Category Archives Legislation, Regulations and Standards

Less than two weeks after a consumer fraud class action was filed in California against the company that makes Muscle Milk® beverages and protein bars, the Food and Drug Administration (FDA) sent a letter to its CEO warning that the products are misbranded because their labels either prominently feature the word “milk” without containing any or state that they contain no milk while made of milk-derived ingredients. The letter also warns that health-related claims or “0 trans fat” assertions are unauthorized because the products contain too much fat or too much saturated fat. The June 29, 2011, letter demands a response within 15 days of receipt. Additional information about the lawsuit appears in Issue 403 of this Update. According to a news source, CytoSport has indicated that it is “proactively and openly addressing the FDA’s labeling concerns” and also notes, “Concerns like this have been raised before when the dairy…

California EPA’s Office of Environmental Health Hazard Assessment (OEHHA) has announced that its Carcinogen Identification Committee will discuss whether 39 chemicals should be prioritized “for possible preparation of hazard identification materials” during the committee’s October 12-13, 2011, meeting. While no decision will be made at this meeting about adding the chemicals to California’s Proposition 65 (Prop. 65) list of substances known to the state to cause cancer, the process OEHHA is following could ultimately lead to their inclusion. Public comments on the 39 listed chemicals are requested by September 20, 2011. Among those chemicals under consideration is bisphenol A (BPA). According to OEHHA’s supporting materials, which include references to numerous carcinogenicity and genotoxicity studies, billions of pounds of BPA are produced each year in the United States, and most human exposure occurs “through the diet.” Other chemicals under consideration are those used in agriculture, such as the fungicides chloropicrin, dicloran,…

The European Union (EU) has reportedly introduced new rules that would halve the percentage of added water allowed in bacon products labeled as such. According to media sources, current laws set the added water limit for bacon at 10 percent, but the updated measure would require bacon containing more than 5 percent added water to be renamed “bacon with added water.” If adopted by the European Council this fall, the regulations would apparently take effect in 2015. The plan has since drawn feedback from both bacon retailers and aficionados, as well as government agencies like the U.K. Department for Environment, Food and Rural Affairs, which said that the stricter requirements would “make it clearer to shoppers exactly what they are buying.” The British Retailers Consortium (BRC), however, was less sanguine, telling reporters that reducing the added water content would make bacon “less moist, less succulent and less tender when it…

The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has issued a proposed rule that would require raw meat and poultry products that contain injected marinades or solutions to be named in a way that clearly distinguishes them from 100 percent meat or poultry products. According to FSIS, consumers are likely unaware that“enhanced products” may contain increased levels of sodium because current labels are unclear as to whether a solution has been added. For example, under current rules, 100 percent chicken breasts and products containing 60 percent chicken and 40 percent solution may both be called and labeled “chicken breast.” The latter product must indicate that a solution has been added, but manufacturers have been doing so in typefaces and fonts that can be difficult to read. To avoid misbranding, FSIS proposes that the labels feature (i) as the product’s “name” an accurate description of the product with the percent…

The U.S. Environmental Protection Agency (EPA) has issued an advance notice of proposed rulemaking (ANPRM) related to bisphenol A (BPA) toxicity testing and the study of its potential environmental impacts. The agency has requested comments by September 26, 2011, on (i) requiring toxicity testing “to determine the potential for BPA to cause adverse effects, including endocrine-related effects, in environmental organisms at low concentrations,” and (ii) monitoring for BPA in surface water, ground water, drinking water, soil, sediment, and landfill leachate “to determine whether environmental organisms may currently be exposed to concentrations of BPA in the environment that are at or above levels of concern for adverse effects, including endocrine-related effects.” According to a July 26, 2011, EPA press release, the ANPRM builds on a March 2010 action plan meant to strengthen the agency’s chemical management program and “assure the safety of chemicals that many American encounter in their daily lives.”…

The National Institute for Occupational Health and Safety (NIOSH) will hold a public meeting August 26, 2011, to solicit public input on a draft document titled “Criteria for a Recommended Standard: Occupational Exposure to Diacetyl and 2,3-pentanedione.” Diacetyl is a butter-flavoring chemical widely used in baked goods and microwave popcorn. Numerous lawsuits have been filed against flavoring manufacturers by workers and others alleging that inhaling the substance caused their bronchiolitis obliterans, a debilitating lung condition. Pentanedione is also a constituent of synthetic flavoring agents. NIOSH will make the draft document available online by August 12, and those wishing to participate in the public meeting must notify the NIOSH docket office no later than August 19. Public comments must be submitted by October 14. With limited meeting space, NIOSH will give priority to those who register to provide oral comments; 10 minutes will be allotted to each presenter. Among the matters…

Consumer advocacy organizations have written to Food and Drug Administration (FDA) Commissioner Margaret Hamburg to report the results of tests conducted on apple juice, showing arsenic levels above federal tolerance levels for drinking water. The organizations, Food & Water Watch and the Empire State Consumer Project, urge FDA to “establish tolerance levels for arsenic in food” and “to focus its import surveillance resources on imported juice concentrate as a product of concern and increase its testing of those imported products.” One apple juice sample apparently contained 55 parts per billion (ppb) of arsenic; the U.S. Environmental Protection Agency’s drinking water tolerance level for arsenic is 10 ppb. According to the groups’ letter to FDA, the agency has admitted that it has “established a ‘level of concern’ when arsenic levels exceed 23 parts per billion, but has no actionable levels for regulatory purposes.” See Food & Water Watch News Release, July…

The American Bakers Association and a number of other industry trade associations have submitted a citizen petition to the Food and Drug Administration (FDA) seeking regulations that would exempt those businesses engaged in storing packaged foods from hazard analysis and prevention controls applicable to food producers and processors. The petition notes that under the Food Safety Modernization Act (FSMA) Congress allowed FDA to implement its food safety provisions “in a manner that acknowledges the difference in risk posed by various types of operations.” Claiming that “storage facilities themselves pose a very limited, if any, food safety risk,” the petition notes that any potential hazards in warehouses are already addressed through existing good manufacturing practices governing warehousing and distribution facilities. The petitioners, including the Grocery Manufacturers Association, International Bottled Water Association, and Snack Food Association, seek a rule that would state, “A facility that is engaged solely in the storage, holding,…

Two U.S. senators have asked the Food and Drug Administration (FDA) to finalize standards for a 2007 proposed rule for gluten-free food labels. In a letter to FDA Commissioner Margaret Hamburg, Senators Ron Wyden (D-Ore.) and Patrick Leahy (D-Vt.) claim the delay is “creating unnecessary confusion for consumers and uncertainty for agricultural producers.” Included as part of the Food Allergen Labeling and Consumer Protection Act of 2004, the proposed gluten-free labeling rule represents the last time “any significant action on this has been taken,” the lawmakers wrote, adding that “regulatory uncertainty surrounding FDA’s inaction has led to a proliferation of ‘gluten free’ standards and labels provided by 3rd party groups.” Wyden also issued a July 21, 2011, press release asserting that “accurate and standard” labeling on gluten-free products is essential for those with Celiac disease—“a painful disorder stemming from the inability to properly digest the gluten found in breads.”

The European Commission (EC) has launched a promotional campaign “to help address the difficulties faced by the fresh fruit and vegetables sector following the E. coli crisis.” Consisting of an advertorial and an audiovisual package for distribution in all European Union (EU) member states, the effort is reportedly an attempt to “win back consumer trust.” As part of the campaign, EC announced that emergency funding of €210 million has been targeted to aid EU fruit and vegetable producers. “In recent weeks, the E. coli crisis forced farmers to dispose of perfectly safe vegetables left to rot by concerned consumers,” noted the EC, adding that the “solution can only come from consumers reintroducing fruits and vegetables into their daily diet.” Initially attributed to several sources from France and Germany, an E. coli outbreak earlier this year reportedly killed 51 people. The outbreak’s source was eventually traced to Egyptian fenugreek seeds and…

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