Category Archives Food and Drug Administration

The Center for Science in the Public Interest (CSPI) has petitioned the Food and Drug Administration (FDA) to require the disclosure of food color additives on front-of-package labeling. Citing “the ubiquity of food colorings” in the American diet, the petition claims that consumers are misled when colorings are used to either mask less-nutritious ingredients or make a product “appear to be of higher quality or nutritional value than it actually is.” The group also points to studies suggesting a link between certain food additives and behavioral effects in children. CSPI urges FDA to “amend the labeling requirements set forth at 21 C.F.R. § 101.22” to require foods containing such additives to state “Artificially Colored” “on the product display package next to the product name in bold letters not less than half the height and weight of the name of the food.” According to CSPI, FDA already possesses the statutory authority and…

A federal court has approved an agreement between the Food and Drug Administration (FDA) and the Natural Resources Defense Council (NRDC) resolving NRDC’s complaint that the agency unreasonably delayed issuing a final decision on its petition seeking a regulation that would prohibit the use of bisphenol A (BPA) in food packaging. NRDC v. HHS, No. 11-5801 (S.D.N.Y., consent judgment filed December 7, 2011). Under the agreement, FDA will issue its final decision on or before March 31, 2012. Noting that its petition was filed three years ago, an NRDC spokesperson said, “While we are glad FDA is finally going to make a decision [on] BPA in food packaging and this is a major step forward in the legal process, it is discouraging that FDA has not responded and that we had to ask the court to intervene just to get FDA to do its job. The agency has been dragging…

The Consumer Federation of America (CFA) has written a letter to the Food and Drug Administration (FDA) supporting a legal petition that demands required labeling of all genetically engineered (GE) food. Information about the October 4, 2011, petition filed by the Center for Food Safety appear in Issue 412 of this Update. Representing nearly 300 nonprofit consumer organizations concerned with food safety, agricultural biotechnology, food and agricultural policy, and nutrition, CFA claims that current FDA regulations fail to provide consumers with information about GE food despite growing public interest in food content. “Genetically engineered foods are required to be labeled in the 15 European Union nations, Russia, Japan, China, Australia, New Zealand, and many other countries around the world,” the November 23 letter states. “U.S. consumers should be provided the same basic information about GE foods as consumers in these other countries.”

The Food and Drug Administration (FDA) is evaluating current allowable levels of inorganic arsenic in apple juice in response to consumer groups’ demand for tighter restrictions. In a November 21, 2011, letter to Food & Water Watch and the Empire State Consumer Project, FDA said, “we are seriously considering setting guidance or other level for inorganic arsenic in apple juice and are collecting all relevant information to evaluate and determine an appropriate level.” Earlier this year, Mehmet Oz, M.D., highlighted concerns about arsenic in apple juice during his nationally syndicated TV show, details of which were highlighted in Issue 410 of this Update. According to FDA guidelines, apple juice cannot contain more than 23 parts per billion (ppb) of inorganic arsenic, which is found in pesticides and can be harmful if consumed at high levels over a long period of time. FDA Deputy Commissioner Michael Taylor told a news source…

Congress has approved and President Barack Obama (D) has signed a bipartisan agricultural spending bill (H.R. 2112) that will block or delay regulations aimed at making school lunches healthier. Signed into law on November 18, 2011, the bill will, among other things, prohibit the U.S. Department of Agriculture (USDA) from limiting starchy vegetables, such as potatoes, to two servings a week and will continue to allow two tablespoons of tomato paste to count as a vegetable. It will also require further study of USDA’s long-term sodium reduction requirements that would reduce by half the amount of sodium in school meals over the next 10 years. Although some lawmakers claim that the bill will prevent costly regulations and provide school districts greater flexibility in improving the quality of school meals, critics assert that it will keep schools from serving an array of vegetables while allowing foods such as french fries to remain…

The Food and Drug Administration (FDA) has issued a final rule requiring animal and pet food labels to list “the common or usual names” of any certified color additives used in the products. Issued in response to the Nutrition Labeling and Education Act of 1990, the final rule brings animal food labeling in line with current human food regulations by adding “paragraph (k) to the animal food labeling regulations at § 501.22 (21 CFR 501.22).” The first part of paragraph (k) explains that any FDA-certified color additive used in animal foods “must be declared in the ingredient list” under the name listed in 21 CFR part 74 or 21 CFR part 82, although manufacturers are permitted to “parenthetically declare an appropriate alternative name of the certified color additive following its common or usual name.” In addition, the new rules require that the term “Lake” be included “in the declaration of…

After a coalition of advocacy organizations filed a lawsuit against the Food and Drug Administration (FDA) seeking an order compelling the agency to rule on 1999 and 2005 petitions that asked the agency to withdraw approval of certain antimicrobial drugs in food animal production, the agency finally acted. Information about the lawsuit appears in Issue 396 of this Update. According to November 7, 2011, letters addressed to the Center for Science in the Public Interest (CSPI) and Environmental Defense, “the Agency has decided not to institute formal withdrawal proceedings at this time and instead is currently pursuing other alternatives to address the issue of antimicrobial resistance related to the production use of antimicrobials in animal agriculture.” FDA contends that withdrawal proceedings can be protracted and consume significant agency resources. While the agency notes that it shares the petitioners’ “concern about the use of medically important antimicrobial drugs in food-producing animals for…

The Food and Drug Administration’s (FDA’s) Center for Veterinary Medicine (CVM) has issued an October 24, 2011, memorandum calling for nationwide testing of pet food “to determine the prevalence of Salmonella” and remove contaminated samples from commerce. According to CVM, regulators are concerned about the transmission of “pathogenic and antibiotic-resistant bacteria to humans and other animals,” as well as the risk that Salmonella-tainted pet food, pet treats and supplements for pets could infect consumers in their homes, where products “are likely to be directly handled or ingested by humans.” CVM has directed investigators to collect and submit non-canned pet food, treats and supplements for analysis, which aims to identify “the serotype, genetic fingerprint, and antimicrobial susceptibilities of each Salmonella found in samples.” The agency will also use these samples for “research purposes” and “providing surveillance information on microbes other than Salmonella.” “Salmonella-contaminated pet foods, pet treats and supplements for pets…

The American Public Health Association (APHA) has reportedly passed a resolution asking the Food and Drug Administration (FDA) to revoke salt’s status as a generally recognized as safe (GRAS) substance within one year. According to the resolution, which was unanimously approved during APHA’s 139th Annual Meeting in Washington, D.C., the revocation of salt’s GRAS status would pave the way for FDA regulation and “substantially improve the cardiovascular health of the American public.” Among other things, the resolution recommends that FDA (i) establish a schedule for food manufacturers and preparers to progressively lower sodium levels by 75 percent within the next 10 years; (ii) require front-of-package labels that clearly identify whether products contain high-, medium- or low-sodium levels; and (iii) require the food industry to use 2,300 milligrams (mg) as the current standard of calculating sodium daily values in processed foods and lower the daily values to 1,500 mg by 2017.…

The Food and Drug Administration (FDA) has announced the availability of guidance aimed at helping industry evaluate the safety of flood-affected crops for human consumption. According to FDA, growers are responsible for ensuring the safety of food affected by flood waters, which “may have been exposed to sewage, chemicals, heavy metals, pathogenic microorganisms, or other contaminants.” See Federal Register, October 24, 2011.

Close