|
Public Health Service Food and Drug Administration |
| 5100 Paint Branch Pkwy College Park, MD 20740-3835 |
February 4, 2003
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED
Ms. Sheryl Reagan
Back to Nature Herbs and Vitamins
PO Box 422
Tonopah, NV 89049
Ref. No.
CL-02-HFS-810-44
Dear
Ms Reagan:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at the Internet address: http://www.back-to-nature-herbs.com and has determined that the products “Cetyl Myristoleate”, “Cholesterol Health”, “Vinpocetine from LifeLink”, “Vimaca”, “Natural Radiance Plus”, “Zanthroplex”, “High Desert Aller-Bee-Gone”, and “Herp-Eeze” 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 web site 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 web site include:
Cetyl Myristoleate
“Many sufferers from arthritis are raving about it.”
Cholesterol Health
“The formula is especially pertinent for those individuals with a family history or a significant risk profile for cardiovascular disease and stoke [sic].”
Vinpocetine from LifeLink
“It has become popular as a memory enhancer and cognitive aid and is used to treat a variety of neurological disorders, including:
- cerebrovascular disorders — low cerebral blood flow, headache, hypoxia, cerebral atherosclerosis, and stroke;
- mental impairment — poor memory, aphasia, motor disorders, senility, and dementias;
- sensory disorders — hearing impairment, inner-ear problems, dizziness, low visual acuity, and diabetic retinopathy”
Vimaca (for women)
“The womens version contains… Siberian Ginseng known to … reduce cholesterol level. … Ginger Root which has significant impact against inflammation and platelet aggregation.”
Zanthroplex (Hypericin)
“Hypericin does, however, have several proven areas of application:
- for improving mood via its anti-depressant and anti-anxiety properties;
- as an antiviral active against cytomegalovirus, human papilloma virus, hepatitis B, and herpes (shown in animals), and skin warts;
- for reducing depression-related anorexia, hypersomnia, or insomnia.
Hypericin has also shown promise for treating cutaneous T-cell lymphoma, since it preferentially kills malignant cells. Limited experimental support also exists for hypericin as a treatment for seasonal affective disorder, and obsessive-compulsive disorder.”
High Desert Aller-Bee-Gone
“A favorite of the people of the desert area who suffer with all types of allergies. Reports have been known that after two bottles people never have to deal with allergies again.”
Herp-Eeze
“[Herpes] is not life threatening but it will cause cold sores, genital herpes, Bell’s Palsy, shingles and many other neurological disorders that upset the quality of life. HERP-EEZE contains the powerful ligan Nordilhydrogualactic acid NGDA [sic] … NDGA INHIBITS AND KILLS CELLS INFECTED WITH THE HERPES VIRUS.”
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 US 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 web site and products your firm may market. It is your responsibility to ensure that all products marketed by your firm are in compliance with theAct and its implementing regulations.
If you need additional information or have questions concerning any products distributed through your web site, please contact FDA. You may reach FDA electronically (e-mail) at [email protected], or you may respond in writing to Angela F. Pope, Compliance Officer, Food and Drug Administration, Division of Compliance and Enforcement, ONPLDS, 200 C St SW, Washington DC 20204. If you have any questions concerning any issue in this letter, please contact Ms Pope at 301-436-2375.
Sincerely
yours,
/s/
John B. Foret
Director,
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 July 31, 2005.
