPPOSITION :
Support
Consumer Federation of California (sponsor)
California Teamsters Public Affairs Council
Consumer Attorneys of California
Mead Johnson Nutrition
United Food and Commercial Workers - Western States Conference
Opposition
California Grocers Association
AB 688
Page 6
California Retailers Association
CVS
Analysis Prepared by : Cassie Royce / HEALTH / (916) 319-2097