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California Prop 65 Complaints Against OTC Generics? Ranitidine Could Be First And Last Target

 
• By Malcolm Spicer

Marketers of copies of national brand OTCs are required under FDA regulations to use the same labeling as the brand, a rule that in effect has limited complaints in California state court alleging Prop 65 violations with nonprescription drug labeling to targeting branded product marketers.

• Source: Shutterstock

A complaint in California state court alleging OTC private label and store brand ranitidine heartburn remedies should have had label warnings for exposure to a potential carcinogenic could be the first and last Proposition 65 litigation against generic copies of nonprescription brands.

The California First Appellate District Division One has upheld a lower court’s August 2021 dismissal of a complaint filed by...

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Xlear Lawsuit Argues To Shelve FTC Policy For Health Claim Substantiation Under Loper Bright

 
• By Malcolm Spicer

Complaint filed Utah federal court says “Supreme Court explicitly rejected Chevron deference to agency interpretations” in the Loper decision, compelling rejection of “an agency’s statutory interpretation unless the court, ‘after applying all relevant interpretive tools, concludes’ the interpretatio

Loper Bright ‘Might Not Be Cataclysmic’ With FDA’s ‘Good Reputation’ For Science – Attorney

 
• By Malcolm Spicer

Bridget Dooling, law school professor who reviewed draft regulations from FDA and other agencies as OMB attorney, says history of federal court decisions in litigation challenging FDA’s interpretation of statutes points to judges typically defer to agency decisions based in science.

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

 
• By Malcolm Spicer

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.

Congress, Researchers Highlight Security Risks At DNA Testing Services

 
• By Elizabeth Orr

Congress launched an inquiry into 23andMe amid privacy concerns following its bankruptcy, particularly regarding the potential sale of sensitive user data. Additionally, a Cybernews report gave 40 DNA testing firms an average cybersecurity grade of D, citing widespread vulnerabilities and data breaches, along with inadequate public information about their security practices.

More from Policy & Regulation

Sunscreen Regulation Reforms Still Could Hitch Ride On Senate OMUFA Reauthorization Bill

As stakeholders and lawmakers pin their hopes on OMUFA reauthorization as a vehicle for enacting sunscreen regulatory changes, Senate version of the bill could be the ticket after a sunscreen-specific amendment withdrawn in the House.

Democrats Slam Trump’s ‘Sledgehammer’ On FDA

 
• By Malcolm Spicer

“We cannot ignore how Trump has taken a sledgehammer to the FDA ability to evaluate new drugs,” says California’s Nanette Diaz Barragán of California during Energy and Comme e markup discussion of five-year reauthorization of FDA’s OMUFA.

EU Green Claims Directive: Commission Says It ‘Has Not Withdrawn’ From Negotiations

 
• By David Ridley

What's going on with the EU Green Claims Directive? HBW Insight speaks to the European Commission, Parliament and Council to find out why trilogue negotiations seem to have stalled.