1. HBW Insight
  2. >>Geography
  3. >>North America
  4. >>United States

VSI, MP Q1 Results: Health And Wellness Industry News

 
• By Eileen Francis

AHPA provides snapshot of 20 years of NDI notifications; MusclePharm, Vitamin Shoppe Q1 reports; and supplement recalls.

More than 20 years of new dietary ingredient notification data from the American Herbal Products Association's database reveals that of 931 notifications submitted or resubmitted to FDA between 1995 and 2016, 226, 24%, did not require a substantive response from the agency. AHPA said in a May 4 release that the data corroborate information FDA has on file on the number of NDI notifications submitted since enactment of the Dietary Supplement Health and Education Act in 1994. Separately, an FDA officials recently said the agency found “no objection” in about a quarter of NDI notifications submitted since 2010. (Also see "FDA Waits For NDI Notifications Increase On Tail Of 'No Objection' Uptick" - HBW Insight, 11 May, 2017.) AHPA's records also show that for 2002-2016, FDA determined that 161, 17%, of NDI notifications submitted were considered incomplete for failing meet regulatory requirements for a notification. AHPA also found the largest number of notifications submitted in one year was 81 in 2007 and the fewest was 33 in 2013.

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 United States

Some Laid Off Employees Called Back At US FDA

 
• By Sarah Karlin-Smith

Some FDA employees who were recently laid off by the Trump Administration are being called back to work, multiple sources confirmed to the Pink Sheet.

US Proposal To Remove Phenylephrine From OTC Monograph Could Stress-Test Streamlined Process

 
• By Malcolm Spicer

Proposed administrative order likely is first to prompt opposition from OTC industry or other stakeholders potentially delaying or deferring the agency’s expectation for moving its proposal to a deemed final order effective one year after it would be published.

FDA Clears Qnovia’s NRT Inhalation IND, Commits To ‘Stimulating’ Smoking Cessation Innovation

 
• By Malcolm Spicer

Qnovia notes NRT inhalation product recently received investigational new drug clearance from FDA as agency and NIH say innovation needed smoking cessation to help improve rate of success for quitting the habit that kills around 500,000 US consumers annually.

Washington State TFCA Violators Likely To Face Conversation Before Penalties – DOE

 
• By Eileen Francis

The Washington State Department of Ecology will try to work with companies that violate the Toxic Free Cosmetics Act, rather than reflexively imposing the $5,000-per-violation fine for first-time offenders, says the law’s implementation planner. She noted financial assistance is available for small businesses, as well as incentives for companies adopting measures “beyond compliance.”

More from North America

Washington State TFCA Violators Likely To Face Conversation Before Penalties – DOE

 
• By Eileen Francis

The Washington State Department of Ecology will try to work with companies that violate the Toxic Free Cosmetics Act, rather than reflexively imposing the $5,000-per-violation fine for first-time offenders, says the law’s implementation planner. She noted financial assistance is available for small businesses, as well as incentives for companies adopting measures “beyond compliance.”

Adcomm Reform: Getting Needed Information More Important Than Vote Or Discussion

 
• By Derrick Gingery

US FDA Office of New Drugs Director Peter Stein says review divisions have made the case that a discussion-only meeting would solicit the necessary input.

US FDA’s Petition Procedures No Place For OTC Acetaminophen Pediatric Dosing Enforcement

 
• By Malcolm Spicer

Requests for “enforcement actions are not within the scope of FDA’s citizen petition procedures,” CDER says, rejecting petition dosing device firm Parenteral Technologies submitted as it prepares for workshop on Pediatric Research Equity Act requirements for OTC NDA sponsors.