Courtesy of Florence Klein

The U.S. Food and Drug Administration issues warning for dietary supplement promoted as drug in treatment of Alzheimer's Disease. The FDA sent a warning letter to PruTect Rx of Highlands Ranch, Colorado over the promotion of their NeuroPruTect product as a drug for the treatment of Alzheimer's and cognitive decline.

Under the Federal Food, Drug, and Cosmetic Act (FFDCA), a product is a drug if it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. The product NeuroPruTect has not been tested as or approved for use as a drug so the FDA issued the warning to protect citizens.

“The FDA has taken these actions because companies may not sell new drugs unless the drugs have been tested by the sponsor and approved by FDA, and they may not make false or unsubstantiated claims about drugs they sell,” said Dara A. Corrigan, the FDA's associate commissioner for regulatory affairs. “Products with unapproved claims are dangerous because they may cause consumers to delay or avoid legitimate treatments.”

A dietary supplement on the other hand is a product taken by mouth intended to supplement the diet. Supplements may contain one or more "dietary ingredients." "Dietary ingredients" in a supplement may include: vitamins, minerals, herbs or other botanicals, amino acids or other substances found in the human diet, such as enzymes.

The FDA has not approved NeuroPruTect for treatment of any neurological disorders and it has not been shown to be safe or effective for this purpose. The FDA urges consumers to contact a physician or health care provider if they believe they have suffered any problems that may be related to taking or using this product.

Problems experienced with the use of products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Online: www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at www.fda.gov/MedWatch/getforms.htm. (Mail to address on the pre-addressed form.)
• Fax: 1-800-FDA-0178

Stay Safe, Florence