Biostar Technology International, LLC "exonerated from FDA warning letter" says CTO
FDA wrongly accused the company Biostar Technology International LLC of marketing natural supplements as cancer drugs.
Nov 13, 2018, 22:01 ET
SANTA CLARITA, Calif., Nov. 13, 2018 /PRNewswire/ -- Biostar Technology International, LLC 4/17/17 (update)
Last year, in 2017, the FDA published a warning letter against Biostar Technology International, LLC in which wrongly accused the company of marketing natural supplements as cancer drugs. The FDA warning letter outlined that natural substances, can't be identified and sold as cancer curing without FDA approval. While the warning letter from the FDA did not provide any proof of actual sales or distribution, the FDA alleged that "descriptions, flyers, and invisible search engine keys" were used to make various claims, even-though the website contained legal notices and the "FDA disclaimer" found on almost every natural supplement website and product label.
What may seem as an oversight by the FDA investigators, the warning letter was published online using the wrong company name. The main website mentioned on the letter was addressed to the owners of www.biostarorganix.com. This website is owned by "Biostar Organix Healthcare Association" which is registered as an Unincorporated Association of California, and not "Biostar Technology International, LLC". It is a little-known fact that, Unincorporated Associations are not recorded electronically or available online to search; therefore, because California does not post this information electronically, it would be difficult for anyone to find. It would seem that the FDA made an oversight on how it verified the website owner to the correct company name. Nonetheless, while this mistake was being overlooked, the warning letter remained posted with the wrong company name. This apparent oversight by the FDA had caused Biostar Technology International, LLC, much confusion on how to react at the time of the publication. Nonetheless, the FDA did update their records and changed a subsequent the letter to reflect the correct company name.
Biostar Organix Healthcare Association shared a copy of the letter from the FDA dated 08/27/18, which now is correctly addressed to Biostar Organix Healthcare Association, and no longer Biostar Technology International, LLC. In response to the letter, Ulysses Sheretov, President and CTO of Biostar Technology, LLC said, "Biostar Technology International, LLC unequivocally denies that they owned or operated any of the websites listed in the past FDA warning letter. While it's not an apology letter from the FDA, we feel this letter has nonetheless exonerated Biostar Technology from FDA warning letter issued on 4/17/17 and when dealing with the ever-changing nature of the FDA, we will take what we can get."
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SOURCE Biostar Technology International, LLC