BILL ANALYSIS ------------------------------------------------------------ |SENATE RULES COMMITTEE | AB 1512| |Office of Senate Floor Analyses | | |1020 N Street, Suite 524 | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ------------------------------------------------------------ THIRD READING Bill No: AB 1512 Author: Lieu (D), et al Amended: 9/4/09 in Senate Vote: 21 SENATE HEALTH COMMITTEE : 9-0, 7/8/09 AYES: Alquist, Aanestad, Cedillo, DeSaulnier, Leno, Maldonado, Negrete McLeod, Pavley, Wolk NO VOTE RECORDED: Strickland, Cox SENATE APPROPRIATIONS COMMITTEE : Senate Rule 28.8 ASSEMBLY FLOOR : 48-29, 5/28/09 - See last page for vote SUBJECT : Food and drugs: sale SOURCE : Consumer Federation of California DIGEST : This bill prohibits a retailer from selling, or permitting to be sold, infant formula, baby food, and drugs, as defined, beyond the expiration date indicated on the product's packaging. Senate Floor Amendments of 9/4/09 (1) provide definitions for infant formula and baby food to correspond with federal definitions; (2) clarify that fines will be calculated between "use by" or expiration date and the date of sale; (3) establish that date of sale shall be established by proof of purchase, including, but not limited to, a sales receipt; (4) provide that nothing in the bill shall be CONTINUED AB 1512 Page 2 construed to preclude any other action authorized by law; (5) add legislative intent that local and sales authorities make reasonable efforts to notify the public about potential threats to public safety resulting from the dale of expired products, and for purchasers of expired products to contact their state or local authorities. ANALYSIS : Existing federal law, under the Food, Drug and Cosmetic Act, provides for the regulation of food, drugs, and cosmetics by the U.S. Food and Drug Administration (FDA). Existing federal law requires expiration dates on drugs, as defined, and requires a "use-by" date on the product label of infant formula and the varieties of baby food under inspection by the FDA. Existing state law establishes the Sherman Food, Drug, and Cosmetic Law (Sherman Act), administered by the Department of Public Health (DPH), to regulate the contents, packaging, labeling, and advertising of food, drugs, and cosmetics in California. Existing state law defines a drug as any article recognized in an official compendium; or any article used or intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in human beings or any other animal; or any article other than food, that is used or intended to affect the structure or any function of the body of human beings or any other animal; or any article used or in tended for use as a component of any article in the first three. Existing state law allows any authorized agent of DPH to, upon presenting appropriate credentials and at a reasonable time, enter any factory, warehouse, or establishment in which any food, drug, device, or cosmetic is manufactured, packed, or held. Existing state law 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 Sherman and its regulations that pertain to retail food establishments, as defined, if DPH determines that the local health department has sufficient personnel with adequate training to do so, and requires AB 1512 Page 3 that the enforcement be limited to the area under the jurisdiction of the local health department. Existing state law provides that any person who violates any provision of the Sherman Act or its regulations shall, if convicted, be subject to imprisonment for not more than one year in the county jail or a fine of not more than $1,000, or both the imprisonment and fine. Existing law provides for higher penalties for other specified violations of the Sherman Act. This bill 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 the federal Food, Drug, and Cosmetic Act and its regulations. This bill prohibits a retailer from selling, or permitting to be sold, after the expiration date, an over the counter drug.. This bill provides that, in lieu of other penalties, any person who violates these prohibitions is 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. The bill provides that the fine shall be calculated based upon the number of days between the expiration or "use by" date and the date of sale. The date of sale shall be established by evidence of the proof of purchase, including, but not limited to, a sales receipt. Monies collected from the fines shall be deposited in the General Fund. Fines collected by local jurisdictions shall be deposited in the General Fund of the local jurisdiction. The bill provides that nothing in this bill shall be construed to preclude any other action authorized by law. For purposes of this bill (1) "infant formula" shall have the meaning given in subdivision (z) of Section 321 of Title 21 of the United States Code, and "baby food" shall mean the processing of canned fresh fruits and vegetables, meats, eggs, fruit juices, cereal, formulated entrees, and desserts and snacks using fresh, preprocessed, or any AB 1512 Page 4 combination of these and other food ingredients necessary for the production of infant foods; (3) "over the counter drug" means a nonprescription drug regulated by the federal FDA that is required to have an expiration date on its packaging pursuant to the federal act and federal regulations adopted pursuant to the federal act, including, but not limited to, Section 211.137 of Title 21 of the Code of Federal Regulations. This bill states that it is the intent of the Legislature in adding Chapter 3.5 (commencing with Section 110286) to Part 5 of Division 104 of the Health and Safety Code that local and state authorities make reasonable efforts to notify the public about potential threats to public safety resulting from the sale of expired products and, for public purchasers of expired products to contact their respective state or local authorities. Background Attorney General's investigation and settlement agreement with CVS . In response to consumer reports about expired products on store shelves in Southern California, the Attorney General (AG) launched an undercover shopping operation in March 2008, which found 48 expired products on the shelves of 26 CVS pharmacies in Los Angeles, Orange, and San Diego Counties. The investigators found that some of the expired products, which included baby formula, toddler food, and over-the-counter medications, were between four and six months old. (Expired dairy and eggs were also found.) The investigation noted that some of the products' "sell by" dates were hidden with price tags or other store stickers. 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 called on the pharmacy to change its policies to ensure that sales of expired products would not occur in the future. On June 10th, the AG and CVS filed a settlement agreement, under a stipulation for entry of final judgment, in Superior Court. The judgment states that CVS is permanently enjoined and restrained from selling or offering to sell expired products to any person at a CVS AB 1512 Page 5 store in California, among other things. As a result, CVS agreed to comply with several terms and requirements, including: implementation, review, or revision of written policies regarding appropriate practices to provide that specified items (infant formula, baby food, eggs, dairy products, and over-the-counter drugs) are not sold past their best-by or expiration dates; reviewing and /or revising its expired products policies and training materials, including policies and contracts with third-party providers; disseminating its expired products policies to designated front-store employees, as specified, and requiring the completion and repetition of training regarding such policies; requiring certification of receipt of policies and training; requiring stores to check expiration or best-by dates of various categories of specified products at least twice a month; implementing a consumer coupon program related to finding expired products in a store; requiring prominent posting of notices in the aisles where specified products are offered for sale; among other requirements. As part of the agreement, CVS was ordered to pay $487,500 to the Unfair Competition Law Fund, and a similar amount in attorney's fees and costs. Federal law and regulations - "use-by" dates . According to the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture, except for infant formula and some baby food, product dating is not generally required by federal 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 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, test, or other information. It is also based on the conditions of handling, storage, preparation, and use printed on the label. FSIS states that baby formula and baby food should not be bought or AB 1512 Page 6 used after its "use-by" date. 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. Product dating in California . According to the Food and Drug Branch (FDB) of DPH, only a few products require "sell by" dates or "expiration dates" in California. State law requires dairy products to have "open dating" (which includes a pack date, expiration date, or quality assurance/freshness date) requirements. 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. Related Legislation SB 550 (Florez) requires a grocery store that uses a point-of-sale system to ensure that when a recalled product is scanned, the point-of-sale system will notify the employee and customer that the product being purchased is subject to a recall. (Pending in the Assembly Business and Professions Committee.) FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes Local: Yes SUPPORT : (Verified 9/8/09) Consumer Federation of California (source) Consumer Federation of California (sponsor) Amalgamated Transit Union AB 1512 Page 7 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, IFPTE L.20, IFPTE L. 21 International Formula Council International Longshore and Warehouse Union UNITE HERE! United Food and Commercial Workers Union, Western States Council OPPOSITION : (Verified 9/8/09) California Grocers Association ARGUMENTS IN 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 writes 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. ARGUMENTS IN OPPOSITION : The California Grocers Association (CGA) 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, rather than AB 1512 Page 8 bad actors, such as organized retail crime rings that steal quantities of infant formula, drugs, and a variety of other products and make no effort to ensure that products sold are safe. ASSEMBLY FLOOR : AYES: Ammiano, Arambula, Beall, Block, Blumenfield, Brownley, Buchanan, Caballero, Charles Calderon, Carter, Chesbro, Coto, Davis, De La Torre, De Leon, Eng, Evans, Feuer, Fong, Fuentes, Furutani, Hall, Hayashi, Hernandez, Hill, Huffman, Jones, Krekorian, Lieu, Bonnie Lowenthal, Ma, Mendoza, Monning, Nava, John A. Perez, V. Manuel Perez, Portantino, Price, Ruskin, Salas, Skinner, Solorio, Swanson, Torlakson, Torres, Torrico, Yamada, Bass NOES: Adams, Anderson, Bill Berryhill, Tom Berryhill, Blakeslee, Conway, Cook, DeVore, Duvall, Emmerson, Fletcher, Fuller, Gaines, Garrick, Gilmore, Hagman, Harkey, Huber, Jeffries, Knight, Logue, Miller, Niello, Nielsen, Silva, Smyth, Audra Strickland, Tran, Villines NO VOTE RECORDED: Galgiani, Nestande, Saldana JJA:cm 9/8/09 Senate Floor Analyses SUPPORT/OPPOSITION: SEE ABOVE **** END ****