Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda. CA 94502-7070
Telephone: 510/337-6700

WARNING 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

Melatonin

Flaxs4eed Meal

DHEA

Cardio Chelate (H-870)

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

This page was posted on October 16, 2010.

Links to Recommended Companies