Global Regulations: Direct Translation

September 9, 2010

With current Good Manufacturing Practices (cGMPs) for dietary supplements now fully in place, the Food and Drug Administration (FDA) has the authority to conduct cGMP inspections of facilities of all sizes. As FDA inspectors hit the ground, so, too, are inspectors from NSF International (NSF; Ann Arbor, MI).

 

With current Good Manufacturing Practices (cGMPs) for dietary supplements now fully in place, the Food and Drug Administration (FDA) has the authority to conduct cGMP inspections of facilities of all sizes. As FDA inspectors hit the ground, so, too, are inspectors from NSF International (NSF; Ann Arbor, MI).

As part of its third-party cGMP certification program, NSF is helping companies that enlist its help ensure their facilities are up to regulatory par-so that if FDA comes knocking, companies will be ready. It’s not just the endpoint-certification-that’s valuable, however; it’s the training and education that comes with it. That training can also translate across the globe. While cGMP training is crucial to U.S. facilities subject to FDA standards, increasingly, says NSF, international firms seeking to sell products according to FDA standards or do business with U.S. companies requiring such standards are applying third-party cGMP standards to their own operations.

Nutritional Outlook spoke to Ed Wyszumiala, general manager of NSF’s dietary supplement certification programs, to discuss how the company has seen cGMP standards develop, at home and abroad.

 

What is the value of NSF’s cGMP certification to international suppliers?

It’s an apples-to-apples comparison. A facility that NSF certifies in China, India, or Malaysia goes through the exact same audit as a facility located in, say, Utah. The same standards are applied across the board, and they’re all based on FDA regulation.

NSF’s certification program adheres to the American National Standards Institute’s accredited certification program. It’s important that materials coming in for sale and distribution in the United States have U.S. standards applied appropriately to ensure supply-chain compliance, especially for incoming materials.

Which countries are currently applying NSF’s cGMP program?

Over the last couple of years, we’ve opened offices in India, Taiwan, Thailand, and Korea. We also have an office in Shanghai, where we’ve been doing a lot of auditing of ingredient suppliers. We’re in the process of building our first testing lab in China to do testing on the ground for material suppliers. We probably now work with approximately 30 different companies there now. We’re definitely seeing growing demand in China, as well as India. In June, I held a cGMP training class in Mumbai. We had more than 75 companies attend, just from the Mumbai market.

A lot of these companies are taking the information from these training sessions and then going back to get their facilities up to speed, prior to certification inspections.

How is NSF providing input on the development of cGMPs in other countries?

One of the key things we’re working on now is providing input to a global delegation working to develop an ISO standard for Chinese traditional medicinals. The program is headed by the American Herbal Products Association’s president, Michael McGuffin.

How does the United States compare to other countries in terms of quality control?

As the cGMPs get enforced, I think you’ll begin to see some of the highest levels you’ll see around the world. Right now, it’s hard to say, just because a lot of companies have still not gone through a regulatory audit. Also, the supply chain is so complex, which can really impact verifying where an ingredient comes from.

Are third-party cGMP certifications trustworthy?

One thing that’s really important about our program is that we audit a facility twice per year, so we’re in there every six months. Other programs may audit a facility maybe once every two or three years. If quality starts to go astray, and it’s not caught for two or three years, you could have a company that’s “certified” when it’s really completely out of conformance.

Also, we have a whole division here that aggressively looks for and goes after companies that misuse the NSF logo-we’re out there policing that. [Editor’s note: In June, NSF revoked its certification of Fayha Al Qassim, a bottled-water manufacturer, after finding that the company was no longer compliant with NSF’s standards. While not dietary supplement–specific, it serves as an example of how NSF will remove a company from its online database of certified companies and issue a public notice.]

I think anyone you talk to, whether a proponent, member, or critic of industry, would agree on one thing: FDA does need more resources to properly and fully enforce outliers and bad actors. We feel that we can help support industry through our third-party certification programs, helping industry show that, yes, we’re meeting these standards.

 

Sidebar: Sourcing Guide

 

In July, NSF introduced its new Source Guide-a listing of all dietary supplement companies that bear NSF certification. NSF says that the guide was developed to help industry companies “make educated sourcing decisions.”

The guide currently features approximately 300 companies certified by one of these NSF programs: 1) product or ingredient certification (meaning that NSF has tested a product’s contents to determine whether they reflect the contents listed on the label-and that there are no undeclared or unacceptable ingredients or contaminants),  2) Certified for Sport (which tests products for banned substances), and 3) cGMP certification.

NSF says that it will publish the guide with updated information twice a year. The current guide can be viewed at www.nsf.org.