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So What’s Up with Hawaiian Organic Noni and the FDA?

On July, 2018 the FDA, Office of Human and Animal Foods issued a Warning Letter to our family Noni business, Hawaiian Organic Noni, after reviewing of our product labels, brochures and website.

Our certified organic family Noni farm has grown, picked, processed and distributed organic Noni products that we developed over the past 25 years.  We have total control over every aspect of the growing, picking, processing and distributing and have always desired to be complaint with all FDA, USDA and State of Hawaii Health Department regulations for cosmetics and dietary supplements concerning our organic Noni products.

We have received annual inspections by the USDA representative (International Certification Services) for our organic growing, handling and processing on our organic family farm.  We have never been in violation with the USDA organic practices. Organic farming is a way of life for my family.

We have received annual inspections by the State of Hawaii Health Department for our Food Establishment and Processing Facility.  We have never received any violation notice after any inspection for the past 25 years. Cleanliness is the guardian rule in our processing facility.

In 1995, when we began our family Noni business, we contacted the FDA offices in San Francisco and Washington DC to make sure we took steps to be complaint with all FDA regulations for cosmetics and dietary supplements.  We consulted with the Hawaii State Health Department on for further guidance on labeling and wording for cosmetics and dietary supplements.

Over the past 25 years, we would receive a surprise inspection by an FDA field inspector for the processing facility, labeling, brochures and website content.  As the FDA regulations changed over the years, we were informed that one or two words could no longer be used in describing the use of our organic Noni products.  We would make the necessary changes and have that approved upon review.

During the 2018 inspection, we were informed that major changes occurred in the FDA regulations on cosmetics and dietary supplements as of January 1, 2018.  We were informed that 3rd party Testimonials could no longer be used even if from a licensed practitioner and much of the wording on our labels, brochures and on our website would no longer be complaint with current regulations.  A formal review would be completed and a Warning Letter would be issued.

The Warning Letter dated July 18, 2018 is the result of the new review and corrections that needed to be taken to compliant. 

Actions that we immediately undertook:

  1. Hired a consultant firm, Goodwin Law Offices in Washington DC for guidance and instructions on being complaint as per the new FDA regulations on cosmetics and dietary supplements.  They provided a list of resources with helpful information on the types of claims that may be appropriate for cosmetics and dietary supplements. We spent hours by phone reviewing new labeling and wording for the brochure and website.  After our Printing Company made the necessary changes to all of our labels and brochure, the new revised labels and brochure were submitted to the FDA Compliance Officer for review.
  2. Contracted with UBE Analytical Laboratories in Brea, CA to perform a new complete Supplemental Fact test, shelf life test and potency retention tests.  The results were received showing a 2 years shelf life (negative for Coliform, E. Coli, Salmonella, Staph, Yeast, Mold) and the New Supplemental Fact panels was added to the back of the Noni Fruit Leather label.  The potency retention tests showed only a 1% drop in potency after 2 years.
  3. We removed the Testimonial Page from our website and removed all testimonials referring to the Noni Fruit Leather, Noni Banana Fruit Leather, Noni Lavender Lotion and Noni BioBandage both for people and pets on product description pages.
  4. We reviewed all labels, brochure and web pages from “top to bottom” to ensure compliance with all FDA regulations for cosmetics and dietary supplements.  The appropriate changes were made or simply deleted specific wording that was not compliant.  
  5. Product descriptions pages were edited to be compliant.
  6. 800 articles and blogs were reviewed and edited for compliance.

     

All the revised labels, brochure and actions taken to our website (www.realnoni.com) were submitted to the FDA Compliance Officer for review. 

We received an email response on Nov. 20,2019:
I have received the labels you have provided and have no additional comments.  I have also reviewed your firm’s website, https://www.realnoni.com/, and have no additional comments. 

My understanding is that “no additional comments” means compliance – that we meet the new FDA regulations for cosmetics and dietary supplements. We are currently waiting for a formal letter from the FDA that we are now compliant and meet their guidelines. 

In closing, I can not stress enough that we have always, for 25 years, strived to be compliant with all FDA regulations.  We realize that the regulations or a reviewer’s interpretation of the rules and guidelines might change but it is our responsibility to remain within those guidelines.  We have spent an enormous amount of time and money to meet the current guidelines – hiring consultants, reviewing new regulations, changing all of our labels (people and pet) and making the appropriate edits and changes to our website.   

We will continue to offer pure raw Noni from the whole fruit, not fermented and low heat processed for maximum potency to support overall health, wellness & energy.


Steve Frailey and Family
Hawaiian Organic Noni