April 21, 2019

FDA Warns Homeopathic Drug Producers For Violations of CGMP

The FDA has sent warning letters to four homeopathic drug producers for "significant violations of current food manufacturing practice (CGMP) regulations." These products are labeled as homeopathic and marketed without FDA approval. The homeopathic industry has grown tremendously in the past several years. The government acknowledges the need to address situations where these products are marketed for serious diseases and the product has not been shown to offer clinical benefits. Products labeled as homeopathic have not been approved by the FDA for any use and may even not meet standards for quality and safety, according to the FDA. These products may be made from plants, healthy or diseased animal or human sources, minerals, and chemicals. They are marketed as natural, safe, and … [Read more...]

New Dates For Implementing Agricultural Water Produce Safety

FDA's Commissioner Dr. Scott Gottlieb and Deputy Commissioner Frank Yiannas have addressed advancing new tools and science for produce safety via agricultural water, and have set new dates for implementation. The two E. coli O157:H7 outbreaks that were linked to romaine lettuce in 2018 were allegedly caused by contaminated agricultural water. In early 2018, 210 people were sickened in an E. coli O157:H7 outbreak linked to romaine lettuce grown in the Yuma, Arizona region of the country. Ninety-six people were hospitalized, and 27 developed hemolytic uremic syndrome (HUS), which can cause kidney failure. Five people died. This outbreak was the largest of its kind since 2006. The outbreak strain was found in canal water in the area. And in late 2018, romaine lettuce grown in … [Read more...]

FDA Warns Nutra Pharma Group For Illegally Marketed Unapproved Products

The FDA posted a warning letter to Nutra Pharma Corporation for illegally marketing unapproved products that were labeled as homeopathic and made medical claims. More specifically, the claims were about ability to treat addiction and chronic pain, including pain that is associated with cancer, diabetes, fibromyalgia, and other serious medical conditions. The targeted products include Nyloxin Oral Spray, Nyloxin Topical Gel, Nyloxin Topical Roll-On, Nyloxin Topical Roll-On ES, Nyloxin Professional Size Pump Topical Gel and Regular Strength Sample Pack. These names are similar to other FDA-approved drugs and may confuse consumers. The claims on these products include "treats conditions that cause chronic pain," and "Cobra venom saw its primary use in the treatment of cancer and … [Read more...]

Gravel Ridge Farms Egg Salmonella Outbreak Details in FDA Warning Letter

The Gravel Ridge Farms shell egg Salmonella outbreak sickened 45 people in 12 states last year. The FDA sent the owners of that facility a warning letter on February 12, 2019, that gives us more information about the issues at the farm. Gravel Ridge Farms recalled more than 600,000 shell eggs in response to this outbreak. First, the final update by the CDC stated that 44 people were sickened in that outbreak. This warning letter adds one more person. The patients were sickend with the same outbreak strain of Salmonella Enteriditis that was found in the company's Cullman, Alabama location in egg laying houses No. 2 and No. 4. The isolates were genetically identical isolates taken from patients. Inspections revealed that the firm was in violation of the FDA's egg safety rule. The … [Read more...]

FDA Plans to Modernize Oversight of Imported Food

The FDA's Commissioner Dr. Scott Gottlieb and Deputy Commissioner Frank Yiannas are announcing a new strategy to modernizing government oversight of imported food. This country imports about 15% of its food supply from more than 200 countries or territories around the world. Other countries supply 32% of our fresh vegetables, 55% of fresh fruit, and 94% of our seafood. And there have been quite a few food poisoning outbreaks linked to imported food in the past few years. Last year, a Salmonella Concord outbreak was linked to tahini imported from Israel. In 2017, a Salmonella outbreak linked to papayas imported from Mexico sickened at least 255 people with nine different strains of the pathogen.  And in 2016, almost a thousand people were sickened across the country with Salmonella … [Read more...]

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...]

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