FDA WARNING_LETTER - rhg & company, inc., - June 26, 2008

An FDA inspection of RHG & Company, Inc., dba Vital Nutrients, in April and June 2008, revealed the firm manufactures and distributes products marketed as dietary supplements, specifically DMSA, Co-enzyme Q10, and Glucosamine. The Warning Letter addresses the firm's marketing of these products on its website with claims indicating intended use for disease diagnosis, cure, mitigation, treatment, or prevention, or to affect body structure/function. DMSA is deemed an unapproved new drug under sections 201(g)(1) and 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act), violating sections 301(d) and 505(a). It is also excluded from the dietary supplement definition per section 201(ff)(3)(B) and misbranded under section 502(f)(1) due to inadequate directions. Similarly, Co-enzyme Q10 and Glucosamine are classified as unapproved new drugs under sections 201(g)(1) and 201(p) due to disease claims, violating sections 301(d) and 505(a), and are misbranded under section 502(f)(1) for lacking adequate directions. The firm must take prompt corrective action and notify the FDA in writing within fifteen working days, detailing steps taken to prevent recurrence. Failure to comply may result in legal action, including seizure and injunction, and impact federal contracts.