U.S.A.'s interesting news

Pulleys pushed with deceptive Made in USA claims By Lesley Fair According to a settlement announced by the FTC, a Texas-based company used misleading Made in USA claims to push its pulleys. Read on for an ironic object lesson related to a specific pulley component engraved with the phrase “Made in USA.” Read more > FTC to host FinTech Forum on March 9 on Artificial Intelligence and Blockchain Technology The Federal Trade Commission will host its third FinTech forum on Thursday, March 9 in Berkeley, California, focusing on artificial intelligence and blockchain. The event is free and open to the public. More details can be found on the event’s web page. WHAT: FinTech Forum on Artificial Intelligence and Blockchain Technology WHO: Panels with representatives from industry, consumer advocacy groups, governmental agencies, and researchers, moderated by Federal Trade Commission staff. WHEN: Thursday, March 9 from 9:00 a.m. to 12:30 p.m. Pacific Time (Registration begins at 8:00 a.m. Pacific Time) WHERE: University of California, Berkeley Banatao Auditorium, 310 Sutardja Dai Hall Berkeley, CA 94720-7200 Distributor of Pulley Block Systems Settles with FTC, Agrees to Drop Misleading ‘Made in USA’ Claims A Texas-based distributor of pulley block systems will stop making misleading unqualified claims that its products  are made in the United States, under a settlement with the Federal Trade Commission. In its complaint against Block Division, Inc., the FTC alleges that the company deceived consumers with false, misleading, and unsupported claims that its pulley blocks and other products are “Made in USA.” According to the complaint, for a period of several years, Block Division’s pulleys featured imported steel plates that entered the United States from overseas already stamped “Made in USA.” The complaint also alleges that Block Division used unqualified “Made in USA” claims in advertising on its website, in stores, through trade shows and authorized dealers, on social media, and through flyers and pamphlets to represent that these pulley blocks, other products, and the parts used to make them, were all or virtually all made in the United States. In fact, the complaint states, Block Division’s pulley blocks and other products include significant imported parts, which are essential to the function of those products. “Consumers have the right to know that they can trust companies to be truthful when it comes to ‘Made in USA’ claims,” said Acting FTC Chairman Maureen Ohlhausen. “This is an important issue for American business and their customers, and the FTC will remain vigilant in this area.” This is the FTC’s second Made in USA case in five weeks. The stipulated final order prohibits Block Division from making unqualified “Made in USA” claims for any product unless it can show that the product’s final assembly or processing – and all significant processing – take place in the United States, and that all or virtually all ingredients or components of the product are made and sourced in the United States. Under the order, any qualified Made in USA claims must include a clear and conspicuous disclosure about the extent to which the product contains foreign parts, ingredients, and/or processing. Block Division also is prohibited from making any country-of-origin claims about its products unless the claims are true and not misleading, and unless the company has a reasonable basis for making them. The Commission vote to issue the complaint and accept the proposed consent order was 2-0. The FTC will publish the consent agreement package in the Federal Register shortly. The agreement will be subject to public comment for 30 days, beginning today and continuing through April 7, 2017, after which the Commission will decide whether to make the proposed consent order final. Comments can be filed electronically or in paper form by following the instructions in the “Supplementary Information” section of the Federal Register notice. 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. When the Commission issues a consent order on a final basis, it carries the force of law with respect to future actions. Each violation of such an order may result in a civil penalty of up to $40,654. The FTC’s Enforcement Policy Statement on U.S. Origin Claims provides further guidance on the Made in USA standard. 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 Testifies Before House Committee About Data Security and Small Businesses Acting Chairman Ohlhausen testifies on behalf of the Commission The Federal Trade Commission told the House Small Business Committee today that the agency is committed to protecting consumers and educating small businesses on ways to keep consumer data secure. Testifying on behalf of the Commission, Acting Chairman Maureen K. Ohlhausen outlined the Commission’s efforts to protect consumers and help small businesses take steps to secure consumer data. “Failing to take reasonable precautions to secure data from identity thieves and other malicious actors hurts consumers and legitimate businesses alike,” Acting Chairman Ohlhausen said in her written testimony. “Data breaches can harm a business’s financial interests and reputation as well as result in the loss of consumer confidence in the businesses to whom they entrust their data. In the case of small businesses, a data breach can be devastating.”  Since 2001, the Commission has taken action in approximately 60 cases against businesses that it charged with failing to provide reasonable and appropriate protections for consumers’ personal information. Acting Chairman Ohlhausen told the committee that FTC staff is working to provide the public with more information about the data security cases it closes. She said that such information would provide businesses, particularly small firms, with additional examples of what practices contribute to reasonable data security. She also outlined the FTC’s extensive efforts to educate business and consumers on data security through blog posts, published guides, videos and workshops. In particular, the Commission provides businesses with user-friendly information to help them protect data in their care and understand what practices may run afoul of the FTC Act. The Commission provides general business education about security issues, as well as specific guidance on emerging threats, such as tips to prevent phishing scams and ransomware. FTC guides for businesses on data security include the Protecting Personal Information: A Guide for Business, which was updated in November, and the Data Breach Response: A Guide for Business, which outlines steps businesses should follow when they experience a data breach. One of the FTC’s most recent efforts is its Start with Security initiative, which includes a guide for businesses that summarizes the lessons learned from the FTC’s data security cases, as well as several short videos.  These materials discuss 10 important security topics and give advice about specific security practices for each topic.  As part of this initiative, the FTC hosted events across the country to bring business owners and app developers together with industry experts to discuss practical tips and strategies for implementing effective data security.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Balloon angioplasty devices to treat autonomic dysfunction: FDA Safety Communication - FDA concern over experimental procedures

AUDIENCE: Neurology, Surgery, Health Professional, Patient

ISSUE: FDA is alerting the public about an experimental procedure called Transvascular Autonomic Modulation (TVAM). This procedure may put patients at risk because is being promoted as treatment for a variety of conditions even though it has not been formally studied in clinical trials. The procedure uses balloon angioplasty devices outside the scope of the FDA-approved indications for use.

BACKGROUND:TVAM consists of threading a catheter into a patient’s venous system, such as the jugular vein, where a balloon attached to the catheter inflates to widen the vein walls. At least one physician, Dr. Michael Arata, claims the procedure treats the signs and symptoms of autonomic dysfunction in a number of neurological disorders. The FDA has not reviewed any data that supports the safety and effectiveness of balloon angioplasty devices for this intended use.
 

RECOMMENDATION:For physicians providing care and potential clinical investigators: Be aware that the FDA has not cleared or approved any balloon angioplasty devices for the treatment of autonomic dysfunction, and has not been presented with data to support the use of such devices in treating autonomic dysfunction. Discuss the benefits and risks of all available treatments for autonomic dysfunction with patients, including the adverse events generally associated with catheter-guided endovascular intervention and those related specifically to use of balloon angioplasty devices for TVAM. Inform patients that TVAM is experimental, and that the FDA has not been presented with any data in order to assure the safety and effectiveness of balloon angioplasty devices used in this procedure. If you become aware of patients who have undergone the procedure, monitor them for potential complications such as excessive pain, discomfort, bruising, excessive bleeding from the puncture site, and stroke or stroke-like complications.

Read the FDA Safety Communication for additional information.

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.htm
• 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 FDA Safety Communication at https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm545619.htm