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U.S. Department of Health and Human Services

Drugs

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Cor Cleanse, SP-19 Glandular Blend (Goldenseal - Gentian Blend), Goldenseal, Goldenseal Glycerite, Standardized Olive Leaf, Suprema Dophilus, Evening Primrose Oil, and Hexane Free Black Currant Seed Oil GLA

Date: April 8, 2004

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Suzanne Schmidt
Suzanne’s Natural Foods
6103 S. Connecticut
Joplin, Missouri 64804

Ref. No. CL-03-HFS-810-63

Dear Ms. Schmidt:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at the Internet address http://www.suzannes4u.com and has determined that numerous products, including “Cor Cleanse,” “SP-19 Glandular Blend (Goldenseal – Gentian Blend),” “Goldenseal,” “Goldenseal Glycerite,” “Standardized Olive Leaf,” “Suprema Dophilus,” “Evening Primrose Oil,” and “Hexane Free Black Currant Seed Oil GLA,” 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 these 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:

Cor Cleanse (Suzanne’s)
“Do you suffer from high cholesterol or heart disease? . . .”
“Cor Cleanse may just be the answer”

SP-19 Glandular Blend (Goldenseal – Gentian Blend) (Solaray)
“It is used in conjunction with the following: bronchitis,…cold sores, common cold, sore throat, conjunctivitis, crohn’s disease, gastritis, influenza, abnormal pap smear, parasites, urinary tract infection, and vaginitis.”

Goldenseal (Suzanne’s)
“Primary Uses: Viral Infection, Sinus Infection, Gum Disease”
“Properties: Anti-Bacterial; Anti-Viral . . .”
“Goldenseal is indicated for acute manifestations of infection on any mucosal tissue which includes the respiratory, digestive, reproductive and urinary systems.”
“Goldenseal is famous for use in colds and flues [sic]. It should be used in situations where traditional anibiotics [sic] are indicated . . . . “
“It is arguably the best remedy for sinus infections . . . and gum diseases . . . “
“It can help urinary tract infections, vaginal infections, intestinal infections, prostate infections and topical infections on the skin.”

Goldenseal Glycerite (Herb Pharm)
“Goldenseal is used to treat the following conditions: Canker sores; Chronic candidiasis; Common cold/sore throat; Conjunctivitis/blepharitis; Infection; Influenza; Parasites; Urinary tract infection; Vaginitis”

Olive Leaf Extract (Solaray)
“…aiding in the treatment of herpes and other viral conditions, flu and colds, fungal infections, chronic fatigue and allergies.”
“It is very effective against many strains of virus, bacteria, and fungus.”

Olive Leaf Extract (Natural Factors)
“. . . exerts powerful antiviral, antibacterial, antifungal and antiparasitic activity. Anecdotal evidence shows it to be helpful for many stubborn infections. It seems to work particularly well for colds, flue [sic] and other respiratory infections.”

Standardized Olive Leaf (Suzanne’s)
“Helps with: human immunodefiency disease (HIV); herpesviruses [sic]; influenza viruses; pneumonia; sore throat; sinusitis; skin diseases (such as chronic infections or rashes); fungal or bacterial infections”

Suprema Dophilus (Suzanne’s)
“. . . can lower cholesterol levels . . . .”
“Supplementation may prevent, or be helpful with, the following conditions: Allergies (food); Atherosclerosis (heart disease); Cancer (colon); Candidiasis (yeast infection); Canker Sores; . . . Crohn's Disease; . . . Eczema; Immunodepression (immune function); Infection (colds, flu, etc.); Irritable Bowel Syndrome (IBS); Ulcerative Colitis”

Evening Primrose Oil (Suzanne’s)
“The anti-inflammatory properties of EPO have been studied in double blind research with people suffering from rheumatoid arthritis. Some, but not all, studies have reported that EPO supplementation provides significant benefit to these people.”

“GLA, the primary active ingredient in EPO, has anti-cancer activity…”
“Injecting GLA into tumors has caused regression of cancer…”
“Very preliminary evidence in people with cancer suggested ‘marked subjective improvement.”
“EPO has been reported to lower cholesterol levels…”
“…diabetes, scleroderma, Sjogren’s syndrome, tardive dyskinesia, and eczema. In preliminary research, supplementation with EPO has helped people with these conditions.”
“…double blind evidence suggests that alcoholics may be deficient in GLA and that alcohol withdrawal may be facilitated with EPO supplementation.”

Hexane Free Black Currant Seed Oil GLA (Solaray)
“GLA, the primary active ingredient in Black Currant Seed Oil, has anti-cancer activity[.] Injecting GLA into tumors has caused regression of cancer in people. Evidence in people with cancer suggested ‘marked subjective improvement.’”

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 C.F.R. 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 the Act 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 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 Parkway, College Park, Maryland 20740-3835. If you have any questions concerning any issue in this letter, please contact Ms. Pope at (301) 436-2375.

Sincerely yours,

/s/


Susan J. Walker, M.D.
Director
Division of Dietary Supplement Programs
Office of Nutritional Products, Labeling
and Dietary Supplements
Center for Food Safety
and Applied Nutrition