FDA WARNING_LETTER - B & A Health Products Inc

The FDA issued a Warning Letter to B&A Health Products Inc. regarding their OTC liquid drug product, Pancold A. The product is deemed an unapproved new drug under sections 201(g)(1)(B), 201(g)(1)(C), and 201(p) of the Act (21 U.S.C. §§ 321(g)(1)(B), 321(g)(1)(C), 321(p)).

Pancold A is intended as a pain reliever-fever reducer, antihistamine, sputum suppressant, sneeze suppressant, and nasal decongestant. However, it does not comply with the final monograph for Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for OTC use (21 CFR Part 341). Specifically, it contains unapproved active ingredients like anhydrous caffeine and di-methylephedrine hydrochloride, and unapproved indications such as "sputum suppressant" and "sneeze suppressant."

The marketing of Pancold A without an FDA-approved application violates section 505(a) of the Act (21 U.S.C. § 355(a)). Additionally, the product is misbranded under section 502(c) of the Act (21 U.S.C. § 352(c)) because its