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  • Lisa Barger
  • August 10, 2017 04:27:22 AM

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LisaBarger dot com offers critical reviews of herbal remedies and analysis of breaking health news.

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Hanna’s Herb Shop Gets FDA Warning

Hanna's Herb Shop removes health claims FDA says the store is not allowed to make about herbal supplements.

The U.S. Food and Drug Administration, or FDA, recently sent a formal warning letter to Thomas Brown and the store he manages, Hanna’s Herb Shop, for non-allowed drug claims the company reportedly made about several of its herbal products.

Thomas Brown and Hanna's Herb Shop are FDA warned for drug claims.
FDA warning letter sent to Thomas Brown and Hanna’s Herb Shop for non-allowed health claims made of the store’s Kolester, Kava Kava, St. John’s Wort and other herbal remedies.

The letter, which was dated March 5th 2019, called out several products in particular. Among them were:

  • Kroeger Herb Kolester
  • Kroeger Herb St. John’s Wort Complete Concentrate
  • Kroeger Herb FLT (Flu Tea) 
  • Kroeger Herb Heart Care Blend
  • Kroeger Herb Circu Flow and Aloe Vera Juice (Inner Leaf)

In the case of the “flu tea” remedy just the name of the product was enough to get the FDA’s attention. And then there was the case of a bee pollen product, which apparently got the company in trouble simply because it was listed under allergy remedies.

But the allegations FDA made about some of Hanna’s herbal remedies were little more serious. A customer testimonial about the Kroeger Herb Circu Flow and Aloe Vera Juice product, for example, seemed to position it as an alternative to a surgical procedure. And Hanna’s Kolester supplement was hawked as an alternative to pharmaceutical statins.

Kroeger Herb Kolester was marketed as an alternative to statin drugs.
Archived screenshot of Hanna’s Herb Shop’s website, where the company seems to hawk its Kroeger Herb Kolester supplement as an alternative to statins.

FDA typically gives supplement peddlers 15 working days to address allegations that they are marketing products with illegal claims and that is the case here.

As of my check this morning, the FDA-cited claims I looked up had been removed from the website. Neither the site’s blog nor any of Hanna’s social media accounts address the FDA formal warning.


Homeopathy No Substitute For Vaccines – Health Canada

Health Canada says it is prepared to take on homeopaths falsely claiming to offer vaccine alternatives.

Earlier this week Health Canada issued a formal statement on “homeopathic” remedies being peddled as alternatives for vaccines. In a statement issued March 06, 2019 the agency says it is “concerned” about fraudulent claims being used to hawk homeopathic nosodes as a way to prevent infections.

In fact, says the agency, homeopathy is not, nor has it ever been, formally recognized as safe or effective as an alternative to any vaccine. And in Canada, no homeopathic remedy can be legally marketed as such.

The remedies are often attached to the buzzword “homeoprophylaxis,” which belivers say describes how homeopathic remedies impart “energetic stimulation” to the body, increasing the body’s natural immunity to a particular infection. They often falsely claim that homeoprophylaxis has been scientifically proven in countries like Japan.

Health Canada says they are following up on reports of such claims and will “take action” against sellers and marketers.

Both the U.S. Food and Drug Administration and Health Canada require special wording on homeopathic labels. In Canada, that wording must include these declarations:

  • “This product is neither a vaccine nor an alternative to vaccination.”
  • “This product has not been proven to prevent infection.”
  • “Health Canada does not recommend its use in children and advises that your child receive all routine vaccinations.”


McDaniel Life-Line FINALLY Recalls Contaminated Water

We now which pathogen contaminted McDaniel Life-Line's Catalytic Activated Energy Water.

Weeks ago we brought you the story of McDaniel Life-Line and its recall of an herbal product so caustic it could, said the FDA, cause “chemical amputations”. Yesterday it was announced that another product, Life-Line Water, was also being recalled.

McDaniel Life-Line LLC Issues Voluntary Worldwide Recall of Life-Line Water
McDaniel Life-Line finally recalls its Catalytic Activated Energy Water–weeks after tests found bacterial contamination in it.

That Life-Line’s bottled water product is contaminated is not news; the FDA actually disclosed that fact weeks ago. But yesterday’s recall notice finally told us the exact pathogen–the bacterium Pseudomonas aeruginosa.

Pseudomonas aeruginosa is of special concern to medical experts because it is one of our “super bugs” resistant to multiple antibiotics. It is especially dangerous to people with weakened immune systems.

As of March 05, 2019 there had still been no reports of anyone using the water and becoming ill.

All lot codes are affected by this recall.


Facebook Pulling Anti-Vax Ads

Facebook is "Combatting Vaccine Misinformation" by reducing exposure to propaganda.

Facebook’s vice president of global policy management announced yesterday that the social media juggernaut will soon implement a plan it says will “tackle vaccine misinformation” by limiting the exposure it gives to groups, pages and ads that spread false or misleading information about vaccine safety.

Combatting Vaccine Misinformation at Facebook
Facebook announces a new effort to fight anti-vaccine propaganda.

In a blog post, Monika Bickert revealed a few of the steps Facebook plans to take against people and organizations it catches distributing anti-vaccine “information”:

  • Reduce their rankings in News Feed and Search
  • Reject their paid ads
  • Hide the info from Instagram’s Explore and hashtag pages

To determine when information is a hoax, says Bickert, Facebook will use criteria from major health organizations like the World Health Organization and the Centers For Disease Control.

Facebook is not censoring individuals but says it will look into ways to offer “educational information”.


GoLean Detox Is Spiked With Laxative Linked To Cancers

Illegally hidden, and potentially deadly sibutramine and phenolphthalein force a recall of the scam detoxification product known as GoLean Detox.

GoLean Detox USA announced earlier today that it was being forced to recall all existing inventory of its scam detoxifying weight loss “supplement” after investigators with the U.S. Food and Drug Administration, or FDA, found two banned pharmaceuticals hidden inside.

Recalled GoLean Detox supplement is recalled.
Image of GoLean Detox taken from company’s website, February 25, 2019, by Lisa Barger

In the press release announcing the recall, GoLean Detox admitted that its product was contaminated with sibutramine and phenolphthalein. Both drugs were banned from over-the-counter sales in the U.S. after being linked to very serious health conditions.

Sibutramine, for example, is a weight loss drug that was pulled from the market after it was realized that it could dramatically raise blood pressure and increase heart rate, triggering a stroke.

Phenolphthalein was once used as an ingredient in over-the-counter laxatives but was banned after it was linked to gastrointestinal issues and even cancer.

GoLean Detox insists that it has not received any reports of anyone being injured by the “supplement”.

If you think you might have any of this still on hand, you’ll need to look for a box made to hold 14 packets containing 2 capsules per packet. The UPC is 8 938510 909013; all lot codes are affected. You should, of course, not use it.

GoLean Detox was hawked nationwide.


Dollar General’s Baby Gripe Water Recalled

Kingston Pharma, recalls all lots of DG™ Baby Gripe Water sold at Dollar General because of an undissolved ingredient, believed to be citrus flavonoid.

New York’s Kingston Pharma has announced a recall of its gripe water “supplement” sold under the Dollar General label DG™ Baby Gripe Water. The problem, says the company in a recall notice published to its website, is the reported presence of an ingredient that is not fully dissolved.

Multiple complaints of an undissolved ingredient prompt a recall of
Image of DG Baby Gripe Water provided by the company.

The product, which is considered an “herbal supplement”, is not contaminated and should not be considered hazardous. It could, however, be difficult for some customers to swallow. Kingston Pharma says it has received one report of a newborn having difficulty swallowing the product and three complaints about the undissolved ingredient.

All production codes are covered by the recall. Look for a 4-ounce amber bottles with a white plastic caps with safety seals and an includedoral syringe. The UPC Code is 8 5495400246 3.

DC Baby Gripe Water was offered in Dollar General stores nationwide. There was no word on how many bottles of the “supplement” may have been sold to customers. If you have any on hand you should throw it out, advises the company.

What Is Gripe Water?

Gripe water is a controversial herbal product typically marketed in the U.S. as a dietary supplement. It almost always contains fennel and/or dill, as well as any number of other “digestive” herbs. Gripe water is most often given to infants to treat colic.

Gripe water has not been exhaustively studied for efficacy and the studies that have been done were not supportive of its use. One of the most recent studies, for example, was done in India in 2015 and found the product ineffective for stomach ache in babies. The study, which was published in the Journal of Clinical & Diagnostic Research, also found that the children who used it were more likely to suffer vomiting and constipation than babies who did not.

Nevertheless, gripe water continues to remain popular and widely available.


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