The Food and Drug Administration (FDA) has announced an initiative to address “the prevalence of animal drug products marketed in the United States without approval or other legal marketing status.” Unapproved animal drugs on the market include injectable vitamins, shampoos, liniments, and electrolyte and glucose solutions. FDA is concerned that the safety and effectiveness of these drugs has not been demonstrated and is open “to using both the agency’s existing authority and new approaches to make more drugs legally available to veterinarians, animal producers and pet owners,” according to a December 20, 2010, press release. The agency requests comments by February 18, 2011, on ways to increase the availability of legally marketed animal drugs and has launched a web page detailing problems involving the use of unapproved products. See Federal Register, FDA Press Release, December 20, 2010.
Category Archives Food and Drug Administration
The Food and Drug Administration (FDA) has reopened the comment period on revisions proposed in 1997 to its rule regarding substances generally recognized as safe (GRAS). Written or electronic comments are requested by March 28, 2011. The proposed revisions would “replace the voluntary GRAS affirmation petition process . . . with a voluntary notification procedure whereby any person may notify us of a determination that a particular use of a substance in human food . . . or in food for animals . . . is GRAS.” The proposal would also “clarify the criteria . . . whereby the use of a substance is not subject to the premarket approval requirements of the [Food, Drug, and Cosmetic Act] because it is GRAS.” The Federal Register notice refers to several developments since 1997, including the use of nanotechnology in foods, a Government Accountability Office (GAO) report on FDA oversight of GRAS…
The Federal Trade Commission (FTC) has filed a motion to dismiss a complaint charging the agency with exceeding its authority in requiring Food and Drug Administration (FDA) pre-approval for health-related claims on food products, violating advertisers’ constitutional rights by requiring compliance with these standards and failing to comply with notice-and-comment rulemaking procedures in establishing the standards. POM Wonderful LLC v. FTC, No. 10-1539 (D.D.C., motion filed November 16, 2010). Additional information about POM Wonderful’s complaint appears in Issue 364 of this Update. FTC contends that the court lacks jurisdiction to consider the matter because the complaint is moot, the company lacks standing, the company is attempting to preclude an enforcement action, and the complaint does not challenge final agency action. Specifically, FTC claims (i) the agency merely created a possible remedy of FDA pre-approval in consent agreements with food producers making health-related claims and not an enforceable rule; (ii) it…
The Food and Drug Administration (FDA) has issued warning letters to four manufacturers of alcoholic energy drinks (AEDs), calling the caffeine added to these malt beverages an “unsafe food additive” and threatening further action against Charge Beverages Corp.; New Century Brewing Co., LLC; Phusion Projects, LLC; and United Brands Company Inc. FDA apparently released its decision after conducting a scientific review that encompassed peer-reviewed literature, expert consultations, information provided by manufactures, and its own independent laboratory analysis. The agency’s findings evidently raised concerns “that caffeine can mask some of the sensory cues individuals might normally rely on to determine their level of intoxication,” leading to “hazardous and life-threatening situations.” As FDA Principal Deputy Commissioner Joshua Sharfstein summarized in a November 17, 2010, press release, “FDA does not find support for the claim that the addition of caffeine to these alcoholic beverages is ‘generally recognized as safe [GRAS],’ which is the…
The Food and Drug Administration (FDA) has announced an extension of the comment period for a draft compliance policy guide that proposes “certain criteria should be considered in recommending enforcement action against animal feed or feed ingredients that are adulterated due to the presence of Salmonella.” FDA will now accept comments until December 31, 2010. Additional information about the draft guidance appears in Issue 359 of this Update. See Federal Register, October 29, 2010.
The Food and Drug Administration (FDA) has proposed two new information collections related to voluntary registration, recordkeeping and mandatory third-party disclosure under section 4205 of the Patient Protection and Affordable Care Act of 2010. Section 4205 requires chain restaurants with 20 or more locations, as well as operators of 20 or more vending machines, to disclose “certain nutritional information on certain food items offered for sale so that consumers can make more informed choices about the food they purchase.” In addition, it provides for restaurants or operators with fewer than 20 locations to biannually opt in to the federal requirements. The first proposed information collection pertains to FDA’s program for voluntary registration under section 4205. FDA anticipates that chains with 10 to 19 outlets “may choose to register, either because they are growing quickly, or because they are concerned about possible regulation.” According to FDA, “[t]he primary source of potential registrants will…
The Food and Drug Administration (FDA) has reportedly confirmed the presence of Listeria monocytogenes at a San Antonio, Texas, processing plant implicated in four deaths. According to a November 3, 2010, FDA press release, the agency’s inspection of SanGar Fresh Cut Produce identified the bacteria “in processed celery and in multiple locations in the plant environment, including on food contact surfaces.” FDA also noted that its samples matched “the DNA fingerprint of the clinical cases of listeriosis reported by the Texas Department of State Health Services [DSHS],” which last month closed the plant and ordered a recall of all products shipped since January 2010. “It comes as no surprise to us,” one DSHS spokesperson was quoted as saying. “If there was any doubt out there, this erases it. It’s another layer of confirmation that this plant had serious issues.” Additional details about the outbreak and recall appear in Issue 369…
The Grocery Manufacturers Association (GMA) and Food Marketing Institute (FMI) have unveiled plans to create a front-of-package (FOP) labeling system that aims to “inform consumers and combat obesity.” According to an October 27, 2010, joint press release, the FOP system will display “important information on calories and other nutrients to limit . . . in a fact-based, simple and easy-to-use format.” The two industry groups have also pledged to consult stakeholders as they work to finalize the system and “provide consumers with information on nutrients needed to build a ‘nutrient-dense’ diet and on ‘shortfall nutrients’ that are under-consumed in the diets of most Americans.” The announcement followed the release of an Institute of Medicine report calling for FOP labels that highlight the nutrients of greatest concern to consumers—calories, saturated fats, trans fat, and sodium—as well as serving size. Co-sponsored by the Food and Drug Administration (FDA), the Phase 1 report…
Public Employees for Environmental Responsibility (PEER) has filed a complaint in federal court under the Freedom of Information Act (FOIA), seeking documents from the White House Office of Science and Technology Policy (OSTP) related to the development of policies to protect scientific integrity in federal agencies, such as the U.S. Department of Agriculture and the Food and Drug Administration. PEER v. OSTP, No. __ (D.D.C., filed October 19, 2010). According to the complaint, President Barack Obama (D) issued an executive order in March 2009, requiring the development of such rules by July. They have not yet been promulgated. OSTP Director John Holdren reportedly wrote online in June 2010 that the “process has been more laborious and time-consuming than expected,” and that an interagency panel has developed draft recommendations for OSTP and Office of Management and Budget review. Representatives from the latter two offices “have been honing a final set of recommendations”…
Washington State Attorney General Robert McKenna has issued an October 25, 2010, letter to Food and Drug Administration (FDA) Commissioner Margaret Hamburg, alleging that a recent incident involving alcoholic energy drinks (AEDs) sent nine college students to emergency rooms with alcohol poisoning. According to the letter, “Once at the hospital, medical staff found the blood-alcohol levels of the impacted students ranged from .123 percent (legally drunk) to .35 percent—a lethal level of alcohol poisoning… The investigation concludes that the students—all under 21 years old—combined AEDs with other kinds of alcohol.” Citing the October 8 police report, McKenna has claimed that the affected students were drinking an AED manufactured by Phusion Projects, LLC , known as “Four Loko,” which contains 12 percent alcohol and “high doses of caffeine and sugar.” Moreover, the letter continues, “The frightening incident… is hardly unique. In fact, AEDs are sweeping college campuses… Twenty-three students at New…
