July 23, 2014

FDA Warning Letters April 26, 2014: Hahn’s, Diondillo’s, Pancrazio


The FDA has sent warning letters to three corporations this week for problems with their product safety. Hahn's Old Fashioned Cake Company was warned for food packed or held under insanitary conditions, as was Biondiollo's Bakery. Pancrazio S.P.A. was cited for violating low acid canned food regulations. Hahn's Old Fashioned Cake Company was cited for "serious violations of FDA's Current Good Manufacturing Practice requirements." The corporation did not have adequate cleaning processes for equipment and prep tables. THe product packaging line was "observed to be encrusted with flour, sugar, and filth." In addition, pests were not excluded from the processing areas. Six birds were observed flying around the production area; a bird was defecating while on a rafter above uncovered finished … [Read more...]

FDA Asked to Monitor False Industry Claims About GMO Salmon


Food & Water Watch and Center for Food Safety asked FDA Commissioner Margaret Hamburg to stop erroneous statements by AquaBounty Technologies. The company's vice present Henry Clifford told the press that the government will let the company sell its GMO salmon without a label to inform consumers. Wenonah Hauter, executive director of Food & Water Watch said in a statement, "FDA's failure to take action on AquaBounty's blatant misrepresentation of the facts typifies the agency's entire hands-off regulatory review of GMO salmon. It also illustrates the dangerous level of miscommunication between FDA and AquaBounty that, historically, has caused the agency to overlook critical risks associated with GMO salmon." Environmental experts are concerned that the genetically engineered … [Read more...]

Class I Recalls from FDA’s April 2 Enforcement Report


These are the Class I recalls from the U.S. Food and Drug Administration's (FDA's) April 2 Enforcement Report. World Pure Foods Wholesalers, Inc. recalled three Kinnikinnick brand products because they contain undeclared milk.  Consumers with allergies to milk should not eat the following products as they run the risk of allergic reaction if they do. Kinnikinnick Panko Style Bread Crumbs sold in 12.5oz boxes with the  UPC 62013360015 3 with the "best by" cocdes 20140209, 20140119, 20140211, 2014MR30, 2014 JN02, 2014JL23, 20131230. Kinnikinnick Cinnamon & Brown Sugar Homestyle Waffles  sold in 7.4 oz boxes with the UPC 620133001981 and the "best by" code BB 20140127, 2014 MA28, 2014JN25. Kinnikinnick Original Homestyle Waffles sold in 7.4 oz boxes with the UPC 620133001981 and the … [Read more...]

FDA Issues Final Guidance for Import Refusal of Ackee

Ackee Can be Toxic

The FDA has issued final guidance on import enforcement for ackee, a fruit that contains the toxin hypoglycin A. When the fruit is fully ripe, the toxin drops to negligible levels, but if the fruit isn't ripe or if it isn't properly processed to remove the seeds and rind, concentrations of hypoglycin A can rise about 100 parts per million and become a health risk. The FDA now has the authority to seize domestic product and to refuse imports. Ackee is a tropical fruit about four inches long. When immature, it is green. A mature fruit is yellow, with an overlay of bright red with three bulging seams. The fleshy, pale yellow arils inside are the edible part. Ackee is found in West Africa, South America, Central America, and the Caribbean. It is also found in Florida. The fruit is … [Read more...]

FDA’s Plan to Allow Ionizing Radiation in Crustaceans Criticized


The FDA is amending food additive regulations to allow the "safe use of ionizing radiation on crustaceans" to control foodborne pathogens and extend shelf life. The petition to allow this method of controlling pathogens was submitted by the National Fisheries Institute. The government agency says the decision is based on potential toxicity, the effect of irradiation on nutrients and potential microbiological risk that may result from treating the fish. Crustaceans include crab, shrimp, lobster, crayfish, and prawns. Ionizing radiation is used to treat cancer patients and in X-rays and CT scans. At the maximum dose of 6.0 kiloGray, the treatment will "reduce, but not entirely eliminate" the number of pathogenic microorganisms on crustaceans. The update does state that "irradiation is … [Read more...]

FDA Publishes Guidance Document for Honey Labeling


The FDA is cracking down on honey labeling, issuing a guidance document that will require companies to label honey that is not 100% honey as "blend of sugar and honey" or "blend of honey and corn syrup". The American Beekeeping Federation and other honey associations have been advocating for this change for years. That organization submitted a citizen petition in 2006 asking that the FDA adopt a U.S. standard of identify for honey. Often products that are labeled as "honey" contain other sweeteners, which some believe is food fraud. Honey is made of glucose and fructose, along with minerals such as iron, potassium, magnesium, and calcium. Honey has antiseptic an antibacterial properties and is a natural anti-inflammatory, while sugar is considered inflammatory. In addition, products … [Read more...]

New York City Fish Closed for Listeria Problems


Federal Judge Roslynn Mauskopf granted the U.S. government's request for a permanent injunction against New York City Fish on Monday, March 30, 2014. Inspectors found that the fish had been processed and packed under "unsanitary conditions where it may be contaminated by filth". The motion for preliminary injunction had been filed on May 17, 2013. Inspectors looked at the facility six times between 2006 and 2012 and found Listeria monocytogenes bacteria in the environment and in the finished product. In addition, there was no evidence that many of the company's employees had been trained to ensure compliance with the Food, Drug and Cosmetic Act. Employees were observed spraying antimicrobial solution in the brining solution and spraying it directly on in-process seafood products during … [Read more...]

FDA Update on Guidance #213


Last year, the FDA announced a new voluntary guidance plan to help "phrase out" the use of medically important antibiotics in factory farm animals for purposes of growth promotion. The government asked the animal pharmaceutical industry to withdraw animal drug approvals used for production and to transfer the remaining uses of the drugs to prescription-only. Now the FDA says that out of 26 affected sponsors, 25 have confirmed in writing their intent to "engage with FDA as defined in Guidance #213" and have given the agency consent to list their names. Those corporations hold 99.6% of the appliances affected by Guidance #213, and represent 99.95% of the total sales of products affected by Guidance #213. Those corporations include Bayer Healthcare LLC Animal Health Division, G.C. … [Read more...]

FDA Closes Jensen’s Old Fashioned Smokehouse


The FDA has closed Jensen's Old Fashioned Smokehouse in Seattle, Washington, after environmental samples confirmed the presence of Listeria monocytogenes in the facility. Inspectors found the pathogenic bacteria in food processing and storage areas. The facility is subject to a consent decree of permanent injunction that was entered in 2001. Under that decree, the company "agreed to comply with requirements to control food safety hazards and ensure that its products are not adulterated." To resume production, Jensen's must meet several requirements, including cleaning and sanitizing the facility and hiring an expert to develop a Sanitation Standard Operation Procedure, along with an environmental monitoring program for Listeria. In addition, the company must test samples of all … [Read more...]

FDA Proposes Rule for Grocery Store Food Recall Notices


The FDA has issued advanced notice of proposed rulemaking to seek public input on part of the Food Safety Modernization Act of 2011. The FDA may require manufacturers and distributors to submit "consumer-oriented" information when a recall is issued that will help consumers accurately identify whether they have the food that has been recalled. The FDA will then prepare and publish on their website a one-page summary of the information to be printed by grocery stores and displayed. The summary must be displayed prominently within 24 hours after it is published in the web site. The FDA wants input on the content of the consumer-oriented information, when it will be required, the formats required, and how updates will be handled. They also want to define "grocery store", and how the … [Read more...]

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