Latest Test Of US FTC’s Standard Of RCTs For Health Claims: Saline Nasal Spray And COVID-19

Saline, Xylitol Spray Firm Xlear Says Referencing Research Isn’t Making Ad Claims

Xlear founder Nate Jones says FTC doesn’t argue that results and other information in research linked in social media posts, its website and a press release are false, but wants to prohibit providing information to consumers on research about preventing and treating COVID-19.

• Source: Alamy

Utah firm Xlear Inc. responds to the Federal Trade Commission’s allegation that it doesn’t have substantiation to say its saline nasal spray formulation prevents and treats COVID-19 by arguing that it’s not making a health claim but referencing research showing efficacy for its product.

Contesting a complaint the Department of Justice filed for the FTC, Xlear becomes the latest consumer health products marketer to question the FTC’s insistence of randomized and controlled clinical trials

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on HBW Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Compliance

Third-Party ‘Testing, Inspection and Certification’ Cleaning Up Amazon Supplement Market

 

Three FDA warnings related to supplement manufacturing, labeling or marketing submitted to Amazon or companies selling vitamin, mineral or supplement products on its e-commerce platform since April 2024.

Accelerating Natural Options Among US FDA’s Steps For Removing Petroleum-Based Food Dyes

 

HHS Secretary Kennedy commends food companies for cooperating, but also says, “We have them on the run now and we are going to win this battle. And four years from now, we're going to have most of these products off the market.”

Deleting Self-Affirmed GRAS Option Could Stretch FDA’s Already Thin Food Safety Resources

 

FDA introduced the option because it didn’t have sufficient staff to handle the volume of GRAS submission reviews requested by food and other firms for ingredients. Requiring submissions for all GRAS determinations “would just be an unworkable situation for the food industry if somehow submitting notice, submitting notices for FDA review and concurrence, was required,” says food and drug attorney Federick Stearns.

Traceability Rule Compliance Extended For Providers Of Herbals, Other Food Ingredients

 

FDA says “extension affords covered entities the additional time necessary to ensure complete coordination across the supply chain in order to fully implement the final rule’s requirements—ultimately providing FDA and consumers with greater transparency and food safety.”

More from Policy & Regulation

Supreme Court 1935 Ruling Limiting Executive Authority On Appointments ‘Unravels’ Today – DoJ

 

In complaint and response to motion to dismiss, Rebecca Kelly Slaughter’s and Alvaro Bedoya’s attorneys elaborate on Supreme Court ‘s 1935 decision, Humphrey’s Executor v. US. Administration attorneys, though, contend the ruling isn’t relevant to the current FTC.

Third-Party ‘Testing, Inspection and Certification’ Cleaning Up Amazon Supplement Market

 

Three FDA warnings related to supplement manufacturing, labeling or marketing submitted to Amazon or companies selling vitamin, mineral or supplement products on its e-commerce platform since April 2024.

Digital Services Deliver Hemp, States Deliver Regulation With Congress Yet To Act

 

Four months into session, no bills have been introduced in Congress to authorize FDA to establish a regulatory pathway for the lawful use of hemp ingredients in products other than drugs or propose some other solution to the federal conundrum present since lawmakers in 2018 de-scheduled hemp.