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

Sunset Naturals Recall, Cancer 'Supplement' Warning: Health & Wellness Industry News Roundup

Sunset Natural's mandated recalls ongoing; PNC-27 'supplement' contaminated with bacteria; FTC Chairwoman Ramirez retiring; and more news in brief.

Sunset Natural Products Inc. recalls 165 separate products in compliance with a 2015 consent decree that required it to cease operations and receive FDA clearance before resuming manufacturing and distributing supplements. The agency's Jan. 4 recalls list includes the Miami firm's FDA-mandated recall of all supplements it manufactured, prepared, processed, packed, labeled, held and/or distributed from April 2014 through the day it entered the decree to settle a complaint the Department of Justice filed in US District Court for the Southern District of Florida. According to the FDA database, supplements marketed under brands such as Super Vita Green,Karma, Body Shape, Triflex, Bioxtron and Via Sex were recalled in quantities from several hundred to nearly 30,000 bottles or as many as 3.9m capsules, but also in unknown quantities for numerous items. The recalls started in October 2015 and are ongoing, according to FDA.

FDA inspected Sunset Natural’s facility in 2012 and submitted a warning letter on GMP violations in 2013 before finding the same problems during follow-up inspections in 2014. Violations noted in the warning included failing to qualify suppliers; to follow a written master manufacturing record for each formulation of supplement it manufactured; and to establish specifications for any point, step, or stage in manufacturing where control is necessary and written procedures for the responsibilities of the quality control operations

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.