You’d think any headline that had the words confidence and supplements in the same headline would be a good thing, right? Not so this past week as the dietary supplement company, Confidence USA, Inc. made the news, but not in a good way. On May 23, 2019, the Department of Justice (DOJ), at the request of the FDA, filed a civil lawsuit seeking a permanent injunction against Confidence USA and the Company President Helen Chian and Company Manager Jim Chao, aiming to prevent the company from marketing dietary supplements. This action is not the first time the DOJ has filed a permanent injunction against a dietary manufacturer, but it is a unique set of complaints and circumstances that makes this complaint significant and newsworthy. The timeline, duration, and the company’s blatant disregard for any FDA oversight raises many questions about this type of entity within our industry, and could be a precursor to other actions.
The DOJ complaint alleges Confidence USA failed to follow current good manufacturing practices (cGMPs) as defined by the FDA. The FDA supports this allegation by having logged 37 citations since 2012. The FDA stated the company continually failed to verify the identity of each ingredient in the manufacture of their supplements and also was unable to verify that their products met specifications for purity, strength, composition and contamination limits. The FDA filed a Warning Letter against Confidence USA on July 7, 2011, following a November 2010 inspection, stating this same complaint and the citation for this complaint was issued at five subsequent inspections. According to the DOJ, complaint Confidence sells approximately 50 products under brand names that include Confidence USA, American Best, USA Natural, and The Herbal Store.
Confidence USA is sold online at its website: Confidenceusa.com as well as on Amazon. On their site, the Confidence USA brand provides 21 products. On Amazon, the product is sold by Confidence itself. The products are not sold on any other websites. Amazon’s Terms of Service indicate that a dietary supplement cannot be sold on its site if the product is named in an FDA Recall or Safety Alert. FDA Warning Letters, 37 Citations and a Department of Justice Complaint is obviously within the boundary of the Terms of Service. One would expect Amazon to activate their terms – we’ll be watching for that.
The Natural Algae Astaxanthin Association (NAXA) recently had the Confidence U.S.A. Astaxanthin product (purchased from Amazon), tested at Eurofins using approved monograph standards for identification and assay of astaxanthin derived from Haematococcus pluvialis. The product did not test positive for any astaxanthin content. The Company was sent, and was confirmed to have received, a Certified Letter detailing the test results indicating this ‘zero active ingredient’ result. To date, no response to the original letter or subsequent notices has been received by NAXA. Amazon has been notified of these findings.
The Confidence USA website also indicates their products are guaranteed for quality and satisfaction:
The Natural Products Association NPA Certified GMP Members list does not include Confidence USA as a currently certified member. The Certificate shown on the Confidence USA website in several places displays an expired certificate but implies it complies. This representation by Confidence USA is probably in violation of the Natural Products Associations licensing agreement and has been for several years.
While the irony starts with the company’s name, which can be seen to project exactly the opposite, the set of circumstances in this allegation is extremely disconcerting. The timeline of escalation, and the abuse of warrants and approvals should distress us all.
It should be safe to say this type of example is not close to typical of the industry. The fact that the FDA, Department of Justice, Amazon, Natural Algae Astaxanthin Association, and the Natural Products Association all have potential issues of complaints that stem back almost a decade is however, a significant concern in itself. This example is proof that we as an industry should be able to work better, faster and smarter together to stop this type of activity before the ‘confidence’ we all seek for our industry is unnecessarily and drastically diminished.
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