Department of Health and Human Services
Public Health Service
5100 Paint Branch Pkwy
August 12, 2002
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED
Marijah McCain, ND
CEO & President,
Herbal Healer Academy, Inc
127 McCain Dr
Mt View, AR 72560
Ref. No. CL-02-HFS-810-33
Dear Sir or Madam:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address: http://www.herbalhealer.com and has determined that the products "Citricidal™," "5-HTP Capsules," "MYOMIN," "STOPSMO," "SHARK CARTILAGE," "ASPARAGUS EXTRACT," "COQ10," "MSM SULPHUR," "INTESTINAL FREEDOM," "HHA GLUCOSAMINE/CHONDROITIN," "ST. JOHN'S WORT," and "HHA NATURAL RELIEF" being offered are 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 USC 321(g)(1)]. 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 continued marketing of these products with these claims violates the Act and may subject you or the products to regulatory action without further notice.
Examples of some of the claims observed on your website include all claims located on the "Top Selling Products" page of your website:
HHA GRAPEFRUIT SEED EXTRACT CONCENTRATE — Citricidal™:
"Very Powerful Antimicrobial Concentrate!" "Marijah McCain ND recommends this for any life threatening ailment such as cancer, MS, etc. Also for chronic candida infections."
HHA GRAPEFRUIT SEED EXTRACT CONCENTRATE — Citricidal™: "Proven effective in helping the following: Candida albicans, Staphylococcus aureus, Staphylococcus sp., Streptococcus faecalis, Salmonella cholerasuis, Escherichia coli, Gingivitis, Plaque bacteria, Proteus vulgaria, Psuedomonas aeruginosa, Lactobacillus pentoaceticus, Klebsiellus pneumonia, Aspergillus niger, Aspergillus oryzae, Aspergillus parasiticus, Aspergillus terreus, Aspergillus flavus, Fusarium oxysaorum, Fusarium oxy., F.sp tuberosi, Fusarium sambucinum, Penicillium sp., Pullularia pullulans, Trichophyton interoigital, Entamoeba histolyica, Giardia lamblia, Herpes simplex Virus Type 1, Influenza virus-A2, Legionella pneumaphilia … Montezuma's revenge…"
5-HTP: "5-HTP may be effective when used as a supplement to help ailments such as irritable depression. … It can be used for depressive obesity, in helping with alcohol addition and SAD (Seasonal Affective Disorder)."
MYOMIN: "The MYOMIN is a specific dietary formula supplementation to be used with fibroid tumors, endometriosis, breast and thyroid cysts, liver cysts, kidneys cysts, etc."
STOPSMO: "How it works is that you paint a small thin line of the herbal extract, using the applicator, on your cigarette and smoke it. If you are determined to quit, give this Chinese formula a try."
SHARK CARTILAGE: "It has been shown to be effective in inhibiting tumor growth and cancer. It is helpful in the treatment of arthritic conditions, macular degeneration, psoriasis and is used where cartilage support is needed."
"ASPARAGUS EXTRACT: 'Anti-Cancer/High Blood Pressure Supplement'"
COQ10: "It is very important for anyone with a heart condition, high cholesterol or artery blockage to be on COQ10. Anyone who is taking chemotherapy should take this enzyme … It … helps normalize high blood pressure, controls and sometimes reverses periodontal disease…"
MSM SULPHUR: "Outstanding supplement for skin disorders, allergies, infections and more." "I have had 'fibromyalgia' and for six years I suffered with this horrible, painful problem. After taking the MSM religiously for one month, I started feeling better!! One morning I just woke up feeling NO PAIN."
"INTESTINAL FREEDOM: "Anti-parasitic formula: a clinically tested parasite and worm formula."
HHA GLUCOSAMINE/CHONDROITIN: "This is our leading supplement for arthritis."
ST. JOHN'S WORT: "A safe & Effective Antidepressant Alternative"
HHA NATURAL RELIEF: "Because of 'authority restrictions' we can not say that it will reduce pain, reduce inflammation, relieve headaches, or does what traditional aspirin will … it is a natural solution to over the counter chemicalized drugs that the FDA has approved to treat headaches, fevers, etc. … This product is sold as a dietary supplement, but in our opinion it will be the leading challenger to conventional day to day OTC drugs."
Furthermore, FDA has no information that your products are generally recognized as safe and effective for the above referenced conditions and therefore, the products may also be "new drugs" under section 201(p) of the Act [21 USC 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 USC 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.
FDA is aware that Internet distributors may not know that the products they offer are regulated as drugs or that these drugs are not in compliance with the law. Many of these products may be legally marketed as dietary supplements or as cosmetics if therapeutic claims are removed from the promotional materials and the products otherwise comply with all applicable provisions of the Act and FDA regulations.
Under the Act, as amended by the Dietary Supplement Health and Education Act (DSHEA), dietary supplements may be legally marketed with truthful and non-misleading claims to affect the structure or function of the body (structure/function claims), if certain conditions are met. However, claims that dietary supplements are intended to prevent, diagnose, mitigate, treat, or cure disease (disease claims), excepting health claims authorized for use by FDA, cause the products to be drugs. The intended use of a product may be established through product labels and labeling, catalogs, brochures, audio and videotapes, Internet sites, or other circumstances surrounding the distribution of the product. FDA has published a final rule intended to clarify the distinction between structure/function claims and disease claims. This document is available on the Internet at http://vm.cfsan.fda.gov/~lrd/fr000106.html (codified at 21 CFR 101.93(g)).
In addition, only products that are intended for ingestion may be lawfully marketed as dietary supplements. Topical products and products intended to enter into the body directly through the skin or mucosal tissues, such as transdermal or sublingual products, are not dietary supplements. For these products, both disease and structure/function claims may cause them to be new drugs.
Certain over-the-counter drugs are not new drugs and may be legally marketed without prior approval from FDA. Additional information is available in Title 21 of the Code of Federal Regulations (21 CFR) Parts 310 and 330-358, which contain FDA's regulations on over-the-counter drugs.
This letter is not intended to be an all-inclusive review of your website and products your firm may market. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act and its implementing regulations.
If you need additional information or have questions concerning any products distributed through your website, please contact FDA. You may reach FDA electronically (e-mail) at APope@CFSAN.FDA.GOV, or you may respond in writing to Angela F. Pope, Compliance Officer, Food and Drug Administration, Division of Compliance and Enforcement, 5100 Paint Branch Pkwy, College Park, MD 20740-3835. If you have any questions concerning any issue in this letter, please contact Ms Pope at 301-436-2375.
John B. Foret
Division of Compliance and Enforcement
Office of Nutritional Products, Labeling and Dietary Supplements
Center for Food Safety and Applied Nutrition
This page was posted on May 4, 2006.