Despite its seven-year investigation into jerky pet treats that may have killed more than 1,000 dogs and left thousands more ill, the U.S. Food and Drug Administration (FDA) “has still not been able to identify a specific cause for the reported illnesses or deaths.” According to an FDA news release, as of May 1, 2014, the agency had received more than 4,800 complaints of illness in pets that ate jerky treats made of chicken, duck or sweet potato. In its ongoing efforts to find a cause for the illnesses, FDA has partnered with the Centers for Disease Control and Prevention to conduct a study to determine whether sick dogs eat more jerky treats than healthy dogs do. Studies of the jerky treats revealed the presence of the antiviral drug amantadine, but “FDA does not believe that amantadine contributed to the illnesses because the known side effects or adverse effects associated…
Category Archives Food and Drug Administration
U.S. Sens. Lamar Alexander (R-Tenn.), Richard Burr (R-N.C.), Johnny Isakson (R-Ga.), and Orrin Hatch (R-Utah) have sent a letter to U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg expressing “significant concern” about the agency’s use of draft guidance to, in their view, make “substantive policy changes.” Noting that draft guidance is “increasingly becoming default FDA policy” although it is issued for comment purposes only, the letter expresses a number of concerns, including that (i) FDA’s website does not differentiate between draft and final guidance; (ii) draft guidance is not revised, finalized or withdrawn in a timely manner; and (iii) the agency issues guidance that “does not take into account, or may even conflict with, the scientific community.” Specifically, the senators request that FDA provide a list of all Level I draft guidances, including the date issued and the timeline on which the agency plans to withdraw, revise or finalize each guidance,…
The U.S. Food and Drug Administration (FDA) has issued draft guidance intended to help the food industry prepare submissions for obtaining exemptions from the labeling requirements for major food allergens. The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) requires that food labels identify products containing major food allergens (milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans). Because an ingredient derived from a major food allergen may be modified to such an extent that it does not contain allergenic protein or does not cause an allergic response that poses a risk to human health, FALCPA apparently provides two processes through which manufacturers can obtain an exemption from this labeling requirement for a specific ingredient. An ingredient may be exempted through submission and approval of either (i) a petition containing scientific evidence which demonstrates that the ingredient “does not cause an allergic response that poses a…
Dubbing powdered alcohol “the Kool-Aid of teen binge drinking,” Sen. Charles Schumer (D-N.Y.) has called on the U.S. Food and Drug Administration (FDA) to supersede the Alcohol and Tobacco Tax and Trade Bureau (TTB) by banning a product known as Palcohol® before it reaches store shelves. Created by Lipsmark, LLC, Palcohol® first attracted media attention when TTB granted and then temporarily rescinded approval for its labels, citing a technical issue with the amount of powdered alcohol in each package. Additional details about Palcohol® appear in Issue 521 of this Update. Now Schumer has written a May 5, 2014, letter to FDA Commissioner Margaret Hamburg, asking the agency to work with TTB “to assess the potential public health concerns that arise by combining this product with food and beverages.” Pointing to a 1976 district court ruling and a memorandum of understanding that saddled both agencies with the responsibility to regulate alcohol,…
In a blog post, U.S. Food and Drug Administration (FDA) Chief Food Safety Inspector Michael Taylor said that the agency will not disrupt the current practice of breweries and food manufacturers selling or donating spent grains to farmers for use as animal feed. The proposed rule would have required breweries to dry, package and inspect spent grain before it could be given to cattle, which could have cost the brewing industry an estimated $50 million per year, according to Sen. Charles Schumer (D-N.Y.). Additional details appear in Issue 519 of this Update. FDA will still issue revised proposals on spent grains this summer, but Taylor said they will not include requirements that human food manufacturers establish separate animal feed safety plans and controls to cover their by-products. “The recycling of human food by-products to animal feed contributes substantially to the efficiency and sustainability of our food system and thus is…
The U.S. Food and Drug Administration (FDA) has released its Food Code Reference System (FCRS), a searchable database that provides information for industry about FDA’s positions and responses to questions related to the FDA Food Code. With an aim “to promote nationwide consistency and increase transparency about the Food Code,” FCRS contains entries that clarify issues such as (i) storing foods that require temperature control for safety; (ii) food establishment design and food equipment cleaning; (iii) bare hand contact with ready-to-eat foods; and (iv) preventing food contamination. FDA plans to add entries that are “important to the uniform application of the Food Code and that may have implications across all jurisdictions that regulate food establishments.” These entries will reflect questions previously answered by FDA as well as responses to future inquires that FDA receives. The Retail Food Protection Team in FDA’s Center for Food Safety and Applied Nutrition (CFSAN) will…
The U.S. Food and Drug Administration (FDA) has issued a final rule, effective April 14, 2014, amending its food additive regulations to allow the use of ionizing radiation on crustaceans (e.g., crab, shrimp, lobster, crayfish, and prawns) to control foodborne pathogens and extend shelf life. In response to a petition first filed in 2001, FDA concluded that use of irradiation to treat chilled or frozen raw, cooked or partially cooked crustaceans, or dried crustaceans, with or without spices, minerals, inorganic salts, citrates, citric acid and/or calcium disodium EDTA used in accordance with applicable laws and regulations, is safe, provided that the absorbed dose does not exceed 6.0 kGy. At this dose, FDA notes, ionizing radiation will reduce but not entirely eliminate, the number of illness-causing microorganisms in or on crustaceans. The agency also observes that irradiation is not a substitute for proper food-handling practices and that crustaceans treated with ionizing…
The U.S. Food and Drug Administration (FDA) has issued draft guidance concerning the proper labeling of honey and honey products to ensure that such products “are not adulterated or misbranded.” In light of its earlier refusal to create a new standard of identity for honey, the agency developed the guidance to respond to labeling issues raised by a March 8, 2006, petition submitted by the American Beekeeping Federation and other honey-related associations. According to FDA, the draft guidance (i) “summarizes FDA’s legal authority over honey and honey products”; (ii) “provides a commonly used definition of honey”; (iii) “offers advice on labeling issues such as the floral source of honey, blends of honey and other sweeteners, and blends of honey and other ingredients, such as flavors”; and (iv) “describes some of the measures FDA takes to guard against honey adulterated with cane sugar, corn syrup, or residues of chloramphenicol or fluoroquinolones.”…
The U.S. Food and Drug Administration (FDA) has issued draft guidance for the food industry titled “Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 3).” Intended to address questions received since publication of the second edition in May 2004, the guidance includes information related to the Food Safety Modernization Act, which requires prior notice indicating whether a food article has been refused entry by any country. FDA will accept comments at any time, but suggests submitting them by May 30, 2014, to ensure consideration before the agency begins work on the final version. See Federal Register, March 31, 2014. Issue 519
After reportedly receiving more than 2,000 comments criticizing its proposal to tighten regulations concerning the transaction of spent grain between brewers and farmers, the U.S. Food and Drug Administration (FDA) has apparently decided to revise its original plan, stating that it will release an amended version of the proposal this summer. According to news sources, brewers, who for years have donated or sold their spent grain to farmers to use as animal feed, were outraged at the proposed regulation—part of FDA’s Food Safety Modernization Act—claiming it would turn an ages-old practice into a heavy burden, requiring them to alter processes and testing requirements and add additional recordkeeping tasks. Brewers also note that under the currently proposed terms, they would either be required to dry and package spent grain before sending it off as animal feed or to discard it entirely, leaving it to sit in landfills. See VoiceofSanDiego. org, April 3, 2014;…
