April 13, 2021

Possible Real Water Non-viral Hepatitis Outbreak Prompts CDC HAN Alert

The possible Real Water non-viral hepatitis outbreak is prompting a Centers for Disease Control and Prevention (CDC) Health Alert Network (HAN) Alert. Five cases of acute non-viral hepatitis of unknown etiology were reported to the Southern Nevada Heath District between November and December 2020. The CDC is assisting the investigation about a potential link between those illnesses and consumption of Real Water alkaline water and other possible etiologies. The CDC and FDA were notified about those five Nevada cases by the SNHD in Nevada on March 13, 2021. The patient age range is from seven months to five years. The children were taken to a hospital between November 10, 2020, and December 3, 2020, with vomiting, poor intake, and fatigue. Lab testing on the paints showed elevated … [Read more...]

FDA Updates Real Water Alkaline Water Hepatitis Outbreak Investigation

FDA has updated its Real Water alkaline water hepatitis outbreak investigation with more information. The latest update, which is not dated, states, "Given a lack of cooperation by the firm, FDA investigators have been unable to complete investigations at the "Real Water" Inc. facilities in Henderson, Nevada and Mesa, Arizona and have not been provided with any records. As a result, on March 23, FDA issued a Demand for Records under section 414 of the Federal Food, Drug, and Cosmetic Act." The FDA, CDC, and the Southern Nevada Health District are investigating a "number of reports" of acute non-viral hepatitis infections in the state of Nevada. These cases are associated with the consumption of Real Water alkaline water. The consumption of Real Water alkaline water is the only … [Read more...]

FDA Warns Two Companies Selling OTC CBD Products For Pain Relief

The FDA has issued warning letters to two companies selling OTC CBD products for pain relief. The items are labeled as containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). The letters address the illegal marketing of unapproved drugs labeled as containing CBD. The FDA has not approved any over-the-counter (OTC) drugs containing CBD, and these products do not meet the requirements to be legally marketed without an approved new drug application. CBD has known pharmacological effects on people, with demonstrated risks, so it can't be legally marketed as an inactive ingredient in OTC drug products that are not approved by the FDA. The letters also cite substandard manufacturing practices, including the failure to comply with … [Read more...]

FDA Warns Earth Tea Against False Statements About COVID-19

The FDA has sent a warning letter to B4B Corporation, makers of Earth Tea, against false statements regarding the treatment and cure of COVID-19. The FDA says that the company is offering the product for sale and that it is intended to "mitigate, prevent, treat, diagnose, or cure COVID-19 in people." That makes the product and unapproved new drug in violation of the Federal Food, Drug, and Cosmetic Act and also makes the product a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. ยง 352. Some examples of claims on the company's website that misleading represent the product as safe and/or effective for the treatment and prevention of the viral illness include, "Earth Tea works fast so it can eliminate quarantine time. With those simple steps we can move to end the … [Read more...]

FDA Warns Mercola Over Products Claiming to Treat and Cure COVID-19

The FDA has sent a warning letter to Mercola.com about their products being marketed as diagnostic tools, treatment options, and cures for COVID-19. The letter, dated February 18, 2021, addresses "Unapproved and Misbranded Products Related to Coronavirus Disease 2019." The company's websites and social media accounts promote these products which are considered unapproved new drugs sold in violation of the FDA's Food, Drug and Cosmetic Act. The FDA is taking urgent measures to protect consumers that, without approval or authorization by that agency, claim to "mitigate, prevent, treat, diagnose, or cure COVID-19 in people." The government states that Mercola must take immediate action to cease the sale of these unapproved and unauthorized products. Some of the claims on the … [Read more...]

Real Water Non-Viral Hepatitis Illnesses Investigated by FDA

The FDA is investigating Real Water non-viral hepatitis illnesses, according to an outbreak investigation notice. The CDC and the Southern Nevada Health District are aiding in the investigation. On March 13, the FDA was told by the Southern Nevada Health District about five cases of acute non-viral hepatitis in infants and children that occurred in November 2020 with an unknown cause. Those cases resulted in acute liver failure. All five patients were hospitalized and have since recovered. All of these children live in Nevada. The last illness onset date was November 29, 2020. All of the children consumed "Real Water" brand alkaline water. The patients lived in four different households. Five more people, including two adults and three children, from two of the four households … [Read more...]

Three Outbreaks on the FDA CORE Investigation Table; Two Are Unsolved

There are currently three outbreaks on the FDA CORE Investigation Table and two remain unsolved. The first is caused by Salmonella Miami, with 64 sickened and no product or place identified. The second is an E. coli O157:H7 outbreak that has sickened 16 people, with no product or place identified. And the third is the Listeria monocytogenes outbreak that has sickened 11 people, linked to recalled El Abuelito queso fresco cheese. The number of identified outbreaks continues to be slow. During the pandemic last year, the number of outbreaks was at a real low, with only ten multistate food poisoning outbreaks identified in the entire year. Two of the outbreaks have CDC investigation notices. The E. coli O157:H7 outbreak has not been updated since February 2, 2021, but officials seem … [Read more...]

FDA Announces Action Plan on Heavy Metals in Baby Food

After the U.S. House Subcommittee report that was issued last month about the amount of toxic heavy metals in baby food, the FDA is announcing new actions. The report found that four of the seven major baby foods made in this country have unacceptably high levels of cadmium, mercury, and lead. The remaining three corporations refused to supply information about their products. First, a letter to industry was issued reminding manufacturers of their responsibilities when producing these foods. And the agency will put a plan into action to reduce toxic elements in foods for babies and young children to levels "as low as is reasonably achievable." Manufacturer's responsibilities include considering risks from chemical hazards, including toxic elements, when conducting a hazard … [Read more...]

What Are the Symptoms of Common Food Allergies?

Food Poisoning Bulletin publishes recalls of food for undeclared allergens from the FDA, USDA, and CFIA every week. These recalls affect just about every food on the market. Food allergies can cause reactions that range from mild to life-threatening. So what are the symptoms of common food allergies? People can be born with food allergies, or they can appear at any time during the lifespan without warning. Some people grow out of their allergies, while others are lifelong. And children are more likely to be allergic to foods than adults. There are some symptoms that are common to most allergens. They include tingling of the mouth, lips, and tongue; itching, rash, and hives; congestion or runny nose; nausea, vomiting, and diarrhea. These are usually early symptoms that may appear … [Read more...]

FDA Tells Parents: Do Not Make Homemade Infant Formula

The FDA is warning parents: do not make homemade infant formula, since it is difficult to achieve the correct proportions and amounts of nutrients that babies need for proper growth and development. The government has received reports of infants who have been hospitalized because they are suffering from low calcium levels (hypocalcemia). Those babies had been fed homemade infant formula. Officials are asking parents or caregivers of infants who have consumed homemade infant formula to contact their healthcare provider and report symptoms to their local Health Department, or file a report through FDA's Voluntary Medwatch form. Homemade infant formula is not the same as homemade baby food. The problem is that infant formula is the only source of nutrition for infants. This product … [Read more...]

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