Nature Made
Facts-only compliance record. Every entry is source-backed and dated.
Event Timeline
Final judgment: TripleFlex false-advertising settlement; $1,935,000 cash fund (not a safety case)
On December 4, 2017, the U.S. District Court for the Central District of California entered final judgment in Barrera v. Pharmavite, LLC, No. 2:11-cv-04153-CAS-AGR (Document 436). Judge Christina A. Snyder signed the order. It certifies, for settlement purposes only, a class of all residents of the United States who purchased a Covered Product for personal use, and not resale or distribution, between May 1, 2007 and June 6, 2017. The amended settlement (Document 420-4, filed June 1, 2017) defines the Cash Settlement Fund as one million, nine hundred and thirty-five thousand dollars ($1,935,000.00), as that amount may be modified for notice and administration costs, litigation-expense reimbursement, and the incentive award. Settlement class members who submit valid claims with adequate proof of purchase may request $25.00 per bottle of Covered Product, and those without adequate proof of purchase may request $12.50 per bottle, up to four bottles per household. Section IV.H states that, without admitting wrongdoing, Pharmavite shall not, for a period of twenty-four (24) months commencing 180 days after the Effective Date, use "rebuild," "renew," "rejuvenate," and the listed variants of those words on Covered Product labels to describe the effect of glucosamine and/or chondroitin on cartilage. The settlement recital states that Pharmavite manufactures and sells various TripleFlex products and other products containing glucosamine and/or chondroitin, sold under the NatureMade brand and under retailer brand names, and that Covered Products are those identified in Exhibit B. The same recital states the named plaintiff does not claim that the Covered Products are unsafe and makes no claims about their safety. The judgment awards $3,475,000.00 in attorneys' fees, $600,000.00 in costs, and a $10,000.00 incentive award, dismisses the litigation with prejudice as to the released parties, and states that the settlement shall not be construed as an admission or concession by Pharmavite. This is not a safety event.
Class II voluntary recall: Salmonella, Staph, yeast/mold, and total viable plate count (F-2065-2016–F-2078-2016)
Pharmavite (Northridge, California) initiated a voluntary Class II recall (FDA event_id 74400; recall numbers F-2065-2016 through F-2078-2016, 14 lines) on 2016-06-06. All 14 lines are Nature Made products. Distribution pattern: nationwide. openFDA reason text falls into four groups. Possible Salmonella: adult gummies Multi (90 count and 150 count), Multi + Omega-3 (150 count), and adult gummies Multi for Her plus Omega-3 (100 count and 150 count), plus one lot on each of the Super B-Complex 360-count and 460-count lines. Possible Staphylococcus aureus: Super B-Complex 140 count, plus the other lot on each of the Super B-Complex 360-count and 460-count lines. Yeast/mold above specification: Vitamin D3 1000 IU tablets in 100-count, 125-count, 300-count, and 350-count bottles. Total viable plate count above specification: adult gummies Hair.Skin.Nails, 90 count and 150 count. Status Terminated; center classification date 2016-09-02; termination date 2017-04-10. This entry uses the openFDA recall initiation date.
Prop 65 consent judgment: Pharmavite $115,000 ($3,000 civil penalty) over PCBs in fish-oil supplements
On December 11, 2012, the San Francisco County Superior Court filed a consent judgment in Manthey and Chiles v. CVS Pharmacy, Inc., et al., No. CGC-10-497334, as to Pharmavite LLC, CVS Pharmacy, Inc., and Thrifty Payless, Inc. (erroneously sued as Rite Aid Corporation). The complaint, filed March 2, 2010, alleged that the defendants manufactured, packaged, distributed, marketed, and/or sold dietary supplements made from fish oils, fish liver oils, shark oils, and/or shark liver oils containing polychlorinated biphenyls (PCBs) without a clear and reasonable Proposition 65 warning. Section 4.1 requires Pharmavite to pay $115,000 ("Settlement Proceeds") within fifteen days after entry, of which $3,000 shall be deemed a civil penalty. The Attorney General's record for settlement 2009-00357S2447 (settlement date December 11, 2012; same court and docket) reports a $3,000 non-contingent civil penalty, $112,000 as payment in lieu of penalty, $0 in attorney fees, and $115,000 in total payments, with injunctive relief described as monitoring/testing and warnings. Exhibit A defines the Dietary Supplement Products to include Nature Made Cod Liver Oil and Nature Made Odorless Fish Oil, Spring Valley Natural Cod Liver Oil, Spring Valley Cod Liver Oil Vitamin A & D, and other fish-oil, shark-oil, krill-oil, algae-oil, and EPA or DHA supplements manufactured by or for Pharmavite and distributed or sold by a settling defendant. Beginning 90 days after the effective date, a settling defendant shall not manufacture for sale in California, distribute into California, or sell directly to a California consumer any covered product that exceeds 290 nanograms of PCBs per day (birth defects and reproductive harm) or 350 nanograms of PCBs per day (cancer), based on the maximum daily dosage on the label, unless the specified warning is used. Plaintiffs' 60-day notice is AG No. 2009-00357, dated August 6, 2009.