| Public Health Service Food and Drug Administration |
| San Francisco District 1431 Harbor Bay Parkway Alameda. CA 94502-7070 Telephone: 510/337-6700 |
Department of Health and Human ServicesWARNING LETTER
Via UPS
October 12, 2010
Dr. Rhonda Henry
247 La Costa Ave.
Dayton, NV 89403
Dear Dr. Rhonda Henry:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the internet address www.drhenry.com in July 2010 and has determined that the products, “Pure Heart,” “Melatonin,” “Flaxseed Meal,” “DHEA” and “Cardio Chelate (H-870)” are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)].
The therapeutic claims on your website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of the products with these claims violates the Act.
Examples of some of the claims observed on your website include:
On a webpage at the Dr. Rhonda’s Health Store entitled, “Lose Weight Permanently By Eating”:
Pure Heart
• “[T]here is a completely safe … therapy that can prevent and even reverse heart disease”
• “The results showed a superior clinical improvement in the Pure Heart group including:
o Decrease of LDL cholesterol
o Increase of HDL cholesterol
o Moderate to Dramatic decrease in angina
o Increase in total blood flow through previously occluded vessels
o Improvement in feeling of depression
o Recovery of myocardial function in previous ischemic and necrotic areas
o Reduction in tachycardia upon stress exercise”
• “The ingredients in Pure Heart appear to be capable of partially or completely reducing ischemia.”
• “Pure Heart was created to help prevent the changes in the blood vessels which result in heart disease.”
Melatonin
• “Melatonin boosts the immune system reducing the likelihood and severity of infectious diseases, it is a super antioxidant that protects cells from free radical damage, slows the growth of tumors, regulates blood pressure, wards off heart disease, prevents cancer....helps control Parkinson’s Disease, stops or delays the formation of cataracts….”
Flaxseed Meal
• “The dynamic health benefits [of Flaxseed Meal] include: lowered blood pressure … and anti-cancer benefits.”
DHEA
• “Research has found DHEA to have significant anti-obesity ... anti-cancer effects.”
• [L]ow DHEA levels correlate to increased risk of cancer, heart disease, osteoporosis, obesity, diabetes …”
• “Scientific research has linked increased levels of DHEA with reduced risk of most degenerative diseases ….”
Cardio Chelate (H-870)
• “Oral Chelation Formula Removes Plaque that Clogs and Hardens Arteries.”
• “Ayurvedic Herbs Work on the Cause of Heart Disease.”
• “This balanced herbal formula displays the following properties:
o “Pushkarmul and kut have beta blocking like activity.”
o “Arjuna has antihypertensive calcium channel blocker activity.”
o “Gugul has hypolipidemic and antithrombic properties.”
o “Shankhpushpi, arjuna and jalneem are … antihypertensive.”
o “Kut has antidiabetic properties.”
o “Gugul decreases obesity … ”
• “[B]romelain, an enzyme from pineapple, and Papain … cleanse the arteries.”
• “These enzymes break down fibrin, inhibit clotting and promote normal healing of surface lesions.”
Your website also contains disease claims in the form of personal testimonials. The following are excerpted from a webpage entitled “Dr. Rhonda Henry’s Health Test”:
• “Recently, an excruciatingly painful arthritis flare up in my knees …. Dr. Rhonda heard of my pain, she came in like an angel, bearing a bag of supplements …. Within 24 hours, my condition turned around. The inflammation left, the mobility increased.”
• “8 years ago, I was a very sick person. I had battled colitis, diverticulitis, Epstein-Barr virus and low blood sugar. I spent thousands of dollars on tests and doctor bills trying to find an end to all my health problems. I picked up parasites in the Yucatan Peninsula …. I was down 93 pounds, couldn’t digest food, and was weak
• and dizzy all the time … I now eat and digest my food, lift weights 3 times a week, and have energy to spare.”
The claims quoted above are supplemented by the metatags used to bring consumers to your website through Internet searches. The metatags include “diabetes”, “arthritis”, “depression”, “menopause”, “peri-menopause”, “Candida”, “digestive disorders”, “osteoporosis”, and “infections”.
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)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
The above violations are not meant to be an inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.
You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].
Please notify this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be directed to Juliane K. Jung-Lau, Compliance Officer, U.S. Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding any issues in this letter, please contact Ms. Jung-Lau at 510-337-6793.
Sincerely,
/S/
Barbara J. Cassens
Director
San Francisco District
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