[{"url":"https://www.ftc.gov/business-guidance/blog/2020/06/ftc-wants-your-feedback-about-proposed-made-usa-rule","titre":"FTC wants your feedback about proposed Made in USA Rule","pubDate":"Mon, 05 Oct 2026 08:07:08 +0200","description":"FTC wants your feedback about proposed Made in USA Rule lfair June 22, 2020 | 4:04PM FTC wants your feedback about proposed Made in USA Rule By Lesley Fair If your clients are interested in Made in USA issues – and you know they are – there are two developments at the FTC they need to know about. First, the FTC just announced a Notice of Proposed Rulemaking for a Made in USA Labeling Rule . You’ll want to read the notice in detail, but the proposed Rule would apply to labels on products that make unqualified Made in USA claims. (In FTC parlance, an “unqualified” claim is a broad representation made without limitations.) The proposed Rule would incorporate established guidance already set forth in FTC decisions and orders and in the agency’s 1997 Enforcement Policy Statement on U.S. Origin Claims . Consistent with that guidance, the proposed Rule would prohibit marketers from making unqualified MUSA claims on labels unless: Final assembly or processing of the product occurs in the United States; All significant processing that goes into the product occurs in the United States; and All or virtually all ingredients or components of the product are made and sourced in the United States. The proposed Rule wouldn’t change or affect any other existing federal or state law or regulation relating to country-of-origin labels, but it suggests one notable modification: The proposed Rule would allow the FTC to seek civil penalties for violations. Once the proposed Rule is published in the Federal Register, we invite you to file a public comment either online or on paper. (Thanks for following the instructions for submitting comments included in the notice of proposed rulemaking.) Development #2 is that the FTC just issued a staff report on last fall’s Made in USA workshop convened to consider consumer perception of Made in USA claims and to discuss the agency’s Made in USA enforcement program. Dive into the report for the details, but according to the one panelist who provided survey evidence on how consumers understand Made in USA claims, a 2013 study suggests that almost 3 in 5 Americans agree that “Made in America” means that all parts of a product, including any natural resources it contains, originated in the United States. According to that same study, one third of consumers believe that 100% of a product must originate in a country for it to be called “made” in that country. The report cites those statistics in support of long-standing guidance in the FTC’s Enforcement Policy Statement on U.S. Origin Claims that at least a significant minority of consumers are likely to be deceived by an unqualified Made in USA claim for a product incorporating more than a trivial amount of foreign content.","id":3197412,"source":"FTC USA Business Blog Posts"},{"source":"Federal Trade Commission Concurrence communiqués","id":2298968,"description":"The Federal Trade Commission today moved to block medical device supplier Edwards Lifesciences Corp.’s (Edwards) proposed acquisition of JenaValve Technology, Inc. (JenaValve) due to concerns that the acquisition would limit patient access to lifesaving medical devices used to treat a potentially fatal heart condition. The FTC alleges that over the span of two days in July 2024, Edwards executed agreements to acquire both JenaValve and JC Medical, the two leading companies competing to bring to market transcatheter aortic valve replacement devices that treat a heart condition called aortic regurgitation (TAVR-AR devices). Edwards closed its acquisition of JC Medical in August 2024, and its proposed $945 million acquisition of JenaValve would combine the only two companies with ongoing clinical trials in the United States for a TAVR-AR device. The deal threatens to reduce competition in the TAVR-AR market, likely resulting in reduced innovation, diminished product quality, and potentially increased prices for consumers, according to the complaint. “ Edwards’ attempt to buy the U.S. market for TAVR-AR devices would eliminate the head-to-head competition that has spurred innovation for lifesaving artificial heart valves,” said Daniel Guarnera, Director of the FTC’s Bureau of Competition. “The FTC is taking action to stop this anticompetitive deal and ensure that JenaValve and Edwards’ JC Medical subsidiary continue competing to innovate, expand treatment eligibility, and keep down costs. Americans deserve all the benefits that come from competition between medical device makers, just as they do in other markets.” More than 8 million Americans suffer from aortic regurgitation, which occurs when the heart’s aortic valve does not close properly, causing blood to backflow into the heart. Currently, surgical valve replacement via open heart surgery is the only U.S. Food and Drug Administration (FDA) approved procedure to treat aortic regurgitation, and TAVR-AR devices offer a new and less invasive way to treat the condition. JenaValve is poised to become the first company to bring a TAVR-AR device, called Trilogy, to the commercial market in the United States. If Edwards acquires JenaValve, Edwards would gain control over the two most advanced TAVR-AR devices, the FTC complaint alleges. FDA approval or commercialization of any other TAVR-AR device in the United States by another company, aside from Edwards and JenaValve, is not expected for the foreseeable future. Direct head-to-head competition between Edwards, through its now-subsidiary JC Medical, and JenaValve has driven the two companies to accelerate the development of their TAVR-AR devices, the FTC’s complaint alleges. Ultimately, patients will benefit if JenaValve and Edwards continue to directly compete to complete their separate TAVR-AR device clinical trials, product improvements, and commercialization plans. The competition concerns caused by Edwards’ dual acquisition strategy are predicated on Edwards owning both JenaValve and JC Medical simultaneously, but Edwards has elected to attempt to buy JenaValve while retaining its ownership of JC Medical. Edwards has not been willing to engage on divesting JC Medical to resolve the competition concerns with the proposed JenaValve acquisition, according to the complaint. The Commission vote to issue an administrative complaint and authorize staff to seek a temporary restraining order and a preliminary injunction was 3-0. The federal court complaint and request for preliminary relief was filed in the U.S. District Court for the District of Columbia to halt the transaction pending an administrative proceeding. 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","pubDate":"Thu, 07 Aug 2025 09:48:21 +0200","titre":"FTC Challenges Anticompetitive Medical Device Deal","url":"https://www.ftc.gov/news-events/news/press-releases/2025/08/ftc-challenges-anticompetitive-medical-device-deal"}]