FDA WARNING_LETTER - Drucker Labs LP - July 13, 2012

An FDA inspection of Drucker Labs L.P. from June 19 to July 13, 2012, and a subsequent website review in December 2013, revealed significant violations. The firm's intraMAX, intraMIN, and intraKID products, marketed as dietary supplements, are promoted on its website with therapeutic claims for conditions such as acne, arthritis, diabetes, fibromyalgia, depression, cancer, ADD/ADHD, autism, and allergies. These claims cause the products to be classified as unapproved new drugs under sections 201(g)(1)(B) and 201(p) of the Act, as they are not generally recognized as safe and effective for their intended uses. Introducing these unapproved new drugs into interstate commerce violates section 301(d) of the Act. Furthermore, intraMAX and intraMIN are misbranded under section 502(f)(1) because adequate directions for use cannot be provided for laypersons for conditions not amenable to self-diagnosis, violating section 301(a). The inspection also identified serious Current Good Manufacturing Practice (CGMP) violations for dietary supplements (21 CFR Part 111), specifically the failure to establish and follow written procedures for quality control operations (21 CFR 111.103, 111.140(b)(1)) and the failure to prepare and follow written master manufacturing records (21 CFR 111.205(a)). While the firm's responses to the FDA 483 regarding CGMP violations appear adequate, their sufficiency will be verified during a future inspection. Drucker Labs must promptly correct all cited violations and respond in writing within 15 working days, detailing corrective actions and providing supporting documentation, to avoid potential enforcement actions like product seizure or injunction.