Vidcast:  https://youtu.be/XPhwd2TDnJQ

The FDA, La Fiesta Food Products Inc., Spice and Chili, El Chavito, El Super Leon Ponchin Snacks Inc., and Rojas Inc now recall La Fiesta Saladitos Con Chile (Salted Plums with Chili), Spice and Chili Saladitos Dried Salted Plums With Chili, El Chavito Saladitos Dried Salted Plums and Saladitos Enchilados Salted Plums With Chili, El Leoncito, El Super Leon branded Saladitos Dry Salted Plums with and without Chili, and finally Lupag Plain Dried Salted Plums.  These products are all contaminated with lead.  Though we are all exposed to tiny amounts of lead on a daily basis, exposure to larger amounts is toxic, particularly for infants and children.  Lead poisoning may trigger signs of illness including abdominal pain, vomiting, lethargy, irritability, weakness, behavior or mood changes, delirium, seizures, and coma.  Chronic exposures may produce no acute symptoms in children but lead to neurotoxicity with learning disability and developmental delay.  The LaFiesta products were sold in California, Nevada, North Carolina, and Georgia, the Spice and Chili products were sold online by amazon.com, the El Chavito products were sold nationwide by retailers and on the El Chavito website, the El Super Leon products were sold at retail stores in California, and the Lupag items were sold in Southern California.  If you purchased the LaFiesta, El Chavito, or Lupag products, return them to the place of purchase for refunds.  The Spice and Chili product should be mailed back to A&E Corrales LLC, PO Box 78531, Seattle, WA 98178 for a refund.  The El Super Leon products should be disposed of.  For additional information, contact LaFiesta by phone at 1-408-326-0487 or via email at [email protected]. For Spice and Chili, email [email protected] for more information.  Contact El Chavito via email at [email protected].  For El Super Leon Ponchin Snacks, call 1-619-271-0846.  For Rojas, call 1-323-266-2192 or contact them via email at [email protected].

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/la-fiesta-food-products-recalls-saladitos-salted-plums-chili-because-possible-health-risk

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ae-corrales-llc-recalls-saladitos-dried-salted-plums-chili-because-possible-health-risk

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/el-chavito-inc-recalls-saladitos-dried-salted-plums-and-saladitos-enchilados-salted-plums-chili

Vidcast:  https://youtu.be/mbafxXz_Ksk

The FDA is trumpeting a rare warning to consumers not to use the E25Bio COVID-19 Direct Antigen Rapid Test or DART.  This test has not been authorized, cleared or approved by the FDA for sale and distribution in the US despite false labeling suggesting that it has been FDA authorized.  This product may also be sold under the trade name E25Bio SARS-CoV-2 Antigen Test Kit.

The FDA is concerned that these test kits may yield false and misleading results as the E25Bio company has not provided the FDA with data that confirms the test’s accuracy.  The FDA is also concerned that the instructions accompanying these test kits instruct users to collect samples from the throat by thrusting the swab through the nose into the upper throat or swabbing the middle portion of the throat through the mouth.  Such self-collection may be hazardous.

This FDA warning will be embarrassing to MIT, the Mass. Institute of Technology as the E25Bio Co. is an MIT spinoff started by Professor Lee Gehrke and research scientist Irene Bosch, both of MIT’s Institute for Medical Engineering and Science.

Those who used this test kit and depended upon the results should retest with an FDA authorized rapid antigen test or with a PDR Covid test.  Those who feel that they may have injured their noses or throats using the collection swab as directed should check with their providers.

Those with further questions may call the FDA’s Division of Industry and Consumer Education at 1-800-638-2041 or 1-301-796-7100.

https://content.govdelivery.com/accounts/USFDA/bulletins/3090e66

https://energy.mit.edu/news/mit-tata-center-startup-e25bio-produces-15-minute-tests-for-covid-19/

#CoVid #antigentest #FDA #approval #falsenegative #falsepositive #warning

Vidcast:  https://youtu.be/_8wXecySftw

A number of viewers have inquired how they may obtain more information about the studies that I report.  There are two ways to obtain the references to the material I use in my broadcasts.

First is via my website drhowardsmith.com.  Go to the website and look for the menu items podnotes.  They are organized by current year and previous years.  Look up the notes for the month and week the report appeared.  Each report has the complete story and clickable references.

Secondly you can go to the report on my YouTube feed.  Each report there has the complete manuscript and clickable references.

Hope this helps for those of you who want to drill down deeper on a particular subject.

Vidcast:  https://youtu.be/NZAh4xw4Cl4

I recently saw an ad for a portable EKG device called the KardiaMobile 6L. It’s a clever little device that permits you to record a 6 lead EKG at home. What caught my eye was the term FDA-cleared on the ad.  So I checked on the FDA’s website to find out just what that means.

The first step in the process of legal marketing of a medical device in the US is registration with the FDA.  If an FDA Registered medical device is substantially similar to a medical device previously registered, proven by rigorous testing to safe and effective, and approved by the FDA, it becomes FDA Cleared for marketing.  A device that is only FDA Cleared has itself not been subjected to the rigorous testing necessary to be labeled FDA-Approved.  If a device is not obviously similar to one approved, the FDA can still grant it an administrative clearance for marketing, the the device will be deemed FDA Granted.  Only devices that have undergone controlled testing and proven beyond a doubt safe and effective are granted the designation FDA Approved.

Sadly, many consumers assume that the two labels, FDA-cleared and FDA-approved mean the same thing.  UNTRUE.  There have been a number of cases where devices have been FDA-cleared based on their similarity to devices that have subsequently been recalled and removed from the market due to patient injuries.  In some cases, unethical manufacturers or importers just slap an FDA registerered, cleared, granted, or even approved label on a product without any justification.

So there is nothing wrong with the KardiaMobile device.  Just know, though, that the FDA has not verified that this so-called cleared device or any other merely cleared or granted device itself is proven safe and effective.  It is merely rubber stamped as cleared.  Buyer beware.

https://www.fda.gov/media/72646/download

https://www.rcclaw.com/understanding-the-difference-between-fda-approved-and-fda-cleared-is-crucial-to-defective-medical-device-litigation/

https://store.kardia.com/products/kardiamobile6l

#fdacleared #fdaapproved #recalls

Vidcast:  https://youtu.be/Qdxd29SFRZ0

Those CoVid positive patients with chronic medical conditions that could land them in the hospital on a ventilator or worse did not receive the relatively scarce outpatient antiCovid monoclonal antibodies that would protect them from those fates.  Public health investigators at Harvard’s and Dartmouth’s medical schools draw this conclusion from their studies of Medicare claims data for services between November 2020 and August 2021.  

Data analysis revealed that the likelihood of receiving this vital preemptive therapy was a relatively robust 23% for those without any complicating medical issues compared with about 6% for those with 1-5 chronic conditions and a shameful 4.7% for those with 6 or more chronic conditions.  Those receiving these cutting edge therapies were also less likely to be black or on Medicaid.

The investigators suggest that those most in need had difficulties navigating the the multiple steps necessary to obtain these infusions and had less access to good care.  But those of us who have been around also know that these in-demand medications often end up in the bodies of the very wealthy and politically connected.

https://news.harvard.edu/gazette/story/2022/02/those-at-risk-for-severe-covid-19-often-least-likely-to-get-monoclonal-antibodies/

#CoVid #monoclonalantibodies #misappropriation

Vidcast:  https://youtu.be/vj2II7cefKI

Long-term cannabis smoking damages the lung in ways different from tobacco smoking.  This conclusion stems from a collaborative study conducted by New Zealand’s University of Otago and our own Duke University,

The researchers reviewed longitudinal data from 881 participants beginning at age 18 and extending to age 45.  Cannabis and tobacco use were recorded through the years, and detailed pulmonary functions were assessed at age 45.  

Cannabis smoking, in contrast to tobacco smoking, leads to marked pulmonary hyperinflation or lung bloating sometimes called bong lung.  Smoking either leaf leads to increased airflow resistance that triggers reduced oxygen extraction and defacto suffocation.

https://www.atsjournals.org/doi/pdf/10.1164/rccm.202109-2058OC

#cannabis #tobacco #lungdamage #emphysema #bonglung

Vidcast:  mhttps://youtu.be/7bMXSdmkPVE

Vaccination with the 2 dose Pfizer mRNA vaccine or the single dose Johnson & Johnson vaccine fails to impact almost any of a healthy person’s physiologic responses to exercise.  Investigators at the University of Arizona report this conclusion after studying 18 young adults 24 to 43 years of age as they participated in a quantitative, graced exercise program.

The data showed that a variety of parameters including respiratory gas exchange and production of exercise-induced metabolites in response to graded exercise were statistically identical before and after vaccination.  The only exercise parameters statistically impacted by the jab were the elevation of heart rate and the production of norepinephrine, and the impact was minimal.

So add vaccination to the other CoVid mitigation maneuvers that has no impact on exercising and that item is masking.

https://journals.physiology.org/doi/full/10.1152/japplphysiol.00629.2021

#CoVid #vaccination #exercise

Vidcast:  https://youtu.be/thstDn0D9ZM

The FDA and Esupplementsales, LLC are recalling Hard Dawn Rise and Shine Capsules.  This product is marketed as a dietary supplement to enhance male virility.  It is contaminated with the phosphodiesterase tadalafil that makes it an unapproved drug for which safety and efficacy have not been proven.  This product may interact with certain medications containing nitrates including nitroglycerin causing dangerous drops in blood pressure.  If you bought this supplement, stop using it and return it to the place of purchase for a refund.  For more information, contact the company by phone at 1-916-626-9275 or via email [email protected].

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/esupplementsales-llc-issues-nationwide-recall-one-lot-hard-dawn-due-presence-undeclared-tadalafil

#harddawn #supplement #tadalafil #phosphodiesterase #nitrates #hypotension #recall

Vidcast:  https://youtu.be/3J8OG27qejg

The FDA and Conagra Brands, Inc. have recalled Wishbone Thousand Island and Chunky Blue Cheese Salad Dressings.  These products contain undeclared egg, and those with an egg allergy could develop a serious or life-threatening allergic reaction after ingesting these salad dressings.  If you have these dressings on the shelf or in your fridge, don’t consume them.  For questions or refunds, contact Conagra Brands Consumer Care at 1-800-881-3989 or via email at [email protected].

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/conagra-brands-issues-voluntary-allergy-alert-undeclared-egg-wish-boner-thousand-island-and-chunky

#wishbone #saladdressings #thousandisland #bluecheese #egg #allergy #recall

Vidcast:  https://youtu.be/lhttXOg24Jc

The CPSC and BAOPTEIL now recall BAOPTEIL Children’s Robes.  These garments fail to meet federal flammability standards for children’s sleepwear.  About 3800 of these robes were sold online at amazon.com.  Immediately obtain a fire-safe robe and stop your child from wearing these recalled garments.  Your may contact Amazon customer service for a prepaid mailer in order to obtain a refund.  Alternatively, you may contact the company via email at [email protected] to obtain the mailer and refund.

https://www.cpsc.gov/Recalls/2022/Childrens-Robes-Recalled-Due-to-Violation-of-Federal-Flammability-Standards-and-Burn-Hazard-Imported-by-BAOPTEIL-Sold-Exclusively-on-Amazon-com

#children #robe #flammable #burns #recall