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Health And Wellness Market News: FTC Settlement, FDA Alert, UK Ad Reviews

 
• By Eileen Francis

FTC settles with operators of a bogus cognitive supplement sales ring for $26.2m; FDA warns on unapproved at-home head injury tests; and UK advertising regulator says HiSmile claims fail, P&G Always Discreet claims pass.

The Federal Trade Commission settled with 12 corporate entities and four individual defendants marketing bogus cognitive supplement brands Geniux, Xcel, EVO and Ion-Z, using “sham” news sites containing false and unsubstantiated efficacy claims. The FTC announced that its complaint, filed in the US District Court for the Northern District of Ohio, alleges Fred Richard Guerra III, Lanty Paul Gray Jr. Rafat Abbas and Robby Salaheddine owned a web of corporate entities that between August 2012 and January 2017 sold the supplements for between $47 and $57 a bottle. False claims for products included that Geniux could “improve short- and long-term memory,” “increase focus” by as much as 300% and prevent memory loss. Claims were made on sites deceptively formatted as actual news sites. Some employed fake consumer endorsements and attributed the achievements of Stephen Hawking and Elon Musk to Geniux products.

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More from Regulation

French Agency Proposes Effective EU Ban On CBD In Foods And Cosmetics

 
• By David Ridley

France's food safety regulator ANSES is proposing a reproductive toxicity category 1B classification for CBD under the EU's CLP regulation, which would mean an effective ban on CBD in cosmetics and foods. However, French hemp industry association UIVEC hopes that new evidence coming out of a European Commission review will put the issue to bed before it gets that far.

Givaudan Has UTI Health Claim Turned Down In EU

 
• By Tom Gallen

European Food Safety Authority finds no cause and effect relationship between Givaudan's Pacran supplement and defense against urinary tract infections.

US Consumer Health Industry Buckles Up For Another Ride As Trump Swings Tariff Tool Again

 
• By Malcolm Spicer

Manufacturers, marketers and other businesses in the industry may be thinking, “Well, this is different” because the president ordered tariffs on a list of countries rather than on his sole first-term target of China.

Some New Tools, More Old For Supplement Sector Enforcement During Trump’s Second Term

 
• By Malcolm Spicer

Tariffs on imports from China and look at eliminating self-affirmed GRAS pathway introduced under Trump while DoJ Consumer Protection Branch also continues supplement sector priorities enduring across administrations.

More from Policy & Regulation

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.

Loper Bright Could Trip FDA On Self-Affirmed GRAS

 
• By Malcolm Spicer

Instead of arguing FDA’s not authorized to offer option under authority from 1958 Food Additives Amendments, potential litigation could contend the law requires agency to continue making self-GRAS without notification available.

French Agency Proposes Effective EU Ban On CBD In Foods And Cosmetics

 
• By David Ridley

France's food safety regulator ANSES is proposing a reproductive toxicity category 1B classification for CBD under the EU's CLP regulation, which would mean an effective ban on CBD in cosmetics and foods. However, French hemp industry association UIVEC hopes that new evidence coming out of a European Commission review will put the issue to bed before it gets that far.