October 6, 2022

Warning Letter to FluxxLab For Unapproved COVID Treatments

The FDA has sent a warning letter to FluxxLab LLC because th company is allegedly selling COVID-19 treatments that have no proof of efficacy. The letter states, "The FDA has observed that your website offers the Covid-19 Immune Support Tincture and the CBDA+CBD Oil Tincture products for sale in the United States and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. Based on our review, these products are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). "Furthermore, these products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. § 352. The introduction or delivery for introduction of these products into interstate commerce is … [Read more...]

Salmonella an Adulterant? National Chicken Council Bawks

The USDA announced plans this week to make it illegal to sell chicken Kiev and other stuffed, breaded, raw chicken products that are contaminated with Salmonella. Declaring Salmonella an "adulterant" in this subset of the vast array of poultry products available to American consumers is a small step forward in the agency's stated goal of remaking its strategy for controlling Salmonella in poultry. But it made big news. Chair of the House Appropriations Committee Rosa DeLauro (CT-03), who is perhaps the greatest champion of food safety in Congress, released a statement calling the announcement a "vital first step to improved protections for the public from foodborne illness." The Centers for Science in the Public Interest, which along with other consumer groups, petitioned the USDA … [Read more...]

Canada Again Puts Import Requirements on U.S. Romaine Lettuce

For the second year in a row, Canada has put import requirements on U.S. romaine lettuce because of several E. coli O157:H7 outbreaks linked to that product. These requirements will be in effect from September 28 to December 22, 2022. These restrictions were also in place in 2021. U.S. authorities have identified a geographical area as a recurring source of these outbreaks: the California Salinas Valley counties of Santa Cruz, Santa Clara, San Benito, and Monterey. The temporary Safe Food for Canadians (SFC) license conditions for the import of romaine from these regions has two requirements. The import requirements on U.S. romaine lettuce are: importers must declare that the product does not originate from those counties, or they must submit an attestation form and Certificate … [Read more...]

Eating Plant Based Meat? You Must Still Cook it Thoroughly

Are you eating plant based meat? The USDA says that you must still cook all of these products thoroughly to 160°F, since any food can be contaminated with dangerous pathogens. In fact, food poisoning outbreaks linked to plants and plant products is quite common. To show that many outbreaks are not necessarily linked to meat or poultry, just this year, there has been a Salmonella outbreak linked to shelled peas in Wisconsin, a Salmonella Senftenberg outbreak linked to Jif peanut butter, a deadly Listeria monocytogenes outbreak linked to Big Olaf Creamery ice cream, a hepatitis A outbreak linked to organic strawberries, and a deadly Listeria monocytogenes outbreak linked to Dole salads. The market for plant based meats, especially replacements for burgers, is growing for several … [Read more...]

USDA Declares Salmonella Adulterant in Breaded Stuffed Chicken

The USDA declares Salmonella adulterant in raw breaded stuffed chicken products, after many outbreaks linked to this type of food, including one that occurred in 2021. This will let the USDA make sure that these products, which can be "highly contaminated" according to the press release, will not be sold to consumers. Since 1998, raw breaded stuffed chicken products have been associated with up to 14 outbreaks and at least 200 illnesses. These products are sold frozen and include products like chicken cordon bleu or chicken Kiev. The chicken appears cooked because the breading is brown, but they are sold raw and must be cooked to 165°F before consumption. They are heat-treated only to set the batter or breading. Companies have improved their product labeling, including warnings … [Read more...]

FDA Works to Improve Safety of Fresh and Frozen Berries

The FDA is working to improve the safety of fresh and frozen berries in the wake of hepatitis A and norovirus outbreaks linked to those items. An ongoing hepatitis A outbreak linked to fresh organic strawberries has sickened at least 18 people in three states, and a hepatitis A outbreak in 2020 linked to blackberries sickened 20 people in seven states. In the United States, there have been three hepatitis A outbreaks and three norovirus outbreak linked to frozen berries from 1990 to 2016, and since 2011, there have been three hepatitis A outbreaks linked to fresh berries. Globally, from 1983 to 2018, there were 50 outbreaks associated with frozen berries, with 36 caused by norovirus and 14 by hepatitis. While freezing preserves berries, it does not inactive viruses. The berries … [Read more...]

Raw Feeding in Dogs Associated With Cattle-like E. Coli in Feces

Raw feeding in dogs is associated with excretion of "cattle-like" antibiotic resistant E. coli in their feces, which poses a "significant zoonotic threat," according to a study conducted at the University of Bristol and published in the Journal of Antimicrobial Chemotherapy. The study, which was conducted on six hundred dogs in England, found that carriage of these pathogens in rural dogs was phylogenetically associated with interaction with local cattle and epidemiologically associated with feeding raw meat. A zoonotic disease is one that can make the leap from animals to humans. People are more likely to be colonized by antibacterial resistant E. coli if they interact with certain animals, including domestic pet dogs. Third generation cephalosporin-resistant E. coli (3GR-E. coli) … [Read more...]

FDA Releases New Total Diet Study Report on Toxic Elements

The FDA has released their new Total Diet Study Report that focuses on the presence of toxic compounds in the foods we eat. The overall takeaway is that the key toxic elements were not detected in most (68%) of the tested foods. The analysis was conducted in foods that were collected from 2018 through 2020. Overall, 3,276 food, beverages, and water products were studied. The key elements studied were lead, arsenic, including inorganic arsenic, the most dangerous form, cadmium, and mercury. Overall, lead was found in 15% of the samples, arsenic in 43%, cadmium in 61%, and mercury in 8%. The categories of food included in the study were alcohol, baked goods, baby food, beverages, candies, condiments, dairy, fruit, grains, meats, ingredients like sugar and flour, compound foods such as … [Read more...]

FDA Warns Four Companies Selling Tainted Honey Products

The FDA has warned four companies allegedly selling tainted honey products that may be contaminated with hidden active drug ingredients. The four companies are Thirstyrun LLC, also known as US Royal Honey LLC; MKS Enterprise LLC; Shopaxx.com; and 1am USA Incorporated doing business as Pleasure Products USA. The FDA says these products can "post a significant health risk to consumers." Laboratory testing conducted by the FDA found that the product samples contained active drug ingredients that were not listed on the product labels. They were the active drug ingredients found in Cialis (tadalafil) and Viagra (sildenafil), which are FDA approved drugs that are restricted to use under the supervision of a licensed health care professional. Those ingredients can interact with nitrates … [Read more...]

FDA Developing New Framework For Expanded Access to Infant Formula

The FDA is developing a new framework for expanded access to infant formula options for parents and caregiver in the wake of the Abbott Nutrition plant shutdown after Cronobacter contamination was found this spring. In May 2022, the FDA issued guidance that the agency was going to temporarily exercise enforcement discretion on a case-by-case basis for some requirements to address this shortage. The FDA has prioritized review of requests from firms that can document the safety and nutritional adequacy of their products, can make the largest volume of product available, and can get their products onto shelves in this country quickly. The infant formula supply has dramatically increased in the weeks since that guidance was issued. Many infants and other people rely on infant formula … [Read more...]

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