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

Public Health Service
Food and Drug Administration
San Francisco District Office

 

1431 Harbor Bay Pkwy
Alameda, CA 94502-7070
Telephone: 510-337-6700

October 7, 1997
WARNING LETTER

Akin Baron, President
ABCO Laboratories, Inc.
2377 Stanwell Dr
Concord, CA 94520

Ref. No. 2917665

Dear Mr Baron:

The Food and Drug Administration (FDA) received a complaint regarding injuries sustained by a young woman who experienced an abnormal heart rate with complete heart block, a potentially life-threatening condition. The consumer's symptoms were consistent with an overdose of digitalis-like cardiac glycosides. The young woman experienced this condition after ingesting a regimen of dietary supplements. FDA's investigation determined that the problem was due to the ingredient plantain found in the dietary supplement "Chomper."

Our investigation found that your firm received contaminated plantain powder from one or more lots and used this plant material in the manufacture of Chomper tablets and Chomper bulk powder for [redacted].

The Chomper tablets and bulk Chomper powder that you produced with the contaminated plantain are adulterated and misbranded under the provisions of the Federal Food, Drug and Cosmetic Act (the Act) as follows:

FDA collected samples of plantain, identified as lot numbers "[redacted]" which were either used or destined for use in the manufacture of Chomper products for [redacted]. Analyses of these samples showed that the plant matter identified as "plantain" contained lanatosides (cardiac giycosides). The presence of lanatosides support that the plant material contains Digitalis glycosides. Digitalis Janafa has been reported to contain these lanatosides. Plantain has not been reported to contain any cardiac gJycosides.

FDA also conducted an analysis of a sample of plantain to determine whether the material identified as plantain actually contained plantain. The analysis found that the characteristic trichomes for plantain were low in concentration in the sample when compared to reference specimens, These analyses indicate the plantain was contaminated with Digitalis. As a manufacturer, you are responsible for ensuring that ingredients which you use manufacturing dietary supplements are safe for human consumption. We note that [redacted] voluntarily recalled the adulterated Chomper products that you manufactured and [redacted]. However, we are concerned that this type of situation does not occur again.

We request that you notify this office in writing within 15 working days of receipt of this letter of the specific steps you have taken to preclude this violation from occurring in the fbture. If you continue to manufacture dietary supplements that are adulterated and misbranded as stated above, FDA may consider initiating regulatory action, such as seizure or injunction.

Your reply should be addressed to:

Sam M. Ali
Recall and Emergency Coordinator
US Food and Drug Administration
San Francisco District
1431 Harbor Bay Pkwy
Alameda, CA 94502
Telephone 510-337-6869
FAX 510-337-6705

Sincerely,
/s/
Charles D. Moss
Acting District Director

This page was posted on August 20, 2006.

Links to Recommended Companies