May 24, 2017

Banzai Sushi Receives FDA Warning Letter

The FDA has sent a warning letter to Northwest Frozen LLC, doing business as Banzai Sushi, in Seattle, Washington. That seafood processing facility has serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations and Current Good Manufacturing Practice regulations for food. The facility must conduct or have conducted a hazard analysis for each kind of fish and fishery product produced. And an HACCP plan that lists the food safety hazards that are reasonably likely to occur. The firm's HACCP plan for "Frozen IQF Sushi Pieces" does not list the following food safety hazards: Clostridium botulinum growth and toxin formation; pathogenic bacteria growth and toxin formation; and undeclared allergens. The letter states that intact vacuum-packaged seafood … [Read more...]

Minnesota Lutefisk Manufacturer Gets FDA Warning Letter

Day Fish Company in Braham, Minnesota was inspected by the FDA from January 17 to January 23, 2017 and received a warning letter. The firm makes lutefisk from imported dried cod distributes pickled herring cutlets. According to the letter, the inspection revealed "serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (21 CFR), Part 123. hat means that fish or fishery products are adulterated. The refrigerated, ready to eat seafood products are adulterated "in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health." The firm must conduct a hazard analysis for each kind of fish and fishery product they produce along with a … [Read more...]

Permanent Injunction Closes Dietary Supplement Makers

The U.S. District Court for the District of Colorado has entered a permanent injunction against EonNutra LLC, two related companies, CDSM LLC and HABW LLC, and their owner, to prevent the distribution of "adulterated and misbranded dietary supplements and unapproved and misbranded drugs." The Department alleges that the defendants, who sell about 150 dietary supplement products, violated the Federal Food, Drug, and Cosmetic Act. Several of those products were labeled as dietary supplements, but were marketed as drugs. The company claimed that the product could help treat or prevent diseases such as "heart disease, diabetes, depression, hypertension, osteoporosis, and liver and kidney disorders." According to the complaint, the defendants offered these claims to the public without … [Read more...]

Permanent Injunction Entered Against Valley Milk Products

The U.S. District Court for the Western District of Virginia entered a consent decree of condemnation and permanent injunction against Valley Milk Products LLC on March 15, 2017. The decree orders the condemnation of seized milk powder products and prevents its distribution.   The seizure action was filed in the Western District of Virginia on November 18, 2016 at the request of the FDA. The complaint alleged that milk powder products were manufactured under insanitary conditions "whereby they may have become contaminated with filth, and/or whereby they may have been rendered injurious to health. That complaint sought to seize and condemn certain adulterated milk powder products at Valley Milk Products’ Strasburg, Virginia facility." Valley Milk Products nonfat dry milk … [Read more...]

FDA Releases 2016 Food Safety Survey Report

The FDA has released the 2016 Food Safety Survey Report. This is a periodic national telephone survey of adults in the 50 states and the District of Columbia. This survey has been conducted since 1988 and is used to help the FDA and USDA make regulatory and education decisions. The 2016 survey was the first time cell phone users were sampled in addition to landline phone users. The survey interviewed 4,169 respondents between October 2015 and January 2016. The key findings are below. The survey found that consumers are somewhat concerned about getting a foodborne illness from how they prepare food, but think that people are more likely to get sick from food prepared at a restaurant.  It is true that more outbreaks (defined as two more more unrelated people sickened with the same … [Read more...]

FDA Tells Pet Owners Not to Feed Two Dog Foods

The FDA is advising pet owners not to feed their pets certain lots of Evander's Hunk of Beef or Against the Grain Grain Free Pulled Beef with Gravy canned dog foods after unopened cans from both brands were found to contain pentobarbital, a barbiturate. This drug is used in animal euthanasia. It should not be in pet food. The FDA was not able to determine from records whether any other Evanger's or Against the Grain products made with beef contained any of the beef used in the recalled products. In addition, the FDA inspected manufacturing facilities on February 14, 2017 and found "numerous significant concerns with conditions" at the company's Wheeling, Illinois and Markham, Illinois plants. The advisory states that "these are initial observations and do not represent a final … [Read more...]

Is That Really FDA-Approved?

When you see the words "FDA Approved" on a product, what does that mean? The FDA is a government agency that is responsible for protecting the public health. It regulates human drugs, biologics, animal drugs, medical devices, tobacco products, food, cosmetics, and electronic products that emit radiation. Not all of those products are reviewed for safety and effectiveness by the FDA before thy are marketed. FDA enforcement efforts often focus on products that are already available to consumers. The FDA can act when safety issues and problems arise. The FDA does not approve companies, health care facilities, labs, or manufacturers. Owners and operators of domestic or foreign food and drug companies must register their facilities with the FDA. The FDA approves new drugs and … [Read more...]

FDA Confirms Belladonna in Homeopathic Teething Products

Last year we told you about a consumer warning issued by the FDA regarding homeopathic teething products that had inconsistent levels of belladonna, which is considered a toxic substance. On Friday, the FDA released a report stating that elevated levels of belladonna have been found in those products; sometimes "far exceeding the amount claimed on the label." The government investigated more than 400 reports of adverse effects linked to those products, which ranged from "seizure, death, fever, shortness of breath, lethargy, constipation, vomiting, sleepiness, to tremor, agitation, and irritability." The FDA has contacted Standard Homeopathic Company in Los Angeles, the maker of Hyland's homeopathic teething products made with belladonna. The company has not agreed to a recall. So … [Read more...]

Cookie Dough Maker Gets Listeria Warning Letter

The FDA has sent the owners of Aspen Hills, Inc., makers of ready to eat cookie dough, a warning letter on January 10, 2017 about environmental samples from their facility that tested positive for Listeria monocytogenes. There is zero tolerance for that pathogenic bacteria in ready to eat products. That means that the cookie dough pucks, pellets, and pails are adulterated within the meaning of the Federal Food, Drug, and Cosmetic Act. Four positive environmental swabs were collected in the manufacturing areas. And between September 18 and 26, 2016, the firm's environmental program found Listeria monocytogenes in ten environmental swabs and in one finished product lot of cookie dough, which was not distributed into commerce. These findings indicate that the "firm is not taking … [Read more...]

Whole Foods Closes Distribution Kitchens

A warning letter sent to the North Atlantic Whole Foods Market Kitchen in June 2016 listed problems at that facility that included the presence of non-pathogenic Listeria bacteria. Whole Foods has just announced it is closing some of its food distribution kitchens on the East coast. The warning letter detailed 20 "serious violations of the FDA's Current Good Manufacturing Practice regulations for manufacturing, packing, or holding human food." These violations included employees mixing ready to eat pesto directly under an area where condensate from ceiling joints was dripping onto the surface below; cutting chives and beets under a leaking condensate drainage pipe, and holding uncovered ready to eat egg salad in barrels placed below a condenser that was dripping. In addition, … [Read more...]

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