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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.

Warnings: New Sun Inc.

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

FDA Warns Seller of Vision and Allergy Supplements