Category Archives Legislation, Regulations and Standards

Dutch social and political science professors have presented a case study on marketing a functional food in the European Union (EU) to demonstrate that nontextual marketing, which the European Food Safety Authority (EFSA) is apparently ill-equipped to regulate, plays a larger role in consumer purchasing decisions than textual product messages. Herman Lelieveldt and Cris Boonen, “EU Health Claims Regulation and the Marketing of Functional Foods: A Regulatory Void?,” 3 European Journal of Risk Regulation 577 (2012). They considered a marketing campaign for Optimel Control®, a yogurt drink first launched in the Netherlands in 2007 with great success but later withdrawn after expansion to other countries due to insufficient sales volume. It contained an ingredient that EFSA ruled in 2011 was not effective to control or manage weight. According to the study, the textual health claims constituted “a relatively small element in conveying the ‘stay in control’ message of Optimel Control.” Those claims,…

Food and Drug Administration (FDA) researchers recently published a study claiming that consumers found it easier to compare food items with singleserving or dual-column nutrition facts (NF) labels as opposed to the NF labels currently in use. Lando and Lo, “Single-LargerPortion-Size and Dual-Column Nutrition Labeling May Help Consumers Make More Healthful Food Choices,” Journal of the Academy of Nutrition and Dietetics, February 2013. Scientists with FDA’s Center for Food Safety and Applied Nutrition apparently asked 9,482 adults to determine the healthfulness of a single product or compare the nutrition information on two products using one of the following NF configurations: (i) a single-column format listing two servings per container; (ii) a dual-column format listing two servings per container, with one column showing NFs per serving and one column showing NFs per container; and (iii) a single-column format listing a larger single serving per container. Within each of these formats, “there were…

Chicago Alderman Edward Burke (14) has introduced a proposed ordinance that would prohibit the distribution of energy drinks in the city. Citing the popularity of the drinks among teenagers and young adults and the dangers they purportedly pose to health, the ordinance defines “energy drink” as “a canned or bottled beverage which contains an amount of caffeine exceeding or equal to 180 milligrams per container and containing Taurine (2-aminoethanesulfonic acid) or Guarana.” The proposed ordinance also states that those violating the ordinance would face fines of $100 to $500 per offense with a mandatory revocation or suspension of business licenses for repeat offenders. Some legal commentators and critics reportedly claim that the proposed ban is rife with legal flaws and misrepresentations about the law regarding energy drinks and that the ambiguity surrounding the regulation of these products needs to be addressed. The proposal was assigned to the City Council Committee…

California EPA’s Office of Environmental Health Hazard Assessment (OEHHA) has issued a notice of its intent to list the chemical bisphenol A (BPA) as a reproductive toxicant under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop. 65). The agency has proposed the action “under the authoritative bodies listing mechanism,” noting that the National Toxicology Program—Center for the Evaluation of Risks to Human Reproduction published a report in 2008 concluding that “the chemical causes developmental toxicity in laboratory animals at high levels of exposure.” Comments are requested by February 25, 2013. OEHHA has also proposed adopting a maximum allowable dose level (MADL) for BPA of 290 micrograms per day. Comments on this proposal are requested no later than March 11, 2013. According to the agency, “Some businesses may not be able to afford the expense of establishing a MADL and therefore may have to defend litigation for a…

The U.K. Food Standards Agency (FSA) will reportedly prosecute a department store for installing raw-milk vending machines at its flagship London location. According to a January 23, 2013, FSA press release, the agency has sought charges against Selfridges Retail Limited as “a person other than the occupier of a production holding or distributor” under Regulation 32 and Schedule 6 Paragraph (2)(1) of the Food Hygiene (England) Regulations. FSA has also included the farmer who supplied the milk as “an occupier of a production holding” under Regulation 32 and Schedule 6(2)(2). Westminster Magistrates Court has set the hearing date for February 6, 2013. The vending machines reportedly came to FSA’s attention in 2011, when the agency initiated an investigation of the retailer and demanded that the unpasteurized milk products carry a warning label. Under current regulations, farmers in England, Wales and Northern Ireland can sell raw cow’s milk directly to consumers…

The U.S. Department of Agriculture’s Food Safety and Inspection Service and the Food and Drug Administration have announced a February 5, 2013, public meeting in Washington, D.C., to provide information and receive public comments on draft U.S. positions for discussion during the 23rd Session of the Codex Committee on Fats and Oils of the Codex Alimentarius Commission in Langkawi, Malaysia, on February 25-March 1, 2013. Agenda items include a proposed draft standard for fish oils, proposed draft amendment to parameters for rice bran oil in the standard for named vegetable oils, discussion paper on the revision of the limit for campesterol in the Codex standard for olive oils and olive pomace oils, and discussion paper on cold-pressed oils. See Federal Register, January 23, 2013.

The Food and Drug Administration (FDA) has requested public comments on the information collection provisions of regulations that “require registration for domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States.” According to FDA, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 requires food facilities to provide information via Form FDA 3537 (§1.231) or the electronic Food Facility Registration Module that will support FDA’s enforcement activities and help the agency issue notifications in the event of accidental or deliberate contamination. In 2011, the Food Safety Modernization Act amended these regulations to compel facilities to renew their registrations biennially and to submit additional information, such as “the email address for the contact person of a domestic facility and the email address of the U.S. agent for a foreign facility.” Based on the registrations received in previous years,…

The Federal Trade Commission (FTC) has issued a final decision in a complaint alleging that POM Wonderful made false and misleading claims by advertising its pomegranate juice products with health-benefit assertions that the company contended were backed by medical research. In re POM Wonderful LLC, No. 9344 (FTC, decided January 10, 2013). Additional information about the matter appears in Issue 441 of this Update. Henceforth, two randomized, controlled clinical trials (RCTs) will be required before POM can make a claim that any of its products treat, prevent or reduce the risk of heart disease, prostate cancer or erectile dysfunction (ED). Any efficacy or health benefit claims falling short of disease claims will require substantiation consisting of “competent and reliable scientific evidence . . . that must be sufficient in quality and quantity when considered in the light of the entire body of relevant and reliable scientific evidence, to substantiate that the…

At the request of a polystyrene custom mold manufacturer, California EPA’s Office of Environmental Health Hazard Assessment (OEHHA) will conduct a February 14, 2013, public workshop “concerning OEHHA’s intent to list styrene as a chemical known to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986 (commonly known as Proposition 65 [Prop. 65]).” According to the agency’s notice, discussions “should be limited to whether the National Toxicology Program (NTP) Report on Carcinogens has identified styrene as a human carcinogen or potential human carcinogen. OEHHA cannot consider scientific arguments concerning the weight or quality of the evidence considered by NTP.” The hearing will be webcast. OEHHA has also extended the public comment period until February 28. See OEHHA News Release, January 17, 2013.

The Food Safety Authority of Ireland (FSAI) has published the results of an investigation “examining the authenticity of a number of beef burger, beef meal and salami products available from retail outlets in Ireland.” According to a January 15, 2013, FSAI press release, the agency’s study revealed “the presence of horse DNA in some beef burger products,” raising concerns about “the traceability of meat ingredients and products entering the food chain.” After testing for horse and pig DNA in 27 beef burger products, investigators evidently reported that 10 (37 percent) of the samples contained horse DNA and 23 (85 percent) contained pig DNA. The study also found that all 19 salami samples and 21 of 31 beef meal products contained pig DNA, though none of these items contained horse DNA. In addition, notes FSAI, “[t]races of horse DNA were also detected in batches of raw ingredients, including some imported from…

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