One sure sign that the gradual implementation of Good Manufacturing Practices (GMPs) is having a major effect on the ingredients-supply industry can be found in this statement:
"A couple of years ago, the ratio of manufacturers to suppliers among our customers was 80:20. Now that number is 50:50."
That's Ed Wyszumiala, the general manager of the dietary-supplements division at NSF International, the nonprofit that for six decades has been helping companies meet health standards for food, water, supplements and more. Though the GMPs really are intended immediately to hold manufacturers responsible, suppliers are feeling more GMP heat as manufacturers demand transparency from them.
"The onus of responsibility is on the manufacturer," Wyszumiala says, "but what kind of due diligence have they brought to bear on their suppliers? They may be testing for identity, but are they testing for melamine? Verifying the botanicals? How do you verify that the broker you're buying from isn't bringing product in from five sources?"
NSF's GMP Registration programme works with contract manufacturers and the internal manufacturing facilities of dietary-supplements companies to ensure they are GMP compliant and, with two audits per year, keep them that way. Many major suppliers, such as Naturex, Sabinsa, Cognis and Cargill, have turned to NSF to re-assure their downstream customers and consumers of the safety, content and efficacy of their output.
Business is booming, Wyszumiala says. "Our listings have almost doubled every year for the last two years. As of now, 143 companies have listed with us, and 40 more are working through their initial audits."
Wyszumiala says that initial audits serve to inform a company about where they might be considered GMP noncompliant. Then the company has a period of time to address those issues, and new audits are performed until the facility is totally certifiable. "The company does the work to comply, then NSF lists the GMP-certified facility's information showing compliance on its website," Wyszumiala says. NSF performs two audits per year, then, providing a continuous monitoring of the supply chain.
Sports, the US national obsession, have contributed mightily to recent vigorous growth at NSF, Wyszumiala says. "There's been a large uptick in the last 12 months in sports. Sports organisations and athletes are worried about testing policies and doping policies."
NSF's 'Certified Clean for Sport' programme came into being just a few years ago, and quickly became essential to such organisations as Major League Baseball, the National Football League, the Professional Golfers Association and the Ladies Professional Golfers Association. All use the programme to ensure the nutritional supplements their athletes use are free of banned substances. "With major league players," Wyszumiala says, "any supplement they take has to be certified by NSF."
The need for authentic certification is not confined to the United States. "China and India, as well, are really ramping up. We have programmes to qualify and calibrate auditors for those countries. And we sometimes do a company's four or five global facilities." It is important, he explains, for a supplier in China to understand how a regulation in the US would affect his business in China. As well, spiking and adulteration have become issues that the industry simply must tackle.
"There has got to be increased transparency in the supply chain," Wyszumiala says. "These things pose the greatest danger to the overall supplement industry. Every new discovery of it erodes safety and consumer confidence."
June 2010 will be a defining moment for many in the industry. That's when the third and final step of GMP implementation takes place, requiring small companies to be compliant. Many think this signals the end of 'me, too' and fly-by-night companies because of both the costs and diligence involved in getting a company on solid certifiable ground. "Small companies really should have started \[getting ready for certification\] back in 2003 when the GMPs were being proposed," Wyszumiala says. "This takes a lot of planning, and while the cost to go through the NSF GMP programme initially may seem expensive, the twice-per-year auditing helps ensure that the facility is fully up to speed and that your staff is comfortable with an outside inspection and used to verifying the process.
"And the truth is that the cost of not being ready for an FDA inspection could be catastrophic for some companies and for the companies they produce products for, not to mention for the entire industry."
To locate NSF GMP-compliant facilities, visit www.nsf.org/business/search_listings.