February 21, 2019

Working Cow Homemade Ice Cream Listeria Outbreak: FDA Lifts Suspension

The FDA has lifted the suspension of Working Cow Homemade, reinstating their facility registration. In October 2018, the FDA suspended the company's registration, so the firm was forced to stop operating. During the months that followed, Working Cow Homemade submitted a proposed shift in business to become a warehouse distributor of ice cream products instead of a manufacturer. The company will not resume manufacturing operations. In October 2018, that company recalled two varieties of their ice cream after one person in Florida was allegedly sickened. The FDA found a strain of Listeria monocytogenes during environmental sampling of the facility n 2017. The government did not release any more information about the ill person. The FDA used their authority granted by the 2011 … [Read more...]

Congresswoman Rosa DeLauro Criticizes FDA Delay of Produce Safety Rule

Congresswoman Rosa DeLauro (D-CT), has released a statement criticizing the FDA on the delay of some parts of the Produce Safety Rule  following the deadly romaine lettuce E. coli O157:H7 outbreak that occurred late last year. The FDA released the findings of its investigation last week. And that was not the only E. coli O157:H7 outbreak linked to romaine lettuce last year. Another was announced in summer 2018. Together, those outbreaks caused 272 illnesses, 121 hospitalizations, and five deaths. Her statement reads, "For all the Agency’s bluster on improving traceability, the FDA has done little to advance real actions that would prevent food outbreaks in the first place. The FDA’s investigations into last year’s romaine lettuce recalls have confirmed what we already knew to be … [Read more...]

Final Investigation of Romaine E. coli O157:H7 Outbreak: Questions Remain

The FDA has released a report on its investigation into the romaine E. coli O157:H7 outbreak that occurred during the fall and early winter of 2018. At least 62 people in 16 states were sickened in this outbreak. Twenty-five people were hospitalized, and two developed hemolytic uremic syndrome (HUS), a type of kidney failure. In November 2018, the FDA took the extraordinary step of telling consumers to avoid all romaine lettuce from all sources until they had more information on the outbreak. Officials eventually found contamination at one particular farm in California, but couldn't explain the entire outbreak. Adam Bros. Farming That farm, Adams Bros. Farming, was located in Santa Anna County in California. Officials found the outbreak strain of E. coli O157:H7 in sediment … [Read more...]

FDA Issues Public Health Alert About Soom Chocolate Tahini Halva

The FDA has issued a public health alert about potential Salmonella Tennessee contamination of Soom Foods Chocolate Sweet Tahini Halva Spread. This spread is packaged in 1 ounce (30 ml) pouches or packets with a stamped lot number of "67333D" on the bottom. The pouches are purple laminated paper packets with a tear-away tab on one end. The FDA analyzed some product samples of Soom Foods Chocolate Sweet Tahini Halva Spread in response to a Salmonella Concord outbreak linked to imported Achdut tahini products. FDA officials found Salmonella Tennessee in that product. This product has been distributed by retailers as samples. The FDA advises consumers to discard that product. While Soom Foods was notified of the product testing and positive test results, but has "not yet acted to … [Read more...]

FDA Strengthens Process For Issuing Recall Warnings

The U.S. Food and Drug Administration (FDA) is taking steps to strengthen the process they use for issuing a public warning about food recalls and notification of recalls. While most companies collaborate with the FDA when a problem, whether it's an undeclared allergen, foreign material in a product, or contamination with a pathogen, the agency sometimes need to provide advice to protect consumers. Dr. Scott Gottlieb, Commissioner of the FDA, says the agency has finalized the mandatory recall guidance for foods. While most companies do cooperate with the government when a problem arises, some cases will not voluntarily issue a recall. FDA was given mandatory recall authority in some cases by the Food Safety Modernization Act of 2011. The agency has used this power just once, when … [Read more...]

FDA Goes After Dietary Supplements That Claim Alzheimer’s Treatment

The FDA is taking action against 17 companies for illegally selling dietary supplement products that claim to treat or cure Alzheimer's disease. The agency posted 12 warning letters and 5 online advisory letters to those corporations. The companies are illegally selling more than 58 products, many sold as dietary supplements, that are unapproved new drugs or misbranded drugs. These products have not been reviewed by the FDA and are not proven safe and effective to treat these diseases and health conditions. In fact, these products could be unsafe and could prevent a patient from seeking proper treatment. FDA Commissioner Dr. Scott Gottlieb said in a statement, "Science and evidence are the cornerstone of the FDA’s review process and are imperative to demonstrating medical … [Read more...]

Congresswoman Rosa DeLauro Urges End to Shutdown

Congresswoman Rosa DeLauro (D-CT) is urging the government to reopen areas that are shutdown, and end food safety risks to consumers. The shutdown is now on Day 28. Some employees at the FDA and USDA are furloughed, and others are working without pay. The FDA has brought back some workers, but they are not being paid. In her statement, she writes, "The President’s shutdown is putting our nation’s food supply at risk—a fundamental responsibility of the FDA and USDA. FDA inspectors are still working without pay, and they are only able to carry out one third of regular inspections. FDA also remains understaffed for food surveillance and food recall operations, and enforcement appears to be down. At the same time, the status of FDA’s work finalizing guidance and implementing rules … [Read more...]

FDA Food Inspections Reduced By Government Shutdown

According to an interview of FDA Commissioner Dc. Scott Gottlieb, the number of inspections conducted by the FDA have been "sharply reduced" by the partial government shutdown. The FDA has oversight over 80% of the food supply in this country. All "routine inspections" of domestic food facilities have been suspended. Gottlieb is trying to bring back about 150 inspectors as soon as possible, hopefully next week, to inspect high-risk facilities, such as those that process soft cheese and seafood or make infant formula, or those that may have had issues with food safety in the past. The Agriculture Department is still inspecting meat and poultry plants in this country, but those inspectors are not being paid for their work. Overseas inspections have continued, according to the New … [Read more...]

How Much Caffeine is Too Much? The FDA Has Answers

The FDA has answers to the question: How much caffeine is too much? While caffeine can be part of a healthy diet, too much can be dangerous to your health. The amount that is safe to consume depends on body weight, individual sensitivity, and the medications you take. In general, a 12 ounce soft drink contains 30 to 40 milligrams of caffeine. An 8 ounce serving or green or black tea has 30 to 50 milligrams. An 8 ounce cup of coffee contains 80 to 100 milligrams, and an 8 ounce energy drink contains 40 to 250 milligrams. For years, the FDA has warned consumers to avoid powdered caffeine since 2014. An 18-year-old teenager in Ohio died after using this product. One teaspoon of the powdered product is the equivalent to 25 cups of coffee. And last year, the government warned … [Read more...]

Consumers Warned to Wash Avocados After Pathogens Found on Skin

The FDA has released a report on avocado and hot pepper sampling, as part of  their "new, proactive sampling program," that was adopted in 2014. The program attempts to help public health investigators identify patterns in certain foods that may help reduce microbial contamination. They found Listeria monocytogenes on 17.73% of the avocado skin samples. They found the overall prevalence of Salmonella on the samples to be about 0.74%. That means that, if you don't rinse the avocado before you cut into it, you will spread any pathogens on the skin into the flesh. And because this fruit is usually eaten uncooked, there is no kill step to destroy that bacteria before you eat it. The FDA began collecting avocados in Many 2015. They collected 1,615 samples to test for Salmonella and … [Read more...]

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