1. HBW Insight
  2. >>Wellness
  3. >>Policy & Regulation
  4. >>Regulation

House Appropriators Propose OTC Monograph User Fee In FDA Budget

 
• By Derrick Gingery and Malcolm Spicer

Nearly $263.4m in additional funding compared to previous fiscal year's total allocated to FDA in the House appropriations bill. More than 70% of increase, about $185.3m, would be in non-user fees or budget authority and $78.1m in would come from user fee revenue. Bill identifies an additional user fee program for agency in the event Congress passes legislation to overhaul FDA's OTC drug monograph process.

Capitol House

The US Food and Drug Administration's fiscal year 2020 budget would grow significantly under House appropriators' plan, but the rate of increase dropped substantially compared to the agency's current appropriations.

Nearly $263.4m in additional funding compared to the previous fiscal year's total is allocated to the FDA in the House...

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
Start Free Trial

Already a subscriber?

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

US FDA Supplement Office Chief Eyes ‘Movement’ This Year On NDI Notifications Final Guidance

 
• By Malcolm Spicer

“We've made some progress and really hope to see some movement as we move forward this year,” says FDA Office of Dietary Supplement Programs director Cara Welch.

Kennedy’s Balancing Act: Push MAHA, Trim Regs

 
• By Malcolm Spicer

Same-day announcements of RFIs from HHS secretary cover nutrient review process for infant formula and Kennedy’s “10-to-1 deregulatory policy” as part of president’s “broader federal effort to reduce regulatory burdens and increase transparency.”

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.”