Department of Health and Human Services
Public Health Service
Bldg 20, Denver Federal Ctr
October 6, 1997
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED
Bill Gay II, CEO
1104 Country Hills Dr #300
Ogden, UT 84404
Ref. No. DEN-98-02
Dear Mr Gay:
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."
FDA's investigation traced this contaminated plantain to your firm, Great Basin Botanical and Processing, Clearfield, UT. This contamination is associated with plantain that Great Basin received directly from [redacted] for custom milling into plantain powder for [redacted].
The plantain leaves and plantain powder made from them are adulterated and misbranded under the Federal Food, Drug and Cosmetic Act (the Act) as follows:
- within the meaning of Section 402(a)(1) in that they contain an added poisonous or deleterious substance, namely lanatosides (cardiac glycosides), which may render them injurious to health.
- within the meaning of section 403(a)(1) in that the labeling is false and misleading because it ftils to reveal the material fact that the product contains lanatosides, e.g. cardiac glycosides, which if ingested, can cause life-threatening heart reactions.
FDA collected multiple samples of plantain from you and from establishments which had received this material from you. FDA analyses of these samples showed that the plant material identified as "plantain" contained lanatosides (cardiac glycosides). The presence of lanatosides support that the plant material contains Digitalis glycosides. Digitalis Janata has been reported to contain these lanatosides. Plantain has not been reported to contain any cardiac glycosides. 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 that the plantain was contaminated with Digitalis. As a processor, you are responsible for ensuring that ingredients that you process and distribute for use in foods or dietary supplements are safe for human consumption. 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 these violations from occurring in the future. If you continue to process foods that are adulterated and misbranded as stated above, FDA may consider initiating regulatory action, such as seizure or injunction.
Please submit your written response to Compliance Officer Shelly L. Maifarth at the above address. You may contact Ms Maifarth at 303-236-3046 if you have any questions.
Gary C. Dean
Mr Daren Petersen, General Mgr
Great Basin Botanical and Processing
Bldg E5, Freeport West
Clearfield, UT 84016
This page was posted on August 20, 2006.