FWD 2 Industry Partnership Educates Dietary Supplement Professionals on Quality

HerbalEGram: Volume 8, Number 7, July 2011

Industry Partnership Educates Dietary Supplement Professionals on Quality
In recent times, members of the mainstream media and various opponents have criticized the dietary supplements industry, alleging that it lacks standards and adequate governmental regulation. Some even call it “The Wild West.”1 In the face of such negative attacks, industry associations are quick to point out that—not only is it regulated by the US Food and Drug Administration (FDA) and Federal Trade Commission under the Dietary Supplement and Health Education Act of 1994 (DSHEA) and other applicable federal laws—the dietary supplements industry also does much to regulate itself. One such new effort, the Dietary Supplement Quality Professional (DSQP) training program, is doing just that by educating the industry on the ways that it can deliver safe, reliable, high quality products.

Established in February of 2011, the DSQP training program is a 3-way partnership among NSF-DBA, a division of NSF International and one of Europe’s leading pharmaceutical training, auditing, and consultancy companies; industry trade association United Natural Products Alliance (UNPA); and the National Center for Natural Products Research (NCNPR) at the University of Mississippi.2 The modular DSQP program focuses on the requirements of FDA’s 21 CFR 111 regulations, also known as current Good Manufacturing Practices (cGMPs), which provide guidelines and requirements for dietary supplement companies on appropriately qualifying ingredients from vendors and producing properly manufactured and labeled products using consistent and reliable manufacturing processes.3

According to Casey Coy, a dietary supplement specialist partner with NSF-DBA, these 3 reputable entities make solid partners (e-mail, June 21, 2011). NSF-DBA has an expansive network of quality auditors, trainers, and consultants offering extensive 21 CFR 111 expertise to the industry; UNPA has a history of working to support the industry through offering extensive informational seminars focused on regulatory compliance; and NCNPR—an FDA Center of Excellence—provides extensive natural product-related analytical method development, ingredient and product analysis, and advisory services.

The DSQP training program consists of 12 individual modules, each having its own specific focus and being led by a pre-selected industry expert.2,4 The program generally covers the in-depth details of the regulations and discusses how they apply to dietary supplement operations. “[It] stresses the underlying purpose of the regulation and the dangers of non-compliance,” said Coy, “while also giving professionals the confidence in implementing quality systems and building a culture of quality in their organization.”

Titles of some of the courses include Testing Methods and Equipment Qualification, Cleaning and Control of Cross-Contamination, International Regulatory Requirements, and much more.4 Courses are offered at all 3 of the partnering organizations’ headquarters: UNPA in Salt Lake City, Utah; NSF-DBA in Ann Arbor, Michigan; and NCNPR in Oxford, Mississippi. Interested professionals can attend one or several of the separate modules. Alternatively, they can complete the entire training program over the course of 2 years, after which they will obtain NSF-DBA DSQP certification through NCNPR. Though the program’s first year is at its midway point, interested professionals can begin attending courses at any time.

While none of the course modules focus exclusively on botanical dietary supplements—aiming to apply to all dietary supplement companies—the “Testing Method Selection, Specification Setting & Equipment Qualification” course discusses challenges specific to botanical dietary supplements and provides guidance on how to determine the most selective and appropriate analytical technique, said Coy.

As of June 2011, more than 100 professionals had attended the DSQP training courses, several of whom will be completing the entire series over the course of 2 years, depending on their company’s budget. “Attendance is only increasing,” said Coy, noting that the most popular modules offered so far have been those on 21 CFR 111 overview, standard operating procedures and record keeping, FDA inspection readiness, and vendor qualification and auditing.

Jera’le Smith, director of quality assurance at Nutritional Laboratories International (NLI) in Missoula, Montana, is working toward completing the entire series of DSQP courses. “[NLI is] always working to implement the most stringent quality systems and looking for opportunities to prove the superiority of our systems,” she said. “DSQP certification is another way for NLI to show a commitment to being a CMO of the highest quality” (e-mail, June 23, 2011).  

Most professionals have attended the training courses at events like SupplySide West, which generated the highest turnout. According to Coy, following years’ training courses will be brought to locations that are more convenient for the industry, such as these trade show events, as well as “supplement hotspots,” like Southern California, New York, and New Jersey. “Overall, the feedback on the courses has been very positive,” said Coy. “We constantly review our feedback forms and look for ways to meet the needs of attendees and make the courses as valuable as possible.”

According to Smith, the course trainers have all had “vast experience and have been aware of the difficulties that manufactures experience.” “I definitely think that the training makes me more marketable from a professional growth standpoint,” she continued. “NLI has benefitted from the information that I have brought back from the training. I have conducted internal training on some of the courses that I attended and have simply passed on other knowledge through improvements to existing processes.”

Another DSQP course participant voiced similar impressions of the program. Kim Pearson, general counsel of Thorne Research, Inc, attended the courses on FDA inspection readiness and corrective action management. Soon after, FDA inspectors visited his company unannounced for a 4-day GMP inspection. “Because I did attend the 2 seminars,” said Pearson, “and because our company assiduously implemented the recommendations made at the two seminars, our company is absolutely convinced that was the number one reason we did not receive an FDA Form 483,” a letter from FDA noting infractions of the cGMP rule (e-mail, June 27, 2011). 

But, as with most programs of such scope and aim, challenges exist for the DSQP program. According to Coy, some in the industry show concern about the financial investment required for sending one or more employees to the training modules. Each individual course costs from $895 to $1,595 per person, with 10% discounts available to those who reserve their spot 4 weeks ahead of time.4 “The investment of quality in the industry will only benefit the industry and a company's livelihood in the long run,” noted Coy. “The individuals who work in the industry and provide quality support understand the value in these courses.”

Smith of NLI realizes that the training can be costly for small businesses. “However,” she said, “it is similar to or even slightly below the prices seen in the drug industry, therefore it was not surprising. I do believe that it’s worth the investment to ensuring that your company is in compliance and manufacturing product that is safe for the public.”


—Lindsay Stafford

References

1. Lipton E. Support is mutual for senator and Utah industry. New York Times. June 20, 2011. Available at: www.nytimes.com/2011/06/21/us/politics/21hatch.html. Accessed June 28, 2011.

2. NSF-DBA Dietary Supplements Quality Professional Training Program. NSF-DBA. Ann Arbor, MI.

3. Stafford L. Impact of current good manufacturing practices for dietary supplements on small manufacturers. HerbalGram. 2009;84:66-68.

4. NSF-DBA DSQP Courses. Course offerings and booking form. NSF-DBA. Ann Arbor, MI.