William S. Carlson
CEO
Nature’s Innovation, Inc.
5317 Palmero Court
Buford , GA 30518
United States
info@naturesinnovation.comFEI 3007963810Issued Aug 18, 2023Center for Drug Evaluation and Research | CDER
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3007963810.
Violations1
Issue DateAug 18, 2023
Product TypeDrugs
StatusOpen
Letter Details
Firm
Nature’s Innovation, Inc.
Location
William S. Carlson
CEO
Nature’s Innovation, Inc.
5317 Palmero Court
Buford , GA 30518
United States
info@naturesinnovation.com
FEI Number
3007963810
Country
United States
Issue Date
August 18, 2023
Issuing Office
Center for Drug Evaluation and Research | CDER
Product Type
Drugs
Status
Open
Summary
Nature's Innovation, Inc. was cited for selling unapproved new drugs, specifically the "Naturasil Molluscum Treatment Kit" and "Naturasil Shingles" products, through their website and social media channels in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act. The FDA found particular concern with the molluscum treatment product being marketed for use in children, a condition that requires professional medical evaluation to rule out serious conditions such as skin cancer and fungal infections, and for which no legally marketed over-the-counter treatments exist. The company failed to obtain FDA approval before introducing these drug products into interstate commerce, and the marketing of these products could lead consumers to forgo or delay proper medical diagnosis and care.
Nature’s Innovation, Inc. FDA Warning Letter, August 18, 2023