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Recalls & Warnings
ConsumerLab.com is keeping you informed with current product recalls and warnings.
Posted July 22, 2022
FDA Warns Seller of Vision, Calcium & Magnesium Supplements and More
On June 14, 2022, the FDA issued a warning letter to New Sun Inc. following inspection of the company’s website which found statements about the company’s products to be drug claims.
For example, the company’s Bilberry Eyebright+ was promoted with statements such as, “Eyebright has been traditionally used to treat all manner of eye maladies including; inflammation, conjunctivitis, red-eye, sties, itchy eyes, stinging eyes, and weak vision.”
See ConsumerLab’s Bilberry Supplements and Vision Supplements Reviews for more information and tests of related products.
Calcium Magnesium Liquid was promoted to treat kidney stones, calcium deposits, among other things with statements such as, “Magnesium has several additional benefits. . . . It neutralizes stomach acids and may help in resisting depression. It may also help in prevention of kidney stones and calcium deposits.”
See ConsumerLab’s Calcium and Magnesium Reviews for more information and tests of related products, including combination products.
The company’s Elderberry Plus Vitamin C product was promoted to, “Aid[s] with cold, flu and virus symptoms,” and “aid[s] with infections.”
See ConsumerLab’s Elderberry Supplements Review for more information and tests of related products.
The company’s Ultra CBD Oil (Hemp Oil), CBD Gummies, and Advanced CBD Oil (Hemp Oil) products were promoted with statements such as, “May help with lowering cholesterol as well as assist with moderating blood sugar levels,” “May relieve pain and inflammation, and aid with anxiety and depression,” and “ May help reduce symptoms related to cancer and side effects related to cancer treatment…” While these products contain a supplement facts panel, the FDA stated that the products cannot be dietary supplements because they do not meet the definition of a dietary supplement.
See ConsumerLab’s CBD & Hemp Extract Supplements, Lotions, and Balms Review for more information and tests of related products.
Kidz DHA was promoted to, “treat certain health problems in children, such as allergies, asthma, and attention deficit-hyperactivity disorder (ADHD).”
See ConsumerLab’s Fish Oil, Krill Oil, and Algal Oil (Omega-3) Supplements Review for more information and tests of related products.
The agency states that these products, and others such as Kidz Super Dophilus, Advanced U-Tract, Advanced Liver Plus and more were unapproved new drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
The company must respond to the FDA within 15 days outlining the steps taken to address any violations.
For more information, use the link below.
See related recalls and warnings:
Seller of Omega-3 Warned for Making Claims to Treat Focus, Mood
FDA Warns Seller of Magnesium, CBD, Herbal Extracts & More
CBD Products Were Promoted to Treat Cancer and Alzheimer’s Without Proof, Says FTC
FDA Warns Seller of Liquid Magnesium, B-12, Berberine & More
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.
Thank you for submitting your report.
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.
Thank you for submitting your report.
