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FDA warns about non-GRAS cold products

This article was originally published in The Tan Sheet

Executive Summary

Boca Pharmacal markets OTCs containing prescription ingredients, making them products not generally recognized as safe and effective for use. In in a July 22 warning letter to the Coral Spring, Fla-based firm, FDA says the labels of the products - Pseudo DM GG Syrup and C-Phen DM Drops - suggest they diagnose, cure, mitigate, treat or prevent disease, although the drugs do not have approved applications. The agency adds the drugs are mislabeled for consumer use because the Rx ingredients are indicated for conditions that are not "amenable to self-diagnosis and treatment of individuals who are not medical practitioners." Boca, which contracted another firm to manufacture the products, has 15 days from receipt of the warning to notify FDA of its work to correct the violations and prevent a recurrence. The warning letter posted Sept. 20 on FDA's website does not identify the contract manufacturer

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