August 17, 2019

FDA Issues Warning Letter to Tahini Supplier After Salmonella Outbreak

The FDA has issued a warning letter to tahini supplier Brodt Zenatti Holdings in Jupiter, Florida, which imported tahini from Israel that was linked to a multistate Salmonella outbreak this spring. That outbreak sickened at least six people in ten states; one patient was hospitalized. This was the first warning letter issued under the authority of the 2011 Food Safety Modernization Act Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals. The FSVP regulation requires that importers perform risk-based activities to make sure that food they import into the U.S. meets applicable food safety standards. FDA has been conducting FSVP inspections since 2017. They help importers understand the requirements and how to make corrective … [Read more...]

FDA Warns Against Miracle or Master Mineral Solution; Illnesses Reported

The FDA has issued a warning to consumers to avoid Miracle or Master Mineral Solution, since they have received many reports that these products have made consumers sick. The government first warned consumers about these products in 2010, but they are still being promoted on social media and sold online by independent outlets. These products are marketed under various names, including Miracle or Master Mineral Solution, Miracle Mineral Supplement, MMS, Chlorine Dioxide (CD) Protocol, and Water Purification Solution (WPS). When these products are mixed according to package directions, they become a chemical that is used as bleach. In addition, some of the distributors are making false and dangerous claims that Miracle Mineral Supplement, when mixed with citric acid, acts as an … [Read more...]

FDA Suspends Topway/Kazy’s Gourmet Food Facility Registration

Last week Food Poisoning Bulletin told you about the FDA warning retailers in Texas and Louisiana to stop selling Topway/Kazy's Gourmet salmon and tuna for sushi for possible Listeria monocytogenes contamination. On July 22, 2019, the FA suspended the food facility registration of the company, after seizure sanitation issues were found at that venue. Inspectors found Listeria monocytogenes bacteria in that facility. Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response said in a statement "The FDA and the Texas DSHS have documented a pattern of food safety violations at the Topway facility as well as an unwillingness and disregard by the company to cease operations and correct severe violations at their facility. Topway’s unsafe practices not only violated the law, but … [Read more...]

Retailers in TX and LA Should Stop Selling Kazy’s Gourmet Seafood For Listeria

The FDA has advised retailers and restaurants in Texas and Louisiana to stop selling or serving products from Topway Enterprises, doing business as Kazy's Gourmet Seafood Production, because of possible Listeria monocytogenes contamination. The government is most concerned about salmon and tuna produced by the company for raw consumption. These products may be incorporated into sushi. The products in questions were sold July 10 through July 13, 2019. They are sold as fillets wrapped in clear plastic wrap. These product do not have a long shelf life, although they may be frozen. These products should be discarded. Retailers and restaurants should also clean and sanitize the surfaces that these products were served, stored, or prepared on. The FDA conducted an inspection of Topway … [Read more...]

Agroson’s Will Not Recall Cavi Papayas Likely Linked to Salmonella Outbreak

The FDA has updated the Salmonella Uganda outbreak likely linked to fresh papayas imported from Mexico, stating that they have asked Agroson's LLC, the distributor of the Cavi brand of papayas, to recall that product. Agroson's has refused to initiate a recall. The FDA has contacted the company's wholesale customers to make sure that the fruit is no longer for sale, has been discarded, or has not been further processed or frozen. The FDA is recommending that consumers in all states not eat Cavi brand whole, fresh papayas and should throw them away. If you can't determine the brand of papayas you purchased, discard them. And retailers, restaurants and other food service providers should not serve or sell whole, fresh papayas under the Cavi brand. The update also states that … [Read more...]

Rep. Rosa DeLauro Criticizes FDA Over Salmonella Papaya Outbreak

Update: Cavi brand papayas distributed by Agroson's LLC of the Bronx are now linked to this outbreak. Representative Rosa DeLauro (D-CT) has released a letter she sent to the FDA this week regarding the multistate Salmonella Uganda papaya outbreak that has sickened at least 62 people in 8 states. She has "serious concerns that the Agency did not provide consumers with necessary information regarding this outbreak in a timely manner, which ultimately put lives at risk." A publication for the fresh produce industry had a story about the outbreak on the morning of Friday, June 28, 2019. The CDC did not publish a food safety alert until five hours later, and the FDA took six hours. Most major media outlets did not start reporting about the outbreak until late afternoon. She also … [Read more...]

FDA Revises 2017 Fish Advice For Pregnant Women, Young Children

The FDA is revising its 2017 fish advice for pregnant and breastfeeding mothers and young children, given the worries about mercury in fish. Dr. Susan Mayne, director of the FDA's Center of Food Safety and Applied Nutrition, said in a statement, "Fish and shellfish are an important part of a well-rounded diet. However, we know many consumers worry about mercury in fish and even choose to limit or avoid fish because of this concern. In fact, we have seen that women in the U.S. who are pregnant are consuming far less than the recommended amount of seafood." In 2017, the FDA released a reference chart to help consumers choose the types of fish to eat more or and less of because of their levels of mercury. The fish species are listed under Best Choices, Good Choices, and Choices to … [Read more...]

In Wake of Papaya Salmonella Outbreak, CSPI Challenges FDA

Update: Cavi brand papayas distributed by Agroson's LLC of the Bronx are now linked to this outbreak, according to the CDC. In the wake of the Salmonella Uganda outbreak linked to fresh whole papayas imported from Mexico, the Center for Science in the Public Interest (CSPI) says that the FDA needs to do more to protect consumers. At least 62 people in 8 states are sick after eating the produce, and 23 have been hospitalized. A statement from CSPI Deputy Director of Regulatory Affairs Sarah Sorcsher reads, in part, "The import protections FDA has in place are clearly not working. Rather than rely on third-party testing, the FDA should directly inspect the farms these fruits may have come from and ensure they are meeting food safety standards. If the safety of the farms cannot be … [Read more...]

Life Rising Dietary Supplements Seized by U.S. Marshals

U.S. Marshals seized more than 300,000 containers of dietary supplements from Life Rising Corporation in June 2019 at the request of the FDA. The seized goods included tablets, capsules, and teas. The brand names for some of the 500 products are Life Rising, Holicare, or HopeStream. The U.S. District Court for the Northern District of Illinois found that there was probable cause that "the company prepared, packed, and/or held dietary supplements under conditions that do not conform to the dietary supplement current good manufacturing practice (CGMP) requirements," according to the FDA news release. The FDA issued an Administrative Detention Order in May 2019 to prevent these products from reaching consumers until they could be seized based on these violations. Melinda K. … [Read more...]

Center For Food Safety Forces FDA to Designate High Risk Foods

The Center for Food Safety (CFS) has forced the FDA to complete the high risk food designations and reporting requirements that were part of the 2011 Food Safety Modernization Act (FSMA). CFS filed a lawsuit against the FDA in October 2018 for delaying those requirements. Now, the FDA must designate "high risk" foods by September 2020 and establish the reporting requirements for those foods by November 2022. The settlement was decided in the United States District Court for the Northern District of California. Ryan Talbott, CFS staff attorney, said in a statement, "This is a major victory for public health. FDA has sat on its hands for years, neglecting to make these high-risk designations, while outbreaks caused by Salmonella, E. coli, and other pathogens have sicken and killed … [Read more...]

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