FDAnews Drug Daily Bulletin

VITAMIN ARCADE GETS WARNING LETTER

April 25, 2006
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The FDA has issued a warning letter to Vitamin Arcade, a New Zealand-based online marketer of health supplements, saying the company's labeling on its Nutramune Plus Nutraferrin (lactoferrin) product qualify it as an unapproved drug under the Federal Food, Drug and Cosmetic Act.

The letter notes that items "intended for [human] use in the diagnosis, cure, mitigation, treatment or prevention of disease are drugs," and that Vitamin Arcade's web site "claims that your product is useful in the prevention and treatment" of avian flu, other forms of influenza and influenza-related pneumonia.

Nutramune Plus "is not generally recognized as safe and effective when used as labeled," which also makes it a drug that cannot be marketed in the U.S. without an approved new drug application (NDA), the FDA said.