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US COVID-19 Fraud: Licorice Promoted As Treatment, Unapproved Tests Offered OTC

 
• By Malcolm Spicer

FDA and FTC continue adding to total each has made during novel coronavirus pandemic. FTC's latest include peroxide gel and licorice as treatments; FDA’s emphasizes in warnings that three businesses' tests were not approved for OTC sales or for home use.

COVID-19 Media kit
Medakit Ltd. in Hong Kong was making its unapproved COVID-19 antibodies test available OTC to US consumers before receiving an FDA warning.

The latest products and services the US Federal Trade Commission identified as making fraudulent claims to treat COVID-19 can be lawfully sold OTC, while direct-to-consumer sales were among the violations the Food and Drug Administration identified for some at-home tests recently appearing on its warnings list.

The agencies’ disclosures of additional warnings continue adding to the total each has made during the novel coronavirus pandemic

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More from Compliance

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

 
• By Malcolm Spicer

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

 
• By Malcolm Spicer

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

 
• By Malcolm Spicer

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

 
• By Malcolm Spicer

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

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

 
• By Malcolm Spicer

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.

Little Industry Opposition To FDA Plan To Remove Synthetic Dyes, Or Agreement They’re Unsafe

 
• By Malcolm Spicer

Dyes and colors which FDA says industries agree should no longer be used aren’t unsafe and are currently used only with the agency’s approval, industry stakeholders say. Center for Science in the Public Interest says the dyes are used “in tens of thousands of foods and beverages that are commonly consumed here in the United States.”

Bayer Study: Self-Care Is Hardest For Those Who Need It Most

 
• By David Ridley

Being poor makes it more likely that you will suffer from self-treatable health conditions but it also means you will find it harder to take advantage of self-care solutions, finds a recently-published study by Bayer Consumer Health and IQVIA.