McPhail, Richard – FDA Warning Letter

This FDA Warning Letter (08-ATL-09) addresses the marketing of P.D.Q.! Herbal Skin Cream and Medicardium on www.pdqherbals.com and www.behealed.biz. The FDA determined these products are unapproved new drugs and misbranded.

The products are deemed drugs under section 201(g)(1) of the Act due to claims of preventing, treating, or curing diseases and affecting body structure/function. Examples include P.D.Q.! Herbal Skin Cream's purported ability to affect "abnormal tissue" and aid the immune system against "dangerous lesions" and "skin cancer," and Medicardium's claims of removing heavy metals like mercury, aluminum, and nickel, which are linked to various diseases. Disclaimers on the websites were deemed insufficient to mitigate these claims.

As new drugs (section 201(p)), they require FDA-approved applications (sections 301(d) and 505(a)), which are absent. Furthermore, the products are misbranded under section 502(f)(1) because the conditions they address are not amenable to self-diagnosis and treatment, meaning adequate directions for lay use cannot be provided.

The firm must take prompt corrective action within fifteen working days, including a written response detailing steps taken to correct violations and prevent recurrence. Failure to comply may result in legal action, including seizure and injunction