Several categories of product supplied by NATURAL TRENDS, LLC. fall under regulation of the FDA, including antibacterial hand sanitizer, SPF sun screen and SPF lip balm. They are considered OTC (over the counter) drug products because of their medical claims of killing germs in the case of the sanitizer, or providing a degree of protection from the sun as with the SPF products.
The FDA requires that all such products be produced in compliance with FDA regulation. Firms producing such products must be registered with the FDA, undergo periodic FDA inspection, meet the FDA formulary and production requirements, and include the proper drug facts label information.
This letter is to confirm that Natural Trends sanitizer and SPF products are produced in compliance with FDA formulary and production requirements, labeled with the FDA required OTC drug facts information, and produced in an FDA registered and audited facility.