October 15, 2019

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...]

FDA Issues Public Health Alert About Hepatitis A in Kroger Frozen Blackberries

The FDA has issued a health alert about hepatitis A in Kroger frozen blackberries. This product was sold under the Kroger grocery store "Private Selection" brand. The problem was discovered by the FDA under an ongoing frozen berry sampling assignment for hepatitis A and norovirus. This sampling program was launched after three hepatitis outbreaks and one norovirus outbreak were linked to frozen berries from 1997 to 2016. Just two of those hepatitis outbreaks sickened more than 300 people in the United States. The recalled products include: PRIVATE SELECTION FROZEN TRIPLE BERRY MEDLEY, 48 OZ (BEST BY: 07-07-20; UPC: 0001111079120); PRIVATE SELECTION FROZEN TRIPLE BERRY MEDLEY, 16 OZ (BEST BY: 06-19-20; UPC: 0001111087808); PRIVATE SELECTION FROZEN BLACKBERRIES, 16 OZ (BEST … [Read more...]

CSPI Calls on FDA to End Sales of Unwashed Poppy Seeds After 12 Americans Die

The Center for Science in the Public Interest (CSPI) is asking the Food and Drug Administration (FDA) to crack down on the sale of unwashed poppy seeds and seed pods after at least 12 Americans have died after consuming these products. The agency sent a letter to the FDA in April 2019. Those deaths are associated with a type of tea that is made from poppy seeds or pods. CSPI President Dr. Peter G. Lurie said in a statement, "Poppy seed teas are responsible for numerous cases of addiction, overdose, and death. This little-known aspect of the opioid epidemic does appear to be worsening in terms of its toll. The FDA and the Department of Justice are aware of the problem but have failed to fully exercise their authorities." One man, Stephen P. Hacala, died after he drank tea made … [Read more...]

FDA Warns Velvet Ice Cream Company About Listeria Monocytogenes

The FDA has sent a warning letter to the Velvet Ice Cream Company of Utica, Ohio, that Listeria monocytogenes has been found in their facility during inspection. The company makes ready-to-eat ice cream. There is zero tolerance for Listeria monocytogenes bacteria in ready-to-eat products, including deli meats and cheeses and ice cream because the consumer does not heat the food before eating, which would kill the pathogen. Once Listeria is introduced into a facility, it can become persistent and be very difficult to eradicate. In fact, there have been several issues with Listeria contamination in ice cream plants for the past few years. In April 2019, the FDA stated they were taking steps to improve ice cream production after finding the pathogen in 19 of the 89 ice cream … [Read more...]

FDA Addresses Consumer Confusion Over Use By Dates

Frank Yiannas, who is Deputy Commissioner of Food Policy and Response for the FDA, wrote a letter to the food industry on May 23, 2019, addressing consumer confusion over "Sell By," "Use By," and "Best If Used By Dates," as they probably contribute to food waste in the United States. The USDA's Economic Research Service estimates that 30% of the food in this country is lost or wasted at the retail or consumer level. That translates to 133 billion pounds of food lost, that is worth $161 billion. Every year. The use of these phrases is voluntary, and are used to describe quality dates, not spoilage dates. In a 2007 survey of U.S. consumers, less than half were able to distinguish between the meanings of these commonly used phrases. The FDA has found that food waste by consumers … [Read more...]

FDA Investigating Raw Oyster Shigella Outbreak That Sickened Five

The FDA is investigating a subset of the Shigella, Vibrio, E. coli, and Campylobacter outbreak that is linked to raw oysters harvested from Estero El Cardon in Baja California Sur, Mexico. That agency is looking at the five people sickened with Shigella infections. Patients sickened in this raw oyster Shigella outbreak got ill in early 2019. The outbreak notice states that restaurants that sell raw oysters in California, Nevada, New York, and Arizona are part of the investigation. The oysters were sold to wholesale distributors with direct sales to restaurants and were not sold to consumers through grocery retail stores. Consumers should not purchase oysters marketed as being harvested from Estero El Cardon, in Baja California Sur, Mexico from restaurants. If you are not sure … [Read more...]

FDA Warns Homeopathic Product Manufacturers

The Food and Drug Administration (FDA) is warning five homeopathic product manufacturers for significant violations of current good manufacturing practice regulations (CGMP). Warning letters were sent to those companies. Four of the letters target companies who jointly produced a product labeled as homeopathic that was not sterile. The fifth outlines a company's failure to have a system in place that makes sure there is proper design, monitoring, and control of the manufacturing process. FDA Acting Commissioner Dr. Ned Sharpless said in a statement, "It’s our public health obligation to protect consumers from unsafe products. Our manufacturing requirements are designed to ensure the quality and safety of drugs distributed to American consumers, and the FDA expects companies to … [Read more...]

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