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Archive for the ‘Compliance Statements’ Category

Statement of FDA Compliance

Friday, February 26th, 2010

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.  

Paul Christensen
President


Statement of Compliance: California Proposition 65

Friday, February 26th, 2010

Prop 65 (short for Proposition 65) refers to the California legislation regarding the prohibition of harmful toxic substances.  The Proposition was intended by its authors to protect California citizens and the State’s drinking water sources from chemicals known to cause cancer, birth defects or other reproductive harm, and to inform citizens about exposures to such chemicals.

The statute states that “no person in the course of doing business shall knowingly and intentionally expose any individual to a chemical known to the state (California) to cause cancer or reproductive toxicity without first giving a clear and reasonable warning…” 

Based upon NATURAL TRENDS knowledge of our business operations and chemicals used, none of the chemicals listed by the State of California Environmental Protection Agency, are used in our products.

NATURAL TREND’S products are printed with lead-free ink and adhere to all safety standards as required by California law.

Paul Christensen
President