FDA Warning Letters

FDA Warning Letters

On October 23, FDA (U.S. Food and Drug Administration) issued three FDA warning letters jointly with the Federal Trade Commission (FTC) to Peterson Research Laboratories dba Covercology, Predator Nutrition, and Beepothecary for selling unapproved and misbranded products with fraudulent COVID-19 claims.

The FDA warns that all products that are given below have not confirmed their impact on COVID-19. Thus, any coronavirus-related prevention or treatment claims regarding such product are not supported by competent and reliable scientific evidence.

Peterson Research Laboratories LLC FDA Warning Letters

FDA and FTC checked website on September 8, 2020, and September 30, 2020, respectively. FDA published “The FDA has observed that your website offers the product “Simple Silver” for sale in the United States and that this product is intended to mitigate, prevent, treat, diagnose, or cure COVID-191 in people. Based on our review, this product is an unapproved new drug 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, this product is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. § 352. The introduction or delivery for introduction of this product into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d).”

Some examples of the claims on websites that misleadingly represent it as safe and/or effective for the treatment or prevention of COVID-19:

  • “Simple Silver (Colloidal Silver) with ionic solubility technology is a dietary supplement that has ionic solubility that may support the Immune system ability to fight off and kill nasty pathogens that can cause illnesses inside and outside the body such as: CORONAVIRUS (COVID-19) . . . Ideal for dedicated health care professionals working with Covid-19 patients . . .” [from website www.covercology.com/shop]
  • “Human coronaviruses can sometimes cause lower-respiratory tract illnesses such as pneumonia or bronchitis. Simple Silver is a dietary supplement that has ionic solubility that supports the Immune system in its ability to fight off and kill nasty pathogens that can cause illnesses inside and outside the body such as: CORONAVIRUS (COVID-19) . . . Try it today! . . . Link in bio” [from a February 28, 2020, post on the company social media website www.facebook.com/Hairreau]

Beepothecary LLC

During verification The FDA has observed that on websites offer various bee products for sale in the United States, including “Elderberry, Honey & Propolis Syrup,” “BEEbread,” and “BEEHive Delight,” and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people.

Some examples from FDA letter:

  • “Here’s an interesting article on the action of bee products in relationship to the actions of the COVID-19 illness. It’s suggestive that taking bee products (like propolis) for prevention is a good idea. That’s what we are all doing! https://www.preprints.org/manuscript/202004.0013/v1” [from a May 4, 2020, post on social media website www.facebook.com/BEEpothecary]
  • “Remember Folks, propolis is ANTIVIRAL. We are taking our dose EVERY DAY! BEEpothecary.US” [from a March 19, 2020, post on social media website www.twitter.com/BEEpothecary] Propolis is an ingredient in “Elderberry, Honey & Propolis Syrup” and “BEEHive Delight,” among other products you sell.

Predator Nutrition

The FDA discovered multiple violations. In the letter they give examples of some of them:

From article titled, “SUPPLEMENTS FOR IMMUNE SUPPORT – CORONAVIRUS (COVID-19) 2020” at www.predatornutrition.com/articlesdetail?cid=supplements-for-immune-support:

  • “Natural Ingredients Used in Treating Covid-19. Doubtless, over time we will learn more about what works best for treating Covid-19 but for now, with widespread adoption in numerous countries of a combined pharmaceutical and nutraceutical approach, we think it’s best to focus on prevention and investing your efforts on those products with the strongest evidence base.”
  • “Of particular interest in the context of potential damage to the lungs as seen in Covid-19, BPC- 157 was shown to reverse even severe lung damage in at least two studies.”

From article titled, “RESEARCH REVIEW – WHAT TREATMENT WORKS BEST FOR COVID-19?” at www.predatornutrition.com/articlesdetail?cid=research-review-covid-19-treatment:

  • “With the wait for a vaccine that can be deployed en masse likely to take us into 2021 at the earliest, everyone should be focused on prevention and immune support such as: . . . Supplementing with evidence based nutrients shown to support immunity, or else those that show antiviral properties, such as oxymatrine, berberine and ecklonia cava (found in the product Elixir).”

Anastasia Kovalenko

Anastasia has an experience of creating articles for about 5 years. Topics of those articles included health, overall wellness, pharmacies and new pharmaceutical products. Wishes to learn more and improve her experience in medical field. Considers archaeology to be the most interesting and exciting hobby among others.

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