60 Day Notice 2015-00555

Withdraw Notice Add a Complaint Add a Settlement Add a Judgment

AG Number: 
2015-00555
Notice PDF: 
PDF icon 2015-00555.pdf
Date Filed: 
06/15/2015
Noticing Party: 
Environmental Research Center, Inc.
Plaintiff Attorney: 
William F. Wraith
Alleged Violators: 
New Whey Nutrition, LLC
Chemicals: 
Lead and lead compounds
Source: 
Dietary Supplements

60-Day Notice Document

Civil Complaint
AG Number:
2015-00555
Complaint PDF: 
PDF icon 2015-00555C4129.pdf
Date Filed:
09/29/2015
Case Name: 
Environmental Research Center v. New Whey Nutrition, LLC
Court Name: 
Alameda County Superior Court
Court Docket Number: 
RG15787566
Plaintiff: 
Environmental Research Center, Inc.
Plaintiff Attorney: 
Wraith Law
Defendant: 
New Whey Nutrition, LLC
Type of Claim: 
Failure to Warn
Relief Sought: 
Warning
Civil Penalty
Injunction
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
Settlement
AG Number:
2015-00555
Settlement PDF: 
PDF icon 2015-00555S5556.pdf
Settlement Date:
02/14/2017
Case Name: 
Environmental Research Center v. New Whey Nutrition, LLC
Court Name: 
Alameda County Superior Court
Court Docket Number: 
RG15787566
Plaintiff: 
Environmental Research Center, Inc.
Plaintiff Attorney: 
William F. Wraith
Defendant: 
New Whey Nutrition, LLC
Injunctive Relief: 
3. INJUNCTIVE RELIEF, REFORMULATION, TESTING AND WARNINGS 3.1 Beginning six months from the Effective Date (“Compliance Date”), NEW WHEY NUTRITION 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 Product which exposes a person to a “Daily Lead Exposure Level” of more than 0.5 micrograms per day of lead as that term is defined in Section 3.1.2 when the maximum suggested dose is taken as directed on the Covered Product’s label, unless it meets the warning requirements under Section 3.2. Beginning on the Effective Date, NEW WHEY NUTRITION shall use Good Manufacturing Practices conforming with National Sanitation Foundation guidelines for manufacturing of any Covered Products distributed into the State of California. 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 NEW WHEY NUTRITION knows 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, minus the amounts of lead listed in Table 3.1.3 below (which for purposes of this Consent Judgment shall be treated as naturally occurring) 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. TABLE 3.1.2 INGREDIENT NATURALLY OCCURRING AMOUNT OF LEAD Calcium (Elemental) 0.8 micrograms/gram Ferrous Fumarate 0.4 micrograms/gram Zinc Oxide 8.0 micrograms/gram Magnesium Oxide 0.4 micrograms/gram Magnesium Carbonate 0.332 micrograms/gram Magnesium Hydroxide 0.4 micrograms/gram Zinc Gluconate 0.8 micrograms/gram Potassium Chloride 1.1 micrograms/gram Cocoa-powder 1.0 microgram/gram If NEW WHEY NUTRITION wishes to exclude the naturally occurring lead set forth in this section, it must, prior to the Effective Date, provide ERC with the percentage and weight of each ingredient for all Covered Products for which it is requesting that the exclusion be applied. In the event that a dispute arises with respect to compliance with the terms of this Consent Judgment as to any contribution from naturally occurring lead levels under the Section, the Parties shall meet and confer as set forth in Section 15. 3.2 Clear and Reasonable Warnings If NEW WHEY NUTRITION is required to provide a warning pursuant to Section 3.1, the following warning must be utilized: WARNING: This product contains lead, a chemical known to the State of California to cause [cancer and] birth defects or other reproductive harm. NEW WHEY NUTRITION shall use the phrase “cancer and” in the warning only if the maximum daily dose recommended on the label contains more than 15 micrograms of lead as determined pursuant to the quality control methodology set forth in Section 3.4. The warning shall be securely affixed to or printed upon the container or label of each Covered Product. In addition, for Covered Products sold over NEW WHEY NUTRITION’s website, the warning shall appear on NEW WHEY NUTRITION’s checkout page on its website for California consumers identifying any Covered Product, and also appear prior to completing checkout on NEW WHEY NUTRITION’s website when a California delivery address is indicated for any purchase of any Covered Product. The warning shall be at least the same size as the largest of any other health or safety warnings also appearing on its website or on the label or container of NEW WHEY NUTRITION’s product packaging and the word “WARNING” shall be in all capital letters and in bold print. No other statements about Proposition 65 or lead may accompany the warning. NEW WHEY NUTRITION must display the above warnings with such conspicuousness, as compared with other words, statements, or design of the label or container, as 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. 3.3 Reformulated Covered Products A Reformulated Covered Product is one for which the Daily Lead Exposure Level, taking in to account the naturally-occurring lead as defined in Section 3.1.2, when the maximum suggested dose is taken as directed on the Reformulated Covered Product’s label, contains no more 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, NEW WHEY NUTRITION shall arrange for lead testing of the Covered Products at least once a year for a minimum of three consecutive years by arranging for testing of at least five randomly selected samples of each of the Covered Products, in the form intended for sale to the end-user, which NEW WHEY NUTRITION intends to sell or is manufacturing for sale in California, directly selling to a consumer in California or “Distributing into California.” The testing requirement does not apply to any of the Covered Products for which NEW WHEY NUTRITION has provided the warning specified in Section 3.2 or for Covered Products that are no longer manufactured. 3.4.2 For purposes of measuring the “Daily Lead Exposure Level”, the arithmetic mean lead detection result of the randomly selected samples set forth in section 3.4.1 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. 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 NEW WHEY NUTRITION’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 Beginning on the Effective Date and continuing for a period of five years, NEW WHEY NUTRITION shall arrange for copies of all laboratory reports with results of testing for lead content under Section 3.4.1 to be automatically sent by the testing laboratory directly to ERC within ten days after completion of the testing. NEW WHEY NUTRITION shall retain all test results and documentation for a period of five years from the date of each test.
*Non-Contingent Civil Penalty:
$ 3,000.00
Attorney(s) Fees and Costs:
$ 37,000.00
Payment in Lieu of Penalty:
$ 0.00
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:
2015-00555
Judgment PDF: 
PDF icon 2015-00555J3468.pdf
Judgment Date:
05/02/2017
Settlement reported to AG: 
Tue, 02/14/2017
Case Name: 
Environmental Research Center, Inc. v. New Whey Nutrition
Court Name: 
Alameda County Superior Court
Court Docket Number: 
RG15787566
Plaintiff: 
Environmental Research Center, Inc.
Plaintiff Attorney: 
William F. Wraith
Defendant: 
New Whey Nutrition, LLC
Injunctive Relief: 
3. INJUNCTIVE RELIEF, REFORMULATION, TESTING AND WARNINGS 3.1 Beginning six months from the Effective Date (“Compliance Date”), NEW WHEY NUTRITION 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 Product which exposes a person to a “Daily Lead Exposure Level” of more than 0.5 micrograms per day of lead as that term is defined in Section 3.1.2 when the maximum suggested dose is taken as directed on the Covered Product’s label, unless it meets the warning requirements under Section 3.2. Beginning on the Effective Date, NEW WHEY NUTRITION shall use Good Manufacturing Practices conforming with National Sanitation Foundation guidelines for manufacturing of any Covered Products distributed into the State of California. 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 NEW WHEY NUTRITION knows 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, minus the amounts of lead listed in Table 3.1.3 below (which for purposes of this Consent Judgment shall be treated as naturally occurring) 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. TABLE 3.1.2 INGREDIENT NATURALLY OCCURRING AMOUNT OF LEAD Calcium (Elemental) 0.8 micrograms/gram Ferrous Fumarate 0.4 micrograms/gram Zinc Oxide 8.0 micrograms/gram Magnesium Oxide 0.4 micrograms/gram Magnesium Carbonate 0.332 micrograms/gram Magnesium Hydroxide 0.4 micrograms/gram Zinc Gluconate 0.8 micrograms/gram Potassium Chloride 1.1 micrograms/gram Cocoa-powder 1.0 microgram/gram If NEW WHEY NUTRITION wishes to exclude the naturally occurring lead set forth in this section, it must, prior to the Effective Date, provide ERC with the percentage and weight of each ingredient for all Covered Products for which it is requesting that the exclusion be applied. In the event that a dispute arises with respect to compliance with the terms of this Consent Judgment as to any contribution from naturally occurring lead levels under the Section, the Parties shall meet and confer as set forth in Section 15. 3.2 Clear and Reasonable Warnings If NEW WHEY NUTRITION is required to provide a warning pursuant to Section 3.1, the following warning must be utilized: WARNING: This product contains lead, a chemical known to the State of California to cause [cancer and] birth defects or other reproductive harm. NEW WHEY NUTRITION shall use the phrase “cancer and” in the warning only if the maximum daily dose recommended on the label contains more than 15 micrograms of lead as determined pursuant to the quality control methodology set forth in Section 3.4. The warning shall be securely affixed to or printed upon the container or label of each Covered Product. In addition, for Covered Products sold over NEW WHEY NUTRITION’s website, the warning shall appear on NEW WHEY NUTRITION’s checkout page on its website for California consumers identifying any Covered Product, and also appear prior to completing checkout on NEW WHEY NUTRITION’s website when a California delivery address is indicated for any purchase of any Covered Product. The warning shall be at least the same size as the largest of any other health or safety warnings also appearing on its website or on the label or container of NEW WHEY NUTRITION’s product packaging and the word “WARNING” shall be in all capital letters and in bold print. No other statements about Proposition 65 or lead may accompany the warning. NEW WHEY NUTRITION must display the above warnings with such conspicuousness, as compared with other words, statements, or design of the label or container, as 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. 3.3 Reformulated Covered Products A Reformulated Covered Product is one for which the Daily Lead Exposure Level, taking in to account the naturally-occurring lead as defined in Section 3.1.2, when the maximum suggested dose is taken as directed on the Reformulated Covered Product’s label, contains no more 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, NEW WHEY NUTRITION shall arrange for lead testing of the Covered Products at least once a year for a minimum of three consecutive years by arranging for testing of at least five randomly selected samples of each of the Covered Products, in the form intended for sale to the end-user, which NEW WHEY NUTRITION intends to sell or is manufacturing for sale in California, directly selling to a consumer in California or “Distributing into California.” The testing requirement does not apply to any of the Covered Products for which NEW WHEY NUTRITION has provided the warning specified in Section 3.2 or for Covered Products that are no longer manufactured. 3.4.2 For purposes of measuring the “Daily Lead Exposure Level”, the arithmetic mean lead detection result of the randomly selected samples set forth in section 3.4.1 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. 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 NEW WHEY NUTRITION’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 Beginning on the Effective Date and continuing for a period of five years, NEW WHEY NUTRITION shall arrange for copies of all laboratory reports with results of testing for lead content under Section 3.4.1 to be automatically sent by the testing laboratory directly to ERC within ten days after completion of the testing. NEW WHEY NUTRITION shall retain all test results and documentation for a period of five years from the date of each test.
*Non-Contingent Civil Penalty:
$ 3,000.00
Attorney(s) Fees and Costs:
$ 37,000.00
Payment in Lieu of Penalty:
$ 0.00
Total Payments:
$ 40,000.00
Is Judgment Pursuant to Settlement?
Yes
Contact Name: 
William F. Wraith
Contact Organization: 
Wraith Law
Email Address:
wraithlaw@
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.