Citizens for Health has filed a citizen’s petition with the Food and Drug Administration (FDA) requesting that the agency amend its high fructose corn syrup (HFCS) regulations. The requested changes would require food producers (i) using HFCS, to identify its concentration f ructose on product labels (e.g., HFCS with 42 percent fructose would be labeled “high fructose corn syrup 42”), and (ii) manipulating the mount of fructose in HFCS “to a different concentration than a standardized blend of 42 or 55,” to also incorporate the concentration into he ingredient name (e.g., HFCS with 90 percent fructose would be labeled “high fructose corn syrup 90”). Citizens for Health also asked that FDA initiate enforcement actions against food companies using HFCS with fructose in amounts other than 42 or 55 percent because these are the concentrations FDA has apparently designated as generally recognized as safe. According to the petition, numerous online articles…
Category Archives Food and Drug Administration
The Food and Drug Administration (FDA) has issued its “Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation.” Comments may be submitted at any time, although the guidance, with nonbinding recommendations for complying with a final rule that took effect in September 2009, has incorporated comments submitted after the draft guidance was published. Presented in a Q&A format, the guidance addresses compliance dates, the egg rule’s coverage, definitions, Salmonella Enteritidis prevention measures, testing, sampling, and registration requirements. See Federal Register, August 21, 2012. Noting that Americans consume 242 eggs per capita annually, New York University Nutrition Professor Marion Nestle draws attention to the guidance in her blog and cites a recent Canadian study claiming an association between the consumption of egg yolks and plaque formation in coronary arteries. She suggests that we should not “be eating so many eggs,”…
The Food and Drug Administration (FDA) has issued a final rule that amends regulations about concentrations of compounds of carcinogenic concern in the diet of food-producing animals and residues of carcinogenic concern in specific edible tissues. The changes clarify certain definitions “to enable the Center for Veterinary Medicine to consider allowing the use of alternative procedures to satisfy the DES [Diethylstilbestrol] Proviso without requiring the development of a second, alternative, set of terminology.” The changes take effect September 21, 2012. Among other matters, the amendment will change the existing emphasis in 21 CFR Part 500 on “no significant increase in the risk of cancer to the human consumer” to an emphasis on “the specific 1 in 1 million risk of cancer to the test animals approach.” See Federal Register, August 22, 2012.
The Food and Drug Administration (FDA) has responded to Senator Dick Durbin’s (D-Ill.) letter requesting that the agency take regulatory action “to address the rising health concerns around energy drinks” purportedly containing high levels of caffeine and other ingredients such as taurine, guarana and ginseng. Among other matters, in its August 10, 2012, letter, FDA suggests that research to date shows that “even when the consumption of energy drinks is considered, most of the caffeine consumed [in the United States] comes from what is naturally present in coffee and tea.” For most healthy adults, according to FDA, caffeine intake up to 400 mg per day is not associated with untoward health effects. Additional details about Durbin’s letter appear in Issue 435 of this Update. FDA’s generally recognized as safe (GRAS) regulation for caffeine applies to cola-type beverages; the agency “has not challenged the use of caffeine in other beverages at…
A federal magistrate judge in New York has determined that the Food and Drug Administration (FDA) must begin proceedings to withdraw its approval of the use of certain antibiotics in livestock for non-therapeutic purposes on the agency’s timeline, thus denying FDA’s request for a stay while the matter is pending on appeal before the Second Circuit. NRDC v. FDA, No. 11-3562 (S.D.N.Y., decided August 8, 2012). In June, the court determined that FDA arbitrarily denied petitions filed by advocacy organizations in 1999 and 2005 requesting the initiation of these proceedings. More information about the case appears in Issue 442 of this Update. The magistrate first ruled on the Natural Resource Defense Council’s (NRDC’s) motion to strike a document from the record; it was an Animal Health Institute statement “expressing general support for the FDA’s plans to reduce the non-therapeutic use of medically-important antibiotics in animal feed through a voluntary guidance…
Turtle Island Restoration Network and the Center for Biological Diversity have filed a complaint for declaratory and injunctive relief in a federal court in California against the Food and Drug Administration (FDA) to force the agency to act on their June 2011 petition seeking to reduce the allowable level of mercury in seafood. Turtle Island Restoration Network v. Hamburg, No. 12-03884 (N.D. Cal., filed July 25, 2012). The organizations claim that while FDA had 180 days, or until December 17, 2011, to respond to the petition, “[t]o date, FDA has neither granted nor denied the petition and has taken no action to reduce human exposure to mercury from commercial fish.” They request a court order declaring that FDA has violated the Administrative Procedure Act and requiring the agency to issue a decision on their petition within 30 days. The plaintiffs contend that FDA’s current action level for mercury in seafood…
The Government Accountability Office (GAO) has issued a July 26, 2012, report criticizing the Food and Drug Administration’s (FDA’s) efforts to implement a comprehensive food advisory and recall process. As directed by the FDA Food Safety Modernization Act, GAO reportedly assessed the agency’s ability to order recalls and effectively inform consumers and retailers about food safety issues, concluding that although FDA has established internal procedures “describing the steps it will take to order a food recall ... these procedures are not yet public and the agency has not issued regulations or industry guidance to clarify its ordered food recall process.” In particular, the report faults FDA for failing to fashion “a comprehensive food recall communication policy and related implementation plans.” Noting that recent foodborne illness outbreaks have drawn national attention to food supply safety issues, GAO argues that FDA has not yet drafted measures to better manage its communication challenges or…
The Food and Drug Administration (FDA) has issued a final rule amending the food additive regulations at 21 CFR part 177 “to no longer provide for the use of polycarbonate (PC) resins,” including bisphenol A (BPA), in infant feeding bottles or spill-proof sippy cups. Effective July 17, 2012, the final rule apparently responds to a petition filed by the American Chemistry Council (ACC), which claimed that “that baby bottles and sippy cups manufactured from PC resins are no longer being introduced into the U.S. market and that manufacturers of baby bottles and sippy cups have abandoned the use of PC resins in making these products.” After reviewing the submitted data and seven public comments addressing the petition, FDA concluded that the use of PC resins in these products has been “completely and permanently abandoned,” and agreed to amend the regulations accordingly. The agency has requested objections to the final rule…
A federal court in Wisconsin has reportedly approved a consent decree between the U.S. government a Wisconsin livestock operation that allegedly violated federal drug laws by failing to maintain adequate animal treatment records, using new animal drugs illegally and failing to adequately distinguish between medicated and non-medicated animals for sale for use as human food. The Food and Drug Administration (FDA) initially warned the owner of Nolan Livestock in 2004 that a U.S. Department of Agriculture inspection revealed the presence of an illegal antibiotic in the edible tissues of its dairy cows. Under the consent decree, the owner must cease operations and then resume only when it has documented to FDA’s satisfaction that it has corrected the problems observed and has instituted appropriate procedures to prevent a recurrence. See U.S. Department of Justice News Release, June 26, 2012; FDA News Release, July 10, 2012.
The Food and Drug Administration (FDA) will take part in a collaborative effort to create a public database that will contain 100,000 foodborne pathogen genomes to help facilitate the identification of those responsible for outbreaks involving bacteria such as Salmonella, Listeria and E. coli. Called “The 100K Genome Project,” the undertaking will apparently be a five-year genetic sequencing program openly accessible to researchers and others helping to develop tests that would identify the type of bacteria present in a sample within days or hours. According to one project participant, “Each year in the United States there are more than 48 million cases of foodborne illness. A problem of this magnitude demands an equally large countermeasure.” See FDA News Release, July 12, 2012.
