BILL ANALYSIS                                                                                                                                                                                                    



                                                                  AB 1512
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          Date of Hearing:   April 28, 2009

                            ASSEMBLY COMMITTEE ON HEALTH
                                  Dave Jones, Chair
                     AB 1512 (Lieu) - As Amended:  April 15, 2009
           
          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)  
          medications beyond the expiration date indicated on the  
          product's packaging and imposes a $10 fine per item per day in  
          violation.  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 human drug that is required  
            to have this expiration date on its packaging pursuant to  
            federal regulations.

          3)Makes any person who violates this bill 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. 

           EXISTING LAW  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.

           FISCAL EFFECT  :   This bill has not yet been analyzed by a fiscal  
          committee.

           COMMENTS  :   

           1)PURPOSE OF THIS BILL  .  The author states that current law does  
            not prohibit the sale of infant formula, baby food, and OTC  
            medications beyond the "use by" or expiration dates indicated  
            on their packaging, but federal law requires these dates to be  
            disclosed on their labels.  The author notes that expiration  
            and "use by" dates are important in keeping consumers safe and  








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            should be regulated at the state level.  The author asserts  
            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  
            author maintains that this bill will make certain that the  
            health and safety of California consumers are protected by  
            prohibiting and penalizing the sale of expired infant formula,  
            baby food, and OTC medications.

           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 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 over-the-counter medications, were  
            between four and six months old.  Investigators also  
            discovered expired food products including milk and eggs. Some  
            of the products' "sell by" dates were 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 its policies to ensure  
            that sales of expired products would not occur in the future.

           3)FEDERAL DATING 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 federal Food  
            and Drug Administration (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; tests;  
            or, other information.  It is also based on the conditions of  
            handling, storage, preparation, and use printed on the label.   


          The FDA began requiring expiration dates on drugs in 1979 in  








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            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.     

           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.









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           5)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 in support 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.  

           6)OPPOSITION  .  The California Grocers Association 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.

           7)TECHNICAL AMENDMENT  .  Federal regulations governing expiration  
            dating of OTC drugs are found in Section 211.137 of Title 21  
            of the Code of Federal Regulations.  This bill should be  
            amended accordingly in line 17 to correctly reference this  
            section. 
           
           REGISTERED SUPPORT / OPPOSITION  :   

           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
          International Formula Council








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          International Longshore and Warehouse Union
          United Food and Commercial Workers Union, Western States Council
          UNITE HERE!

           Opposition 
           
          California Grocers Association
           
          Analysis Prepared by  :    Cassie Rafanan / HEALTH / (916)  
          319-2097