FDA Warns Nutraceutical Firm
About Claims on Website
A nutraceutical
maker has been issued a warning letter from the FDA
for making therapeutic claims about a product that has
not been approved by the agency as a new drug.
 Washington
state-based nutraceutical firm Flora was cited for marketing
Pure Hawaiian Noni Juice on its website as a therapy
for high blood pressure, arthritis and diabetes.
Because the
company claims the product could be used to cure, mitigate,
treat, or prevent these conditions, the FDA has ruled
that the product is an unapproved new drug, according
to the warning letter.
The agency added the Pure Hawaiian
Noni Juice was misbranded because the labeling for the
drug did not carry adequate directions for use and therefore
could not be introduced into interstate commerce.
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