Vitafusion
Facts-only compliance record. Every entry is source-backed and dated.
Event Timeline
Class II voluntary recall: potential metallic mesh in vitafusion gummies (F-0461-2021–F-0466-2021)
Church & Dwight Co., Inc. OGI Distribution Center (North Brunswick, New Jersey) initiated a voluntary Class II recall (FDA event_id 87745; recall numbers F-0461-2021 through F-0466-2021, six lines) on 2021-04-19. openFDA reason text, on every line: "Potential presence of a metallic mesh material in products." Voluntary: Firm initiated. Initial firm notification: Letter. Distribution pattern as recorded: "The product was distributed thru out the US and Canada, Panama, China,". Status Terminated; center classification date 2021-04-28; termination date 2022-02-03. F-0461-2021 is vitafusion MultiVites 150ct, 683 bottles (product code 027917019192; lot WA03044959). F-0462-2021 is vitafusion Fiber Well 220ct, 2,928 bottles (product code 027917019840; lots WA03087520, WA02487524, and WA03086273). F-0463-2021 is vitafusion Fiber Well 90ct, 7,782 bottles (product code 027917018904; lots WA02187020, WA03086671, and WA03087521). F-0464-2021 is vitafusion Melatonin 140ct and vitafusion Melatonin 44ct. Product quantity as recorded: "5475 Bottles 44ct Bottles, 2081 Bottles 140 CT". Code info as recorded lists product code 0-27917-02671-8 with lots WA03076990, WA03077852, and WA02608988, and product code 0-27917-28011-0 with lot WA03076270; openFDA does not pair each code to a count. F-0465-2021 is vitafusion Kids Melatonin 50ct, 1,320 bottles (product code 027917001708; lot WA03076268). F-0466-2021 is vitafusion SleepWell 250ct, 120 bottles (product code 0-27917-02524-7; lot WA03077414). This entry uses the openFDA recall initiation date.
NAD #6355, upheld by NARB Panel #268: discontinue “Clinically Proven Absorption”; Church & Dwight said it will comply
On March 23, 2020, BBB National Programs' National Advertising Division recommended that Church & Dwight Co., Inc. discontinue the claim "clinically proven absorption" on product labels, the vitafusion website, tradeshow materials, and video advertisements for its vitafusion gummy line of dietary supplements. The claim was challenged by Pharmavite LLC, manufacturer of Nature Made dietary supplements. The NAD press release states that the advertiser said it will appeal NAD's findings to the National Advertising Review Board. NAD found that many of the disclosures do not effectively limit the claim to vitamins C and D3 in vitafusion products that contain those ingredients, so consumers can reasonably take away that the products themselves have been tested and that all of their ingredients, not just vitamin C and D3, demonstrate "clinically proven absorption." NAD also determined that one message reasonably communicated by the claim is clinical proof of absorption in consumer-meaningful amounts, that the vitamin C and D3 studies were not a good fit for that message, and recommended that the claim be discontinued. In its advertiser statement, Church & Dwight said it will appeal and that it "fundamentally disagrees with NAD's conclusion that the claim 'clinically proven absorption' reasonably communicates to consumers the implied message that absorption of vitamins C and D3 occurs 'at clinically meaningful levels' . . . or that the challenged advertising making the claim is not substantiated." BBB National Programs' 2020 NAD annual report lists Church & Dwight Co., Inc. (Vitafusion Gummy Vitamins) as case #6355, case type MOD/DISC, March 2020 (NAD/CARU Case Reports, March 2020), and lists #6355C, case type COM, August 2020 (NAD/CARU Case Reports, August 2020). The report's NARB summary lists Panel #268, Church & Dwight Co, Inc. / Vitafusion Gummy Vitamins, as Decision Upheld. The report does not print a day for Panel #268 or for #6355C. A note dated August 29, 2020 identifies the decision as NARB Panel #268, July 31, 2020, from an appeal to NAD Case Report #6355. An August 25, 2020 report of the NARB recommendation states that the panel rejected Church & Dwight's argument that NAD had violated procedural rules, agreed that the amount of vitamin C and vitamin D3 absorption "clinically proven" to occur must be clinically meaningful, concluded that the studies could not quantify the amount absorbed and so failed to show that the amount is clinically meaningful, and recommended that the claim be discontinued. That report quotes Church & Dwight stating that it will comply with NARB's decision and "remains strongly committed to the self-regulatory process," and that it "does not feel it received a fair process or result either before NAD or NARB."
Prop 65 out-of-court settlement: Church & Dwight $46,724.29; 0.5 micrograms of lead per day unless warned
Environmental Research Center, Inc. and Church & Dwight Co., Inc. entered a settlement agreement and release, effective on the date it is fully executed. The California Attorney General's record for notice 2018-01419 lists the settlement date as April 5, 2019, the case name as Environmental Research Center vs. Church & Dwight Co., Inc., the court as an out-of-court settlement, and the docket number as N/A. The settlement PDF on that record is 2018-01419S7527. The 60-day notice was served August 17, 2018 and alleges that products manufactured, distributed, or sold by Church & Dwight contained lead at a level requiring a Proposition 65 warning. The agreement defines Covered Products as the products identified in that notice. The notice names nine products: Vitafusion Simply Good Bone & Muscle Support Calcium Plus Vitamin D Natural Peach Flavor; Vitafusion Simply Good The Sunshine Vitamin Vitamin D₃ 3000 IU Natural Blueberry Flavor; L' il Critters Fruit n' Honey Vitamin C Plus Vitamin D & Zinc Natural Cherry & Orange Flavors; Vitafusion MultiVites Complete Multivitamin Natural Berry, Peach & Orange Flavors; Vitafusion Fiber Well Fit Natural Peach, Raspberry & Berry Flavors; Vitafusion Melatonin SugarFree Natural White Tea with Passion Fruit Flavors; Vitafusion PreNatal Natural Lemon & Raspberry Lemonade Flavors; L'il Critters Powered By Vitafusion Probiotic Overall Wellness Support Vanilla Cream Flavor; and Vitafusion Fiber+ Calcium PreNatal Support Natural Pomegranate & Orange Flavors. Section 5.6 states that nothing in the agreement is intended to apply to any of Church & Dwight's products other than the Covered Products. Section 1.1 permanently enjoins Church & Dwight, beginning on the Effective Date, from manufacturing for sale in California, "Distributing into the State of California," or directly selling in California any Covered Product with a Daily Lead Exposure Level of more than 0.5 micrograms of lead per day, unless it meets the warning requirements in Section 3. Section 1.4 and Table 1 allow a deduction for lead deemed naturally occurring in elemental calcium, up to 0.8 micrograms per gram. Section 2.1 requires testing of at least two randomly selected gummies from each lot for three consecutive years, after which testing of a Covered Product is no longer required if no warning was required in each of those years. Section 3.1 sets out the warning required for a lot that exceeds 0.5 micrograms of lead per day, and Section 3.2 states that the phrase "cancer and" is used in that warning only if the Daily Lead Exposure Level is greater than 15 micrograms of lead, or if Church & Dwight has reason to believe another Proposition 65 chemical is present at a level requiring the cancer warning. Section 4.1 requires a total payment of $46,724.29 within ten days after the due-date conditions. Section 4.2 allocates $2,000.00 as a payment under Health and Safety Code section 25249.7(b)(1), of which ERC remits 75 percent ($1,500.00) to OEHHA and retains 25 percent ($500.00); $6,492.12 as reimbursement of ERC's costs; $13,950.00 to Michael Freund as attorney's fees; $617.50 to Ryan Hoffman as attorney's fees; and $23,664.67 as ERC's in-house legal fees. The Attorney General's settlement record reports a $2,000.00 non-contingent civil penalty, $44,724.00 in attorney fees and costs, $0.00 payment in lieu of penalty, and $46,724.00 in total payments, and quotes the 0.5-microgram injunctive term. Church & Dwight denies any wrongdoing, including the allegations in the notice, and the agreement states that nothing in it shall be construed as an admission of any fact, issue of law, or violation of law.