This is the area that houses many of the larger supplement manufacturing operations, which were the first required to meet new Good Manufacturing Practices regulations.
The final rule of the GMP legislation was passed last year in an effort to provide standards specific to supplements for purity, safety and legality in manufacturing. Big companies (over 500 employees) had to implement the new standards in June last year. Mid-sized firms have until June 2009, while small firms (less than 20 employees) have until June 2010 to comply.
Refined inspection plans
With the new rules comes the risk of inspection from FDA officials, and according to trade group United Natural Products Alliance (UNPA), “FDA is refining its inspection plans for 2009”.
The organization’s executive director Loren Israelsen told NutraIngedients-USA.com this morning that the comments were made by a senior FDA official at a recent UNPA-hosted seminar on GMP implementation.
Brad Williams, manager at CFSAN’s Division of Dietary Supplement Programs told attendees that FDA would clearly be focusing its inspection resources on areas where the industry is “large and strong”, which includes the Utah area and Southern California, said Israelsen.
“A number of companies from the area have also reported to me that they’ve already seen FDA inspectors over the last six months,” he said, adding that the “real surge” of inspections is likely to occur after June this year, and through the end of 2009 – and this time will include medium-sized companies.
One obstacle to manufacturers trying to comply with the new regulations has been a lack of information. So far, industry has had very little guidance on how FDA interprets the new GMPs – the only information that has come close to guidance is FDA’s preamble to the legislation.
However, the director of the agency’s Division of Dietary Supplement Programs, Dr Vasilios Frankos has said that more guidelines are in the making.
“Next year we’ll publish a compliance guide for small companies,” he told industry members at the Supply Side West trade show in Las Vegas in October.
Trade groups have been trying to plug the gap by holding targeted seminars and workshops. UNPA was due to hold another seminar next month to provide guidance on what companies should do if FDA inspectors visit their facilities.
However, the group today said that the seminar is now postponed until late spring.