The Center for Science in the Public Interest (CSPI) recently sent a letter to Food and Drug Administration (FDA) Commissioner Margaret Hamburg urging the agency to act on an April 2005 advance notice of proposed rulemaking (ANPR) related to serving-size regulations. According to the letter, CSPI first responded to the ANPR by asking FDA to (i) “take enforcement action against manufacturers that mislabel products as multiple servings when they are typically consumed in one eating occasion,” and (ii) “initiate a rulemaking proceeding to revise the Reference Amounts Currently Consumed (‘RACC’) regulations to reflect consumption patterns that have developed since the data were collected” in the 1970s. In particular, the consumer watchdog has singled out canned soup, ice cream, coffee creamer, and aerosol non-stick cooking sprays as bearing “unrealistic” serving-size labels that “understate the calories, sodium and saturated fat consumers are likely to get from those products.” “Given the prevalence of…
Category Archives U.S. Government and Regulatory Agencies
A coalition of 38 industry organizations has sent a letter to U.S. House and Senate leaders urging Congress to allow the Food and Drug Administration (FDA) to complete its review of an application for genetically engineered (GE) salmon. The coalition’s letter comes on the heels of a recent House-approved appropriations amendment that prohibits FDA from using money in fiscal year 2012 to finalize its review of AquaBounty Technologies’ application to produce fast-growing GE Atlantic salmon and the efforts of a bipartisan group of congressional lawmakers to halt the application’s approval process. According to the “Animal Agriculture Coalition,” if it the amendment becomes law, FDA’s ability to process such applications using best-available science would be diminished, damaging the agency’s credibility “at home and overseas.” Coalition members include the Biotechnology Industry Organization (BIO), whose president and CEO was quoted as saying that “disrupting FDA’s science-based assessment process based on non-scientific political concerns would…
The U.S. Department of Agriculture’s National Organic Program (NOP) has issued a final rule renewing exemptions for 12 substances on the National List of Allowed and Prohibited Substances, which governs the use of synthetic and nonsynthetic ingredients in organic production and handling. After reviewing public input, the National Organic Standards Board recommended renewals for the following substances set to expire in September 2011: (i) ferric phosphate and hydrogen chloride (synthetic substances used in organic farming); (ii) egg white lysozyme, L-Malic acid and microorganisms (nonsynthetic, nonorganic substances used as ingredients and in processed organic products); and (iii) activated charcoal, cyclohexylamine, diethylaminoethanol, octadecylamine, peracetic acid/peroxyacetic acid, sodium acid pyrophosphate, and tetrasodium pyrophosphate (synthetic, nonorganic substances used as ingredients and in processed organic produces). The final rule becomes effective September 12, 2011.
The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has issued a public health alert “due to concerns about illnesses caused by Salmonella Heidelberg that may be associated with the use and consumption of ground turkey.” According to FSIS, an epidemiological investigation led by the Centers for Disease Control and Prevention (CDC) and state health departments has linked an estimated 77 illnesses in 26 states to a Springdale, Arkansas, plant operated by Cargill Meat Solutions Corp., which voluntarily recalled 36 million pounds of ground turkey produced between February 20 and August 2. “The outbreak strain of Salmonella Heidelberg is resistant to several commonly prescribed antibiotics; this antibiotic resistance may increase the risk of hospitalization or possible treatment failure in infected individuals,” stated an August 4, 2011, CDC investigation update. “Consumers should check their homes for recalled ground turkey products and not eat them; restaurant and food service operators…
The Food and Drug Administration (FDA) has issued a notice and request for comments about fiscal year 2012 fees under the Food Safety Modernization Act (FSMA). The fee rates, intended to “capture 100 percent of the costs of each activity,” will be assessed for facility reinspections, recalls and importer reinspections. If no foreign travel is required, the rate will be $224 per hour, and if foreign travel is required, the fee increases to $335 per hour. While a separate schedule has not been established for small businesses, FDA indicates that it will waive the fees “in limited cases . . . based on a severe economic hardship, the nature and extent of the underlying violation, and other relevant factors.” FDA has also established a docket “to obtain information that will be used to formulate a proposed set of guidelines in consideration of the burden of fee amounts on small business, as…
The Food and Drug Administration (FDA) has reopened the comment period for its proposed “gluten-free” food labeling rule. Originally published in January 2007, the proposed rule would have defined the term “for voluntary use in the labeling of foods, to mean that the food does not contain an ingredient that is any species of wheat, rye, barley, or a crossbred hybrid of these grains (collectively referred to as ‘prohibited grains’); an ingredient that is derived from a prohibited grain and that has not been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food; or 20 ppm or more gluten.” FDA seeks comments on a report titled “Health Hazard Assessment for Effects of Gluten Exposure in Individuals with Celiac Disease: Determination of Tolerable Daily Intake Levels and Levels of Concern for…
The Food and Drug Administration (FDA) has warned the company that makes Lazy Larry® brownies containing melatonin that they are adulterated under federal law. According to FDA, “Your ‘Lazy Larry’ product is represented for use as a conventional food, and accordingly is not a dietary supplement.” The company apparently uses the term “dietary supplement” in the product’s “statement of identity” and a “Supplement Facts” panel for its nutrition labeling. FDA contends that these statements do “not make your product a dietary supplement,” because it is marketed alongside snack foods, its website refers to the product as a conventional food, and the appearance and packaging make the product look like a brownie. Noting that the agency “is not aware of data to establish the safety of melatonin for use as an ingredient in conventional foods” and that “reports in the scientific literature have raised safety concerns about the use of melatonin,” FDA…
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…
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…
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…
