Del Monte Fresh Produce N.A., Inc. has filed a complaint for declaratory and injunctive relief against the Food and Drug Administration (FDA) in a federal court in Maryland alleging that the agency lacked an adequate factual basis after a Salmonella outbreak in early 2011 to conclude that the company’s Guatemalan cantaloupe supplier was the source of the contamination. Del Monte Fresh Produce N.A., Inc. v. United States, No. __ (D. Md., filed August 23, 2011). On the basis of that conclusion, FDA allegedly demanded that the company issue a recall or “suffer the consequences of an FDA consumer advisory questioning the wholesomeness of Del Monte cantaloupes.” The agency also imposed an import alert under which Del Monte is prohibited from importing cantaloupes from its Guatemalan source without proving the fruit is “negative” for Salmonella and other pathogens. According to Del Monte, “this prohibition will continue indefinitely into the future unless…
Category Archives Food and Drug Administration
The Food and Drug Administration (FDA) has issued its “Strategic Plan for Regulatory Science,” a document deemed to be the agency’s “blueprint for overhauling the science it uses to develop and evaluate food, medicines, and medical devices.” In a section underscoring the agency’s emphasis on food safety, the document focuses on prevention and risk-based priorities required by the Food Safety Modernization Act. “To effectively implement this new food safety mandate, it is imperative that FDA ensures a strong science infrastructure, clearly identifies its research needs, and collaborates with other public health and research agencies in the [f]ederal government, state government agencies, academia, and private industry,” states the document, which details FDA’s Regulatory Science Initiative outlined in October 2010. Regarding food science, FDA plans to (i) “[e]stablish and implement centralized planning and performance measurement processes,” (ii) “[i]mprove information sharing internally and externally,” (iii) “[m]aintain mission critical science capabilities,” and (iv) “[c]ultivate…
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…
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 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…
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,…
