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. § 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...]
Ultrasonic Cleaning Could Reduce Leafy Greens Outbreaks
A new study conducted at the University of Southamptom has found that ultrasonic cleaning could reduce leafy greens outbreaks in the future. The cleaning is done by spraying food with streams of water that carry sound and microscopic air bubbles. This can clean greens more effectively than current washing methods. The study was conducted in a collaboration between the University of Southampton, North Carolina State University, with lead scientist Professor Timothy Leighton. The work was sponsored by Vitacress. There have been several deadly E. coli O157:H7 outbreaks in the past few years that were linked to leafy greens, particularly romaine lettuce harvested in Arizona and California. While most of the investigations conducted by the CDC, FDA, and local officials have not been … [Read more...]
If You Travel, the CDC Has Info About Food and Water Safety Abroad
If you travel, or if you are going to start traveling once the pandemic eases, the CDC has information about food and water safety abroad that is important. There are some countries where the food and water are infamous for causing illness, whether true or not. But no matter where you travel there are some things you should know to avoid food poisoning. Hot food is usually safe. The only thing that reliably destroys most bacteria and pathogens is heat. The exception is toxins produced by some bacteria as they grow, and spores of some bacteria, such as Clostridium botulinum. Just beware of foods that are sitting at warm or room temperature, such as at a buffet because it could be re-contaminated. Dry or packaged food is also usually safe. Most bacteria and other pathogens require … [Read more...]
After Severe Weather, What Does a Boil Water Notice Mean?
Many people in different parts of the country have been, and will be, under a "boil water" notice after severe weather strikes. So what does a boil water notice mean? These advisories are often issued after a flood or when there is an issue with local water services, such as broken water mains or a sewage spill. Everyone should pay attention to these advisories and notices and follow them rigorously to protect health. Boil water notices are issued to protect the public from waterborne infectious agents that can range from parasites to E. coli and other pathogens to viruses. When a notice is issued, everyone should stop using water from the tap until a government agency says that the water is again safe to drink and use in cooking and cleaning. Heat treatments and filtration can … [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...]
Did You Get Unsolicited Seed Packets in the Mail? The USDA Has Answers
Did you get unsolicited seed packets in the mail in the past few months? The USDA has some answers. The government received thousands of reports from people who got these packets and has completed a months-long investigation. The USDA's Animal and Plant Health Inspection Service (APHIS) is providing guidance to help people, as well as those who buy plants and seeds online from other countries. U.S. consumers began receiving strange packets of seeds in the mail starting in July 2020. Some were sent to recipients unsolicited, but others were those people ordered, since they were unaware that they were coming from a foreign country. Most of these shipments are illegal since they came into the country without a permit or a phytosanitary certificate. Plant Protection and Quarantine … [Read more...]
Permanent Injunction Issued Against Dietary Supplement Confidence USA
An order of permanent injunction has been entered against Confidence USA Inc. of Long Island, New York, and the company's president Helen Chian and general manager and founder Jim Chao by Judge Edward R. Korman of the U.S. District Court for the Eastern District of New York. The order was entered until the company "comes into compliance with federal supplement current good manufacturing practice regulations and other Federal Food, Drug, and Cosmetic Act (FD&C Act) requirements." The defendants must cease manufacturing, holding, or distributing dietary supplements until the FDA tells them they can resume operations. The company has made and distributed more than 50 dietary supplements under brand names that include Confidence USA, American Best, USA Natural, and The Herbal Store. … [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...]
