Confidence should be a good thing, right?

June 5, 2019

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: 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.

Anthony Reyes
Author: Anthony Reyes

Unlock the Power of Transparency: Schedule a Meeting Now

Ready to Illuminate Your Path?
Partner with Trust Transparency Today.

Get inTouch

Lori Diez

Lori Diez combines compassion and excellence to lead organizations to their next level. A small-town Texas childhood taught her the value of hard work and relationships, which she uses to foster teamwork that brings results that have transformed cultures and programs to their highest potential. Her successful career in pharmaceutical and nutraceutical sales leadership and event hosting has prepared her to deliver results as the COO of TrustTransparency, where she uses her industry knowledge to ensure that the company’s operations run smoothly as they support nutraceutical companies in their mission to help others. Lori’s passion for charity reflects her belief that individuals working together can change the world, no matter how small their contribution to the effort. This year, she looks forward to continuing over a decade of service at the Houston Livestock Show And Rodeo, where she will be the Chairman of the Livestock Committee.

Conference Handouts

Conference Handouts

CoQ10 Statin Associated Myaglia Meta Study Barry Tan 0618 Case Study

CoQ10 Statin Associated Myaglia Meta Study Barry Tan 0618 (1)

Statin Q10 Effect Case Study

Statin Q10 Effect Case Study

Schedule Consultation with Trust Transparency

Glynnda Steinford

Glynnda Steinford, Trust Transparency Consulting’s Director of Customer Relations, brings over four decades of healthcare experience to her vital role in client engagement and relationship building. Her diverse background spans from administering medical groups to impactful stints in pharmaceutical and nutraceutical sales, all underlined by her degree in Healthcare Administration.

At the heart of Glynnda’s work is her talent for nurturing long-term connections, a skill she leverages to enhance client experiences and partnerships within the consultancy. Beyond her professional commitments, she enjoys life’s simple pleasures, whether it’s her love for cats and cooking or her ventures into golf, always prioritizing cherished moments with family and friends. Her personal interests echo the dedication and warmth she extends in her professional network, making her an invaluable asset to the team.

Caiti Dowden

Caiti Dowden stands as a crucial pillar at Trust Transparency Consulting, bringing invaluable insight and expertise to her role as Senior Executive Assistant’ since her start in 2018. With an academic background from Sam Houston University and a career shift from education to the nutraceutical sphere in 2010, Caiti has cultivated a sharp acumen for dissecting industry trends and bolstering strategic decision-making.

Her transition from Data Analyst reflects her growth and deep understanding of the business landscape. Caiti’s commitment goes beyond professional excellence; she thrives on balance, drawing from her rich life outside of work to enhance her organizational contributions. Whether it’s family time, volunteering, or rooting for Houston’s sports teams, she believes in embracing experiences to fuel her professional creativity and insight.

In her current role, Caiti’s dedication to dynamic business analysis and operational support proves her to be an irreplaceable asset to our team, embodying the synergy of personal enrichment and professional success.

Pam Hilpert

Pam Hilpert, Chief of Staff at Trust Transparency Consulting, has been instrumental in the firm since its inception, leveraging her 17 years of accounting experience, including a significant tenure in the nutrition sector. Her collaboration with Scott Steinford spans various successful ventures, emphasizing her integral role in the company’s financial and strategic initiatives.

An alumnus of Sam Houston State University, Pam holds degrees in both Business Administration and Accounting, as well as an MBA, adding academic heft to her practical industry insights. Beyond her professional prowess, Pam is passionate about family, enjoys live music, delves into quilting, and volunteers at her church, reflecting her well-rounded life.

Her multifaceted expertise and longstanding dedication make Pam a cornerstone of Trust Transparency Consulting’s operational strength and team unity.

Scott Steinford

Scott Steinford, a trailblazer in strategic leadership, boasts a certified M&A background, having navigated companies from their genesis to industry prominence. His brainchild, Trust Transparency Consulting, born in 2007, stands as a testament to his dedication to ethical business practices and strategic foresight, offering industry stakeholders invaluable guidance.

Beyond founding and steering companies, Scott has enriched the business landscape with his insightful keynotes and prolific written contributions, emphasizing his commitment to elevating industry standards. His executive tenure shines in roles as CEO or President of for-profits like ZMC-USA and Doctor’s Best, extending to significant contributions in non-profit sectors.

Notably, Scott’s influence is a driving force in the CoQ10 market, where his leadership has significantly bolstered the ingredient’s global presence. His roles in various capacities, including as a New Hope Ambassador, keep the community informed, providing in-depth industry reports and insights.

An active advocate within professional associations and an Editorial Advisor for leading industry publications, Scott’s expertise is both recognized and sought after. With academic roots in Pre-Law and a Master’s in Law, his journey transcends textbooks, embodying real-world business acumen and transformative leadership.

Scott Steinford merges visionary entrepreneurship with principled leadership, creating a legacy of innovation, growth, and unwavering commitment to industry excellence.