In its October 2014 issue, Consumer Reports will publish an analysis of the U.S. Food and Drug Administration’s (FDA’s) data that supported the agency’s recommendations for fish intake by pregnant women and children, released jointly as draft guidance with the U.S. Environmental Protection Agency (EPA) in June 2014. The magazine compiled a list of low-mercury—including haddock, trout, catfish, and crab—and lowest-mercury fish—including shrimp, tilapia, oysters, and wild and Alaska salmon—and detailed the amounts considered safe for consumption for young children and women of childbearing age. The guide includes more conservative advice than the draft guidance from FDA and EPA, such as recommending that most women and young children avoid marlin and orange roughy in addition to the listed swordfish, shark, king mackerel, and gulf tilefish. The magazine cites Deborah Rice, co-author of the EPA document that established the current limit on methylmercury consumption as 0.1 microgram per kilogram of body weight…
Category Archives Food and Drug Administration
The U.S. Public Interest Research Group (PIRG) Education Fund has published a white paper titled “Ending the Overuse of Antibiotics in Livestock Production: The Case for Reform.” Contending that the use of antibiotics in healthy animals to accelerate their growth or “prevent disease caused by unhealthy and unsanitary conditions” has accelerated the development of antibiotic-resistant bacteria, the paper calls on the U.S. Food and Drug Administration (FDA) to act immediately to restrict the use of antibiotics in livestock production. According to the consumer-interest group’s paper, the U.S. Centers for Disease Control and Prevention has found that some 2 million Americans are sickened each year by drug-resistant bacteria, and of those, 23,000 die. The paper also states that more than “70% of antibiotics in classes used in human medicine are sold for use in food animals.” FDA data reportedly indicate that in 2011, 29.9 million pounds of antibiotics were sold in the…
The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service is convening a September 25, 2014, public meeting in Washington, D.C., to receive public comments about draft positions to be discussed at the 21st Session of the Codex Committee on Food Import and Export Inspection and Certification Systems of the Codex Alimentarius Commission in Brisbane, Australia, on October 13-17. Issues on the September 25 meeting agenda include (i) a discussion paper on Principles and Guidelines for Monitoring Regulatory Performance of National Food Control Systems and (ii) draft amendments to Guidelines for the Exchange of Information between Countries on Rejections of Imported Food. USDA and the Food and Drug Administration have a public meeting slated for October 23 in Washington, D.C., to provide information and receive public comments about draft positions to be discussed at the 46th Session of the Codex Committee on Food Hygiene in Lima, Peru, on November…
The U.S. Food and Drug Administration (FDA) recently issued a consumer update warning that the lupin (or lupine) legume could cause allergic reactions in susceptible individuals, especially those with existing peanut allergies. According to FDA, the use of lupin-derived ingredients has increased in recent years because they are used in gluten-free products as a substitute for other flours. “Although lupin is a food staple for many Europeans—who may be more aware of its allergenic properties and are accustomed to seeing it listed as a food ingredient—it is relatively new to the U.S. market,” notes FDA, which “is actively monitoring complaints of lupin allergies.” To this end, the agency has asked consumers and healthcare professionals to report lupin-related adverse events through the FDA reporting system. See FDA Consumer Update, August 15, 2014. Issue 535
Following similar decisions from courts across the country, two California federal courts have delayed final rulings in cases accusing Kashi and Trader Joe’s of mislabeling their products by using the term “evaporated cane juice” (ECJ) in their ingredient lists rather than simply “sugar,” which the plaintiffs allege is the same substance. Gitson v. Trader Joe’s Co., No. 13-1333 (N.D. Cal., order entered August 7, 2014); Saubers v. Kashi Co., No. 13-899 (S.D. Cal., order entered August 11, 2014). In the proposed class action against Kashi, the plaintiffs accused the Kellogg-owned company of “misbranding” more than 75 different food products by listing ECJ instead of sugar on its labels to conceal its inclusion in the foods. The court found that the plaintiffs’ claims relied “heavily, if not entirely, on the premise that the [U.S. Food and Drug Administration (FDA)] has concluded that ‘evaporated cane juice’ is not the common or usual name…
The U.S. Food and Drug Administration (FDA) has amended food additive regulations pertaining to the safe use of vitamin D3 in response to a petition from Abbott Laboratories. The company requested that FDA approve use of the fat-soluble hormone “as a nutrient supplement at levels not to exceed 500 IUs per 240 mL in meal replacement beverages that are not intended for special dietary use in reducing or maintaining body weight and that are represented for use such that that the total amount of vitamin D3 provided by the product does not exceed 1,000 IU per day, and at levels not to exceed 1.0 IU per kilocalorie in food represented for use as a sole source of nutrition for enteral feeding.” Objections to FDA’s approval of Abbott’s petition or requests for a hearing must be filed by September 11, 2014. See Federal Register, August 12, 2014. Issue 534
The U.S. Food and Drug Administration (FDA) has released an executive report summarizing the data collected by the National Antimicrobial Resistance Monitoring System (NARMS) since 1996. Implemented by FDA, the Centers for Disease Control and Prevention, and the U.S. Department of Agriculture, NARMS tracks antibiotic resistance in foodborne bacteria, focusing on antibiotics “that are considered important to human health as well as multidrug resistance [MDR]” to three or more antibiotic classes. According to an August 11, 2014, news release, FDA identified “positive and negative trends in antimicrobial resistance in bacteria isolated from humans, retail meats and food animals.” For non-typhoidal Salmonella, which showed no resistance in 85 percent of samples isolated from humans, the report found that “MDR among humans, slaughtered chicken and slaughtered swine was the lowest [in 2011] since testing began,” though “MDR Salmonella from retail poultry meats generally increased.” NARMS also concluded that “erythromycin resistance in Campylobacter jejuni…
The U.S. Food and Drug Administration (FDA) seeks public comments on the estimated time burdens relating to the extension of an existing information collection pertaining to the recalls of all FDA-regulated products (including food, animal feed, drugs, animal drugs, medical devices, cosmetics, biological products intended for human use, and tobacco). The estimates are based on the total number of recalls from 2011 to 2013 (11,403) averaged to 3,801 per year and involve the time burdens of complying with the voluntary reporting requirements of the agency’s recall regulations. Comments must be submitted by October 3, 2014. See Federal Register, August 4, 2014. Issue 533
The U.S. Food and Drug Administration (FDA) this week reminded consumers that “gluten-free” “now means what it says” after a final rule outlining the voluntary labeling standards took effect on August 5, 2014. According to FDA, the new standards stipulate that foods labeled “gluten-free,” “without gluten” or “no gluten” can contain gluten in amounts less than 20 parts per million (ppm) only, “the lowest level that can be consistently detected in foods using valid scientific methods.” “This level is consistent with those set by other countries and international bodies that set food safety standards,” explained the agency, which gave manufacturers one year to bring products into compliance. Additional details about the final rule appear in Issue 492 of this Update. See FDA Consumer Update, August 5, 2014. Issue 533
A recent perspective article in the New England Journal of Medicine (NEJM) has questioned whether nutrient-content claims—such as “sugar-free,” “high in oat bran,” or “contains 100 calories”—are confusing to consumers. Authored by Allison Sylvetsky and William Dietz, the article claims that sugar- and calorie-related claims “may lead parents to underestimate the products’ energy content and allow their children to consume more than they otherwise would.” According to the authors, the use of nonnutritive sweeteners in sugar- and calorie-modified products “may still foster the development of a ‘sweet tooth’ because nonnutritive sweeteners are a hundred times sweeter than table sugar by weight.” In addition, U.S. consumers have no way to gauge whether their children have exceeded the acceptable daily intake for a particular nonnutritive sweetener because the amount added to any given product is considered proprietary information. “We believe that adopting a more straightforward and easily understandable ingredient-labeling system in the…
