FDA Combines Supplement GMP Recordkeeping, Testing Waiver Estimates

FDA didn't change its estimates for industry's annual regulatory burden – 929,140 hours – from compliance with recordkeeping requirements in supplement GMPs, its estimates of eight hours needed to prepare a request for exemption from identity-testing requirement also in unchanged.

RulesRegulationsBooks_1200x675

The US Food and Drug Administration combined its estimates on separate parts of dietary supplement firms' regulatory burden from good manufacturing practices requirements in 2020, though the Natural Products Association ays the agency continues underestimating the costs.

"They're kind of downplaying what the recordkeeping costs, and so much of it is recordkeeping," said NPA president and CEO...

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

More from Manufacturing

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

 
• By 

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.

Good News? 90-Day Pause On Most Tariff Changes – Bad News? 125% Rate Imposed Against China

 

US businesses across industry sectors remain apprehensive about higher tariffs going into effect on imports from China after three-month pause allowed on other changes.

European Food Supplement CDMOs Bolstered By Acquisitions

 
• By 

With the acquisition of HKS Health Solutions, 1Q Health Group states its ambition to be the leading full-service CDMO in Europe. Separately, Italy's Ourvita enhances its capabilities through a deal for Poland's Laboratoria Natury.

Clean Label Project’s ‘Wake Up Call’ About Protein Powder Purity Prompts Alarm From CRN

 

Testing by third-party lab accumulated 35,862 data points from 70 brands and 160 products as a benchmark for the study’s findings. Council for Responsible Nutrition criticized the study as lacking “critical context” and potentially “misleading consumers rather than empowering them.”

More from Business

Urgo Makes Moves In Poland And Belgium

 
• By 

French consumer health player Urgo has added to its dietary supplements offering with separate deals in Poland and Belgium.

IQVIA Consumer Health: Digestive Category Driving Global OTC Market Growth

 
• By 

An increasing awareness of and interest in gut health helped the global OTC market grow by 4.6% in value terms in 2024, according to IQVIA Consumer Health.

Dermapharm Seeks To Put Stop To Spanish Slide

 
• By 

Dermapharm shakes up management of Arkopharma subsidiary in Spain with turnaround plan not showing results.