U.S.A.'s latest

The Kroger Company has recalled Comforts FOR BABY Purified Water with Fluoride  The Kroger Company has recalled Comforts FOR BABY Purified Water with Fluoride Added 1 GAL (3.78 L) with sell by dates from 4/26/2018 to 10/10/2018, after receiving complaints about mold in the product. Testing by Kroger has identified the mold as Talaromyces penicillium. The water is sold in clear containers, but the mold may not be visible with the naked eye. The FDA is issuing this consumer alert to reach parents and caregivers who may have bought the product, which is intended for infants. The products were distributed to Kroger stores, including Food 4 Less, Jay C, Jay C Food Plus, Kroger, Kroger Marketplace, Owen’s, Payless Super Market, and Ruler stores in Alabama, Arkansas, Georgia, Illinois, Indiana, Kentucky, Mississippi, Missouri, North Carolina, Ohio, South Carolina, Tennessee, Virginia and West Virginia.  The Kroger Company has instructed its stores to remove the recalled products. Pharmacist Choice Alcohol Prep Pads by Simple Diagnostics: Recall - Lack of Sterility Assurance and Other Quality Issues AUDIENCE: Pharmacy, Consumer ISSUE: Simple Diagnostics is voluntarily recalling three lots of Pharmacist Choice Alcohol Prep Pads (UPC # 898302001050, NDC # 98302-0001-05), which were manufactured by Foshan Flying Medical Products Co. Ltd., located in China, due to the lack of sterility assurance and other quality issues. The affected lots are: SD2070421201 (Exp. 12/2019) SD2070420925 (Exp. 09/2019) SD2070420601 (Exp. 12/2019) The affected lots were distributed between 10/18/2016 and 07/19/2017. The use of impacted Alcohol Prep Pads could result in adverse events such as infections. BACKGROUND: Pharmacist Choice Alcohol Preps are supplied to distributors and pharmacies. Pharmacist Choice Alcohol Preps are used by health care professionals and patients for preparation of the skin prior to injection, as well as in first aid to decrease germs in minor cuts, scrapes and burns. RECOMMENDATION: Simple Diagnostics is notifying its distributors and customers by issuing a “Dear Customer” letter and arranging for the return of all recalled products. Healthcare providers that have affected lots of Pharmacist Choice Alcohol Prep Pads that have been recalled should stop using the product and should return them to Simple Diagnostics. Health professionals and consumers with questions regarding this recall can contact Simple Diagnostics at 1-877-342-2385. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report Online: www.fda.gov/MedWatch/report Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 Read the MedWatch Safety Alert, including a link to the press release, at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm587711.htm Public Health Alert Recent Food and Beverage Alerts Advisories and Safety FDA Alerts Consumers About Potentially Life-Threatening Health Problems Linked to Limbrel December 5, 2017 On this page: Update Fast Facts What is the Problem and What is Being Done About It? What are the Symptoms? Who is at Risk? What Specific Products are in Question? What Do Consumers Need To Do? What do Health Care Providers Need to Do? Who Should be Contacted? What’s New December 4, 2017 The U.S. Food and Drug Administration has recommended that Primus Pharmaceuticals, Scottsdale, Arizona, voluntarily recall Limbrel, a capsule marketed to “manage the metabolic processes associated with osteoarthritis.” The company has not yet acted to remove the product from the market. Although the product is marketed as a medical food, the preliminary determination of the FDA investigation is that Limbrel is an unapproved new drug. The agency does not have mandatory recall authority over drug products. The FDA reminds consumers not to use Limbrel because of the risk of drug-induced liver injury, and a lung condition called hypersensitivity pneumonitis. Consumers taking this product should stop immediately and contact their health care provider. Health care providers who are aware that their patients are taking Limbrel should advise them to stop using it.   Fast Facts The FDA continues to investigate a rise in reports of serious adverse events, including drug-induced liver injury and a lung condition called hypersensitivity pneumonitis, involving Limbrel, a product in capsule form currently marketed to “manage the metabolic processes associated with osteoarthritis.” On November 30, 2017, the FDA reiterated to Primus Pharmaceuticals the agency’s safety concerns and serious health risks associated with continued use of the product. The FDA recommended a voluntary recall but so far the company has declined to take the product off the market. In early September, the FDA began investigating a rise in reports of serious adverse events, including drug-induced liver injury and a lung condition called hypersensitivity pneumonitis, involving Limbrel, a product in capsule form that has been marketed as a medical food to “manage the metabolic processes associated with osteoarthritis.” As of November 21, 2017, the FDA has received a total of 194 adverse event reports regarding Limbrel. In 30 of those cases, there was sufficient information for FDA medical experts to determine whether Limbrel was likely associated with these adverse events. Since issuing its initial public advisory on November 21, the agency has and continues to receive additional reports, which it is currently evaluating.  The FDA is advising consumers not to use Limbrel because of the risk of drug-induced liver injury and a lung condition called hypersensitivity pneumonitis. If you are taking this product, discontinue it immediately and contact your health care provider. Health care providers who are aware that their patients are taking Limbrel should advise them to stop using it. Symptoms of drug-induced liver injury can vary and may include jaundice, nausea, fatigue, and gastrointestinal discomfort. If you experience any of these symptoms, contact your health care provider immediately. Symptoms of hypersensitivity pneumonitis can vary and may include fever, chills, headache, cough, chronic bronchitis, shortness of breath or trouble breathing, weight loss, and fatigue. If you experience any of these symptoms, contact your health care provider immediately. back to top What is the Problem and What is Being Done About It? The FDA is investigating a rise in reports of serious adverse events involving Limbrel. While a range of adverse events have been reported, two serious and potentially life-threatening medical conditions are among them: drug-induced liver injury and hypersensitivity pneumonitis. In total, the FDA has received 194 adverse event reports regarding Limbrel; 30 of these contained sufficient information to use the Council for International Organizations of Medical Sciences (CIOMS) causality assessment method to determine the likelihood that an association between the consumption of Limbrel and the adverse events reported exists. On November 8, 2017, the FDA first contacted Primus Pharmaceuticals regarding the adverse events and requested information about the formula for Limbrel. The formula is being reviewed by the FDA. The FDA also obtained product samples from the company and the samples are undergoing testing. The FDA continues to investigate Primus Pharmaceuticals and the manufacturing process for Limbrel, and will share updates as they become available. What are the Symptoms of Drug Induced Liver Injury and Hypersensitivity Pneumonitis? The symptoms of drug-induced liver injury may vary. Common symptoms include jaundice, nausea, fatigue, and gastrointestinal discomfort. Symptoms of hypersensitivity pneumonitis may include fever, chills, headache, cough, chronic bronchitis, shortness of breath or trouble breathing, weight loss, and fatigue. back to top Who is at Risk? Anyone who is currently taking Limbrel may be at risk for developing symptoms associated with drug-induced liver injury and/or hypersensitivity pneumonitis. If you are taking Limbrel, immediately stop taking the product and contact your health care provider. What Specific Products are in Question? Limbrel is available in capsule form in two dosages: Limbrel250 and Limbrel500. The labeling states that the products contain two types of flavonoids: baicalin (from Scutellaria baicalensis) and catechin (from Acacia catechu).  Both dosages also contain zinc.  Claims made on the product label and in labeling indicate that Limbrel is intended to manage the metabolic processes associated with osteoarthritis. back to top What Do Consumers Need To Do? If you are taking Limbrel, immediately stop taking it and contact your health care provider.  If you have experienced any of the above-mentioned symptoms or other health problems while taking Limbrel, work with your health care provider to report your symptoms to the FDA through the MedWatch Safety Information and Adverse Event Reporting Program. What Do Health Care Providers Need To Do? Health care providers who are aware that their patients are taking Limbrel should advise them to immediately stop taking the product. If your patients have experienced any of the above-mentioned symptoms or other health problems while taking Limbrel, the FDA encourages you to work with them to provide clinical information through the MedWatch Safety Information and Adverse Event Reporting Program. back to top Who Should be Contacted? Consumers and health care professionals who have questions about Limbrel are encouraged to contact the FDA’s Division of Drug Information at 888-INFO-FDA (888-463-6332) or druginfo@fda.hhs.gov. The information in this release reflects the FDA’s best efforts to communicate what it has learned from the manufacturer and the state and local public health agencies invo Simple Diagnostics, Inc. Issues Voluntary Nationwide Recall of Foshan Flying Medical Alcohol Pads Due to the Lack of Sterility Assurance and Other Quality Issues Simple Diagnostics, is voluntarily recalling three lots of Pharmacist Choice Alcohol Prep Pads (UPC # 898302001050, NDC # 98302-0001-05), which were manufactured by Foshan Flying Medical Products Co. Ltd., located in China, due to the lack of sterility assurance and other quality issues. The use of impacted Alcohol Prep Pads could result in adverse events such as infections. To date, Simple Diagnostics has not received any reports of adverse events associated with use of these Sterile alcohol prep pads, referenced below. Pharmacist Choice Alcohol Preps are supplied to distributors and pharmacies. Pharmacist Choice Alcohol Preps are used by health care professionals and patients for preparation of the skin prior to injection, as well as in first aid to decrease germs in minor cuts, scrapes and burns. FTC Challenges Proposed Merger of Major Titanium Dioxide Companies Agency alleges that combining Tronox Limited and Cristal would reduce competition for white pigment used in a variety of products ranging from paint to plastic The Federal Trade Commission issued an administrative complaint challenging the merger of two top suppliers of chloride process titanium dioxide (“TiO2”), a white pigment used in a wide variety of products including paint, industrial coatings, plastic, and paper. The FTC’s administrative complaint [a public version of which will be linked to this news release shortly] charged that Tronox Limited’s proposed acquisition of competitor Cristal, for $1.67 billion and a 24 percent stake in the combined entity, would violate the antitrust laws by significantly reducing competition in the North American market (comprised of the United States and Canada) for chloride process titanium dioxide. The FTC alleges that the acquisition, if consummated, would increase the risk of coordinated action among the remaining competitors, and increase the risk of future anticompetitive output reductions by Tronox. The Commission also authorized agency staff to seek a temporary restraining order and preliminary injunction in federal court, if necessary, to maintain the status quo pending an administrative trial on the merits. Stamford, Conn.-based Tronox, and Cristal, which is headquartered in Saudi Arabia, are two of the top three producers of chloride process titanium dioxide in the North American market. Titanium dioxide is manufactured using either a chloride process or a sulfate process. According to the FTC’s complaint, the vast majority of titanium dioxide sold in the United States and Canada is made using the chloride process, which produces brighter, more durable coatings than the sulfate process. The FTC alleges that, in the North American market, sulfate titanium dioxide is not a viable substitute for chloride process titanium dioxide. The complaint notes that the major customers for titanium dioxide in the North American market, principally coatings manufacturers, could not easily or cost-effectively shift away from chloride process titanium dioxide in favor of sulfate process titanium dioxide. The Commission alleges that without a remedy, the acquisition would allow the newly merged firm and the other top supplier, Chemours Company, to control the vast majority of chloride titanium dioxide sales in the North American market and more than 80 percent of chloride titanium dioxide manufacturing capacity in the North American market. According to the complaint, the acquisition would increase the likelihood of successful coordination among the remaining four suppliers. The market is already dominated by a few large players with a history of seeking to support higher prices by restricting production. According to the complaint, proprietary technology and the significant investment needed to build a new titanium dioxide plant constitute significant barriers to entry into the market from new producers, and expansion by existing producers sufficient to defeat anticompetitive effects in the North American market is unlikely. Recently, the Third U.S. Circuit Court of Appeals observed in Valspar Corp. v. E.I. DuPont de Nemours and Co., 873 F.3d 185 (3rd Cir. 2017) that the titanium dioxide industry “is an oligopoly” that is “dominated by a handful of firms” and has “substantial barriers to entry.” The Third Circuit recognized further that the industry is “primed for anticompetitive interdependence” and “it operated in that manner,” without the need for an explicit conspiracy. The evidence supporting the FTC’s complaint shows that the proposed merger would make that situation even worse—a classic case for prohibiting a merger under Section 7 of the Clayton Act. The complaint names Tronox, Cristal’s U.S. agent Cristal USA, and Cristal’s ultimate parent companies, Saudi Arabia-based National Industrialization Company and National Titanium Dioxide Company Limited. On December 3, 2017, Tronox issued a press release announcing that “the waiting period in the United States under the Hart-Scott-Rodino Act expired at 11:59 p.m. EST on Dec. 1, 2017 without further action by or communication from the U.S. Federal Trade Commission.” However, the statutory waiting period had expired on or about Oct. 7, 2017, and the subsequent period was the subject of a written agreement not to close between the merging firms and Commission staff. That agreement required the parties to provide Commission staff 10 business days of advance notice before consummating the transaction. At the time of Tronox’s press release, the company was aware that the matter was pending before the Commission for imminent further action, and that it could not close the proposed acquisition because of still pending reviews in other jurisdictions. The Commission vote to issue the administrative complaint and to authorize staff to seek a temporary restraining order and preliminary injunction in the U.S. District Court for the District of Columbia was 2-0. The administrative trial is scheduled to begin on May 8, 2018. NOTE: The Commission issues an administrative complaint when it has “reason to believe” that the law has been or is being violated, and it appears to the Commission that a proceeding is in the public interest. The issuance of the administrative complaint marks the beginning of a proceeding in which the allegations will be tried in a formal hearing before an administrative law judge. FTC to Hold Public Workshop in Washington, D.C. on March 7, 2018 to Examine the Contact Lens Marketplace and Proposed Changes to the Commission’s Contact Lens Rule The Federal Trade Commission will hold a public workshop in Washington, DC, on March 7, 2018 to explore issues regarding competition in the contact lens marketplace, consumer access to contact lenses, prescription release and portability, and related subjects. The workshop is being held in conjunction with the Commission’s regulatory review of the Contact Lens Rule. A Notice of Proposed Rulemaking (NRPM) was issued in December 2016 announcing proposed changes to the Commission’s Contact Lens Rule. The Rule, in place since August 2004, helps to promote competition in the retail sale of contact lenses by facilitating consumers’ ability to comparison shop for contact lenses. It imposes obligations on both eye-care prescribers and contact lens sellers. When a prescriber completes a contact lens fitting, the Rule requires the prescriber to automatically provide the patient with a complete copy of the contact lens prescription, and to verify or provide the prescription to authorized third parties. The Rule also requires that contact lens sellers dispense contact lenses only in accordance with a valid prescription the seller has received from either the patient or prescriber, or has verified via direct communication with the prescriber. Topics to be discussed at the workshop include, but are not limited to: Consumers’ ability to comparison shop for contact lenses; The use of electronic health records, patient portals, and other technology to improve prescription portability; The interaction between the Contact Lens Rule and emerging telehealth business models; The potential for new technology to improve the prescription verification process; and Modifications to the Rule to foster competition and maximize consumer benefits, including benefits to eye health. The workshop is free and open to the public, and the Commission is accepting requests to participate as a panelist from interested parties through January 5, 2018, via email at: contactlensworkshop2018@ftc.gov. The FTC also welcomes written comments on the issues to be discussed at the workshop. Interested parties may file a comment online until April 6, 2018, at: https://ftcpublic.commentworks.com/ftc/contactlensworkshop. To file a comment or request to participate on paper, write “Contact Lens Rule, 16 CFR Part 315, Comment, Project No. R511995” on your comment, or “Contact Lens Rule, 16 CFR Part 315, Request to Participate, Project No. R511995,” on your request, and mail your submission to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue, NW, Suite CC-5610 (Annex F), Washington, DC 20580, or deliver your submission to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street, SW, 5th Floor, Suite 5610 (Annex F). Requests to participate must be received on or before January 5, 2018. The public comment period will remain open until April 6, 2018, and comments received will be posted on the workshop’s public webpage. The workshop will be held at the FTC’s Constitution Center Conference Center, 400 7th St., SW, Washington, DC 20024. The Commission will publish a detailed agenda at a later date.  The Commission vote approving the Federal Register notice announcing the workshop was 2-0. FTC Proposes Updates to R-Value Rule for Home Insulation Products The Federal Trade Commission has proposed amendments to the R-value Rule, which governs ratings for home insulation, as part of its systematic review of all current FTC rules and guides. Issued in 1979, the R-value Rule requires home insulation manufacturers, professional installers, new home sellers, and retailers to provide R-value information, based on the results of standard tests, to help inform consumers. The R-value rates a product’s ability to restrict heat flow and thus reduce energy costs. The FTC sought comments on the Rule (formally, the “Trade Regulation Rule Concerning the Labeling and Advertising of Home Insulation”) in 2016. Based on comments received, the Commission proposes amendments that would: exempt space-constrained ads from required energy savings claims disclosures; clarify that commercial products sold for residential use are subject to the Rule; require R-value claims for non-insulation products to be substantiated by the Rule’s ASTM standards (commonly used tests for measuring R-value); update the Rule’s references to ASTM test procedures and revise Rule provisions for updating those tests; add information to fact sheets about the importance of air sealing and proper insulation installation; and direct online retailers to post labels and fact sheets for covered insulation products sold directly to consumers. The Commission vote approving the Notice of Proposed Rulemaking was 2-0. The notice will be published in the Federal Register soon. Instructions for filing comments appear in the Federal Register Notice. Comments must be received by February 12, 2017; they will be posted at ftc.gov/policy/public-comments. (FTC File No. R811001; the staff contact is Hampton Newsome, Bureau of Consumer Protection, 202-326-2889) The Federal Trade Commission works to promote competition, and protect and educate consumers. You can learn more about consumer topics and file a consumer complaint online or by calling 1-877-FTC-HELP (382-4357). Like the FTC on Facebook, follow us on Twitter, read our blogs and subscribe to press releases for the latest FTC news and resources. FTC Seeks Order to Stop Copycat Scam Pitching Bogus Credit Card Interest-Rate Reduction Services Defendants allegedly started the scheme weeks after FTC closed a similar robocall operation The Federal Trade Commission has filed a complaint in federal district court in Orlando to halt an alleged credit card interest-rate reduction scam that, the FTC alleges, deceived numerous consumers struggling with credit card debt. The Commission alleges that the individuals charged in this case, who previously worked for a nearly identical telemarketing operation shut down by court order in 2016 at the request of the FTC, set up a new operation selling similar bogus credit-card interest-rate-reduction services within weeks of the court order shuttering the earlier operation. According to the FTC’s complaint, Higher Goals Marketing LLC, Sunshine Freedom Services LLC, Brandun L. Anderson, Lea A. Brownell, Melissa M. Deese, Gerald D. Starr, Jr., and Travis L. Teel, have engaged in a telemarketing scheme that has deceived financially distressed consumers nationwide by pitching bogus credit-card interest-rate-reduction services. These telemarketers allegedly received substantial help in developing and carrying out the scheme from defendant Wayne T. Norris, who previously worked for the defendants in two other FTC cases involving the telemarketing of deceptive debt-relief services, 2016’s FTC v. Life Management Services of Orange County, LLC and 2012’s FTC v. Ambrosia Web Design, LLC. In fact, the complaint alleges that Norris began working with Anderson to set up the Higher Goals Marketing scheme weeks after the court entered a temporary restraining order (TRO) in the Life Management Services case. In this case, Norris is charged with violating the Telemarketing Sales Rule by helping the other defendants organize the telemarketing infrastructure they used to bombard consumers with illegal robocalls, putting a team of managers together to oversee the entire robocall operation, and helping to set up a shell company to collect illegal up-front fees from consumers. The complaint alleges that the other defendants used illegal robocalls to contact consumers and pitch their fake debt-relief services. They guaranteed that consumers would substantially and permanently lower their credit card interest rates, and would save thousands of dollars in interest payments. In reality, the complaint alleges, the scheme was rarely, if ever, able to obtain the promised results. In some instances, the defendants would obtain new credit cards for consumers with low introductory teaser rates – but the promotional rates on these cards were only temporary and the defendants failed to disclose that consumers would need to pay a fee to transfer their existing credit-card balances to the new cards. The defendants (other than Norris) allegedly violated both the FTC Act and the Telemarketing Sales Rule by misrepresenting that they could reduce credit card interest rates and save consumers money, as well as by failing to disclose that consumers could wind up paying a range of additional bank fees totaling one to three percent of their entire credit card debt. They are charged with additional TSR violations for collecting illegal up-front fees, calling consumers whose numbers are on the National Do Not Call Registry, making illegal robocalls, and failing to pay required fees to access the Do Not Call Registry. The FTC is seeking a TRO to stop the defendants’ allegedly illegal conduct. In seeking the TRO, the Commission is asking the court to stop the defendants’ alleged violations of the FTC Act and TSR pending resolution of the case. The Commission also is seeking the appointment of a receiver to take control of the corporate defendants, an asset freeze to preserve funds for potential consumer redress, as well as limited, expedited discovery. The Commission vote authorizing the staff to file the complaint seeking a temporary restraining order was 2-0. It was filed in the U.S. District Court for the Middle District of Florida, Orlando Division. A complete list of the defendants in this case can be found in the Commission’s complaint. The FTC appreciates the help of Florida’s Office of the Attorney General, Department of Legal Affairs, Consumer Protection Division. NOTE: The Commission files a complaint when it has “reason to believe” that the law has been or is being violated and it appears to the Commission that a proceeding is in the public interest. The case will be decided by the court. The Federal Trade Commission works to promote competition, and protect and educate consumers. You can learn more about consumer topics and file a consumer complaint online or by calling 1-877-FTC-HELP (382-4357). Like the FTC on Facebook, follow us on Twitter, read our blogs and subscribe to press releases for the latest FTC news and resources.