FDA Warning Letters 34028

FDA Warning Letters

WASHINGTON--In May, two supplement companies received warningletters from the Food and Drug Administration (FDA) regarding labeled claims.North Hampton, N.H.-based Vision Group was sent a May 16 letter reporting itsproduct, Precision Vision, cannot make claims such as "Eye health researchhas shown evidence of reduced risks and slowed progression degenerative eyedisease by maintaining high levels of antioxidants and minerals." FDA alsopointed out labeling problems, including not declaring daily values or statingthe name and place of business of the manufacturer, packer or distributor on thelabel.

On May 29, The Sportsman's Guide (www.sportsmansguide.com)in St. Paul, Minn., was sent a letter stating its potassium iodate tablets wereinappropriately marketed as "anti-radiation" pills. This labelingmakes the supplement fall under "new drug" territory, and FDA askedthe company to stop making such claims.