FDA Warns Pharmacist's Ultimate Health for Hormone Health Claims
Examples of some of the claims on the following websites:
Topical medications: Natural Therapy Doctor PuhCorp.com natural estrogen (estriol) Cream (. 3 oz pump) "Increase low estrogen levels, helps relieve symptoms of menopause, estrogen dominance Balance" Doctor Natural Progesterone Cream Natural Therapy (3 oz pump.) "Help relieve symptoms of PMS, help protect against osteoporosis" Doc-nt.com Doctor Naturopathy natural progesterone cream (3 ozpump) "A natural option for women seeking alternatives to conventional therapy hormone replacement" "Helps restore hormonal balance in women and men" "may also help reduce the risk of osteoporosis" " Helps relieve symptoms of PMS, including cramps, mood swings, hormones related headaches and weight gain "In addition, the FDA warned that the cream USP natural estrogen and natural progesterone USP cream products are subject to the final rule for over-the-counter (OTC) hormone-containing topical products labeled or promoted for use as drugs under Title 21, Code of Federal Regulations (21 CFR), 310.53 (b) because their label describes them as containing an ingredient of hormone and promotes as topical products that contain hormones to drug use. By the CFR, while nonprescription drug, other than hydrocortisone, which is labeled, represented or promoted as a topical application of products containing hormones to drug use is considered a new drug. FDA provided the following examples from PuhCorp.com:
Pharmacist Ultimate Health Allergy Relief Complex (60 tablets per bottle count) "bromelain [an ingredient in your product] is an effective natural treatment for seasonal allergy symptoms" "anti-inflammatory agents"And from, Doc-nt.com, the FDA found the drug claims:
Dr. relief natural allergy therapy (60 tablets per bottle count) "antihistamine-like properties" "synergistic properties allergy relief"The FDA also called for a PuhCorp.com article, entitled "Support allergy" includes therapeutic claims on the product's ultimate pharmacist Health Corp Allergy Relief complex.Examples:
"Pharmacists Ultimate Health Allergy Relief Complex contains a combination of... Nutrients that work together synergistically to relieve allergies." "Bioflavonoid compounds [ingredients in your product] ... have natural anti-inflammatory effects."Pharmacist Ultimate Health Products Corp. is not GRAS (generally recognized as safe) and effective for use in the claims, and therefore the products are "new drugs" under section 201 (p) of the Act, 21 USC § 321 (p).The FDA gave the company 15 working days of receipt of the letter to outline the specific steps it has taken to correct violations and to ensure that similar violations do not occur.
▷▷▷▷▷ Natural Estrogen/Estriol Cream (Bioidentical) 2 Oz. 150 ...
(Visit the Hot New Releases in Feminine Hygiene list for authoritative information on this product's current rank.) Review & Description
Do not let other competitors trick you into buying over priced creams that are ineffective. We sell the strongest Estriol Cream on the market- lasting the longest and made with the best ingredients. Do not be confused by other merchants and tricked to believe you need to pay $49.95. They are robbing you. We sell our Natural Estriol Cream for a fair price of $19.95. Natural estriol USP is a low potency estrogen deemed the Safest Estrogen. Not to be confused with Phyto-Estrogens: foreign estrogen functioning as the female sex hormone. We offer a natural estrogen (estriol) that mimics the type made by the human body. Research suggests, estriol is safer in hormone replacement therapy than traditional synthetic and animal derived versions such as CEE and MPA. Studies also show that when applied topically, it does not increase the risk of hormone dependent cancer as discussed with phyto-estrogens. However, the low potency of this natural estrogen is enough to reap huge benefits involving symptoms of menopause. New research shows another great advantage of topical estriol USP. Post-pregnancy women with scars/stretch marks can now find relief using this product: We offer a 2oz product with 150mg (.25%) of natural estriol USP. Suggested use: *Vaginal Dryness Initial use: Apply 1 serving of Estriol USP to the vagina daily for 7 -10 days(10 for extreme cases of atrophy). Maintenance: Apply 2-3 times per week *Stretch marks/Scars: Apply 1 serving (1/4 teaspoon) directly to problem area daily.
Natural Estriol Cream - Bookshelf
Natural Progesterone Cream
I recommend use of natural progesterone cream along with the estriol cream. In four months, if all is going well, consider weaning from the estriol but ...Women's Encyclopedia of Natural Medicine, Alternative Therapies and Integrative Medicine for Total Health and Wellness
I often prescribe estriol vaginal cream or suppositories for dry or itchy ... Estriol cream is equal to the estradiol ring in decreasing vaginal dryness, ...The Natural Superwoman, The Scientifically Backed Program for Feeling Great, Looking Younger, and Enjoying Amazing Energy at Any Age
Special uses for estriol cream or gel. On page 96, I discuss the unique benefits of supplementing estriol (E3), the “little” estrogen that can do so much. ...No more horse estrogen, natural progesterone for women : a safe, natural and effective means of helping women with PMS, menstrual dysfunction, menopause, and aging
Natural progesterone and an intravaginal estriol cream can be helpful here along with the usual better diet, supplements and hormone balancing. ...Finally-- the truth about women's health care, how and why women are lied to by the medical establishment
After using these natural approaches for three to six months, if you still have vaginal dryness and hot flashes, you may want to try using estriol cream. ...Casual Guide Directory
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According to most experts, Estriol is considered the most effective and safest estrogen. ... Directions: Each 1/4 teaspoon cream provides 1 milligram Natural Estriol USP. ...
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