3. INJUNCTIVE RELIEF, REFORMULATION, TESTING AND WARNINGS 3.1 Beginning on the Compliance Date, NUTREX 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 that do not qualify as a Reformulated Covered Product under Section 3.3 unless they meet 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 NUTREX 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” and “Daily Cadmium Exposure Level” shall be measured in micrograms, and shall be calculated using the following formula: micrograms of lead or cadmium 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 or cadmium exposure per day. 3.2 Clear and Reasonable Warnings If NUTREX is 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] [and] [cadmium] which is [are] 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. NUTREX shall use the phrase “cancer and” in the Warning only if the “Daily Lead Exposure Level,” after subtracting the amount of lead deemed “naturally occurring” for the purposes of this Consent Judgment Only for each ingredient listed in Table 3.3.3 below, is greater than 15 micrograms of lead as determined pursuant to the quality control methodology set forth in Section 3.4. As identified in the brackets, the warning shall appropriately reflect whether there is lead, cadmium, or both chemicals present in each of the Covered Product in amounts that exceed the requirements of Reformulated Covered Products described at Section 3.3.1 below. The Warning shall be securely affixed to or printed upon the container or label of each Covered Product. 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. 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 NUTREX’s product packaging 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. NUTREX must display the above Warning with such conspicuousness, as compared with other words, statements, design of the label, container, or on its website, 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 3.3.1 A Reformulated Covered Product is one for which the “Daily Lead Exposure Level” is no greater than 0.5 micrograms of lead per day, after subtracting the amount of lead deemed “naturally occurring” for the purposes of this Consent Judgment only for each ingredient listed in Table 3.3.3 below, and/or “Daily Cadmium Exposure Level” is no more than 4.1 micrograms ofcadmium per day as determined by the quality control methodology described in Section 3.4 3.3.2 The amount of lead deemed “naturally occurring” in each of the Covered Products for the purposes of this Consent Judgment only is the sum of the amounts of “naturally occurring” lead supplied by the quantity of each ingredient listed in Table 3.3.3 that is present in each Covered Product. For each ingredient listed in Table 3.3.3, the amount of lead deemed “naturally occurring” is listed in Table 3.3.3 in micrograms of “naturally occurring” lead per gram of the ingredient that is contained in the Covered Product. 3.3.3 If NUTREX seeks to utilize the allowances provided in Table 3.3.3 it must, prior to its first distribution or sale of Covered Products after the Compliance Date, provide to ERC the percentage of each ingredient in each of the Covered Products subject to confidentiality. Table 3.3.3 Ingredient Amount of lead per gram of ingredient deemed naturally occurring Calcium (elemental) 0.8 mcg Ferrous Fumarate 0.4 mcg Zinc Oxide 8.0 mcg Magnesium Oxide 0.4 mcg Magnesium Carbonate 0.332 mcg Zinc Gluconate 0.8 mcg Potassium Chloride 1.0 mcg Cocoa Powder 1.0 mcg 3.4 Testing and Quality Control Methodology 3.4.1 Beginning within one year of the Effective Date, NUTREX shall arrange for lead and/or cadmium testing of the Covered Products at least once a year for a minimum of three (3) consecutive years by arranging for testing of five (5) randomly selected samples of each of the Covered Products, in the form intended for sale to the end-user, which NUTREX 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 thisSection demonstrate that no Warning is required for a Covered Product during each of three (3) 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 three-year testing period, NUTREX changes ingredient suppliers for any of the Covered Products and/or reformulates any of the Covered Products, NUTREX shall test that Covered Product annually for at least three (3) consecutive years after such change is made. 3.4.2 For purposes of measuring the “Daily Lead Exposure Level” and/or “Daily Cadmium Exposure Level,” the highest lead and/or cadmium 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 NUTREX’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, NUTREX shall deliver lab reports obtained pursuant to Section 3.4 to ERC. NUTREX shall retain all test results and documentation for a period of five years from the date of each test.
