| Public Health Service Food and Drug Administration |
| Minneapolis District Office Central Region 250 Marquette Avenue, Suite 600 Minneapolis, MN 55401 Telephone: (612) 334-4100 FAX: (612) 334-4142 |
Department of Health and Human ServicesAugust 22, 2011
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 11 - 48
Stephen J. Poindexter
President, Senior Executive VP, Secretary & Treasurer
Pharmacist’s Ultimate Health Corp.
200 South Owasso Boulevard
St. Paul, Minnesota 55117
Dear Mr. Poindexter:
This letter is to advise you that in August 2011 the Food and Drug Administration (FDA) reviewed your websites at the internet addresses http://www.puhcorp.com and http://doc-nt.com and determined that your Estrogen Cream, Progesterone Cream, and Allergy Relief products are promoted for conditions that cause the products to be drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(g)(1). The therapeutic claims on your websites establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with claims violates the Act. You can find the Act and implementing regulations through links on the FDA’s home page at www.fda.gov.
Examples of some of the claims on your websites include:
Topical Drugs:
www.puhcorp.com
Doctor’s Natural Therapy Natural Estrogen (Estriol) Cream (3 oz. pump)
• “Increase low estrogen levels, Helps relieve menopause symptoms, Balance Estrogen Dominance”
Doctor’s Natural Therapy Natural Progesterone Cream (3 oz. pump)
• “Help Relieve Symptoms of PMS, Help Protect Against Osteoporosis”
Doctor’s Natural Therapy Natural Progesterone Cream (3 oz. pump)
• “A natural option for women seeking alternatives to conventional hormone replacement therapies”
• “Helps restore hormone balance in women and men”
• “Can also help reduce the risk of osteoporosis”
• “Helps relieve symptoms of PMS including cramps, mood swings, hormone-related headaches, and weight gain”
Furthermore, based on the labeling claims noted above, your Natural USP Estrogen Cream and Natural USP Progesterone Cream products are subject to the final rule for over-the-counter (OTC) topical hormone-containing products labeled or promoted for use as drugs under Title 21, Code of Federal Regulations (21 CFR), 310.53(b). This rule states that any OTC drug product, other than hydrocortisone, that is labeled, represented or promoted as a topically applied hormone-containing product for drug use is regarded as a new drug. Your products fall within this rule because their labeling describes them as containing a hormone ingredient and promotes them as topical hormone-containing products for drug use, as discussed above.
Drugs:
Pharmacist’s Ultimate Health Allergy Relief Complex (60 count tablets per bottle)
• “Bromelain [an ingredient in your product] is an effective natural treatment for seasonal allergy symptoms”
• “anti-inflammatory agents”
Doctor’s Natural Therapy Allergy Relief (60 count tablets per bottle)
• “antihistamine-like properties”
• “synergistic allergy relief properties”
Your web site www.puhcorp.com also contains an article entitled “Allergy Support” which includes therapeutic claims about your Allergy Relief Complex product. Examples include:
• “The Pharmacist's Ultimate Health Allergy Relief Complex contains a combination of . . . nutrients that work together synergistically for allergy relief.”
• “Bioflavonoid compounds [ingredients in your product] . . . have natural anti-inflammatory effects.”
Your products are not generally recognized as safe and effective for the above referenced uses and therefore, the products are “new drugs” under section 201(p) of the Act, 21 U.S.C. § 321(p). Under sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. The introduction into interstate commerce of unapproved new drugs without approved applications violates these provisions of the Act.
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that all of your products are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct the violations described above. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
Please notify FDA in writing, within 15 working days of the receipt of this letter, of the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be directed to Jane E. Nelson, Compliance Officer, at the address on the letterhead. If you have any questions regarding compliance with the laws and regulations enforced by FDA, please contact Ms. Nelson at (612) 758-7119.
Sincerely,
/s/
Gerald J. Berg
Director
Minneapolis District
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