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FDA Warns Pharmacists Ultimate Health for Hormone Health Claims
September 12, 2011
3 Min Read
MINNEAPOLISFDA warned Pharmacists Ultimate Health Corp. that marketing for its Estrogen Cream, Progesterone Cream and Allergy Relief products step into the realm of drug claims. In an Aug. 22 warning letter to Stephen J. Poindexter, president, senior executive vice president, secretary and treasurer, Pharmacists Ultimate Health Corp., St. Paul, MN, FDA said it reviewed the companys two websites PuhCorp.com and Doc-nt.com, and found products were 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) because they are intended for use in the cure, mitigation, treatment or prevention of disease.
Examples of some of the claims on the websites include:
Topical Drugs:
PuhCorp.com
Doctors Natural Therapy Natural Estrogen (Estriol) Cream (3 oz. pump)
Increase low estrogen levels, Helps relieve menopause symptoms, Balance Estrogen Dominance"
Doctors Natural Therapy Natural Progesterone Cream (3 oz. pump)
Help Relieve Symptoms of PMS, Help Protect Against Osteoporosis"
Doc-nt.com
Doctors 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"
Further, FDA warned that the 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) because their labeling describes them as containing a hormone ingredient and promotes them as topical hormone-containing products for drug use. Per the CFR, 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. FDA provided the following examples from PuhCorp.com:
Pharmacists 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"
And from, Doc-nt.com, FDA found these drug claims:
Doctors Natural Therapy Allergy Relief (60 count tablets per bottle)
antihistamine-like properties"
synergistic allergy relief properties"
FDA also called out an article on PuhCorp.com, titled Allergy Support" that includes therapeutic claims about Pharmacist's Ultimate Health Corp.s 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."
Pharmacist's Ultimate Health Corp.s products are not GRAS (generally recognized as safe) and effective for the uses in the claims, and therefore, the products are new drugs" under section 201(p) of the Act, 21 U.S.C. § 321(p). FDA gave the company 15 working days of the receipt of the letter to outline the specific steps it has taken to correct the violations and to ensure that similar violations do not occur.
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