Recalls & Warnings
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Posted February 9, 2021
FDA Warns Seller of Vitamin D and More for COVID-19 Claims
On February 2, 2021, the FDA issued a warning letter to Clarke Pharmaceutical Manufacturing, Inc. following a review of the company's website, which found statements made about the company's products OsteoBLAST, Cell Block #19, High Potency Vitamin D3, Neupanex, and Natural Progesterone Skin Cream to be drug claims. In addition, Cell Block #19 was sold 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)."
High Potency Vitamin D3 was promoted with statements such as "Those ailments, illnesses and diseases reported to benefit from vitamin D include, but are not limited to: osteoporosis, conditions of the heart and blood vessels, high blood pressure and high cholesterol, diabetes, obesity, multiple sclerosis, rheumatoid arthritis, chronic obstructive pulmonary disease (COPD), asthma, bronchitis, tooth and gum disease, and skin conditions including vitiligo, scleroderma, psoriasis, actinic keratosis, and lupus vulgaris."
See ConsumerLab's Vitamin D Supplements Review for tests of related products.
Cell Block #19 was promoted with statements such as "This compound is designed to strengthen your immunity to viruses and bacterial infection" and "Vitamin D [an ingredient in Cell Block #19] proteins pair up with Vitamin A proteins... then bind to a Vitamin D receptor and this causes the CAMP gene in immune cells to secrete peptides defensin, cathelicidin and LL-37 all of which simply put, KILL BUGS! Both viruses and bacteria."
See ConsumerLab's answer to the question: What are natural remedies for coronavirus (COVID-19)? Do supplements like zinc, vitamin C, or herbals work?
In addition, the products were found to be misbranded because they do not contain adequate directions for safe use, as required by federal regulations.
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