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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:
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
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:
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:
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.
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