FDA WARNING_LETTER - SmartPractice Denmark ApS

On May 3, 2013, the FDA's Center for Biologics Evaluation and Research (CBER) issued a Warning Letter to SmartPractice Denmark AS regarding promotional materials for T.R.U.E. TEST, an epicutaneous patch test for allergic contact dermatitis. The FDA reviewed materials submitted on January 17, 2013, in response to a November 29, 2012, information request.

The letter identified several violations: 1. **False or Misleading Promotional Materials/Omission of Risk Information:** Most promotional materials (excluding the final reference manual 78314 and sales aid 78199-A) were deemed false or misleading because they omitted crucial risk information, including contraindications (e.g., severe allergic reactions, injured skin) and warnings/precautions (e.g., acute allergic reactions, sensitization, extreme positive reactions, excited skin syndrome, tape reactions, irritant contact dermatitis), and common adverse reactions (e.g., burning, tape irritation, persistent reactions, erythema, hyper/hypo pigmentation). This misbrands T.R.U.E. TEST under Sections 502(a) and 201(n) of the Federal Food, Drug, and Cosmetic Act (the Act). 2. **Lack of Adequate Directions for Use:** All referenced promotional materials appeared to be disseminated without the FDA-