Image for U.S. Marshals Seize Unapproved and Improperly Labeled Drugs
News
Copyright 2013 Natural Standard (www.naturalstandard.com)
April 2012

U.S. Marshals Seize Unapproved and Improperly Labeled Drugs

Recently, the U.S. federal marshals seized more than 1,600 containers of drugs because the products were not approved by the U.S. Food and Drug Administration (FDA) and were not properly labeled according to the guidelines of the Federal Food, Drug and Cosmetic Act.

Prior to the seizure, the drugs were being held by Notions-n-Things Distribution of Bogard, MO. The three products that were confiscated included Chickweed Healing Salve, To-Mor-Gone, and R.E.P.

The Chickweed Healing Salve was previously marketed as a skin cancer treatment despite the fact that it was not approved by the FDA. In addition, the product contains comfrey, an herb that studies have shown may increase the risk of toxic health effects. In 2001 the FDA sent a letter to various dietary supplement organizations, including the American Botanical Council, the American Herbal Products Association, the Council for Responsible Nutrition, the Consumer Healthcare Products Association, the National Nutritional Foods Association, the Utah Natural Products Alliance, the American Association of Oriental Medicine and the American College of Acupuncturists and Traditional Medicine, stating its concern about chemicals found in comfrey plants. These chemicals, called pyrrolizidine alkoloids, can be found in common comfrey, prickley comfrey and Russian comfrey. Many studies have shown that these chemicals may cause serious health hazards, particularly to the liver, when consumed. Based on this information, the FDA recommended that dietary supplements that contain comfrey be removed from the market more than a decade ago. In addition, shortly before the FDA made this request, the Federal Trade Commission (FTC) had begun to take legal action against unsafe products that contained comfrey as one of the ingredients.

In addition, To-Mor-Gone was allegedly marketed as a drug that could cure cancer and other diseases. However, like the Chickweed Healing Salve, To-Mor-Gone was never approved by the FDA for treating diseases. Furthermore, the product contains bloodroot, a corrosive herb that may cause significant scarring. If used on tissue that was previously diagnosed as being cancerous, the scarring caused by bloodroot may mask tumor recurrence. Furthermore, expert opinion considers bloodroot unsafe when used internally. In 2005, legal action was taken against an unlicensed practitioner for prescribing bloodroot to several women with breast cancer who suffered disfigurement and tissue damage after applying the cream to their skin.

Finally, R.E.P. was allegedly marketed as a drug that could cure stress headaches and sinus infections but was never approved by the FDA. Furthermore, the product label contains no ingredient information, which violates the Federal Food, Drug and Cosmetic Act.

The seizure of these products by the U.S. marshals was prompted by the FDA, who had inspected Notions-n-Things Distribution on January 25, 2012. This FDA inspection had been initiated by consumer complaints of Chickweed Healing Salve, as well as the administration recognizing that the company was distributing a pamphlet that claimed that the unapproved Chickweed Healing Salve could treat skin cancer. Federal regulations require that any product marketed as a drug to "cure" or "treat" diseases must be evaluated and approved by the FDA.

For more information regarding possible health effects of either comfrey or bloodroot, please visit Natural Standard's Food, Herbs & Supplements Database.

References

  1. Natural Standard: The Authority on Integrative Medicine. www.naturalstandard.com
  2. U.S. Food and Drug Administration (FDA). www.fda.gov
The information in this brief report is intended for informational purposes only, and is meant to help users better understand health concerns. This information should not be interpreted as specific medical advice. Users should consult with a qualified healthcare provider for specific questions regarding therapies, diagnosis and/or health conditions, prior to making therapeutic decisions. Copyright 2013 Natural Standard Inc. Commercial distribution or reproduction prohibited.