Department of Health and Human Services
Public Health Service
College Park, Maryland 20740
November 30, 2004
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED
American Biologics, Inc.
1180 Walnut Ave.
Chula Vista, California 91911
Ref. No. CL-04-HFS-810-104
Dear Ms. Bradford:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at the Internet address americanbiologics.com and has determined that the products AB-fem Glandular, AB-Male Glandular, Flu Solve™, Candida Albicans, Ultra Brain Power™, Bronchostem™, Calcium A.E.P., Pancreas Glandular, Pituitary Glandular, and Sub-Adrene™ Adrenal Cortex Extract are promoted for conditions that causes the product to be a drug 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 is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act.
Examples of some of the claims observed on your web site include:
AB-Fem Glandular and AB-Male Glandular
"[S]pecific for ... viral or bacterial challenge.... Designed to help ... rebuild from long term illness."
"Flu Solve benefits acute feverish inflammations ... viral and bacterial overload ... acute and chronic infections and high fever."
"Candida Albicans aids in the treatment of ... depression, ... yeast vaginities [sic], ... kidney and bladder infections, allergic symptoms like hay fever, sinusitis, food allergies...."
Ultra Brain Power™
"Brain Power™ is a science-based formulation aimed at É arresting or reversing age-related brain decline. ... Catastrophic brain decline [includes] Alzheimer's disease, vascular dementia, and other dementias..."
"Bronchostem benefits Rhinolaryngopharyngitis, especially bronchitis and whooping cough ... Effective exptorant. [C]hronic bronchitis, bronchial asthma...."
"Calcium A.E.P. may be an important adjunct in autoimmune dysfunctions."
"Often used as adjunctive support for individuals with poor blood sugar control...."
"Many individuals with endocrine imbalances ... have lost pituitary function ... [C]onsider this glandular when presented with an endocrine problem."
Sub-Adrene™ Adrenal Cortex Extract
"[E]xcellent in weaning individuals from cortisone drugs."
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 if claims about diagnosis, cure, mitigation, treatment, or prevention of disease 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, 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 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 markets. It is your responsibility to ensure that all products marketed by your firm comply 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 Kenneth.Taylor@CFSAN.FDA.gov, or you may respond in writing to Kenneth M. P. Taylor, PhD, Chemist, Food and Drug Administration, Division of Dietary Supplement Programs, 5100 Paint Branch Parkway, College Park, Maryland 20740-3835. If you have any questions concerning this letter, please contact Dr. Taylor at (301) 436-1439.
Susan J. Walker, MD
Division of Dietary Supplement Programs
Office of Nutritional Products, Labeling and Dietary Supplements
Center for Food Safety and Applied Nutrition
This page was posted on February 14, 2004.