Mr. Frank D’Amelio Jr.
Chief Executive Officer
Bio-Botanica, Inc./Nature’s Answer, Inc.
85 Commerce Dr.
Hauppauge , NY 11788-3943
United StatesIssued May 5, 2021Office of Human and Animal Food Operations East – Division 1
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.
Violations1
Issue DateMay 5, 2021
Product TypeDietary Supplements
StatusClosed
Closeout LetterMay 23, 2022
Letter Details
Firm
Bio-Botanica, Inc./Nature’s Answer, Inc.
Location
Mr. Frank D’Amelio Jr.
Chief Executive Officer
Bio-Botanica, Inc./Nature’s Answer, Inc.
85 Commerce Dr.
Hauppauge , NY 11788-3943
United States
FEI Number
N/A
Country
United States
Issue Date
May 05, 2021
Issuing Office
Office of Human and Animal Food Operations East – Division 1
Product Type
Dietary Supplements
Status
Closed
Closeout Letter
May 23, 2022
Summary
Bio-Botanica, Inc./Nature's Answer, Inc. was cited for marketing Coral Calcium, a dietary supplement containing cesium chloride, without meeting regulatory requirements for new dietary ingredients. The company failed to demonstrate that cesium chloride was either present in the food supply before October 15, 1994, or that it had submitted the required safety documentation to FDA at least 75 days before marketing the product. Because cesium chloride lacked pre-1994 market history and the company provided no safety evidence to FDA, the product was deemed adulterated under federal law.
Bio-Botanica, Inc./Nature’s Answer, Inc. FDA Warning Letter, May 5, 2021
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