Warning Letter to Herborium/Agnes Kondratowicz


May 4, 2006

Department of Health and Human Services' logo
Department of Health and Human Services

Public Health Service
Food and Drug Administration
5100 Paint Branch Pkwy
College Park, MD 20740-3835

August 12, 2002
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Agnes Kondratowicz
Owner,
Herborium
3 Oak St
Teaneck, NJ 07666-3826

Ref. No.
CL-02-HFS-810-37

Dear
Ms Kondratowicz:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address: http://www.herborium.com and has determined that the products “Liver Activator Series™ (Hep-Aid™, Liver Relief™, Liver Rejuvenator™, and Liver Healer™)” and “AcnEase” 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:

“When I found the AcnEase website, I was having a bout with very bad cystic acne, and desparate to find something that truly works. I have had acne every since I was in elementary school. I have tried antibiotics, accutane, proactive, serious skin care, you name it, but nothing seemed to really help… I have been using AcnEase for seven weeks and the results have been amazing. This is truly the best product I have ever used for acne. I no longer have those big painful cysts that made me sad and ashamed to leave my apartment.”

“The Liver Activator Series™ is composed of four distinct yet complementary medicines designed specifically to improve liver function and well being in patients with Hepatitis C, B, A, and/or Cirrhosis.”

“The following table is designed to help those suffering from hepatitis B or C, cirrhosis, fibrosis, or other liver disease and symptoms determine which LAS products may be of use.

Disease State Symptoms Products
Hepatitis C Acute Early Stage No Evidence of Liver Damage
Normal Albumin Levels
Moderate Increase AST/ALT
Hep-Aid™
Hepatitis C Chronic
Chronic Hepatitis C
elevated liver enzymes (AST and ALT) with decreased Albumin and A/G ratios Liver Rejuvenator™ until Albumin normalizes then Hep-Aid™
Hepatitis B
Acute and Chronic Hepatitis B
elevated liver enzymes (AST and ALT) Liver Rejuvenator™
Cirrhosis Early Stage Alcohol induced Fatty Infiltration of Liver
Decreased liver function, early signs of cirrhosis
Liver Relief™
Cirrhosis Late Stage with Fibrosis Liver Hardness and Hepatic Portal Hypertension, Ascites, Edema, increased clotting times Liver Healer™
Liver Disease Prophylaxis with Liver Health No visible signs of liver disease. Liver “overworked” due to diet rich in fatty food, moderate alcohol consumption, chronic drug use Liver Rejuvenator™

 

“Liver Healer™ is recommended for individuals having cirrhosis with or without hepatic portal hypertension. Symptoms in advanced cirrhosis include: liver hardening (fibrosis), portal hypertension, development of varices, internal bleeding, ascites, vomiting of blood and black stools … Liver Healer™ may be used in combination with other members of the LAS including Liver Rejuvenator™ and Hep-Aid™ for those patients suffering from Hepatitis B and C respectively.”

“Individuals with Chronic Hepatitis C receiving an initial course of therapy with Liver Rejuvenator followed by Hep-Aid have…restored liver enzymes to normal levels. Individuals who received Interferon Therapy and failed to respond or suffered a relapse following discontinuation of Interferon treatment can also use Hep-Aid™.”

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 website 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 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, 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 May 4, 2006.