BILL ANALYSIS                                                                                                                                                                                                    



                                                                  AB 1512
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          ASSEMBLY THIRD READING
          AB 1512 (Lieu and Jones)
          As Amended May 5, 2009
          Majority vote 

           HEALTH              14-4        APPROPRIATIONS      11-4        
           
           -------------------------------------------------------------------- 
          |Ayes:|Jones, Adams, Ammiano,    |Ayes:|De Leon, Ammiano, Charles    |
          |     |Block, Carter, De La      |     |Calderon, Davis, Fuentes,    |
          |     |Torre, De Leon,           |     |Hall, John A. Perez, Price,  |
          |     |Hall, Hayashi, Hernandez, |     |Skinner, Solorio, Torlakson  |
          |     |                          |     |                             |
          |     |Bonnie Lowenthal, Nava,   |     |                             |
          |     |V. Manuel Perez, Salas    |     |                             |
          |     |                          |     |                             |
          |-----+--------------------------+-----+-----------------------------|
          |Nays:|Fletcher, Emmerson,       |Nays:|Nielsen, Duvall, Harkey,     |
          |     |Gaines,                   |     |Audra Strickland             |
          |     |Audra Strickland          |     |                             |
          |     |                          |     |                             |
           -------------------------------------------------------------------- 
           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  








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          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  :  According to the Assembly Appropriations  
          Committee, minor absorbable workload to DPH to continue  
          oversight of state food and product labeling laws.

           COMMENTS  : 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 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.

          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.  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.

          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  








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          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  
          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.
           
          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.

          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.








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          Analysis Prepared by  :    Cassie Rafanan / HEALTH / (916)  
          319-2097 


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