Many dietary supplement companies are not fully compliant with GMP regulations, putting them at risk of warning letters and more, but resources are available to help companies prepare for an FDA inspection, says the Council for Responsible Nutrition (CRN).
Recent comments by Food and Drug Administration (FDA) officials during a CRN hosted webinar are a wake-up call to the industry, said Steve Mister, president and CEO of CRN.
Speaking with NutraIngredients-USA, Mister said that a number of companies in the industry, and these are not limited to the ‘small players’, are just not prepared when the FDA shows up at their doors.
“We have a responsibility to comply with the regulations, and failing to do so will negatively impact consumer confidence in our products as well as triggering follow-up action by FDA,” said Mister.
The Food and Drug Administration (FDA) has increased the number of GMP inspections over the last few years. Only seven GMP inspections occurred in 2008, which increased to 34 in 2009, 84 in 2010. As of September 13 of this year, there have been 145 inspections, according to FDA data.
The increase in inspections has been followed by a significant uptick in the number of warning letters for GMP violations: In 2010, FDA issued 8 letters regarding GMP violations. In 2011, that number quadrupled, with 34 companies being cited for a wide range of violations – from failure to establish product specifications to failure to maintain adequate records, according to Ivan Wasserman and La Toya Sutton from Manatt Phelps & Phillips in Washington, DC .
During the recent CRN webinar, the FDA panelists advised companies to improve their chances for a successful inspection by focusing on key areas like:
• developing detailed master manufacturing records;
• preparing accurate batch records;
• establishing specifications, verifying that specifications have been met, and documenting everything including any corrective actions taken;
• testing incoming ingredients as well as finished products for identity, strength, purity and composition;
• making sure that everything is documented. FDA repeated its often-heard mantra that ‘if it isn’t written down, it didn’t happen’.
The senior officials from FDA who participated in the webinar included Daniel Fabricant, PhD, director, Division of Dietary Supplement Programs (DDSP), Center for Food Safety and Applied Nutrition, (CFSAN), Brad Williams, GMP team leader, DDSP, CFSAN, Carl Reynolds, senior consultant to DDSP, and Angela Pope, consumer safety officer, GMP Team, DDSP, CFSAN.
Mister added that there are a number of resources available to companies to help them prepare for their first inspections, such as consultants, webinars, and books.
“With so many resources available in this area, I hope that companies will take advantage of them in order to meet their obligations for GMPs,” he said. “Being prepared when FDA knocks on the door will remove a lot of the anxiety from the process.”
Mister added that some anger and hostility towards the Agency’s New Dietary Ingredient (NDI) draft guidance may have given people permission in their own minds to not be fully compliant in other areas, including GMPs.
These are two different issues, he said, and GMP compliance is compulsory.
Industry insiders have also raised concerns about FDA inspectors not being fully trained in dietary supplement GMPs, but while Mister said such observations do concern CRN, it should not detract from the fact that many companies are not GMP compliant.
“Not having a designated QA person, or no testing of raw materials are issues that are not affected by the background of the inspectors,” he noted.
CRN’s most recent GMP webinar was held on January 18 and is available for purchase on-demand until April 23. For more information, contact Trainor Walsh at firstname.lastname@example.org .