The Food and Drug Administration (FDA) has issued a final rule amending 21 C.F.R. 175.300 to reflect the industry’s abandonment of bisphenol A (BPA)- based epoxy resins as coatings in infant formula packaging. As of July 12, 2013, the food additive regulations will no longer provide for this use of BPA. According to FDA, its action followed Rep. Edward Markey’s (D-Mass.) petition asserting that industry had stopped using BPA in infant formula packaging; the action “is not “related to the safety of BPA.” See FDA Center for Food Safety and Applied Nutrition—Constituent Update, July 11, 2013.
Category Archives Food and Drug Administration
Finding the Food and Drug Administration’s (FDA’s) proposed “target time-frames” “an inadequate response to the request that the parties submit a proposal regarding deadlines that can form the basis of an injunction,” a federal court in California will require the agency to publish all proposed regulations required under the Food Safety Modernization Act by November 30, 2013. Ctr. for Food Safety v. Hamburg, No. 12-4529 (N.D. Cal., decided June 21, 2013). The court further ordered FDA to close each comment period no later than March 31, 2014, and to finalize the rules no later than June 30, 2015. The order follows the court’s determination that FDA violated the FSMA and Administrative Procedure Act by failing to comply with the food safety rulemaking deadlines established by Congress. Additional details about the litigation appear in issues 481 and 487 of this Update.
The Center for Food Safety and the Food and Drug Administration (FDA) have filed separate proposals to implement a court order requiring the agency to complete its rulemaking under the Food Safety Modernization Act (FSMA) after finding that FDA had violated the law by failing to meet its rulemaking deadlines. Ctr. for Food Safety v. Hamburg, No. 12-4529 (N.D. Cal., proposals filed June 10, 2013). Additional information about the court’s order appears in Issue 481 of this Update. According to plaintiff’s proposal for injunctive relief, FDA “utterly fails to comply with the Court’s Order and FSMA,” because the agency has insisted on establishing “a schedule of target timeframes” that the agency “will endeavor to meet” with caveats that could require new timeframes. The Center proposes May 1, 2014, as the date on which seven final implementing rules must be submitted to the Federal Register. It would add an additional year to…
A federal judge in California has notified the parties to a consumer-fraud action against the company that makes Mission® tortilla chips of her inclination to stay the litigation for six months and refer to the Food and Drug Administration (FDA) the question “whether products containing GMO [genetically modified organisms] or bioengineered ingredients may properly be labeled ‘Natural’ or ‘All Natural.’” Cox v. Gruma Corp., No. 12-6502 (N.D. Cal., notice filed June 7, 2013). The plaintiffs have opposed the tentative stay order, arguing that a prompt regulatory determination is unlikely given FDA’s past inaction on the matter. They reportedly cited a recent Florida decision denying a soup company’s motion to dismiss similar litigation on preemption grounds because FDA does not regulate “Natural” or “All Natural” food labeling claims. The court, however, cited a Ninth Circuit ruling deferring to FDA’s regulatory authority so that the agency’s “considered judgments” would not be undermined…
The Food and Drug Administration (FDA) has issued a final rule that amends color additive regulations to provide for “the safe use of mica-based pearlescent pigments prepared from titanium dioxide and mica as color additives in distilled spirits containing not less than 18 percent and not more than 23 percent alcohol by volume but not including distilled spirits mixtures containing more than 5 percent wine on a proof gallon basis.” The action follows a petition filed by E. & J. Gallo Winery and takes effect July 15, 2013. See Federal Register, June 12, 2013.
The Food and Drug Administration (FDA) has issued a notice about a collection of information titled “Experimental Study on Consumer Responses to Nutrition Facts Labels with Various Footnote Formats and Declaration of Amount of Added Sugars” that the agency has submitted to the Office of Management and Budget for review. FDA reported that it plans to use the information to promote public health and explore consumer responses to various food label formats for the footnote section of the Nutrition Facts label, including “those that exhibit information such as a description of percent Daily Value, a succinct statement about daily caloric intake, a general guideline for interpreting percent Daily Values, or a footnote about nutrients whose daily intake should be limited.” This study will also reportedly explore “how declaring the added sugars content of foods might affect consumers’ attention to and understanding of the sugars and calorie contents and other information…
U.S. Reps. Rosa DeLauro (D-Conn.) and Frank Pallone Jr. (D-N.J.), have written a letter to the Office of Management and Budget asking for the release of the Food and Drug Administration’s (FDA’s) voluntary industry guidelines for levels of arsenic in fruit juices currently under review by the Office of Information and Regulatory Affairs. Citing studies that have found “concerning” levels of arsenic in food and beverages, DeLauro and Pallone assert that FDA’s guidance document will be “instrumental” to industry members and consumers in their efforts to address “this public health issue.” It is “inexcusable that the guidelines are stalled while consumers continue to be exposed to potentially dangerous levels of arsenic,” the letter states. “Inorganic arsenic is a known carcinogen that can increase the risk of bladder, lung and skin cancers, [which is] particularly concerning because children consume large quantities of juice and may be at risk for more harmful…
Sens. Kirsten Gillibrand (D-N.Y.), Dianne Feinstein (D-Calif.) and Susan Collins (R-Maine) have introduced bipartisan legislation to combat antimicrobial drug resistance by requiring the Food and Drug Administration (FDA) to report more information on the annual sales of antibiotics used among industrial farm animals. The “Antimicrobial Data Collection Act” would also reportedly give the agency a deadline to finalize policies proposed in 2012 that would eliminate the use of antibiotics for growth-promoting uses. “Antimicrobial resistance is a public health concern that needs to be adequately addressed,” Gillibrand said in a statement. “Increased data collection, transparency, and accountability are part of a comprehensive solution that will help protect American citizens from drug resistant microbes, saving lives and tax dollars.” “Our bill would not create any new reporting requirements for drug companies, feed mills, or farmers. It would only require the FDA to provide more transparency in reporting the antimicrobial data which is already being reported to it,”…
Food and Drug Administration (FDA) Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor said this week that the agency “is taking a fresh look at the potential impact that the totality of new and easy sources of caffeine may have on the health of children and adolescents, and if necessary, will take appropriate action.” According to Taylor, “[t]he only time that FDA explicitly approved the added use of caffeine in a food was for cola and that was in the 1950s.” He acknowledged that in today’s environment children and adolescents can be exposed to the substance “beyond anything FDA envisioned when it made the determination regarding caffeine in cola.” In 2010, FDA warned companies producing alcoholic malt beverages that the added caffeine was an unsafe additive and that seizure of their products was possible under federal law. The companies ceased producing the caffeinated products. Additional information about the 2010…
Food and Drug Administration (FDA) Commissioner Margaret Hamburg has reportedly informed Senate appropriators that the agency would extend for 120 days the comment period for two proposed rules—one relating to fresh produce and the other to food processors issued in January 2013 to implement the Food Safety Modernization Act (FSMA). According to Hamburg, “We appreciate that these are complex rules, the proposed rules, to go through and analyze, and we do intend to extend the comment period so that we can hear all of the concerns and address them fully, and I think it’s a reasonable request.” Hamburg also reportedly indicated that a rule requiring restaurants to post calorie information is a “high priority” for the agency, but hesitated when asked if it would be issued by October 1, at the start of the new fiscal year. See CQ Healthbeat News, April 18, 2013.
