Inspections, Compliance, Enforcement, and Criminal Investigations
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REQUESTED
June 2, 2008
2852 Sawtelle Blvd, Suite 33
Los Angeles, CA 90064
Dear Sir or Madam:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address www.dherbs.com and has determined that the products "Astragulus-Goldenseal-Echinacea (extract)," "Full Body Detox Kit," "Prostate Formula," "Oxy-Drops," "Parasite and Worm Kit & Regimen," "Bio Insulin," and "Female Breast Oil" 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:
•"This combination of Astragulus . . . Goldenseal root . . . and Echinacea root . . . is a great antiviral, antibacterial, antibiotic, antifungal, and antimicrobial formula. It is also good for . . . all skin diseases and disorders (eczema, psoriasis, etc.), . . . treating childhood cancers, cleaning (sic] respiratory diseases, remedying childhood diseases, and so-called colds and flu."
Full Body Detox Kit
• WHAT DOES THE FULL BODY DETOX CONSIST OF?
Consists of seven (7) potent, safe, and effective herbal formulas. (1) Blood and Lymphatic . . . Great for all skin disorders which in fact are blood disorders (e.g., eczema, psoriasis, herpes, dermatitis, etc.). Very beneficial for anemia, especially sickle cell anemia. . . (2) Cardiovascular . . . Helps correct irregular heart beat, angina, high and low blood pressure, congestive heart failure and other maladies of the heart. . . .(3) Liver and Gallbladder . . . Great for all liver maladies including hepatitis, jaundice, cirrhosis, and cancer of the liver. . . .(4) Lungs & Respiratory . . . Great for all respiratory ailments including asthma, bronchitis, pneumonia, and whooping cough . . . .(5) Kidneys and Bladder . . . helps to prevent or heal kidney disease . . . ."
• "No matter what disease or so-called incurable disease you may be presently afflicted with diabetes, genital herpes, AIDS, bronchitis or asthma, cancer, obesity, fibroid tumors, multiple sclerosis, Parkinson's, Alzheimer's, impotence, infertility, STDS . . . the Full Body Detox will start the healing and eradicating process."
• "This natural supplement will greatly help in the treament [sic] all -prostatic conditions, such as prostatitis, prostate cancer, BPH (benign prostatic hyperplasia), etc."
• "Oxy-drops is . . . great for . . . preventing cancer, healing herpes viruses, combating so-called AIDS, and healing sickle cell anemia."
Parasite and Worm Kit & Regimen
• "Parasites and worms may be found anywhere in the body from head to toe and theymay be -the unknown and/or hidden cause of many degenerative diseases including . . . Meningitis . . . Cancer, A.i.d.s. [sic] . . . Genital Herpes, Chlamydia, Gonorrhea, Syphilis and a host of other degenerative diseases and pathologies. Even malaria is a parasite and worm infestation condition. And yes, parasites and wormsare also involved in every case of cancer and so-called A.I.D.S."
"[T]he Parasite and Worms kit and regimen has a major focus and emphasis of removing (killing and expelling) parasite and worms from the tissues of the glands and organs of thebody."
• "Dherbs Bio-insulin . . . is 100% safe, sane, and effective and is the perfect and natural alternative to harmful pharmaceutical-grade insulin commonly prescribed bydoctors to individuals with diabetes . . .
• "Bio-insulin is ideal in addressing and healing from all pancreas disorders and problems such as pancreatitis, hyperglycemia, hypoglycemia, and cancer of the pancreas."
Female Breast Oil
• "A first of its kind all-natural breast massage formula . . . helps to prevent degenerative diseases of the breasts such as fibrocystic breast disease, breast tumors and cysts; disease, and breast cancer."
Your website also contains disease claims in the form of personal testimonials, including:
• "The herpes is gone and I can feel it!"
• "[T]he detox kit I gave my friend knocked out his hepatitis in 3-weeks."
The claims quoted above are supplemented by the metatags used to bring consumers to your website through Internet searches. Examples of the metatags include "how to prevent breast cancer" and "insulin alternative."
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. Your products "Astragulus-Goldenseal-Echinacea (extract)," "Full Body Detox Kit," "Prostate Formula," "Oxy-Drops," "Parasite and Worm Kit & Regimen," "Bio Insulin," and "Female Breast Oil" are also misbranded within the meaning of section 502(f)(1) of the Act, in that labeling for these drugs fail to bear adequate directions for use [21 U.S.C. § 352(f)(I)].
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. While reviewing your website, we noticed that you were promoting other products for disease treatment and/or prevention. The unlawful disease treatment and prevention claims on your website were too numerous to list in this letter. 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 written reply should be sent to:
Director, Compliance Branch
Food and Drug Administration
Irvine, CA 92612-2506
If you have any questions regarding this letter, please contact MaryLynn Datoc, Compliance Officer, at 949-608-4428.
Alonza E. Cruse
Los Angeles District
Cc: Jeff Farrar, DVM, PhD, MPH
Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue - MS 7602
P.O. Box 997413
Sacramento, CA 95899-7413