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Recalls & Warnings
ConsumerLab.com is keeping you informed with current product recalls and warnings.
Posted February 02, 2021
FDA Warns Seller of Reishi Mushroom Supplements
On January 6, 2021, the FDA issued a warning letter to Entia Biosciences, Inc following a review of the company's website, which found statements made about the company's products Lion's Mane - All Natural Supplement, Antrodia Mushroom Powder, Maitake Mushroom Powder, Reishi Mushroom Powder, Cordyceps Mushroom Powder, and Cordyceps - All Natural Mushroom Dietary Supplement to be drug claims.
For example, Lion's Mane - All Natural Supplement was promoted with statements such as "It has been linked to having positive implications towards reducing cholesterol levels and inflammation."
See ConsumerLab's Cholesterol-Lowering Supplements Review (Sterols/Stanols and Policosanol) for tests of related products.
Reishi Mushroom Powder was promoted with statements such as "Prevention of heart disease," "Reduce high blood pressure," and "Lower high cholesterol."
See ConsumerLab's Reishi Mushroom Supplements Review for tests of related products.
In addition, the products were found to be misbranded because they do not contain adequate directions for safe use, as required by federal regulations.
For more information, use the link below.
Warning Letter: Entia Biosciences, Inc
See related warnings:
Seller of Omega-3 Warned for Making Claims to Treat Focus, Mood
Seller of Cholesterol, Weight Loss Products, and More Warned for Claims
FDA Warns Seller of Evening Primrose Oil and Beta Glucan
Report a Problem
If you have experienced an unexpected and adverse reaction to a dietary supplement, nutritional product, or generic drug, we would like to hear about it, as we may investigate the problem. Please select from one of these options:
Dietary Supplement or Nutritional Product Problem Report
If you believe that a dietary supplement (e.g., vitamin, mineral, or herbal supplement) or other nutritional product has caused an unexpected, adverse reaction, we would like to know about it. We are collecting and organizing this information and may publish it. We might test the product in the future. You may also want to report the problem to the U.S. FDA through their Safety Reporting Portal at https://www.safetyreporting.hhs.gov.
Please complete the form below as accurately as possible. You may need to check the label on the product.
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Generic Drug Problem Report
If you believe that a generic drug has not acted like the original drug, we would like to know about it. We are collecting and organizing this information and may publish it. We might test the product in the future. You may also want to report the problem to the U.S. FDA through their MedWatch program at the FDA MedWatch website.
Please complete the form below as accurately as possible. You may need to check the label on the drug.
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