The Food and Drug Administration (FDA) has released a draft strategic priorities document for fiscal years 2011-2015 that outlines four key cost-cutting strategic priorities and four strategic program goals designed to help FDA achieve its public health mission. According to an October 1, 2010, Federal Register notice, the four cost-cutting priorities seek to (i) “advance regulatory science and innovation,” (ii) strengthen the safety and integrity of the global supply chain,” (iii) “strengthen compliance and enforcement activities,” and (iv) “expand efforts to meet the needs of special populations.” Among the program goals, FDA has highlighted intentions to establish effective tobacco regulation as well as advance food safety and nutrition by ensuring the safety of the food supply from farm to table and promoting healthy dietary practices and nutrition. FDA will accept comments until November 1, 2010.
Category Archives Food and Drug Administration
Pinnacle Foods Group LLC has reportedly agreed to reformulate its Log Cabin Syrup® after Vermont Representative Peter Welsh (D) called on the Food and Drug Administration (FDA) to investigate the company for selling a product in apparent violation of agency regulations. Welsh’s September 8, 2010, letter noted that the company’s “All Natural Syrup” contains caramel color, among other ingredients. Welsh suggested that consumers outside the state “who have come to expect quality from natural Vermont products may be fooled by this misleading labeling.” The product is apparently being sold in a beige plastic jug similar to real maple syrup packaging, raising the ire of maple syrup producers. While FDA has not defined the term “natural,” the agency allows it to be used if the claim is truthful and “the product does not contain added color, artificial flavors or synthetic substances,” according to an agency spokesperson. Claiming that its product “provides consumers…
Led by U.S. Senator Mark Begich (D-Alaska), a group of legislators has asked the Food and Drug Administration (FDA) to halt its ongoing review of genetically engineered (GE) salmon, citing “serious concerns with the current approval process and many potential health and environmental risks that are associated with producing GE fish.” FDA recently held public hearings to decide the fate of a new animal drug application (NADA) for AquAvantage® salmon, an Atlantic variety that uses genes from ocean pout and Chinook to increase the speed of maturation. Additional details about these hearings appear in Issue 365 of this Update. In their September 28, 2010, letter to FDA Commissioner Margaret Hamburg, the Senators argue that the NADA process lacks transparency and does not adequately address the “creation of a new animal, especially one intended for human consumption.” The signatories specifically point to reports that GE salmon “‘have slightly higher levels of…
A Food and Drug Administration (FDA) advisory panel has reportedly declined to take action or make any recommendations about the safety of genetically modified (GM) salmon at the conclusion of hearings that drew considerable media and public attention. A Massachusetts based company has been trying to bring its AquAvantage® salmon to the market for more than 10 years. If it succeeds, the fish, which reportedly grow to full size in half the time as conventional salmon, will be the first GM animal sold for human consumption. According to a news source, FDA’s Veterinary Medicine Advisory Committee indicated that it lacked sufficient safety data to make a determination and suggested that the government undertake a more rigorous analysis of potential health effects and environmental impact. Agency documents made available before the hearing reportedly indicated that FDA was prepared to conclude that no biologically relevant differences between GM salmon and conventional salmon…
The Food and Drug Administration (FDA) recently issued a warning letter to the New York-based manufacturer of “Magic Power Coffee,” a product that purportedly contains the active ingredient used in erectile dysfunction medications. According to the letter, INZ Distributors, Inc., has marketed the coffee as a conventional food despite the presence of hydroxythiohomosildenafil, an analogue of sildenafil that is a phosphodiesterase type 5 inhibitor “well known to have an effect on the structure or function of the body.” The company has also included instructions to use its product “approximately 30-45 minutes prior to engaging in sexual intercourse.” On the basis of the synthetic active pharmaceutical ingredient and these labeling claims, FDA has concluded that “Magic Power Coffee” is not primarily consumed “for its taste, aroma or nutritive value.” The agency has thus deemed the product an unapproved new drug and a misbranded drug in violation of the Food, Drug, and…
The Corn Refiners Association has petitioned the Food and Drug Administration (FDA) “to allow manufacturers the option of using ‘corn sugar’ as an alternative name for high fructose corn syrup.” The trade group contends that the public is confused about what the sweetener is and that “‘corn sugar’ succinctly and accurately describes what this natural ingredient is and where it comes from—corn.” According to an association press release, “Contrary to widespread consumer belief, high fructose corn syrup—a safe and affordable natural sweetener found in many popular products on grocery shelves—is not high in fructose when compared with other commonly used nutritive sweeteners, including table sugar, honey and fruit juice concentrates.” Food industry critics immediately responded to news about the petition by claiming those who produce high-fructose corn syrup (HFCS) are less concerned about “epidemic rates of obesity, diabetes and corn allergies” than they are about “a 20 year low in…
The Food and Drug Administration (FDA) has notified the presidents of the Dr. Pepper Snapple Group and Unilever, Inc. warning them that their green tea products are misbranded because they make nutritional or health-related claims in violation of federal law. Specifically, FDA takes issue with antioxidant claims used to promote Canada Dry Sparkling Green Tea Ginger Ale® and the cholesterol-lowering claims used to promote Lipton Green Tea 100% Natural Naturally Decaffeinated®. According to FDA, ginger ale, as a carbonated beverage, is a snack food that may not be fortified, and therapeutic claims make green tea a drug requiring the agency’s pre-marketing approval. The letters call for corrective action and a response.
The Food and Drug Administration (FDA) has released a briefing packet in advance of public meetings to discuss a new animal drug application for genetically engineered (GE) salmon. Produced by AquaBounty Technologies, Inc. (ABT), the AquAdvantage salmon contains genes from Chinook and ocean pout that accelerate maturation. Additional details about the September 19-21, 2010, meetings appear in Issue 362 of this Update. According to the FDA briefing packet, “[T]here are no material differences in food from ABT salmon and other Atlantic salmon.” The assessment therefore concludes that “triploid ABT salmon is . . . as safe as food from conventional salmon,” although it recommends further allergenicity studies for diploid salmon because the ones provided were of “low quality.” In addition, an environmental impact statement (EIS) has found that the fish “are not expected to have a significant impact on the quality of the human environment.” As the EIS summary notes,…
Linking a Salmonella Typhi outbreak to frozen mamey fruit pulp, the Food and Drug Administration (FDA) has urged consumers to discard La Nuestra® or Goya® fruit products in their possession and find out what brand is in use by street vendors before purchasing the mamey fruit-based juices and fruit shakes they sell. At least nine consumers in California and Nevada have apparently developed typhoid fever from the outbreak. FDA has also indicated that it will increase its border sampling to prevent contaminated product from entering the United States. See Product Liability Law 360, August 20, 2010.
Representative Rosa DeLauro (D-Conn.), who chairs the Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) appropriations subcommittee, is seeking information from the agencies about the unfolding Salmonella outbreak linked to two Iowa egg producers. Representatives Henry Waxman (D-Calif.) and Bart Stupak (D-Mich.) have also stepped into the massive egg recall, requesting information from the same agencies and demanding documents and information from the egg company owners. Stupak’s oversight subcommittee of the House Committee on Energy and Commerce has scheduled a September 14, 2010, hearing into the matter and has apparently invited Wright County Egg owner Austin “Jack” DeCoster and Hillandale Farms owner Orland Bethel to testify. More than a half-billion eggs, representing less than 1 percent of the U.S. egg supply, have been recalled after an upswing in Salmonella cases came to the attention of state regulators and the Centers for Disease Control and Prevention beginning in May.…
