BILL ANALYSIS                                                                                                                                                                                                    



                                                                  SB 190
                                                                  Page  1

          Date of Hearing:   July 7, 2009

                            ASSEMBLY COMMITTEE ON HEALTH
                                  Dave Jones, Chair
                     SB 190 (Wright) - As Amended:  July 1, 2009

           SENATE VOTE  :   36-1
           
          SUBJECT  :   Misbranded food: pomegranate juice.

           SUMMARY  :   Directs the Department of Public Health (DPH) to  
          adopt regulations establishing definitions and standards of  
          identity for 100 percent pomegranate juice (PJ) in consultation  
          with interested parties by July 1, 2011.  Specifically,  this  
          bill  :   

          1)Requires DPH, in consultation with interested parties, to  
            adopt regulations establishing definitions and standards of  
            identity for 100% PJ, consistent with ensuring the public  
            health by July 1, 2011.

          2)Clarifies that the regulations in 1) above must apply  
            regardless of the origin or source of the pomegranates.

          3)Requires moneys deposited on or after January 1, 2010, into  
            the Food Safety Fund, to be made available, upon appropriation  
            by the Legislature, to fund the development and adoption of  
            the regulations required by this bill.

           EXISTING FEDERAL LAW  :  

           1)Establishes the federal Food, Drug, and Cosmetic Act (FDCA),  
            enforced by the federal Food and Drug Administration (FDA), to  
            regulate the safety of food, drugs, and cosmetics. 

          2)Requires, pursuant to regulations, juices directly expressed  
            from a fruit or vegetable, i.e. not concentrated or  
            reconstituted, to be considered as 100% juice and declared  
            100% juice.

          3)Prescribes, in regulations pursuant to the FDCA, national  
            uniform standards for beverages purporting to be 100% PJ,  
            including that such beverages may be comprised of any of the  
            following: 









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             a)   Juice from one or more varieties of pomegranate fruit; 
             b)   Solely from juice directly expressed from one or more  
               varieties of pomegranate fruit; 
             c)   PJ concentrate and water, provided that the use of the  
               concentrate be disclosed in the name of the product and its  
               ingredient statement; and,
             d)   100% PJ and non-juice ingredients that do not result in  
               a diminution of the juice soluble solids, provided that  
               "100% PJ" declarations be accompanied by a phrase  
               disclosing the non-juice ingredient, i.e. "100% PJ with  
               added sweetener" or "100% PJ with added preservatives."

          4)Prohibits, pursuant to the FDCA, any State, or political  
            subdivision of a State, from establishing requirements for the  
            labeling of food of the types regulated under the FDCA,  
            including PJ, that are not identical to the regulations  
            promulgated by the FDCA.

           EXISTING STATE LAW  :

          1)Establishes the Sherman Food, Drug, and Cosmetic Law to  
            regulate the contents, packaging, labeling, and advertising of  
            food, drugs, and cosmetics.

          2)Specifies, with certain exceptions, that any food fabricated  
            from two or more ingredients is misbranded unless it bears a  
            label clearly stating the common or usual name of each  
            ingredient and, if the food purports to be a beverage  
            containing vegetable or fruit juice, a statement with  
            appropriate prominence on the information panel indicating the  
            total percentage of fruit or vegetable juice contained in the  
            food. 

          3)Makes it a misdemeanor, punishable as prescribed, to misbrand  
            any food.  

          4)Declares that all food labeling regulations adopted pursuant  
            to the FDCA are the food labeling regulations of this state. 

          5)Authorizes DPH, by regulation, to establish definitions and  
            standards of identity, quality, and fill of container for any  
            food, when, in its judgment, such action will promote honesty  
            and fair dealing in the interest of consumers. 

           FISCAL EFFECT  :   According to the Senate Appropriations  








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          Committee, to implement this bill, DPH would need a staff person  
          to promulgate regulations for about two years at an estimated  
          cost of $90,000 in fiscal years 2009-10 and 2010-11.

           COMMENTS  :

           1)PURPOSE OF THIS BILL  .  The author contends that this bill is  
            intended to address issues of adulteration of PJ from foreign  
            sources.  According to the author, PJ from foreign suppliers  
            in Iran and other Middle Eastern countries is purchased for  
            well below the established market price for pure PJ  
            concentrate and then used in juice products that are falsely  
            labeled with claims of "100% PJ with no sugar added" to induce  
            consumers to purchase the product in hopes of receiving  
            substantial health benefits.  The author asserts that, given  
            the inherently high cost of producing PJ, many suppliers  
            resort to adulteration, an illegal practice of tainting PJ  
            with filler ingredients such as sugar, high fructose corn  
            syrup, low-cost juices, colorants, and flavor enhancers.  The  
            author notes that California is the only commercial growing  
            region of pomegranates in the United States and adulterated PJ  
            damages California growers by driving down the price they get  
            for their commodity.  Lastly, the sponsor of this bill, the  
            Partnership for Unadulterated, Real and Ethical Pomegranate  
            Juice (PURE PJ), a non-profit group comprised of juice  
            processors and 15 California pomegranate growers, adds that  
            this bill will ensure that all retail PJ is 100% pure and  
            unadulterated so consumers can enjoy the health value of this  
            product and California growers and juice processors can enjoy  
            a fair and level playing field.    

           2)HEALTH BENEFITS OF PJ  .  According to various studies provided  
            by the author's office, scientists have determined that 100%  
            PJ has high levels of unique polyphenols that are largely  
            responsible for its health benefits.  Polyphenols are  
            antioxidants that are also found in red wine, green tea and  
            blueberry juice.  A February 2009 article in the Journal of  
            Agricultural and Food and Chemistry found that the pomegranate  
            fruit has become an international high-value crop for the  
            production of commercial PJ and noted that perceived consumer  
            value of PJ is due in large part to its potential health  
            benefits based on a significant body of medical research  
            conducted with authentic pomegranate juice.  Additionally, a  
            2004 article from the Journal of Biomedicine and Biotechnology  
            cited epidemiological studies linking antioxidants in PJ to a  








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            reduction in blood pressure and heart disease in a population  
            of patients who consumed it for three years.  More recently, a  
            2009 study produced for the American Urological Association  
            suggested that, based on a population of patients who drank  
            eight ounces of PJ daily, PJ may slow the progression of  
            post-treatment prostate cancer recurrence.

           3)FDA REGULATION  .  The FDA allows three types of claims on food  
            labels: a health claim, a structure or function claim, and a  
            nutrient claim.  The FDA recognizes 17 specific health claims,  
            each linking a food or dietary ingredient to a disease or  
            health-related condition.  Twelve were authorized through a  
            process in which the agency evaluates the evidence for a  
            food's reputed health effects.  The other five were  
            incorporated as part of the FDA Modernization Act of 1997,  
            which allows for health claims based on an authoritative  
            statement of a scientific body of the federal government or  
            the National Academy of Sciences.  In addition, the FDA sets  
            standards for labeling for any beverage that purports to  
            contain fruit or vegetable juice, including, but not limited  
            to advertising, labeling, and direct or indirect  
            representation to any fruit or vegetable.  These standards  
            include mandatory labeling of which juice it contains and the  
            percentage of juice it contains. 

           4)FEDERAL STANDARDS OF IDENTITY  .  The FDCA requires regulations  
            to be promulgated that fix and establish for any food, under  
            its common or usual name so far as practicable, a reasonable  
            definition and standard of identity; a reasonable standard of  
            quality; and, reasonable standards of fill-of-container,  
            whenever such action will promote honesty and fair dealing in  
            the interest of consumers.  Standards of identity define a  
            given food product, its name, and the ingredients that must be  
            used, or may be used, in the manufacture of the food.  A food  
            which is represented or purports to be a food for which a  
            standard of identity has been promulgated must comply with the  
            specifications of the standard in every respect.  A key  
            component of the standard of identity established for PJ  
            relates to its Brix level, which is an approximate measure of  
            the amount of sugars in a given liquid.  FDCA regulations  
            require 100% PJ to have a minimum Brix level of 16.

           5)RECENT LITIGATION  .  In July 2008, the U.S. District Court in  
            the Central District of California issued a ruling affecting a  
            lawsuit that POM Wonderful, LLC. (POM), a member of the  








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            sponsor of this bill, filed against Purely Juice, Inc.   
            According to court documents provided by the sponsor, POM  
            alleged that the defendant labeled its juice as 100% pure when  
            it had, in fact, been using juice imported from Iran that had  
            cane sugar and corn sweetener as major ingredients.  The juice  
            in question was sold from January 7, 2007, to August 30, 2007.  
             The defendant argued that it had received certificates of  
            authenticity for the juice and had not experienced any  
            problems with it.  POM contended that consumers purchase PJ  
            for the advertised health benefits and the defendant was using  
            misleading claims to take away market share.  The court agreed  
            with testing results from seven different laboratories that  
            concluded that the defendant's juice could not have been pure  
            PJ since it contained foreign sugars, colorants, and filler  
            juices.  Subsequently, the court ruled that the defendant sold  
            a product that contained false or misleading representation of  
            fact concerning the nature, characteristics and qualities of  
            its product and ordered Purely Juice to pay $1.5 million in  
            damages. 

           6)SUPPORT  .  Supporters, including Roll International, owner of  
            POM and a member of PURE PJ, the sponsor of this bill, and  
            many California pomegranate farms and farmers, state that this  
            bill will lead to the establishment of a standard of identity  
            for PJ, similar to the existing standard that California has  
            for olive oil, and require the labeling of PJ as "100% PJ" to  
            mean exactly that.  Individual pomegranate growers and PJ  
            producers argue that this bill will protect the interests of  
            consumers who wish to buy authentic PJ and provide an even  
            playing field for the 250 farmers in the state who grow  
            commercial pomegranates on 35,000 acres.  The American  
            Federation of State, County and Municipal Employees, AFL-CIO  
            (AFSCME) writes in support of a prior version of this bill,  
            stating that the misrepresentation of the percentage level of  
            actual PJ in a product not only hurts this California  
            industry, but also serves as false advertising.  Supporters  
            add that this bill will for the first time establish a  
            standard for what constitutes 100% PJ so California growers  
            will be protected from competing with adulterated imported  
            products and California consumers will be assured that they  
            are getting what they pay for.

           7)OPPOSITION  .  DPH opposes this bill because it is unnecessary.   
            DPH writes that existing law already states, in part, that  
            food fabricated from two or more ingredients is misbranded  








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            unless it bears a label clearly stating that the common or  
            usual name of each ingredient and, if the food claims to be a  
            beverage containing vegetable or fruit juice, it must include  
            a prominent statement on the information panel disclosing the  
            total percentage of fruit or vegetable juice contained in the  
            food.  Furthermore, DPH adds that any person who violates  
            these provisions, or violates any regulation adopted pursuant  
            to these provisions, shall, if convicted, be subject to fines  
            and/or imprisonment.  The Grocery Manufacturers Association  
            (GMA) points out that the FDA has already established criteria  
            for 100% PJ in its percent juice labeling regulations under  
            the FDCA.  Additionally, the Juice Products Association notes  
            that these same FDA rules deem juices directly expressed from  
            fruit or vegetables to be 100% juice and implicitly allow for  
            beverages of less than 100% juice by requiring a statement of  
            percentage juice on these items.  The California League of  
            Food Processors objects to the use of the Food Safety Fund,  
            which is dedicated to industry fee-based programs, as the  
            source of funding for the regulations required by this bill,  
            and argues that if the PJ industry wants to create definitions  
            and standards of identity for PJ, the PJ industry should pay  
            for the regulations.  

           8)POLICY COMMENT  .  Pursuant to the national uniformity standards  
            specified in the FDCA, nothing more or less can be required  
            under state law to define 100% PJ than what is already  
            required under federal law.  Consequently, the author may wish  
            to address the potential for this bill to be subject to court  
            challenges based on federal preemption.    

           REGISTERED SUPPORT / OPPOSITION  :

           Support 
           
          Partnership for Unadulterated, Real and Ethical Pomegranate  
          Juice (sponsor)
          American Federation of State, County and Municipal Employees,  
          AFL-CIO (prior version)
          Da Neibru Farming Co.
          Homewood Mountain Partners, LLC
          JAY, LLC
          Jedessa Partners, LP
          Pilibos Family Trust
          Pilibos Sisters Inc.
          POM Wonderful, LLC








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          R.A. Sano Farms, Inc.
          Roll International
          Simonian Farming Company
           
            Opposition 
           
          American Fruits & Flavors
          Apple & Eve, LLC
          California League of Food Processors
          California Nevada Soft Drink Association (prior version)
          Clement Pappas & Co., Inc.
          Cliffstar Corporation
          Department of Public Health
          Fallon Trading Co., Inc.
          Grocery Manufacturers Association
          Juice Products Association
          Natural Products Association West
          Smucker Natural Foods, Inc.
          Steinhauser, Inc.
          Stiebs Pomegranate Products
          Sun Opta Global Organic Ingredients

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