Pharmacist's Ultimate Health Corp. – FDA Warning Letter, Aug 31, 2011

This FDA Warning Letter, dated August 2011, addresses Pharmacist's Ultimate Health Corp. regarding their Estrogen Cream, Progesterone Cream, and Allergy Relief products. The FDA reviewed the company's websites, http://www.puhcorp.com and http://doc-nt.com, and determined that the products are promoted for conditions that classify them as drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act).

The therapeutic claims on the websites, such as "Increase low estrogen levels, Helps relieve menopause symptoms," "Help Relieve Symptoms of PMS, Help Protect Against Osteoporosis," and "effective natural treatment for seasonal allergy symptoms," establish the products' drug intent. The Estrogen Cream and Progesterone Cream are further cited under 21 CFR 310.53(b) as unapproved OTC topical hormone-containing products.

These products are considered "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective for their promoted uses. Introducing unapproved new drugs into interstate commerce violates sections 301(d) and 505(a) of the Act.

The letter requires prompt corrective action within 15 working days, including written notification of specific steps taken and documentation. Failure to comply may result in regulatory actions like seizure or injunction.