A Hawaiian fruit leather manufacturer is on notice from the FDA after inspectors determined the claims on the company’s product labels, product brochures and website established that its products are drugs.

The Food and Drug Administration reported the drug designation is accurate for the products “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.” Introducing or delivering these products for introduction into interstate commerce for such uses violates the Federal Food, Drug and Cosmetic Act (the Act).

Staff from FDA inspected the Anahola, HI, location of Hawaiian Organic Noni LLC from Aug. 15-21, 2017, according to a July 18, 2018, warning letter made public by the FDA in recent days. The FDA also reviewed the firm’s website in May and July this year.

“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,” according to the warning letter sent to company owner Steven H. Frailey.

Specifically, FDA’s Division 5 West Director Darla Bracy’s letter, noted the following observations:

• “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.”

Because of this, the FDA said it is impossible to write adequate directions for a layperson to use the 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.”
• “The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act.”

The firm made the following claims on product labeling, as well as their website, for their ‘Hawaiian Organic Noni Fruit Leather’, which provides evidence that their products are intended for use as drugs in humans:

• “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”

The firm made the following claims on product labeling, as well as their website, for their ‘Hawaiian Organic Noni Banana Fruit Leather’, which provides evidence that their products are intended for use as drugs in humans:

• “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 products are misbranded, as they fail to bear adequate directions for their intended uses, according to FDA.

“’Adequate directions for use’ means directions under which a layperson can use a drug safely and for the purposes for which it is intended,” however, prescription drugs can only be used safely at the direction, and under the supervision, of a licensed practitioner, according to federal law.

The firm’s products above are also “not generally recognized as safe and effective for the above referenced uses”, therefore, “the products are ‘new drugs;’” The FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

The FDA reminded the firm that the warning letter is not intended to be an “all-inclusive list of violations” at their 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.”

Food companies are given 15 working days to respond to FDA warning letters.

“You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by FDA without further notice, including, without limitation, seizure and injunction,” according to the warning letter.

--------------------------------------------------------------------------------------------------------------------------------------------

Editors Note:

To apply for becoming a contributor of EN-SJGLE.com,

welcome to send your CV and sample works to us,

Email: Julia.Zhang@ubmsinoexpo.com.