Warning Letters

Warning Letters

The Food and Drug Administration (FDA) routinely sends out warning letters tocompanies that violate various regulations enforced by the agency. Unlikecourtesy letters, warning letters require the offending company to takeimmediate action to correct the listed violations or face additional FDAenforcement, including product seizure, injunctions and criminal prosecution.The following recent warning letters are presented to provide the industry withexamples of FDAs activity in the dietary supplement market:

Health Authority LLC/Doctors Trust Vitamins. At www.doctorstrust.com,labeling claims involving protection from flu and avian flu render the companysISD-10 Immune System Defense product an unapproved drug.

RxIBR Corp. The companys two Web sites, www.healtharising.com andwww.healtharisingpro.com, feature drug claims for numerous supplement products,including N-reX, Diab-eX, MD-eX, V- reX, Aller-X, N-reX II Professional Series,Add-eX II Professional, and CuNeXuS II Professional, which are touted astreatments for various diseases, such as Alzheimers, influenza, herpes andADD.

David Price. On his companys Web site, www.vitamin-and.com, claims forvarious supplements cause the products to be an unapproved new drugs, includingHealth Formula sGH-Xtra, which the claim said could reverse human biologicalaging by addressing infectious disease, Alzheimers and Parkinsons.

Wellness Resources Inc. A physical inspection of the firms Edina,Minn., location and a review of its Web site (www.wellnessresources.com) foundnumerous labeling violations. Its iron supplement failed to contain a requiredlabeling statement concerning accidental overdose in children; a psyllium huskproduct using a qualified health claim failed to also include a requiredstatement advising of the need for increased fluid intake; and labels forvarious supplement products used drug claims for pain and arthritis.