AERs – A unique opportunity to build confidence in supplements: SafetyCall
24-May-2013 - Establishing robust systems for safety surveillance and the reporting of adverse events presents the dietary supplements industry with an opportunity to instill confidence in the products, says Rick Kingston, PharmD, from SafetyCall.
More FDA warning letters for website claims and cGMP violations
16-May-2013 - The US Food and Drug Administration has issued warning letters to two dietary supplement companies, as the agency maintains its vigilance of website claims and cGMP compliance.
Special focus: Recent FDA warning letters offer important lessons for companies
15-May-2013 - The US Food and Drug Administration has issued some important warning letters in recent weeks. In this special focus, we revisit the lessons for all companies, from website claims, to the obligations of private label distributors.
FDA warning letter highlights obligations of private label distributors
10-May-2013 - A new warning letter illustrates FDA’s stance on the obligations of private label distributors to ‘ensure that all phases of the production of [a] product are in compliance with dietary supplement CGMP requirements’.
UNPA's Israelsen proposes new carrot to go with FDA's GMP stick
29-Apr-2013 - The dietary supplement industry is falling behind on GMP compliance, says Loren Israelsen, executive director of the United Natural Products Alliance. Fixing that is a matter of coming up with a new carrot to go with the stick wielded by the Food and Drug Administration.
Drug-tainted weight loss, bodybuilding, and sexual enhancement products top DS recall lists
18-Apr-2013 - Weight loss, bodybuilding and sexual enhancement products tainted with unapproved drug ingredients are responsible for 98% of recalls for ‘dietary supplements’, says a new analysis.
‘The industry is recognizing that spending good dollars gets you good products’: BI Chief on GMPs, adulteration, and the Dr Oz effect
16-Apr-2013 - The dietary supplements industry is making ‘heartening’ progress on taking a hard look at raw material sourcing, but GMP issues and adulteration issues continue to cause concern, says the CEO of BI Nutraceuticals.
Strapped by FSMA, FDA seeks authority for new user fees in budget request
11-Apr-2013 - The US Food and Drug Administration has requested a $4.7 million dollar budget for fiscal year 2014, an increase of $821 million, or 21%, over FY 2012. The biggest chunk of that increase is due to the Food Safety Modernization Act and almost all of that would be borne by new user fees.
FSMA guidance document serves as reminder to make sure facilities are registered
05-Apr-2013 - A new guidance document made public by the Food and Drug Administration serves as a reminder to industry to review their FSMA registration status, experts say.
NPA's GMO labeling stance headlines annual lobbying day
21-Mar-2013 - The Natural Products Association’s newly announced stance on GMO labeling was the biggest attention getter as members spoke with members of Congress during the organization’s annual lobbying event Tuesday.
AHPA expands staff with program development position
12-Mar-2013 - To go with an expanding membership, the American Herbal Products Association has expanded its staff with the addition of Jane Wilson in the newly created role of director of program development.
GMP compliance is a 'huge opportunity' for dietary supplements market: Chromadex CEO
07-Mar-2013 - FDA enforcement of the current good manufacturing practices (cGMP) regulations is ‘a huge opportunity for the dietary supplements market’, says Frank Jaksch, CEO of Chromadex.
NSF had ample opportunity to find Beehive's GMP problems, but didn't, attorney says
07-Mar-2013 - A breakdown in communication between Beehive Botanicals and its GMP certifier NSF International created the situation in which Beehive received an FDA Warning Letter over GMP violations. And, from Beehive’s point of view, receiving a favorable judgment from NSF on things that FDA specifically cited as violations was most disturbing.
NSF responds to Beehive Botanicals warning letter situation
05-Mar-2013 - NSF International has responded to an article in NutraIngredients-USA on the FDA Warning Letter received by Beehive Botanicals after having GMP audits conducted by NSF. A Beehive Botanical company official expressed dismay at getting the letter even after receiving a clean bill of GMP health from NSF.
Beehive Botanicals gets GMP warning letter despite clean bill of health from NSF
01-Mar-2013 - Beehive Botanicals Inc. has received an FDA Warning Letter even though the company had received a successful GMP audit by NSF International and had NSF review the changes it made to its operations to address FDA concerns.
Peanut indictments show there's a new sheriff in town, lawyer says
25-Feb-2013 - Former officials of a peanut company have been indicted in criminal court on charges of food violations, mail fraud and conspiracy. The indictments are not a surprise, said a prominent lawyer, but should serve to put the food and dietary supplement industries on notice of a more stringent regulatory atmosphere now that FSMA is in full swing.
ABC honors Chinese professor with Farnsworth award
20-Feb-2013 - The American Botanical Council has given its annual ABC Norman R. Farnsworth Excellence in Botanical Research Award to professor De-an Guo, PhD, of Shanghai, China.
USPlabs slapped with warning letter over drug claims, GMP failures
16-Feb-2013 - USPlabs, the maker of the DMAA-containing sports supplement Jack3d, has received a warning letter over drug claim violations and GMP deficiencies, the Food and Drug Administration confirmed Friday.
FDA sends more GMP-related warning letters to four dietary supplement manufacturers
14-Feb-2013 - Four dietary supplements have received independent warning letters from the Food and Drug Administration for alleged GMP violations, as the agency maintains its focus on compliance.
NX Generation Ltd. warned for alleged GMP violations
06-Feb-2013 - The Food and Drug Administration (FDA) has sent a warning letter to New York based NX Generation Ltd for ‘serious violations’ of the current Good Manufacturing Practice (cGMP) regulation for dietary supplements.