July 16, 2019

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...]

Stericycle: Recalls Declined in First Quarter 2019; Shutdown to Blame?

According to Stericycle Expert Solutions, which releases a summary of recall trends every quarter, recalls of food, pharmaceutical, and consumer products declined "significantly" for the first time since 2012 in the first quarter of 2019. The press release states that "The declines were largely due to reduced oversight from the government shutdown earlier this year which stopped or limited many government safety inspections for food, pharmaceutical, automotive, medical device, and consumer products, the industries tracked in the Stericycle Recall Index. When the shutdown ended at the end of January, it took several more weeks for the regulatory agencies to ramp safety inspections back up to normal levels." The shutdown lasted for 5 weeks from December 2018 to January 2019. FDA … [Read more...]

FDA Sampling Frozen Berries For Hepatitis A and Norovirus

The FDA is sampling frozen berries for both hepatitis A and norovirus, in the wake of three hepatitis A outbreaks and one norovirus outbreak linked to those products from 1997 to 2016. Two of those hepatitis A outbreaks, one in 2013 and the other in 2016, sickened more than 300 people in this country. The 2013 outbreak was linked to Townsend Farms Organic Antioxidant Blend, a mix of frozen berries, and sickened at least 162 people in 10 states with hepatitis A infections. The source of the virus was eventually determined to be pomegranate seeds that were imported from Goknur Foodstuffs Import Export Trading in Turkey. The 2016 outbreak, which sickened at least 143 people in 9 states, was linked to frozen strawberries made into smoothies at Tropical Smoothie Cafe restaurants in … [Read more...]

l’Explorateur Soft Cheese Recalled for Listeria as FDA Issues Public Health Alert

The FDA has issued a public health alert about possible Listeria monocytogenes contamination of l'Explorateur soft ripened cheese. This pasteurized, cow's milk cheese was made in St. Simeon, France and is distributed throughout the United States. The government is advising consumers and retailers not to eat, sell, or serve any cheese labeled as l'Explorateur.   The cheeses is packaged in clear plastic containers and is sold in the form of small, circular wheels in 250 gram containers. The sell by dates on the package are May 7, 2019 and May 14, 2019. The product lot codes are 7742-H 057 and 77432-H 064. Société Fromagère de la Brie firm are subject to an FDA Import Alert. That means that the government can detain food at the border without physical examination until the … [Read more...]

FDA Warning Letter: JBS Souderton Tallow Contained Pentobarbital

An FDA warning letter dated April 23, 2019, states that the manufacturer JBS Souderton's products from its rendering plant contain pentobarbital, which is a drug used to euthanize dogs and cats in the United States. The pentobarbital was found in the pure tallow the company produces that was used to make pet food. JBS Souderton does business as MOPAC and supplies beef tallow to several animal food manufacturers. This letter is significant because pentobarbital was found in some brands of dog food last year, including canned Smucker dog food such as Gravy Train, Kibbles 'n Bits, and Skippy products. It is illegal for pet food to contain pentobarbital, because the food then contains an unsafe new animal drug. And no food can be sold in this country that is adulterated or … [Read more...]

FDA to Launch “New Era of Smarter Food Safety”

Acting FDA Commissioner Dr. Ned Sharpless and Deputy Commissioner Frank Yiannas are announcing a "New Era of Smarter Food Safety" to help combat increasing cases of foodborne illness in this country.  It will incorporate elements and requirements of the Food Safety Modernization Act of 2011 with new and emerging technologies. This program will develop a "Blueprint for a New Era of Smarter Food Safety," which will address digital technologies, traceability, and food business models. One of the tools the press release lauds as a success in this type of model is the GenomeTrakr Network, which helps with investigations into foodborne outbreaks. One of the most important areas of foodborne illness investigation is traceability. Unless a contaminated food can be identified and then … [Read more...]

FDA Strengthening Process For Initiating Voluntary Recalls

The Food and Drug Administration (FDA) is strengthening the process of initiating voluntary recalls. These recalls remove food from the marketplace that may be contaminated with pathogens or contain undeclared allergens.  Melinda K. Plaisier, FDA Associate Commissioner for Regulatory Affairs, is commenting on this plan. There were 382 food recalls in 2018, for undeclared allergens, pathogens, and foreign material contamination. The FDA regulates all foods except for some aspects of meat, poultry and egg products. If food needs to be recalled because it is a threat to public health, and the company will not act, the FDA has regulatory power to force a recall. The first mandatory recall order was issued for Kratom products last year. The FDA is guiding companies on the steps … [Read more...]

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...]

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