REPORT

Investigation Request: 

Zilis UltraCell® Products

Disclaimer:

The Texas Cannabis Industry Association (“TCIA”) is not an investigative body and has no enforcement authority whatsoever. Neither TCIA as a whole, the board, or the individual members are state or federal regulatory experts.

 

This report is not the result of an investigation. It contains publicly documented conflicts of interests  and four lab results, the first two of which were submitted unsolicited to TCIA from a Fort Worth retail store owner who was given them by two separate Zilis Ambassadors six months apart.

 

For the sake of public safety, TCIA took referrals for two more independent labs and purchased two more products from different Zilis distributors. TCIA does not vouch for the quality of the labs and offers no legal interpretation of the results. TCIA makes no claims as to Zilis as a company or the products it markets.

 

This report is intended to be reviewed by reasonable adults who are able to come to their own conclusions. TCIA will continue to report the facts as they are received. 

Table of

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Conclusion - Request for Investigation

by State & Federal Authorities

Introduction

Over the course of a year, multiple Texas Cannabis Industry Association (“TCIA”) members raised concerns about the CBD Company Zilis and their ‘Ultracell’ product line. Zilis markets itself to physician offices, retailers and the general public. After multiple independent test results showed heavy metal contaminant levels, TCIA was compelled to take action. The following information is the culmination of months of research conducted by volunteer TCIA members.

        

TCIA is now publishing these findings with the intent to inform the public, FDA, and Texas Department of Health and Human Services ("DSHS") with the information we have found. We strongly suggest research be conducted by state and/or federal authorities including the FDA to determine Zilis product safety.

The Zilis Ultracell Product Line

Zilis LLC is the manufacturer of the product “Ultra Cell” full spectrum hemp CBD oil. Zilis touts itself as being certified by the US Hemp Authority. Zilis also bolsters its product by a “Medical Advisory Board” for the purpose “To better serve our Ambassadors and bring the best possible CBD oil products to the world Zilis has created a Medical Advisory Board.”[1]

Zilis has a portion of its website devoted to providing laboratory reports on batches and has a portion entitled “Understanding the Certificate of Analysis.” In answering the question “What are heavy metals?,” Zilis states “These are lead, mercury, arsenic and cadmium. These elements are naturally found in the soil, air, and water, and can be absorbed by plants. Testing ensures that our products are not only FDA compliant but also safe for your customers.”[2]

Zilis markets its product through “Ambassadors” or a multilevel marketing platform and uses several strategies to entice people including a “dynamic structure pays you up to $30,000 a week”. [3] Zilis even offers Jeep Bonus incentive similar to the pink Cadillac Mary Kay Cosmetics offers. The stark difference between the two is Mary Kay promotes cosmetics to adults; Zilis is promoting ingested hemp supplements.

Zilis is US Hemp Authority Certified

 

Zilis products are listed as “US Hemp Authority Certified.”  The US Hemp Authority asserts that their “U.S. Hemp Authority® Certification Program is our industry’s initiative to provide high standards, best practices, and self-regulation, giving consumers and retailers confidence in hemp and CBD Products.”[4] The US Hemp Authority has published a Guidance Procedure [5] for growers and processors to obtain certification by the US Hemp Authority. When referring to heavy metal contaminants, the Guidance Procedure [6] does not link to the FDA limits. Instead, it directs visitors to a site owned by the American Herbal Products Association and charges $99.00 to download the information. [7]

The US Hemp Authority operates on a “pay to play system,” meaning that a company must pay thousands of dollars to participate in the certification program. TCIA is not the first to raise concerns regarding the US Hemp Authority. On February 19, 2019 an open letter by several hemp industry leaders criticized the US Hemp Authority Certification process. [8]

Zilis & US Hemp Authority Conflicts of Interest

The US Hemp Authority was founded by the US Hemp Roundtable in 2018 as in independent subsidiary[9].  Zilis is on the US Hemp Roundtable’s Board of Directors[10], a position that requires a “$30,000 annual contribution” and “provides the governance of the organization.[11]

The US Hemp Roundtable is housed in the Lexington Kentucky offices of Frost, Brown & Todd (FBT LLC). FBT LLC is the incorporator of both US Hemp Authority and for US Hemp Roundtable. All three entities share the same mailing address[12].  

Jonathan Miller is the “Office Member-in-Charge” of that FBT LLC Lexington Office[13]. Jonathan Miller is also both “General Counsel” of the US Hemp Roundtable[14] and the “Exclusive Hemp Counsel” of Zilis[15].

The most fundamental conflict of interest between U.S. Hemp Authority and Zilis is at the top of both organizations. The “President” of the U.S. Hemp Authority, Marielle Weintraub, is also the “Director of Scientific Research and Development” for Zilis[16]. Ms Weintraub and Mr. Miller are literally overseeing themselves and their employer, providing the “U.S. Hemp Authority Certification” seal of approval, and using that seal aggressively for marketing and sales.

Class Action Litigation Against A Similar

US Hemp Roundtable Company

There is a current class action lawsuit filed in the Southern District of Florida Michael Davis et al v. CBD American Shaman, LLC [17] against another US Hemp Roundtable Board Member, CBD Company “American Shaman.” The lawsuit claims that American Shaman markets products as organic and containing no heavy metals; but when tested by independent laboratories, those claims were found to be false.

The US Hemp Authority used the American Shaman litigation to promote its certification program.  In a recent interview, President of the US Hemp Authority, Meriella Weintraub, stated “Too little CBD is not going to harm anyone, it’s wrong and you’re lying to people [if the amount in your product doesn’t match what you say is on the label].  What scares me more is when people are not testing for heavy metals, not following GMPs, not testing what a phytoremediation plant needs to be tested for.” [18]

The self-regulation by a “pay to play” organization such as the US Hemp Authority does not ensure safety for consumers. The US Hemp Authority has ignored the Zilis conflicts of interest from the beginning and continues to fail to regulate Zilis as a “Certified Company.” The Zilis testing history below shows comparable heavy metal contaminants to those found in defendant American Shaman’s products.

Zilis Independent Testing History

 

In May 2019, a third-party retailer who is a TCIA Member was approached by a Zilis Ambassador to sell Zilis hemp supplements at his Forth Worth area CBD retail store. The Ambassador gave the TCIA Member samples of the Zilis CBD product. As is the practice and policy of the TCIA Member, they laboratory test all products for purity and content prior to offering that product in their retail outlet to the public.

The Zilis Ultra Cell sample was sent to independent third party laboratory Desert Valley Testing. The laboratory results found in one of the samples 57.50 ppm of lead.[19]

Zilis also markets this product direct to physician offices. Weeks earlier on April 2nd, another TCIA member who is a Dallas-area physician had submitted to TCIA Zilis multilevel marketing material. A Zilis Ambassador bought this physician lunch and left behind the materials, touting the sales benefits of a high profit margin, full spectrum and safe product.

Because of these two incidents, TCIA reached out to a number of industry leaders to determine if there had been additional complaints received about Zilis products or marketing. There was nothing for approximately six months. Then in December 2019, TCIA received a second test certificate from another independent laboratory that analyzed a different sample of Zilis’s Ultracell product.

The second sample test results revealed Ethanol (also known as ethyl alcohol or C2H5OH); 6,368 ppm which converts to 0.6368%. This independent testing months later of a second Zilis product sample showed a second heavy metal contaminant.

As a result, the TCIA Board was compelled to take action. It acquired two bottles of Zilis Ultracell from two separate suppliers and submitted them to two separate independent laboratories for testing. One sample was sent to C4 Laboratories, with the report created on February 19, 2020. Those results found both Arsenic and Ethanol contaminants. One sample tested at 0.07 ppm, which converts to 70 parts per billion. The Ethanol content of this sample was 27,132 ppm. TCIA sent the second sample to the independent laboratory Cannalysis. The results showed Lead contents.

 

Request for Investigation by Texas DSHS and The FDA

 

Zilis validates their products using the US Hemp Authority Certification seal on all of its product packaging and marketing. Four different independent labs tested four different Zilis samples at different times and from different direct Zilis sources. All of the tests came back with results for at least one (sometimes more) of four different heavy metal contaminants.

For these reasons, the Texas Cannabis Industry Association is publishing these findings with the intent to inform the public and relevant agencies with the information we have found. TCIA has formally requested a complete investigation be conducted by the FDA and Texas DSHS to determine Zilis product safety.

 

The Test

Results

See a summary chart of the lab results and view the original documents.

Test Before

You Ingest

The story of a class action lawsuit that started when  a consumer found heavy metals.

Dangerous Contaminants

Dangerous Contaminants Currently Prevalent in the CBD Industry

Unregulated

CBD

The Dangers of Contaminants in Unregulated CBD Products

CITATIONS

[1] Zilis website at https://www.zilis.com/company/medical-advisory-board/

[2] Zilis “Understanding the Certificate of Analysis” https://zilis.com/wp-content/uploads/2020/03/COA_Flyer_2-12-20.pdf

[3] Zilis marketing website https://zilis.com/opportunity/comp-plan/

[4] US Hemp Authority website https://ushempauthority.org/about

[5] US Hemp Authority Guidance Procedure https://ushempauthority.org/assets/uploads/USHA-Guidance-Procedures-Version-2.0-WEB-VERSION-Rev-3-25-20_200504_141204.pdf

[6] US Hemp Authority Guidance Procedure refer to page 41 https://ushempauthority.org/assets/uploads/USHA-Guidance-Procedures-Version-2.0-WEB-VERSION-Rev-3-25-20_200504_141204.pdf

[7] American Herbal Products Association “Guidance on Heavy Metals: Analysis and Limits in Herbal Dietary Supplements http://www.ahpa.org/News/LatestNews/tabid/96/ArtMID/1179/ArticleID/226/Default.aspx

[8] Open Letter to the US Hemp Authority dated 2/19/2019 https://cannabusiness.law/open-letter-regarding-the-us-hemp-authority-certification-program/

[9] “Once the US Hemp Roundtable approved the final version of what is now titled the Guidance Procedures, it provided $200,000 for seed funding and handed off administration of the program to a newly created, fully independent organization: the US Hemp Authority.” https://ushempauthority.org/about

[10] US Hemp Roundtable About Page as of 5/20/20 https://hempsupporter.com/about

[11] US Hemp Roundtable downloaded “2020 Membership Document” https://hempsupporter.com/assets/uploads/USHRT_2020.pdf

[12] 250 West Main Street, Suite 2800 Lexington, KY 40507 https://ushempauthority.org/certified-companies, https://hempsupporter.com/about, https://frostbrowntodd.com/offices/lexington/

[13] Frost, Brown & Todd Firm search 5/20/2020 https://frostbrowntodd.com/search-results/?fwp_site_search=Jonathan%20Miller&fwp_content_type=people

[14] Jonathan Miller Frost, Brown & Todd Biography as of 5/20/20 https://frostbrowntodd.com/people/jonathan-miller/

[15] Zilis corporate bios page 5/20/2020 https://www.zilis.com/company/corporate-bios/

[16] https://ushempauthority.org/about/board-bios

[17] Michael Davis et al v. CBD American Shaman, LLC, Case No. 20-CV-60897, Petition filed on May 4, 2020 and can be found at https://www.classaction.org/news/class-action-claims-all-natural-cbd-american-shaman-products-contain-multiple-heavy-metals#embedded-document

[18] Food Navigator USA article dated May 11, 2020 “Lawsuit Over Heavy Metals in CBD Products ‘Raises More Questions than Answers’ says Attorney as Hemp Authority Seal Gains Traction.”  https://www.foodnavigator-usa.com/Article/2020/05/11/Lawsuit-over-heavy-metals-in-CBD-products-raises-more-questions-than-answers-says-attorney-Hemp-Authority-seal-gains-traction

[19] The FDA calculated a maximum daily intake for lead from food, called the Interim Reference Level (IRL). In determining the IRL, the FDA takes into account the amount of a particular food a person would need to consume daily, as well as other factors, that would result in blood lead levels of 5 ug/dL, the level at which the CDC recommends clinical monitoring of lead exposure in children. The FDA calculated the current IRL at 3 µg per day for children and 12.5 µg per day for adults. https://www.fda.gov/food/metals-and-your-food/lead-food-foodwares-and-dietary-supplements

 
 
 
 
 
 
 
 
 

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TCIA is a self-sustaining, independent association. TCIA is not an affiliate or chapter or subsidiary of any other group. TCIA works closely with multiple local, state, national and international organizations.