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Recalls & Warnings
ConsumerLab.com is keeping you informed with current product recalls and warnings.
Posted April 2, 2021
FDA Warns Sellers of Prostate, Reishi, Immune Products, and More
On March 16, 2021, the FDA issued warning letters to two companies following reviews of their websites which found statements made about the companies' products to be drug claims. These products are Prostate Health and Children Liquid Vitamins from Anna Health, LLC; Ganoderma Lucidum Red Reishi Mushroom and Papaya Leaf Extract from Duoc Thao Tre Xanh, LLC; and Fucoidan sold by both companies. In addition, both companies sold the product Immune Health with unsupported claims that it can treat coronavirus (COVID-19).
The FDA has previously stated: "There currently are no vaccines, pills, potions, lotions, lozenges or other prescription or over-the-counter products available to treat or cure coronavirus disease 2019 (COVID-19)."
More details about each recently-warned company can be found below (use the link to read the full warning letter).
- Anna Health, LLC: Prostate Health was promoted with statements such as "Improves... urinary flow," "Relieves symptoms of BPH (Enlarged Prostate)," and "Protects against prostate cancer."
- Duoc Thao Tre Xanh, LLC: Ganoderma Lucidum Red Reishi Mushroom was promoted with statements such as "THE WONDER MUSHROOM THAT CURES MANY DISEASES AT ONCE."
See ConsumerLab's Reviews of Prostate Supplements (Saw Palmetto and Beta-Sitosterol) and Reishi Mushroom Supplements for tests of related products.
Immune Health was promoted with statements such as "COVID-19 Influenza" and "Helps Boost Your Immune System Against: Coronavirus... Influenza... Bronchitis... Dyspnea... Common Cold."
See ConsumerLab's answer to the question: What are natural remedies for coronavirus (COVID-19)? Do supplements like zinc, vitamin C, or herbals work?
See Related Warnings:
Seller of Earth Tea Warned for COVID-19 Claims
FDA Warns Dr. Paul's Lab for COVID-19 Claims
Seller of BioCBD+ Products Warned for COVID-19 and Drug Claims
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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