June 6th, 2013

According to a warning letter from the FDA, the Danish company, SmartPractice, promoted an allergic contact dermatitis test kit called T.R.U.E. Test® without adequate potential risk information, including that the product could cause burning, irritation, and acute allergic reactions.

The FDA has requested that SmartPractice stop using its misleading promotional materials immediately, and submit a plan to “disseminate truthful, non-misleading, and complete corrective messages” about the product.

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