Re: CharanteaUSA press release regarding the seizure
Date: 10/23/2007 7:15:27 AM ( 10y ago ) Hits:10445 Status:R [Message recommended by a moderator!]
Safe, Reliable Diabetic Supplement Seized by FDA Over Website Wording
By Dante Abelarde
With reference to "Approximately $71,000 of Dietary Supplements Seized at FDA Request" here is our view of the recent FDA seizure of our food supplement product Charantea Ampalaya Bitter Melon Tea and Capsules. We fear such negative impressions created by the FDA's move may harm what is otherwise a safe, reliable and well-known natural remedy used by diabetics around the world.
We would like to clarify to the public at large that the FDA's move was a result of their negative interpretation of the wordings on our website found at http://www.charanteausa.com
and has nothing to do at all with Charantea's efficacy or safety. Again, the trouble with the FDA is only rooted with the wordings and is not due to any safety or efficacy issues of the product. And much of the literature the FDA apparently took offense to was referring to the actual Bitter Melon plant's well-established benefits and the studies establishing its hypoglycemic properties and not to the finished product. In fact, even the public information website of the National Library of Medicine and National Institute of Health (www.pubmed.gov), contains over 365 individual scientific studies conducted worldwide on the Bitter Melon (Momordica charantia Linn.) since the 1970s. We have merely made this and other similar helpful information available to our customers on our website so that they may be better informed and make informed decisions.
We have been coordinating with the FDA for several months before this recent incident, trying to comply with their requirement that there be no implied claims to diagnose, treat, cure or prevent any disease (these are only allowed for pharmaceutical drugs). For this, we have adjusted our website claims and testimonials several times in the past few months. We have records of our email correspondence with the FDA agent in charge of our case, informing her of the changes and asking her to see if our changes were satisfactory as it was their interpretation that mattered, not ours. She refused to comment several times, citing that the FDA does not give advice on this and that compliance is solely our responsibility.
We agree that compliance is our responsibility. However, because only the FDA's own interpretation of what implies a claim or not is what will bring them to take damaging action, we feel it unjust to have our repeated requests for their comments to be ignored and to suddenly have a crippling blow struck against an otherwise honest business. We are a small business, with no resources for expensive lawyers to guide us through the labyrinthine maze the FDA seems to have set up for dietary supplements. We will probably close down as we have been told to stop selling despite our customer requests for Charantea. If we cannot sell, our business cannot survive.
Charantea is currently freely available and well-accepted around the world including Europe, the Middle East and Asia-Pacific. Only in the USA has it been considered an illegal drug.
We have not given up. We are still trying to find a way to do business that is acceptable to the FDA's opinion, and are determined to renew our efforts to comply with their requirements. We would like to thank all the people who have expressed their support for our company and in Charantea, and to our customers, whose approval is ultimately what really matters.