Self-Regulation and Certification: The Rest of the StorySelf-Regulation and Certification: The Rest of the Story
"By seeking legitimate certification for your company, it will strengthen our industry as a whole," writes Dr. Corey Hilmas, senior vice president, scientific and regulatory affairs, for the Natural Products Association.
February 2, 2015
I remember listening to Paul Harvey on Saturdays as a boy while sitting shotgun in a car with only an AM radio. While it was not so long ago, could the Millennials or my own kids fathom an era with only AM radio at their typing, callused fingertips? Other than being the “most listened to man” in America, and his undeniably unique delivery and sense of humor, Paul Harvey told a story better than anyone. My father would either nod in agreement or roll his eyes to his news segments at noon. Whether you agreed or disagreed with him or his politics, Harvey set the standard for the radio listening audience.
So what does Paul Harvey have to do with self-regulation and quality in industry? Harvey actually lectured about it. He used to say self-government won’t work without self-discipline. So I thought I would spend my Saturday writing and tell you about the “Rest of the Story” on the evolution of dietary supplement Good Manufacturing Practices (GMP), third-party certification, and self-regulation exhibited by the industry, a story that the Natural Products Association (NPA) can share as a principal player in the development of quality for dietary supplements. Self-discipline in the dietary supplement industry fostered government regulation.
Can you imagine a time when the industry was waiting on the Food and Drug Administration (FDA) to develop a standard of quality for a commodity the agency was authorized to regulate? While it may seem like an eternity, it was not that long ago, and the solution to the problem was self-regulation by the industry with third-party certification. While quality can be characterized as that standard, barometer, or measuring stick that one compares items against, quality certification is a test or demonstration of quality to those outside the organization. Where quality is a grand scale on the yellow brick road between perfection and error, or success and failure, quality certification is the independent observer’s assessment of where we land on the scale.
In 1994, the FDA was granted the power to develop manufacturing standards for dietary supplements as a result of the passage of the Dietary Supplement Health and Education Act (DSHEA). The FDA, the dinosaur that was slow to respond on defining quality for consumers and industry, did not offer the final GMP rules for dietary supplements (21 CFR Part 111) until June 2007. The agency and industry often talk about what has happened in the industry since 2007 until now, but we fail to remember what took place in the intervening years. Or we do not retell it enough because the agency’s story only began in 2007. We forget to tell the importance of association membership and the part that the dietary supplement industry played, but it is a story we need to tell.
Prior to the GMP final rule roll out, dietary supplement manufacturers were only required to adhere to GMPs for foods (21 CFR Part 110), which were largely enforced by local and state health departments. NPA recognized that while food GMPs are certainly significant in regard to controlling general sanitation practices and monitoring sink log records, they did not address product quality with regard to specifications including identity, purity, strength, and composition, as well as incorporating process control and quality control features to prevent mix-up and contamination which could potentially render a product adulterated. The association, in conjunction with other stakeholders, helped develop a standard for the regulation of dietary supplement GMPs and passed it to the FDA in late 1995. This standard served as the model of the FDA’s proposed GMPs in 1997. The FDA released an advanced notice of proposed rulemaking (ANPR) on February 6, 1997.
Following publication of the ANPR, NPA realized the FDA would not finalize the GMPs for dietary supplements for many years to come. Rather than waiting for the FDA, the association began developing its own GMP quality standard behind the scenes, incorporating the ANPR and hiring appropriate consultants and experts in inspection of FDA-regulated products to ensure that the necessary quality assurance aspects were present. The end result was birth of the NPA GMP audit program in January 1999. It was the first large-scale effort of its kind in the supplement industry, and the first third-party certifications were issued in July. Associations develop self-regulatory programs or initiatives that demonstrate industry transparency and maturity, and provide the consumer valuable information that can be used to evaluate products. Based upon NPA’s commitment to advocating for the rights of manufacturers, suppliers, and retailers to have a marketplace in which to sell products—but also to consumers having access to quality products to maintain their health—it is not surprising that NPA has developed several self-regulatory programs that are firsts for the natural products and dietary supplement industry.
The public and private benefits of industry self-regulation are numerous, and they typically outweigh the costs incurred to industry. Self-regulatory programs may lead to the establishment of product or ingredient standards to ensure quality and safety. In turn, these standards may facilitate the emergence of markets by establishing baseline levels of product quality and safety, result in improved consumers’ understanding, impart brand recognition through seals/marks representing third-party certification, induce brand loyalty, and garner trust in new products. Standard setting and implementation can be a further benefit to manufacturers by lowering production costs, which can be passed on to the consumer.
For example, a standard can be established to assist manufacturers in producing interconnecting or interchangeable parts. Especially in high-tech industries, standards assure a manufacturer that if its product conforms, the product will interconnect with complementary or rival products of similar specifications. But most important in the days of the global marketplace is that industry self-regulation helps consumers evaluate products and services by providing information about the qualities and characteristics of the seller’s products.
NPA also rolled out dietary supplement GMP education in 1999, and our program is entering its 16th year. One negative aspect of GMP audits is that firms do not know whether they have a good auditor or whether their auditor will remain consistent in their approach compared to the previous one. After all, dietary supplement firms want reassurance that certification will keep their compliance measures simpatico with that of the agency. Assurance that auditors are trained to know what to look for during GMP audits can only happen when there is quality in the audit, consistency in the auditors, and transparency in the process of how auditors are qualified to perform part 111 cGMP audits.
In an effort to address concerns over auditor quality, consistency, and transparency in how auditors are trained, NPA has developed an education partnership with UL, a leading global independent safety science company. We envision this joint partnership and program, with direction from two of the agency’s top former regulatory officials on dietary supplements, will set the standard once again to install quality, consistency, and transparency in the murky world of GMP audits and certification. Auditor training should also go beyond part 111 to incorporate other elements that will be evaluated for compliance during an FDA inspection.
With all the different companies and types of certifications available, it is important to recognize and evaluate who is doing the certifying and their qualifications in providing the audit. Questions you should ask of your auditor are the following:
Do they have prior experience directly in or involving FDA investigations?
How many dietary supplement audits have they done in the past year?
What type of training have they received?
Have they apprenticed under someone if they have no FDA training, who did they apprentice with, and how long?
How long have they been an auditor at that company?
Is there a revolving door of auditors at the company which could impact the consistency from your previous audit?
What do they know about intimate labeling regulations?
Are they knowledgeable about the types of claims you can make on your labels?
All of those activities should be included as part of the audit, which should demonstrate both quality and compliance. You do not want to throw your money away on a GMP audit or certification.
Combining NPA’s track record on educating the dietary supplement industry and providing self-regulatory programs with the history and brand recognition of UL, third-party certifiers and auditors will have even more opportunities to increase their education opportunities in the regulatory and compliance arena. This will serve to increase the number of quality GMP auditors. Dietary supplement manufacturers and distributors should not stop there. They should seek to independently evaluate their quality and compliance through third-party certification and not assume. We all know what happens when we ass-u-me anything. By seeking legitimate certification for your company, it will strengthen our industry as a whole, continue to provide consumers with safe and effective products and foster brand loyalty.
And I can’t resist, fellow Americans, but that is the rest … of the story.
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