Inspections, Compliance, Enforcement, and Criminal Investigations

Hawaiian Organic Noni, LLC 7/18/18

 

  

Black HHS-Blue FDA Logo

 

 

 
 OHAFO West Division 5
1431 Harbor Bay Parkway,
Alameda, CA 94502

 

WARNING LETTER
 
 
UNITED STATES POSTAL SERVICE
CERTIFIED MAIL
 
July 18, 2018
WL# 540887
Steven H. Frailey, Owner
Hawaiian Organic Noni, LLC
PO Box 267
Anahola, HI 96703-0267
 
Dear Mr. Frailey:
 
The United States Food and Drug Administration (FDA) inspected your facility located at #3 Larsens Beach Rd. Anahola, Hawaii, from August 15, 2017 through August 21, 2017. As part of the inspection FDA collected finished product labeling, including product labels and brochures, for your Hawaiian Organic Noni products. FDA reviewed the finished product labeling and also reviewed your website at the Internet address https://www.realnoni.com in May and July 2018.  FDA has determined that you take orders at this Internet address for your Hawaiian Organic Noni Fruit Leather, Hawaiian Organic Noni Banana Fruit Leather, Hawaiian Organic Noni Lavender Lotion, Hawaiian Organic Noni BioBandage, Pet Noni Fruit Leather, Pets Noni Lavender Lotion, and Pets Noni BioBandage products. The claims on your product labels, product brochures, and website establish that these products are drugs under sections 201(g)(1)(B) and/or 201(g)(1)(C) of the Federal Food, Drug and Cosmetic Act (the Act),[ 21 U.S.C. § 321(g)(1)(B) and/or  § 321(g)(1)(C)], because they are intended for use in the cure, mitigation, treatment, or prevention of disease in humans or other animals and/or to affect the structure or function of the body of man or other animals. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and the FDA regulations through links on FDA’s home page at www.fda.gov.  
 
Examples of some of the claims in your product labeling, including your website, that provide evidence that your products are intended for use as drugs in humans include:
 
Hawaiian Organic Noni Fruit Leather:
  • “Helps to maintain & support... cholesterol levels, blood sugar & blood pressure levels…”
  • “Alleviates Pain & Inflammation”
  • “Our raw food organic Noni Fruit Leather with 165 beneficial compounds is used as a preventative or to address chronic symptoms internally or externally”
  • “Can alleviate pain & inflammation”
  • “The true traditional use for thousands of years among Polynesian cultures was to eat the raw noni fruit, as a natural preventative to keep themselves from getting sick.”
  • “Noni Fruit Leather Can: “Help combat common infections…Decrease the body’s inflammatory response in arthritis”
  • “In fact, Noni fruit is one of the world’s richest sources of the potent phytochemical known as damnacanthal. This compound is widely known for its ability to kill parasites, such as those responsible for malaria.”
  • “Other functions of the Noni fruit include…relieving pain and inflammation, as well as restoring bodily organs to their normal state. This means it can help with everything from digestive problems…to cardiovascular trouble and nervous conditions.
  • “Noni helps to maintain and support healthy…Cholesterol Levels, Blood Sugar Levels, Blood Pressure Levels…”
  • “Traditional Uses of Noni: Abrasions, Aches…Boils and Abscesses, Bowel Disorders, Bruises, Burns…Rashes, Sore Muscles, Sore Throat, Swelling, Toothaches”
  • “It’s believed that this might lower your risk of chronic disease, help you fight off chronic diseases”
Hawaiian Organic Noni Lavender Lotion:
  • “Skin Conditions: Eczema & Psoriasis”
  • “Instant Sunburn Relief”
  • “Anti-bacterial & Anti-fungal”
  • “Helps Relieve Pain & Joint Stiffness”
  • “Instant Sunburn Relief”
  • “Noni Lavender Lotion can be used to address and soothe multiple ailments and conditions above and beneath the surface of your skin…it has the ability to penetrate into aching joints or bruises to help repair the damage at its source. This product is even shown to help heal sun-damaged skin and reduce scarring.”
  • “Noni Lavender Lotion is Able to Address: Skin Conditions, Bruises, Pain and Swelling, Stiffness, Sprains, Fractures, Acne-Anti-bacterial & Anti-fungal, Sunburn.”
 
Hawaiian Organic Noni BioBandage:
  • “Skin Conditions & Skin Ailments”
  • “Skin tags”
  • “Seals and protects damaged skin”
  • “Skin Conditions and Skin Aliments”
  • “As an organic remedy, Noni Biobandage can be applied directly to skin conditions and skin aliments.” 
  • “Made with the same care as our Noni Fruit Leather, the Noni Biobandage is sure to speed up your recovery time for small localized injuries or growths.  The Noni Biobandage may be applied as a thick paste to skin growths or skin tags to air in their removal in several days.”
  •  “Used for a localized abrasion or skin injury to promote healing of the tissue”
  •  “Removal of external skin growths or skin tags by applying the paste to the growth or skin tag, leaving the growth or skin tag completely covered with the paste for several days”
  • “Use as a facial mask for improved skin texture or to address acne symptoms”
  • “Apply to fingernails or toenails to address fungus issues” 
Hawaiian Organic Noni Banana Fruit Leather:
  • “Can alleviate pain & inflammation
  • “The true traditional use for thousands of years among Polynesian cultures was to eat the raw noni fruit, as a natural preventative to keep themselves from getting sick.”
  • “Noni Fruit Leather Can: Help combat common infections…Decrease the body’s inflammatory response to arthritis”
  • “In fact, Noni fruit is one of the world’s richest sources of the potent phytochemical known as damnacanthal. This compound is widely known for its ability to kill parasites, such as those responsible for malaria.”
  • “Other functions of the Noni fruit include…relieving pain and inflammation, as well as restoring bodily organs to their normal state. This means it can help with everything from digestive problems…to cardiovascular trouble and nervous conditions.”
  • “Noni help to help maintain and support healthy… Cholesterol Levels, Blood Sugar Levels, Blood Pressure Levels…”
  • “Traditional Uses of Noni: Abrasions, Aches…Boils and Abscesses, Bowel Disorders, Bruises, Burns…Rashes, Sore Muscles, Sore Throat, Swelling, Toothaches”
The following claims on the Noni Health Terms page of your website provide evidence that the aforementioned Hawaiian Organic Noni products are intended for use as drugs:
  • From the Natural Antibacterial section
o   “Research has shown noni fruit to be very antibacterial”
o   “Some of the antraquinones in noni are antibacterial agents, able to help protect injuries from infection”
o   “[H]ighest antibacterial properties are found in ripe raw noni fruit”
  • From the Morphine section
o   “Looking for a natural pain relief alternative? Try noni fruit! An impressive study published in Acta Pharmacologica Sinica found that noni extract did not exhibit any toxic effects but did show significant, dose-related, anti-inflammatory and central analgesic activities. So significant, in fact, that it was 75 percent as strong as morphine, yet totally safe and side-effect free.”
 
Examples of some of the website claims that provide evidence that your products are intended for use as drugs in animals include:
 
Pet Noni Fruit Leather:
  • “Our raw food organic Noni Fruit Leather with 165 beneficial compounds is used as a preventative or to address chronic symptoms internally or externally.”
  • “Natural flea, tick, worm and parasite preventative”
  • “Can alleviate pain & inflammation”
Pets Noni Lavender Lotion:
  • “Can relieve pain & inflammation”
  • “Helps heal skin ailments like hot spots, scratches and rain rot”
  • “Helps heal common injuries such as muscle and ligament strain”
  • “Anti-bacterial & anti-fungal”
Pets Noni BioBandage:
  • “Promotes healing from skin conditions & skin ailments”
  • “Aids in the removal of skin tags and growths”
  • “Seals and protects damaged skin acting like a natural band aid”
  • “Helps restore damaged tissue, including muscle, skin, and bone” 
Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of your Hawaiian Organic Noni Fruit Leather product for the cure, mitigation, treatment, or prevention of disease in humans. Examples of such testimonials include:
  • “Have had Lyme disease for over 30 years. Had severe Peripheral neuropathy. On Lyrica for over a year…Stopped the Lyrica and a bunch of other medications (for other complications of Lyme) …This product, BECAUSE OF HOW ITS PROCESSED, is nothing short of a miracle.”
  • “I bought some of the fruit leather…In just a few days my severe neck arthritis pain was gone!...if I missed a "dose" then my neck pain would return, including numbness down my arm and into my fingers.”
  • “I had ulcers and H-py-lori…I took Noni fruit leather for six weeks and retested. I am bacteria free. Thank You for such a wonderful product! Thirty years I have fought ulcers.”
  • “I have been very pleased with the noni fruit leather. It has been quite effective in lowering my blood pressure…”
  • “[S]e has had Hay Fever for years and her throat is always giving her trouble, but since she started this routine of letting the Noini [sic] melt in her mouth, her throat doesn't pain her anymore”
  • “I had the worst-in-my-life-episode-of gastric reflux…I sucked a small piece of Noni leather and within 2 minutes my esophagus opened up and the bolus of food that was stuck in my throat was released.”
  • “My husband suffers terrible ostio-arthritis in his knees…It is giving him much needed relief…”
  • “I have a lot of joint pain due to rheumatoid arthritis…my joint pain was all but gone…I cannot wait to see my Dr and have him see my inflammation is down.”
  • “His skin has a lot of Sun damage, (real bad BLACK sun damage Spots). Now the Sun spots are turning WHITE and disappearing.”
  • “If you have diabetes we promise within 3 weeks of taking the leather NOT only did the daily glucose levels drop by a hundred (it was in the 175-225 range) the A1C number dropped to 7.2…My bf has been taking it for the past month twice a day and he has slight case of asthma and now he sleep so much better!”
  • “[M]y CFS & Fibromyalgia inflammation and pain was much less.”
  • “My cholesterol went from 218 to 184 in 6 months.”
  • “I have seen first hand my vision improve…I started using Noni leather right away. The first exam had significant corrective lenses prescribed. Eight months later my vision was re-tested again, but this time the results were significantly better…”
  • “About two weeks of eating a two inch square of fruit leather everyday, the psoriasis began to disappear, and was gone before I finished the entire two ounces.”
  • “[M]y husband was having serious problems with infection in his gums. He was thinking he would have to have all 4 lower front teeth removed when we got back to the mainland. He started putting a strip of the Noni leather between his gums and cheek. Within a few hours the inflammation was down and he was out of pain.”
Your Hawaiian Organic Noni Fruit Leather, Hawaiian Organic Noni Lavender Lotion, Hawaiian Organic Noni BioBandage, and Hawaiian Organic Noni Banana Fruit Leather products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. 
 
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR § 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner. 
 
Your Hawaiian Organic Noni Fruit Leather and Hawaiian Organic Noni Banana Fruit Leather products are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner.  Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, your Hawaiian Organic Noni Fruit Leather and Hawaiian Organic Noni Banana Fruit Leather products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].
 
Further, your above animal products are new drugs under section 201(v) of the Act [ 21 U.S.C. § 321(v)] because they are not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. They are not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the Act [21 U.S.C. §§ 360b, 360ccc, and 360ccc-1]. Therefore, these products are unsafe within the meaning of section 512(a) of the Act, [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)]. The introduction or delivery for introduction into interstate commerce of these adulterated drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].
 
This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products.  It is your responsibility to ensure that your products and product labeling are in compliance with the Act and its implementing regulations. 
 
You should take prompt action to correct all violations associated with your products, including the violations identified in this letter. Failure to do so may result in enforcement action by FDA without further notice, including, without limitation, seizure and injunction.
 
You should respond in writing within 15 working days of receipt of this letter describing the specific steps you have taken to correct the noted violations and to prevent these violations or other similar violations from occurring again.  In your response, you should include documentation, including photographs, corrective actions you have taken to date, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should state the reason for the delay and the time within which you will complete the corrections. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
 
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs.  A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility.  The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
Your written response should be sent to:
 
Sergio Chavez, Director Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
San Francisco District Office
1431 Harbor Bay Parkway
Alameda, CA 94502
                                                                                                                                                                                        
Refer to the Unique Identification Number (CMS #540887) when replying.
 
If you have questions regarding this letter, please contact Rochelle R. Blair, Compliance Officer at rochelle.blair@fda.hhs.gov, or (949) 608-4496. 
 
 
Sincerely,
/S/ 
Darla Bracy, Division Director
Office of Human and Animal Foods
Division 5 West
US Food and Drug Administration

 

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