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Message on Sanitizer Safety and FDA Compliance
 

Dear Customers,

With the explosion in sanitizer demand related to the Covid-19 Virus, many are understandably anxious to be assured the sanitizer they are ordering is safe, effective, and fully compliant with all FDA regulations.

We hope the following information will be informative.

  • Classification. Consumer hand sanitizer is regulated and classified by the FDA as an OTC (over-the-counter) drug product.

  • Requirements. The FDA requires that sanitizer be compliant with all requirements established in their monograph or “final rule.”

  • Alcohol Content. The requirements include that all alcohol based hand sanitizer must contain at least 60% alcohol--ours is 70% or higher.

  • Labeling. The ruling specifies the information and format for the drug facts label, with which we are fully compliant.

  • Compliance vs Approval. While we’ve observed some providers using the phrase “FDA approved,” this designation is inaccurate. The FDA does not require, or have a process for producers to get “approval” of consumer hand sanitizers. The correct phrase would be “FDA compliant” as producers are required by law to “comply” with all FDA formulary and labeling requirements.

It is troubling to find some products in the industry clearly not compliant, lacking even a drug facts label. These often seem to come from those hurriedly jumping into the market in a crisis, without proper experience.

Natural Trends is experienced, and has been providing safe and effective hand sanitizer to the promo industry for over 20 years and we are fully compliant with FDA formulary and labeling requirements. We’re more experienced than most because not only have we been doing it longer, we previously owned a retail division which provided sanitizer to mass retailers. Hence we’ve been through their extensive vetting processes as well.

We hope this information will provide you with confidence that all sanitizer from Natural Trends is always safe, effective, and FDA compliant.

We are honored to be entrusted with your orders,

Paul Christensen
President
Natural Trends, LLC

 

To download a PDF version of this letter, please cllck here.

 

   
                 
   
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