The Government Accountability Project (GAP) has filed a lawsuit under the Freedom of Information Act (FOIA) against the Food and Drug Administration (FDA), alleging that the agency has wrongfully withheld information requested about the use of anti-microbial drugs in food-producing animals. GAP v. FDA, No. 12-1954 (D.D.C., filed December 5, 2012). GAP requests an order requiring FDA to make the requested information available within 10 working days and further seeks costs and attorney’s fees. According to the complaint, GAP sought information in February 2011 about anti-microbial drugs collected from animal-drug sponsors under 21 U.S.C. § 360b. While FDA produced, as requested, educational and outreach materials that assist drug sponsors in fulfilling their reported duties, it withheld (i) “FDA’s data for use of anti-microbial drugs in food-producing animals in 2009 as broken down by container size, strength, and dosage form”; and (ii) “FDA’s data for use of anti-microbial drugs in food-producing…
Category Archives Issue 464
Indiana farmer Vernon Bowman claims in his U.S. Supreme Court merits brief that the Federal Circuit Court of Appeals, which ruled that he infringed patents by planting second-generation genetically modified (GM) seeds, has “significantly curtailed the patent-exhaustion defense” by refusing to “hold Monsanto’s patent rights exhausted with respect to the seeds Bowman purchased from [a] grain elevator.” Bowman v. Monsanto Co., No. 11-796 (U.S., petitioner’s brief filed December 3, 2012). The U.S. Supreme Court agreed to review whether “the Federal Circuit erred by (1) refusing to find patent exhaustion in patented seeds even after an authorized sale, and by (2) creating an exception to the doctrine of patent exhaustion for self-replicating technologies.” Additional information about the dispute appears in Issue 434 of this Update. The allegedly infringing seeds that Bowman planted as a second crop were purchased in a commodity grain mix from a grain elevator. Such mixes can, according to…
Peru has passed a law that prohibits genetically modified organisms (GMOs) from being imported, produced or used anywhere within the country for the next 10 years. The law, which was approved by President Ollanta Humala last year and took effect last week, is aimed at preserving Peru’s agricultural diversity, preventing cross-pollination and supporting local farmers. According to news sources, GMOs threaten the country’s heritage plant species, including several varieties of colorful corn, which are becoming increasingly popular export commodities. Violating the law will result in a maximum fine of 10,000 UIT tax units, which is about 36.5 million soles ($14 million). The goods can also be seized and destroyed. See Andean Air Mail & Peruvian Times, November 17, 2012.
A Mexican lawmaker has proposed a 50 percent tax on chewing gum. According to news sources, Institutional Revolutionary Party Deputy Juan Manuel Diez Francos claims such a tax could fund efforts to clean up the gum discarded in various public venues. Mexico is apparently the second largest consumer of gum behind the United States—citizens chew an average of 2.5 pieces daily. A similar proposal is currently being sought in Northern Ireland for the same reasons. See VOXXI, November 28, 2012.
Health Canada has issued a notice of modification adding steviol glycosides derived from the stevia plant to its list of permitted sweeteners. After concluding a technical consultation published on July 31, 2012, in response to three separate food additive submissions, Health Canada has evidently agreed that “available data support the safety and efficacy of steviol glycosides when used as described.” The revised list of permitted sweeteners authorizes the use of steviol glycosides as a tabletop sweetener and as a food additive in a number of food categories, including those pertaining to breakfast cereals, confections, nut and peanut spreads, fruit spreads, sauces, beverages, baking mixes, desserts, chewing gum, and condiments. Health Canada has directed food labeling questions about the use of common names for steviol glycosides, such as “purified stevia extract” and “stevia leaf extracts,” to the Canadian Food Inspection Agency.
The Food and Drug Administration (FDA) has issued final rules amending food additive regulations pertaining to the use of ionizing radiation in the production, processing and handling of meat and poultry products. Promulgated at the request of the U.S. Department of Agriculture, the rules took effect on November 30, 2012. FDA requests written objections or requests for a hearing by December 31. The meat-product irradiation amendment would “provide for the safe use of a 4.5 kilogray (kGy) maximum absorbed dose of ionizing radiation to treat unrefrigerated (as well as refrigerated) uncooked meat, meat byproducts, and certain meat food products to reduce levels of foodborne pathogens and extend shelf life.” The poultry-irradiation amendment would “increase the maximum dose of ionizing radiation permitted in the treatment of poultry products, to include specific language intended to clarify the poultry products covered by the regulations, and to remove the limitation that any packaging used…
The Food and Drug Administration (FDA) has proposed revoking “the standards of identity for artificially sweetened jelly, preserves and jam,” concluding that these standards “are both obsolete and unnecessary in light of [] regulations for food named by use of a nutrient content claim and a standardized term.” Responding to a citizen petition submitted by the International Jelly and Preserve Association (IJPA), the proposed rule notes that standards implemented in 1959 for fruit spreads containing nonnutritive sweeteners (NNSs) only provided for the use of saccharin, sodium saccharin, calcium saccharin, or any combination thereof (21 CFR 150.140 and 150.160). These standards did not include other NNSs approved for food use since 1959, although FDA later established under the Federal Food, Drug and Cosmetic Act a general standard of identity for foods named by a nutrient content claim such as “low calorie” or “sugar free” “in conjunction with a standardized food term,”…
The Food and Drug Administration (FDA) has issued a proposed rule that would update tolerances “for residues of approved and conditionally approved new animal drugs in food by standardizing, simplifying, and clarifying the determination standards and codification style.” According to FDA, the regulations describing how to set animal drug tolerances for human food are not uniform, do not provide all relevant information, and “no longer accurately reflect current regulatory science.” “For example, the regulations provide the ADI [acceptable daily intake] and safe concentrations for some, but not all, drugs,” states the proposed rule. “In addition, the regulations list some tolerances as being for ‘negligible’ residue, and others as ‘no residue,’ ‘zero’ or ‘not required,’ but they do not explain what these important terms mean. The proposed rule addresses these inconsistencies by simplifying and standardizing the determination standards and codification style and by adding definitions for key terms.” FDA will accept…
U.S. Rep. Edward Markey (D-Mass.) has written a November 30, 2012, letter to Federal Trade Commission (FTC) Chair Jon Leibowitz asking the agency to investigate advertising claims made by energy-drink manufacturers. Alarmed by recent media reports allegedly linking products such as 5-Hour Energy® to consumer deaths, Markey notes that many energy drinks “are sold as dietary supplements” that do not fall under Food and Drug Administration (FDA) rules for caffeine content or labeling, and do not require FDA approval before going on the market. “As you know, the FTC has in the past successfully investigated and took action against claims made by alcohol-containing energy drinks found to be engaging in unsafe, deceptive marketing claims,” writes Markey, who has also asked FTC to describe its coordination with FDA and other federal agencies. “I believe an investigation into energy drinks that do not contain alcohol and are often targeted at children may…
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