60 Day Notice 2016-01130

AG Number: 
2016-01130
Notice PDF: 
Date Filed: 
10/04/2016
Noticing Party: 
Environmental Research Center, Inc.
Plaintiff Attorney: 
William F. Wraith
Alleged Violators: 
Essante Organics, LLC
Chemicals: 
Lead and lead compounds
Source: 
Dietary Supplements

60-Day Notice Document

Civil Complaint
AG Number:
2016-01130
Complaint PDF: 
Date Filed:
12/16/2016
Case Name: 
Environmental Research Center, Inc. v Essante Organics, LLC
Court Name: 
Alameda County Superior Court
Court Docket Number: 
RG16842657
Plaintiff: 
Environmental Research Center, Inc.
Plaintiff Attorney: 
William F. Wraith
Defendant: 
Essante Organics, LLC
Type of Claim: 
Failure to Warn
Relief Sought: 
Warning
Civil Penalty
Contact Name: 
William F. Wraith
Contact Organization: 
Wraith Law
Email Address:
Address: 
24422 Avenida de la Carlota, Suite 400
City, State, Zip:
Laguna Hills, CA 92653
Phone Number:
(949) 452-1234
Settlement
AG Number:
2016-01130
Settlement PDF: 
Settlement Date:
01/27/2017
Case Name: 
Environmental Research Center v. Essante Organics, LLC
Court Name: 
Alameda County Superior Court
Court Docket Number: 
RG16842657
Plaintiff: 
Environmental Research Center, Inc.
Plaintiff Attorney: 
William F. Wraith
Defendant: 
Essante Organics, LLC
Injunctive Relief: 
3. INJUNCTIVE RELIEF, REFORMULATION, TESTING AND WARNINGS 3.1 Beginning on the Effective Date, ESSANTE shall be permanently enjoined from manufacturing for sale in the State of California, “Distributing into the State of California”, or directly selling in the State of California, any Covered Products which exposes a person to a “Daily Lead Exposure Level” of more than 0.5 micrograms of lead per day unless it meets the warning requirements under Section 3.2. 3.1.1 As used in this Consent Judgment, the term “Distributing into the State of California” shall mean to directly ship a Covered Product into California for sale in California or to sell a Covered Product to a distributor that ESSANTE knows or has reason to know will sell the Covered Product in California. 3.1.2 For purposes of this Consent Judgment, the “Daily Lead Exposure Level” shall be measured in micrograms, and shall be calculated using the following formula: micrograms of lead per gram of product, multiplied by grams of product per serving of the product (using the largest serving size appearing on the product label), multiplied by servings of the product per day (using the largest number of servings in a recommended dosage appearing on the product label), which equals micrograms of lead exposure per day. 3.2 Clear and Reasonable Warnings If ESSANTE is required to provide a warning pursuant to Section 3.1, the following warning must be utilized (“Warning”): WARNING: 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. ESSANTE shall use the phrase “cancer and” in the Warning only if 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. The Warning shall be provided on the invoice in boxes of Covered Products shipped to California. ESSANTE shall provide one invoice Warning for each Covered Product in a box or one invoice Warning that lists all of the Covered Products in the box. The Covered Products may be returned by the consumer for a refund within 30 days of the invoice date at no cost to the consumer if the consumer references the Warning as a reason for the return. The Warning must be present on the front of the invoice. The Warning shall be at least the same size as the largest of any other health or safety warnings also appearing on the invoice 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, or reducing the clarity 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. ESSANTE must display the above Warning with such conspicuousness, as compared with other words and statements on the invoice, to render the Warning likely to be read and understood by an ordinary individual under customary conditions of purchase or use of the product. 3.3 Reformulated Covered Products A Reformulated Covered Product is one for which the “Daily Lead Exposure Level” is no greater than 0.5 micrograms of lead per day as determined by the quality control methodology described in Section 3.4. 3.4 Testing and Quality Control Methodology 3.4.1 Beginning within one year of the Effective Date, ESSANTE 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 five randomly selected samples of each of the Covered Products, in the form intended for sale to the end-user, which ESSANTE 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, ESSANTE changes ingredient suppliers for any of the Covered Products and/or reformulates any of the Covered Products, ESSANTE 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 five (5) randomly selected samples of the Covered Products will be controlling. 3.4.3 All testing pursuant to this 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, qualification, 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 0.010 mg/kg or any other testing method subsequently agreed to in writing by the Parties and approved by the Court through entry of a modified consent judgment. 3.4.4 All testing pursuant to this 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 Consent Judgment shall limit ESSANTE’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, ESSANTE shall deliver lab reports obtained pursuant to Section 3.4 to ERC. ESSANTE shall retain all test results and documentation for a period of five years from the date of each test.
*Non-Contingent Civil Penalty:
$ 7,612.00
Attorney(s) Fees and Costs:
$ 26,679.00
Payment in Lieu of Penalty:
$ 5,709.00  (Actual Payment Terms: 4. SETTLEMENT PAYMENT 4.1 In full satisfaction of all potential civil penalties, additional settlement payments, attorney’s fees, and costs, ESSANTE shall make a total payment to ERC of $40,000.00 (“Total Settlement Amount”) in six monthly installments plus 8% per annum simple interest on the balance remaining after the first payment. The Total Settlement Amount including interest shall be paid on the following schedule (“Due Dates”): $6,666.67 due within 5 days of the Effective Date $6,888.89 due within 35 days of the Effective Date $6,844,45 due within 65 days of the Effective Date $6,800.00 due within 95 days of the Effective Date $6,755.56 due within 125 days of the Effective Date $6,711.09 due within 155 days of the Effective Date 4.2 ESSANTE shall make these payments by wire transfer to ERC’s escrow account, for which ERC will give ESSANTE the necessary account information. The Total Settlement Amount shall be apportioned as follows: 4.3 $7,611.95 shall be considered a civil penalty pursuant to California Health and Safety Code section 25249.7(b)(1). ERC shall remit 75% ($5,708.96) of the civil penalty to the Office of Environmental Health Hazard Assessment (“OEHHA”) for deposit in the Safe Drinking Water and Toxic Enforcement Fund in accordance with California Health and Safety Code section 25249.12(c). ERC will retain the remaining 25% ($1,902.99) of the civil penalty. 4.4 $2,994.75 shall be distributed to ERC as reimbursement to ERC for reasonable costs incurred in bringing this action. 4.5 $5,708.95 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 benefitted 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 (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 (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 Consent Judgment. ERC shall provide the Attorney General, within thirty days of any request, copies of documentation demonstrating how such funds have been spent. 4.6 $7,875.00 shall be distributed to William F. Wraith as reimbursement of ERC’s attorney’s fees, while $15,809.35 shall be distributed to ERC for its in-house legal fees. Except as explicitly provided herein, each Party shall bear its own fees and costs. 4.6 In the event that ESSANTE fails to remit any settlement payment owed under Section 4 of this Consent Judgment on or before its respective Due Date, ESSANTE shall be deemed to be in material breach of its obligations under this Consent Judgment. ERC shall provide written notice of the delinquency to ESSANTE via electronic mail. If ESSANTE fails to deliver the past due settlement payment within five (5) days from the written notice, the Total Settlement Amount shall become immediately due and owing and shall accrue interest at the statutory judgment interest rate provided in the California Code of Civil Procedure section 685.010. Additionally, ESSANTE agrees to pay ERC’s reasonable attorney’s fees and costs for any efforts to collect the payment due under this Consent Judgment. )
Total Payments:
$ 40,000.00
Will settlement be submitted to court?
Yes
Contact Name: 
William F. Wraith
Contact Organization: 
Wraith Law
Email Address:
bill@wraithlaw.com
Address: 
24422 Avenida de la Carlota, Suite 400
City, State, Zip:
Laguna Hills, CA 92653
Phone Number:
(949) 452-1234
Judgment
AG Number:
2016-01130
Judgment PDF: 
Judgment Date:
04/04/2017
Settlement reported to AG: 
Fri, 01/27/2017
Case Name: 
Environmental Research Center, Inc. v. Essante Organics, LLC
Court Name: 
Alameda County Superior Court
Court Docket Number: 
RG16842657
Plaintiff: 
Environmental Research Center, Inc.
Plaintiff Attorney: 
Willliam F. Wraith
Defendant: 
Essante Organics, LLC
Injunctive Relief: 
3. INJUNCTIVE RELIEF, REFORMULATION, TESTING AND WARNINGS 3.1 Beginning on the Effective Date, ESSANTE shall be permanently enjoined from manufacturing for sale in the State of California, “Distributing into the State of California”, or directly selling in the State of California, any Covered Products which exposes a person to a “Daily Lead Exposure Level” of more than 0.5 micrograms of lead per day unless it meets the warning requirements under Section 3.2. 3.1.1 As used in this Consent Judgment, the term “Distributing into the State of California” shall mean to directly ship a Covered Product into California for sale in California or to sell a Covered Product to a distributor that ESSANTE knows or has reason to know will sell the Covered Product in California. 3.1.2 For purposes of this Consent Judgment, the “Daily Lead Exposure Level” shall be measured in micrograms, and shall be calculated using the following formula: micrograms of lead per gram of product, multiplied by grams of product per serving of the product (using the largest serving size appearing on the product label), multiplied by servings of the product per day (using the largest number of servings in a recommended dosage appearing on the product label), which equals micrograms of lead exposure per day. 3.2 Clear and Reasonable Warnings If ESSANTE is required to provide a warning pursuant to Section 3.1, the following warning must be utilized (“Warning”): WARNING: 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. ESSANTE shall use the phrase “cancer and” in the Warning only if 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. The Warning shall be provided on the invoice in boxes of Covered Products shipped to California. ESSANTE shall provide one invoice Warning for each Covered Product in a box or one invoice Warning that lists all of the Covered Products in the box. The Covered Products may be returned by the consumer for a refund within 30 days of the invoice date at no cost to the consumer if the consumer references the Warning as a reason for the return. The Warning must be present on the front of the invoice. The Warning shall be at least the same size as the largest of any other health or safety warnings also appearing on the invoice 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, or reducing the clarity 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. ESSANTE must display the above Warning with such conspicuousness, as compared with other words and statements on the invoice,to render the Warning likely to be read and understood by an ordinary individual under customary conditions of purchase or use of the product. 3.3 Reformulated Covered Products A Reformulated Covered Product is one for which the “Daily Lead Exposure Level” is no greater than 0.5 micrograms of lead per day as determined by the quality control methodology described in Section 3.4. 3.4 Testing and Quality Control Methodology 3.4.1 Beginning within one year of the Effective Date, ESSANTE 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 five randomly selected samples of each of the Covered Products, in the form intended for sale to the end-user, which ESSANTE 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, ESSANTE changes ingredient suppliers for any of the Covered Products and/or reformulates any of the Covered Products, ESSANTE 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 five (5) randomly selected samples of the Covered Products will be controlling. 3.4.3 All testing pursuant to this 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, qualification, 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 0.010 mg/kg or any other testing method subsequently agreed to in writing by the Parties and approved by the Court through entry of a modified consent judgment. 3.4.4 All testing pursuant to this 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 Consent Judgment shall limit ESSANTE’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, ESSANTE shall deliver lab reports obtained pursuant to Section 3.4 to ERC. ESSANTE shall retain all test results and documentation for a period of five years from the date of each test.
*Non-Contingent Civil Penalty:
$ 7,612.00
Attorney(s) Fees and Costs:
$ 26,679.00
Payment in Lieu of Penalty:
$ 5,709.00  (Actual Payment Terms: 4. SETTLEMENT PAYMENT 4.1 In full satisfaction of all potential civil penalties, additional settlement payments, attorney’s fees, and costs, ESSANTE shall make a total payment to ERC of $40,000.00 (“Total Settlement Amount”) in six monthly installments plus 8% per annum simple interest on the balance remaining after the first payment. The Total Settlement Amount including interest shall be paid on the following schedule (“Due Dates”): $6,666.67 due within 5 days of the Effective Date $6,888.89 due within 35 days of the Effective Date $6,844,45 due within 65 days of the Effective Date $6,800.00 due within 95 days of the Effective Date $6,755.56 due within 125 days of the Effective Date $6,711.09 due within 155 days of the Effective Date 4.2 ESSANTE shall make these payments by wire transfer to ERC’s escrow account, for which ERC will give ESSANTE the necessary account information. The Total Settlement Amount shall be apportioned as follows: 4.3 $7,611.95 shall be considered a civil penalty pursuant to California Health and Safety Code section 25249.7(b)(1). ERC shall remit 75% ($5,708.96) of the civil penalty to the Office of Environmental Health Hazard Assessment (“OEHHA”) for deposit in the Safe Drinking Water and Toxic Enforcement Fund in accordance with California Health and Safety Code section 25249.12(c). ERC will retain the remaining 25% ($1,902.99) of the civil penalty. 4.4 $2,994.75 shall be distributed to ERC as reimbursement to ERC for reasonable costs incurred in bringing this action. 4.5 $5,708.95 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 benefitted 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 (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 (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 Consent Judgment. ERC shall provide the Attorney General, within thirty days of any request, copies of documentation demonstrating how such funds have been spent. 4.6 $7,875.00 shall be distributed to William F. Wraith as reimbursement of ERC’s attorney’s fees, while $15,809.35 shall be distributed to ERC for its in-house legal fees. Except as explicitly provided herein, each Party shall bear its own fees and costs. 4.6 In the event that ESSANTE fails to remit any settlement payment owed under Section 4 of this Consent Judgment on or before its respective Due Date, ESSANTE shall be deemed to be in material breach of its obligations under this Consent Judgment. ERC shall provide written notice of the delinquency to ESSANTE via electronic mail. If ESSANTE fails to deliver the past due settlement payment within five (5) days from the written notice, the Total Settlement Amount shall become immediately due and owing and shall accrue interest at the statutory judgment interest rate provided in the California Code of Civil Procedure section 685.010. Additionally, ESSANTE agrees to pay ERC's reasonable attorney's fees and costs for any efforts to collect the payment due under this Consent Judgment.)
Total Payments:
$ 40,000.00
Is Judgment Pursuant to Settlement?
Yes
Contact Name: 
William F. Wraith
Contact Organization: 
Wraith Law
Email Address:
wraithlaw@earthlink.net
Address: 
24422 Avenida de la Carlota, Suite 400
City, State, Zip:
Laguna Hills, CA 92653
Phone Number:
(949) 452-1234


* A non-contingent civil penalty is the civil penalty that must be paid pursuant to the settlement, regardless of future events or actions of the defendant. If a settlement includes a contingent penalty, the plaintiff should report the additional penalty amount when it becomes due.