FDA Launches Crackdown on Deceptive Drug Advertising - Food & Drug Administration
The U.S. Department of Health and Human Services and the Food and Drug Administration today announced sweeping reforms to rein in misleading direct-to-consumer pharmaceutical advertisements. Today, the FDA is sending thousands of letters warning pharmaceutical companies to remove misleading ads and issuing approximately 100 cease-and-desist letters to companies with deceptive ads.
In addition to enforcing existing law, the FDA is initiating rulemaking to close the “adequate provision” loophole created in 1997, which drug companies have used to conceal critical safety risks in broadcast and digital ads, fueling inappropriate drug use and eroding public trust.
“Pharmaceutical ads hooked this country on prescription drugs,” Health and Human Services Secretary Robert F. Kennedy, Jr. said. “We will shut down that pipeline of deception and require drug companies to disclose all critical safety facts in their advertising. Only radical transparency will break the cycle of overmedicalization that drives America’s chronic disease epidemic.”
The FDA is concerned patients are not seeing a fair balance of information about drug products. This concern is magnified when serious risks are not clearly presented, or the information is too difficult for seniors to read or hear.
“For far too long, the FDA has permitted misleading drug advertisements, distorting the doctor-patient relationship and creating increased demand for medications regardless of clinical appropriateness,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Drug companies spend up to 25% of their budget on advertising. Those billions of dollars would be better spent on lowering drug prices for everyday Americans.”
Americans also live in a new era of social media. An increasing reliance on digital and social media channels, including undisclosed paid influencer promotion, has blurred the lines among editorial content, user-generated media and pharmaceutical advertising, making it increasingly difficult for patients to distinguish between evidence-based information and promotional material.
A 2024 review in the Journal of Pharmaceutical Health Services Research reveals that while 100% of pharmaceutical social media posts highlight drug benefits, only 33% mention potential harms. Moreover, 88% of advertisements for top-selling drugs are posted by individuals and organizations that fail to adhere to the FDA fair balance guidelines.
The stakes surrounding prescription drug ads are high. While these ads can raise awareness of disease states and beneficial therapies, they must also disclose important risks and limitations. Current law requires that advertisements present a fair balance between a product’s risks and benefits; avoid exaggerating benefits; not create a misleading overall impression; properly disclose financial relationships; and include information regarding major side effects and contraindications.
Despite widespread violations, the FDA has been increasingly lax and reactive in its enforcement approach over the last few decades. The FDA used to send more than a hundred warning letters each year, and misleading ads were rare. But over time, enforcement waned and the number of warning letters sent to pharmaceutical companies dropped to one in 2023 and zero in 2024.
The FDA will no longer tolerate such deceptive practices. Going forward, the agency will aggressively deploy its available enforcement tools. The FDA is already implementing AI and other tech-enabled tools to proactively surveil and review drug ads. ______________________________________________________________________________
Federal Register Notices:
• Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Heavy Walled Rectangular Welded Carbon Steel Pipes and Tubes From Mexico: Amended Final Results of Antidumping Duty Administrative Review; 2022-2023
• High Purity Dissolving Pulp From Brazil: Initiation of Countervailing Duty Investigation
• Investigations; Determinations, Modifications, and Rulings, etc.: Hexamine (Hexamethylenetetramine) From China
• Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Aluminum Foil From the Sultanate of Oman: Final Results of Countervailing Duty Administrative Review; 2022
• Sales at Less Than Fair Value; Determinations, Investigations, etc.: Certain Monomers and Oligomers From Taiwan: Preliminary Affirmative Determination of Sales at Less Than Fair Value and Preliminary Affirmative Determination of Critical Circumstances
• Investigations; Determinations, Modifications, and Rulings, etc.: Wooden Cabinets and Vanities From China; Determinations
• Sugar From Mexico; Determinations
• Investigations; Determinations, Modifications, and Rulings, etc.: Certain Women's Flats With Colored Outsoles Thereof; Notice of a Commission Determination To Review in Part an Initial Determination Granting Complainant's Motion for Summary Determination of Violation; Request for Written Submissions on Remedy, the Public Interest, and Bonding
• Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Carbon and Alloy Steel Cut-To-Length Plate From Belgium: Preliminary Results and Rescission, in Part, of Antidumping Duty Administrative Review; 2023-2024
• Carbon and Alloy Steel Cut-to-Length Plate From the Republic of Korea: Preliminary Results of Antidumping Duty Administrative Review; 2023-2024
• Citric Acid and Certain Citrate Salts From the People's Republic of China: Preliminary Results of the Antidumping Duty Administrative Review; 2023-2024
• Circular Welded Carbon Steel Standard Pipe and Tube Products From the Republic of Türkiye: Preliminary Results of Antidumping Duty Administrative Review; 2023-2024
• Polyethylene Terephthalate Resin From the Sultanate of Oman: Preliminary Results of Antidumping Duty Administrative Review; 2023-2024
• Large Diameter Welded Pipe From the Republic of Korea: Preliminary Results and Partial Rescission of the Countervailing Duty Administrative Review; 2023
• Large Diameter Welded Pipe From the Republic of Türkiye: Preliminary Results and Rescission, in Part, of Countervailing Duty Administrative Review; 2023
• Certain Carbon and Alloy Steel Cut-to-Length Plate From the Republic of Korea: Preliminary Results and Partial Rescission of Countervailing Duty Administrative Review; 2023
• Hexamethylenetetramine From the People's Republic of China: Antidumping Order and Countervailing Duty Order
• Non-Refillable Steel Cylinders From the People's Republic of China: Preliminary Results and Partial Rescission of the Antidumping Duty Administrative Review; 2023-2024
• Certain Steel Nails From the United Arab Emirates: Preliminary Results and Partial Rescission of Antidumping Duty Administrative Review; 2023-2024
• Chlorinated Isocyanurates From the People's Republic of China: Final Results of Countervailing Duty Administrative Review; 2022
• Certain Preserved Mushrooms From the Netherlands: Preliminary Results of Antidumping Duty Administrative Review; 2022-2024
• Certain Softwood Lumber Products From Canada: Amended Final Results of Antidumping Duty Administrative Review; 2023
• Glycine From India, Japan, Thailand, and the People's Republic of China: Notice of Court Decision Not in Harmony With Final Scope Ruling and Notice of Amended Final Scope Ruling Pursuant to Court Decision
• Certain Preserved Mushrooms From Poland: Preliminary Results of the Administrative Review of the Antidumping Duty Order; 2022-2024
• Welded Stainless Pressure Pipe From India: Final Results of Antidumping Duty Administrative Review; 2022-2023
• Carbon and Alloy Steel Cut-to-Length Plate From the Republic of Korea: Preliminary Results of Antidumping Duty Administrative Review; 2023-2024
• Silicomanganese From India: Preliminary Results of Antidumping Duty Administrative Review; 2023-2024
• Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Temporary Steel Fencing From China; Scheduling of the Final Phase of Countervailing Duty and Antidumping Duty Investigations
• Investigations; Determinations, Modifications, and Rulings, etc.: Freight Rail Couplers and Parts Thereof From Czech Republic and India; Determinations
• Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Aluminum Foil From the Sultanate of Oman: Final Results of Antidumping Duty Administrative Review; 2022-2023
• Certain Aluminum Foil From Brazil: Final Results of Antidumping Duty Administrative Review; 2022-2023
• Large Diameter Welded Pipe From Canada: Preliminary Results, Preliminary Determination of No Shipments and Rescission, in Part, of Antidumping Duty Administrative Review; 2023-2024
• Steel Concrete Reinforcing Bar From the Republic of Türkiye: Final Results of Countervailing Duty Administrative Review; 2022
• Circular Welded Non-Alloy Steel Pipe From the Republic of Korea: Final Results of Antidumping Duty Administrative Review; 2022-2023
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Imposing Sanctions on Online Scam Centers in Southeast Asia - U.S. Department of State
Criminal actors across Southeast Asia have increasingly exploited the vulnerabilities of Americans online. In 2024, Americans lost at least $10 billion to scam operations in Southeast Asia, according to a U.S. government estimate.
In response, the U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC) today imposed sanctions on nine targets involved in operations in Shwe Kokko, a scam center hub in Burma operating under the protection of the already sanctioned criminal organization Karen National Army (KNA). The KNA is a transnational criminal organization that facilitates online scam operations that target Americans and exploit workers in forced labor.
Additionally, OFAC sanctioned four individuals and six entities for their roles operating forced labor compounds in Cambodia, where workers are forced to carry out virtual currency investment scams against victims in the United States, Europe, China, and elsewhere.
These sanctions protect Americans from the pervasive threat of online scam operations by disrupting the ability of criminal networks to perpetuate industrial-scale fraud, forced labor, physical and sexual abuse, and theft of Americans’ hard-earned savings.
The Department of the Treasury’s sanctions designations were taken pursuant to Executive Order (E.O.) 13581, as amended by E.O. 13863, E.O. 14014, E.O. 13818, and E.O. 13694, as amended. For more information, see Treasury’s Press Release.
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Recovery Begins of Fallen Containers at Port of Long Beach - Port of Long Beach
Salvage operations have begun in order to open a channel to allow ships to safely transit to and from Pier G at the Port of Long Beach following an incident on Tuesday morning that caused an estimated 75 shipping containers to fall from the cargo ship Mississippi.
Officials from the Unified Command – consisting of federal, state, local agencies and representatives of the vessels involved – gathered again on Wednesday at the Port of Long Beach Joint Command and Control Center to guide operations in response to the incident.
Two sunken cargo containers were retrieved from the bottom of the basin on Wednesday. Additionally, responders secured the source of a fuel leak originating from an at-berth emissions control barge moored alongside the container vessel. The tank contained about 2,000 gallons of renewable diesel.
Cargo operations at the Port have been mostly unaffected by the incident, except in a 500-yard safety zone placed around the Mississippi, which was carrying 2,412 containers at the time of the incident. Containers began falling at 8:48 a.m. Tuesday. The Coast Guard, Jacobsen Port Pilots and the Port of Long Beach are working together to facilitate navigation in accordance with the safety zone.
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Online Marketplace Temu to Pay $2 Million Penalty for Alleged INFORM Act Violations - Federal Trade Commission
Action is the first brought under the Act, which ensures consumers can report suspicious activity to online marketplaces and contact major third party sellers
Whaleco, Inc., which operates the online marketplace Temu, will pay $2 million to resolve allegations that it violated the INFORM Consumers Act of 2023, by failing to provide consumers with required information and tools to help them avoid and report stolen, counterfeit, or unsafe goods while shopping online.
“The INFORM Act is designed to ensure consumers have the information and tools they need to not only report suspicious activity to online marketplaces, but to directly identify and contact high-volume, third party sellers in many cases,” said Christopher Mufarrige, Director of the Federal Trade Commission’s Bureau of Consumer Protection. “Temu, one of the most recognizable online marketplaces, is responsible for complying with the Act. Today’s action serves as a reminder to online marketplaces that violating the INFORM Act can result in serious consequences, including civil penalties.”
This is the first action to enforce the INFORM Act, which requires online marketplaces to disclose a reporting mechanism on the product listings of all high-volume third party sellers that consumers can use to report suspicious activity to the online marketplace either electronically or by telephonic means. The Act also requires online marketplaces to disclose identifying information for many high-volume third party sellers—the name of the seller, its physical address, and contact information to allow consumers to reach the seller directly.
According to the complaint, Temu failed to provide any telephonic means for consumers to report suspicious marketplace activity. When it did provide such a mechanism, the complaint alleges, it was difficult for consumers to access. In addition, Temu failed to provide any reporting mechanism for product listings in its gamified shopping experiences, which allow shoppers to play games, spin wheels, earn coupons, and undertake other activities while browsing and purchasing products, until November 2024, according to the complaint. When Temu eventually added a reporting mechanism, it was not clear and conspicuous as required by law, the complaint alleged.
Next, the complaint alleges that for part of the time the Act has been in effect, Temu failed to disclose clearly and conspicuously required information about third party sellers as part of its gamified product listings and for its mobile website.
The proposed consent order announced today addresses each of the INFORM Act violations alleged in the complaint. The proposed order, if approved by the district court, will require Temu to:
• Provide a telephonic reporting mechanism that allows consumers to listen back to, re-record, and accept any report before submitting it, and provide instructions in a way that consumers can easily hear and understand; and
• Disclose certain information as required under the Act—including electronic and telephonic reporting mechanisms and high-volume third party sellers’ names, addresses, and a means of contacting them—in a way that is easy for consumers to notice and understand. This includes making required disclosures for gamified product listings and for all versions of the Temu online marketplace including its smartphone app and desktop and mobile websites.
The proposed order also includes a $2 million civil penalty against Temu, which must be paid within seven days of the district court’s entry of the stipulated order.
The Commission vote to authorize the staff to refer the complaint and proposed consent decree to the Department of Justice was 3-0. The DOJ filed the complaint and proposed consent decree upon referral from the Commission in U.S. District Court for the District of Massachusetts, Eastern Division.
NOTE: The Commission authorizes the filing of a complaint when it has “reason to believe” that the named defendants are violating or are about to violate the law and it appears to the Commission that a proceeding is in the public interest. Consent decrees have the force of law when approved and signed by the District Court judge.
The staff attorneys on this matter are Tiffany Woo and Carl Settlemyer of the FTC’s Bureau of Consumer Protection.
Learn more about the INFORM Act and report violations of the INFORM Act through the FTC’s special portal for potential INFORM Consumer Act violations.