Judgment Date:
04/18/2023
Settlement reported to AG:
Case Name:
Environmental Research Center v. Cymbiotika
Court Name:
Alameda County Superior Court
Plaintiff:
Environmental Research Center, Inc.
Plaintiff Attorney:
William F. Wraith, Esq.
Wraith Law
Injunctive Relief:
appearing on the label), which equals micrograms of lead exposure per day. If the label contains no recommended daily servings, then the number of recommended daily servings shall be one.
3.2 Clear and Reasonable Warnings
If Cymbiotika is ever required to provide a warning pursuant to Section 3.1, the following warning must be utilized (“Warning”):
WARNING: Consuming this product can expose you to chemicals including lead which is known to the State of California to cause [cancer and] birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov/food.
If Cymbiotika is ever required to provide a warning pursuant to Section 3.1, Cymbiotika shall also comply with the following additional conditions of this Section 3.2: (1) Cymbiotika shall use the phrase “cancer and” in the Warning if Cymbiotika has reason to believe that the “Daily Lead Exposure Level” is greater than 15 micrograms of lead as determined pursuant to the quality control methodology set forth in Section 3.4 or if Cymbiotika has reason to believe that another Proposition 65 chemical is present which may require a cancer warning.
(2) The Warning shall be securely affixed to or printed upon the label of each Covered Product and it must be set off from other surrounding information and enclosed in a box. In addition, for any Covered Product sold over the internet, the Warning shall appear on the checkout page when a California delivery address is indicated for any purchase of any Covered Product. An asterisk or other identifying method must be utilized to identify which products on the checkout page are subject to the Warning. In no event shall any internet or website Warning be contained in or made through a link.
(3) The Warning shall be at least the same size as the largest of any other health or safety warnings also appearing on the website or on the label and the word “WARNING” shall be in all capital letters and in bold print. No statements intended to or likely to have the effect of diminishing the impact of the Warning on the average lay person shall accompany the Warning. Further, no statements may accompany the Warning that state or imply that the source of the listed chemical has an impact on or results in a less harmful effect of the listed chemical.
(4) Cymbiotika must display the above Warning with such conspicuousness, as compared with other words, statements or designs on the label, or on its website, if applicable, to render the Warning likely to be read and understood by an ordinary individual under customary conditions of purchase or use of the product.
For purposes of this Stipulated Consent Judgment, the term “label” means a display of written, printed or graphic material that is printed on or affixed to a Covered Product or its immediate container or wrapper.
3.3 Conforming Covered Products
A Conforming Covered Product is a Covered Product for which the “Daily Lead Exposure Level” is no greater than 0.5 micrograms of lead per day as determined by the exposure methodology set forth in Section 3.1.2 and the quality control methodology described in Section 3.4, and that is not known by Cymbiotika to contain other chemicals that violate Proposition 65’s safe harbor thresholds.
3.4 Testing and Quality Control Methodology
3.4.1 Beginning within one year of the Effective Date, Cymbiotika shall
arrange for lead testing of the Covered Products at least once a year for a minimum of five consecutive years by arranging for testing of three (3) randomly selected samples of each of the Covered Products, in the form intended for sale to the end-user, which Cymbiotika intends to sell or is manufacturing for sale in California, directly selling to a consumer in California or “Distributing into the State of California.” If tests conducted pursuant to this Section demonstrate that no Warning is required for a Covered Product during each of five consecutive years, then the testing requirements of this Section will no longer be required as to that Covered Product. However, if during or after the five-year testing period, Cymbiotika changes ingredient suppliers for any of the Covered Products and/or reformulates any of the Covered Products, Cymbiotika shall test that Covered Product annually for at least four (4) consecutive years after such change is made.
3.4.2 For purposes of measuring the “Daily Lead Exposure Level,” the highest lead detection result of the three (3) randomly selected samples of the Covered Products will be controlling.
3.4.3 All testing pursuant to this Stipulated Consent Judgment shall be performed using a laboratory method that complies with the performance and quality control factors appropriate for the method used, including limit of detection and limit of quantification, sensitivity, accuracy and precision that meets the following criteria: Inductively Coupled Plasma-Mass Spectrometry (“ICP-MS”) achieving a limit of quantification of less than or equal to 0.005 mg/kg.
3.4.4 All testing pursuant to this Stipulated Consent Judgment shall be performed by an independent third party laboratory certified by the California Environmental Laboratory Accreditation Program or an independent third-party laboratory that is registered with the United States Food & Drug Administration.
3.4.5 Nothing in this Stipulated Consent Judgment shall limit Cymbiotika’s
ability to conduct, or require that others conduct, additional testing of the Covered Products, including the raw materials used in their manufacture.
3.4.6 Within thirty (30) days of ERC’s written request, Cymbiotika shall deliver lab reports obtained pursuant to Section 3.4 to ERC. Cymbiotika shall retain all test results and documentation for a period of five years from the date of each test.
3.4.7 Prior to the date of this Stipulated Consent Judgment, Cymbiotika contracted with an independent third-party laboratory certified by the California Environmental Laboratory Accreditation Program, to independently test the Covered Products (and other Cymbiotika products) including to the provisions provided in this Section 3.4.
*Non-Contingent Civil Penalty:
$ 15,000.00
Attorney(s) Fees and Costs:
$ 29,366.00
Payment in Lieu of Penalty:
$ 10,634.00 ((Amounts rounded. Actual Amounts: Civil Pen. $15,000.00, Atty Fees & Costs: $29,365.61, ASP: $10,634.39; 4.4 $10,634.39 shall be distributed to ERC as an Additional Settlement Payment (“ASP”), pursuant to California Code of Regulations, title 11, sections 3203, subdivision (d) and 3204. ERC will utilize the ASP for activities that address the same public harm as allegedly caused by Defendant in this matter. These activities are detailed below and support ERC’s overarching goal of reducing and/or eliminating hazardous and toxic chemicals in dietary supplement products in California. ERC’s activities have had, and will continue to have, a direct and primary effect within the State of California because California consumers will be benefited by the reduction and/or elimination of exposure to lead in dietary supplements and/or by providing clear and reasonable warnings to California consumers prior to ingestion of the products. Based on a review of past years’ actual budgets, ERC is providing the following list of activities ERC engages in to protect California consumers through Proposition 65 citizen enforcement, along with a breakdown of how ASP funds will be utilized to facilitate those activities: (1) ENFORCEMENT (up to 65-80%): obtaining, shipping, analyzing, and testing dietary supplement products that may contain lead and are sold to California consumers. This work includes continued monitoring and enforcement of past consent judgments and settlements to ensure companies are in compliance with their obligations thereunder, with a specific focus on those judgments and settlements concerning lead. This work also includes investigation of new companies that ERC does not obtain any recovery through settlement or judgment; (2) VOLUNTARY COMPLIANCE PROGRAM (up to 10-20%): maintaining ERC’s Voluntary Compliance Program by acquiring products from companies, developing and maintaining a case file, testing products from these companies, providing the test results and supporting documentation to the companies, and offering guidance in warning or implementing a self-testing program for lead in dietary supplement products; and (3) “GOT LEAD”PROGRAM (up to 5%): maintaining ERC’s “Got Lead?” Program which reduces the numbers of contaminated products that reach California consumers by providing access to free testing for lead in dietary supplement products (Products submitted to the program are screened for ingredients which are suspected to be contaminated, and then may be purchased by ERC, catalogued, sent to a qualified laboratory for testing, and the results shared with the consumer that submitted the product). ERC shall be fully accountable in that it will maintain adequate records to document and will be able to demonstrate how the ASP funds will be spent and can assure that the funds are being spent only for the proper, designated purposes described in this Stipulated Consent Judgment. ERC shall provide the Attorney General, within thirty days of any request, copies of documentation demonstrating how such funds have been spent.)
)
Total Payments:
$ 55,000.00
Is Judgment Pursuant to Settlement?
Address:
25361 Commercentre Drive, Suite 150
City, State, Zip:
Lake Forest, CA 92630
Phone Number:
(949) 452-1234
