The U.S. Senate has confirmed Scott Gottlieb to lead the Food and Drug Administration (FDA) in a 57-42 vote. Gottlieb previously served as a deputy FDA commissioner and an official at the Centers for Medicare and Medicaid Services during the George W. Bush administration. Among Gottlieb's critics are senators who expressed concern over his connections with the pharmaceutical and medical device industry, but Gottlieb has promised to divest himself from several companies and recuse himself from decisions involving those companies for one year. See New York Times and Washington Post, May 9, 2017. Issue 634
Category Archives Food and Drug Administration
A budget plan passed to fund the U.S. government until September 2017 reportedly includes $3 million to pay for an information campaign about genetically modified organisms (GMOs) in food. As a partnership between the U.S. Food and Drug Administration (FDA) and the Department of Agriculture, the campaign will apparently seek to counter "misinformation about agricultural biotechnology." “It is not the responsibility of the FDA to mount a government-controlled propaganda campaign to convince the American public that genetically modified foods are safe,” Rep. Nita Lowey (DN.Y.) said. See The Washington Post, May 3, 2017. Issue 633
The U.S. Food and Drug Administration (FDA) denied a citizen petition to ban the use of perchlorates in dry food packaging while revoking regulations permitting the use of potassium perchlorate in food-container seals, saying industry makers no longer use the chemical. FDA said it will amend food additive regulations allowing the use of potassium perchlorate as a component in sealing gaskets for food containers. Trade groups petitioned for the change, arguing that plastics manufacturers have stopped using the compound. The following day, FDA rejected a petition from public interest groups seeking to ban use of potassium perchlorate and sodium perchlorate monohydrate in dry food packaging and requesting that the agency issue new regulations prohibiting use of perchlorates in packaging. Neither request was “the proper subject of a food additive petition,” the agency stated, but the groups could petition to revoke or reevaluate the Threshold of Regulation exemption. Issue 633
The U.S. Food and Drug Administration (FDA) has extended the compliance date for calorie-count menu labeling from May 5, 2017, to May 7, 2018, and is inviting public comment on the issue. The menu-labeling rule applies to restaurants with 20 or more locations, as well as “grab-and-go” foodservice vendors such as supermarkets, coffee shops and bakeries, concession stands at movie theaters and amusement parks. While the rule is supported by the National Restaurant Association and many restaurant chains have already posted the required information, other trade groups say that the FDA underestimated the costs of compliance and that the rule is an unnecessary regulatory burden on businesses. Issue 633
The U.S. Food and Drug Administration (FDA) has announced an extension to its comment periods for information on the use of genome editing techniques in animals and in plant varieties used for human or animal food. Comments on FDA's draft guidance, "Regulation of Intentionally Altered Genomic DNA in Animals," and on the use of genome editing techniques to produce new plant varieties will be accepted until June 19, 2017. Issue 631
The Senate Agriculture Committee has approved Sonny Perdue's nomination to lead the U.S. Department of Agriculture (USDA), with Perdue receiving support from all members of the committee except Sen. Kirsten Gillibrand (D-N.Y.), along with an abstention from Sonny Perdue's cousin, David Perdue (R-Ga.). The full Senate vote has not yet been scheduled. See Politico, March 30, 2017. After criticism over potential conflicts of interest, nominee for commissioner of the U.S. Food and Drug Administration (FDA) Scott Gottlieb has promised to recuse himself for one year from agency decisions involving more than a dozen companies. Gottlieb faces a Senate confirmation hearing on April 5, 2017. See The New York Times, March 29, 2017. Issue 629
The Government Accountability Office (GAO) has issued a March 2017 report noting several oversight gaps in federal agencies’ efforts to track and curtail antibiotic use in food animals. According to GAO, the Departments of Health and Human Services (HHS) and Agriculture (USDA) have implemented several measures designed to reduce antibiotic resistance by increasing veterinary supervision of animal drug use; altering drug labeling guidance; and collecting data from food producers on their antibiotic regimens. But GAO notes that these initiatives fall short of the more stringent government regulations promulgated by Canada, Denmark and the European Union, which have reportedly achieved reductions in antibiotic use in food animals and improved data collection. “For example, changes to drug labels do not address longterm and openended use of antibiotics for disease prevention because some antibiotics do not define duration of use on their labels,” states GAO. “FDA officials told GAO they are seeking public…
Concerns about how or whether the term “healthy” should be used in food labeling and packaging prompted the U.S. Food and Drug Administration (FDA) to hold a public comment meeting on the issue on March 9, 2017. Current FDA regulations allow the use of the term “healthy,” as well as similar terms, as implied nutrient-content claims. However, the criteria for use vary for different food categories, and the criteria themselves are linked to elements of the nutrition facts panel and serving size regulations—both of which have undergone significant changes in recent years. FDA also received a citizen petition in 2015 from Kind LLC, a producer and distributor of snack bars, requesting the agency amend its regulations defining the use of the term with respect to total fat intake and emphasizing whole foods and dietary patterns instead of specific nutrients. Accordingly, FDA’s 2016 publication of “Use of the Term ‘Healthy’ in…
Responding to food manufacturers’ requests, the U.S. Food and Drug Administration (FDA) has published industry guidance to clarify when fruit and vegetable juices “may be used as color additives for foods without additional premarket review and approval from the agency under its color additive petition process.” Under current regulations, the agency provides that “the safety of fruit juice and vegetable juice as color additives for use in food is assured by the fact that the fruit or vegetable from which the color additive is derived has been safely consumed as food, such that there would not be safety concerns in using the juice or water soluble color components from the fruit or vegetable as a color additive.” In particular, FDA clarifies what it means by the terms “fruit,” “vegetable,” “mature,” “fresh,” and “edible,” as well as “expressing the juice” and “water infusion of the dried fruit or vegetable.” The agency…
The U.S. Food and Drug Administration (FDA) has denied a February 9, 2012, petition filed by the Center for Science in the Public Interest (CSPI) that requested “a performance standard of non-detectable as determined by the best available method of detection for Vibrio vulnificus in molluscan shellfish intended for raw or processed raw consumption.” Citing V. vulnificus as “the leading cause of seafood-associated deaths in the United States,” the petition notes that FDA already enforces a zero tolerance standard for V. vulnificus in ready-to-eat fish and a non-detectable standard of less than 30 most probable numbers per gram (MPN/g) for post-harvest processed shellfish. According to CSPI, the Food Safety Modernization Act directs the agency to set performance standards for significant foodborne contaminants. In rejecting the petition, FDA notes that other strategies—including state adherence to and federal oversight of control measures designed to manage V. vulnificus risk—have effectively reduced oyster-associated V.…
