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US FDA Explains Why Remote Interactive Evaluations Guidance Took So Long

 
• By Bowman Cox

Time taken for interagency alignment, lessons learned from foreign counterparts will increase use of remote video tours, say FDA officials..

The extra time the US Food and Drug Administration took to produce guidance on live remote video plant tours reflects the agency’s enthusiasm for them, not a reluctance to supplement inspections with them during the pandemic, agency officials say.

The FDA produced a blizzard of COVID-19-related guidance documents in the spring and summer of 2020, including some that were related to inspections. But guidance on live remote inspection alternatives...

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More from Regulation

CHPA Navigates Trump Administration’s ‘Mixed Messages,’ Ready To Traverse DSHEA Changes

 
• By Malcolm Spicer

Some changes the administration has proposed are a “great example of regulating by press release,” says Duffy MacKay, CHPA’s dietary supplements chief. But “after 30 years, the Dietary Supplement Health and Education Act could be modernized to serve the consumer better.”

Proponent For Age-Restricting Diet Supplement Sales Adds ‘Health Inequities’ To Argument

 
• By Malcolm Spicer

Result of firms marketing weight loss products to Black and Latino girls and to lower-income households is to “worsen health inequities by gender, race, ethnicity and income,” says Harvard researcher Bryn Austin, director of Strategic Training Initiative for the Prevention of Eating Disorders.

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.

More from Policy & Regulation

Supplementation Unlikely To Help With Hereditary Hair Loss, Says German Agency

 
• By David Ridley

Germany’s Federal Institute for Risk Assessment says that there is "no evidence that people with androgenetic alopecia have special dietary needs or a special nutrient requirement.”

NAD Asks FTC To Pull Bandage Off Firm’s Plan To Exhaust Inventory Using ‘2X Faster Healing’ Claim

 
• By Malcolm Spicer

After National Advertising Division attorneys, in a review prompted by a challenge by Band-Aid line marketer Kenvue, recommended ASO LLV cease use of its “up to 2x faster healing” claim, they determined the firm had not fully complied.

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.