By Of Counsel John Johnson III The U.S. Food and Drug Administration’s (FDA) Warning Letter to Maribel’s Sweets, Inc., provides an important look into how FDA is implementing the Food Safety Modernization Act (FSMA)’s Preventive Control Rule. This is the requirement that a food facility must have and implement a written food safety plan to control known or reasonably foreseeable food safety hazards. Additionally, the warning reflects that FDA continues to prioritize seeking compliance with preventive controls and sanitation practices to avoid undeclared Major Food Allergens (which we discussed in A Taste of FDA’s 2021 Food Priorities: Undeclared Major Food Allergens. The list has been expanded to include sesame, which we discussed in Look Beyond the Label: How the FASTER Act Impacts Food Manufacturing). FDA has been relatively silent about the Preventive Control Rule in 2021, issuing only four Warning Letters directly on that topic. For context, FDA issued at…
Tag Archives recall
The U.S. Food and Drug Administration (FDA) has issued draft guidance on initiating voluntary recalls of food and other agency-regulated products. The guidance discusses (i) "what preparations firms in a distribution chain, including manufacturers and distributors, should consider making to establish recall initiation procedures"; (ii) "preparations firm in the distribution channel should consider making to ensure timely responses to a recall communication"; and (iii) "how FDA assists firms with carrying out their recall responsibilities to protect the public health from distributed products in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other laws administered by the FDA." Comments on the draft guidance will be accepted until June 24, 2019.
The U.S. Food and Drug Administration (FDA) has announced the availability of "Public Warning and Notification of Recalls," final guidance that aims to "increase and expedite the appropriate and accurate use of public warnings and public notification and to increase public health protection by better informing the public about violative products being recalled." "We’re taking a new step to help ensure appropriate public warnings and notification of recalls when FDA-regulated products are involved," FDA Commissioner Scott Gottlieb said in a statement. "The final guidance we’re issuing today outlines circumstances when a company should issue a public warning about a voluntary recall, describes the general timeframe for companies to issue such a warning, discusses what information should be included in a public warning, and describes situations where the FDA may take action to issue its own public warning should a company’s warning be deemed insufficient."
The U.S. Food and Drug Administration (FDA) has released several reports and guidance documents on food-related issues, including draft guidance on reasonable serving sizes and a report on foodborne illnesses in restaurants. Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics. This draft guidance details how food companies determine reasonable serving sizes for the nutritional panels on their products. Comments submitted before January 4, 2019, will be considered before FDA begins working on the final version of the guidance. Nutrition and Supplement Facts Labels: Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals; Guidance for Industry. FDA has provided a series of questions and answers on quantifying added sugars, vitamins and minerals. Several questions focus specifically on calculating added sugars in fruit juices…
A consumer has filed a lawsuit alleging that he contracted Salmonella from beef supplied to a restaurant by JBS Tolleson Inc. Rozich v. JBS Tolleson Inc., No. 18-1929 (D. Nev., filed October 8, 2018). The plaintiff alleges his infection stemmed from an outbreak of Salmonella that resulted in JBS recalling nearly seven million pounds of beef on October 4, 2018. The complaint cites a July 2017 notice from the U.S. Department of Agriculture’s Food Safety and Inspection Service purportedly alleging a JBS facility president enabled “‘egregious’ and ‘inhumane’ practices with livestock.” The plaintiff seeks damages and costs for allegations of strict product liability, negligence and breach of warranty.
The U.S. Food and Drug Administration (FDA) has issued draft guidance on the release of retailer information during the food-recall process. The guidance indicates when the agency may find that identifying retailers is necessary during Class I recalls—"recalls where there is a reasonable probability that the use of, or exposure to, the food will cause serious adverse health consequences or death to humans or animals"—as well as a limited number of Class II recalls associated with foodborne illness outbreaks. "Assisting food producers in having effective recall practices in place, as well as taking immediate action to address unsafe products, are high priorities of mine," FDA Commissioner Scott Gottlieb said in a statement. "Our recall authorities – and how we deploy them – are a cornerstone of our vital consumer protection mission."
A woman has filed a lawsuit alleging she was hospitalized after eating Salmonella-contaminated eggs from Rose Acre Farms Inc. Roberts v. Rose Acre Farms, Inc., No. 18-61082 (S.D. Fla., filed May 14, 2018). The plaintiff alleges that she purchased eggs packaged by Coburn Farms, a Sav-A-Lot Food Stores brand, and became ill enough to require two hospitalizations. The Centers for Disease Control and Prevention has linked Rose Acre Farms eggs to a nine-state outbreak of Salmonella infections. Claiming strict product liability, breach of warranty, negligence and negligence per se, the plaintiff seeks damages and attorney’s fees.
An Ohio poultry facility linked to the latest egg recall over Salmonella-contamination concerns was reportedly the recipient of a $125 million investment by Austin “Jack” DeCoster, the man who owned the two Iowa farms linked to the August 2010 recall of 550 million potentially contaminated eggs. The Ohio Agriculture Department apparently indicated earlier this year that DeCoster was still an investor in Ohio Fresh Eggs. The latest recall involves nearly 300,000 eggs distributed in eight states. While no confirmed illnesses have been linked to the eggs, egg seller Cal-Maine, Inc. reportedly said “consumers who believe they may have purchased potentially affected shell eggs should not eat them.” According to a news source, the Centers for Disease Control and Prevention linked the August outbreak to at least 1,600 illnesses. DeCoster was called before a House oversight subcommittee in September and apologized for the incident, saying “We were horrified to learn that…
Nestlé Prepared Foods Co. has filed a complaint against the suppliers of ingredients for its Lean Cuisine® frozen meals, which it was apparently forced to recall when it learned that some of the meals were contaminated with foreign, hard blue plastic pieces. Nestlé Prepared Foods Co. v. Nat’l Food Trading Corp., No. 10-1077 (D. Utah, filed October 29, 2010). According to the complaint, the plastic pieces were mixed into the sun-dried tomatoes that defendants sold to Nestlé. Customer complaints purportedly alerted Nestlé to the contamination, and “[a]t least one consumer reported an injury caused by the hard blue plastic materials.” Recalling some 880,000 pounds of frozen meals allegedly caused Nestlé to incur “substantial losses, including, but not limited to, refunds to customers, the value of the recalled meals, the value of the unusable sun dried tomatoes, cancelled orders, and the costs of shipping, storage, plant operations, and investigation, as well as…
The Texas Department of State Health Services (DSHS) has ordered a San Antonio produce plant to stop processing food and recall all products shipped since January 2010 because “laboratory tests of chopped celery from the plant indicated the presence of Listeria monocytogenes.” DSHS has prohibited Sangar Fresh Cut Produce from reopening without approval from the department, which issues such orders when conditions pose “an immediate and serious threat to human life or health,” according to an October 20, 2010, DSHS press release. After an eight-month investigation into a Listeriosis outbreak that included five deaths, DSHS allegedly linked Sangar’s chopped celery to six illnesses in people “with serious underlying health problems.” State inspectors also reportedly “found sanitation issues at the plant and believe the Listeria found in the chopped celery may have contaminated other food product there.” The recall primarily affects fresh produce sealed in packages and distributed “to restaurants and…
