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Supplement certifications don’t mean regulatory compliance.jpg

Product certifications not a certainty of legal compliance

“Pay for paper” certifications in the natural products industry meet a consumer—not regulatory—demand.

The concept of certification is common through a variety of industries, and the natural products industry is no exception. Certifications, driven by consumer demands, vary in importance, but all serve a purpose. The “pay for paper” certifications offered by private businesses come from a variety of organizations and cover different aspects of product development and distribution, such as the systems and processes used in the manufacture of foods and dietary supplements products or ingredients. These primary certifications convey the message of compliance, despite no regulatory requirement for such certification. These certifications evaluate the performance of the operation against regulations,and often include additional requirements imposed by the certifying entity to further distinguish it. Important messages here derived from the failures of the industry to self-regulate or to successfully comply with the existing regulations.

The success of these “pay for paper” certifying bodies is owed in large measure to the successful marketing of the services themselves. While initial efforts to offer certifications (especially toward dietary supplement brands) were met with indifference from brands, these certifications continued to be offered. Some companies were early adopters, but the overall effect was minimal. What happened next is a lesson in marketing. The certifying bodies pressed on the customers of the companies with whom they wished to do business. This resulted in a swell of demand for certification from the customers of the brand owners and manufacturers. The certification of products by an independent organization (since the regulatory agencies are not inclined deem an operation compliant even after a positive inspection) was the solution to a problem that industry did not know existed. This affirmation of performance after the necessary expenditure of cash toward compliance (and more since each organization holds additional requirements) hangs on the wall of the lobbies of operations throughout the country. Most of the costs are necessary since they are legal requirements while others are to ensure certification exclusively.

Companies insist upon return from such investments. The root of the demand, though, resides with the consumer rather than from retailers. Brands can say, “Yes, we are certified by [insert appropriate certifying entity here].” That answers the immediate question often asked by the customer in one simple sentence rather than having to detail all the things that have been put in place to ensure the identity, purity, strength and composition of dietary supplements and that the foods introduced are safe and not adulterated. Additionally, the continuing review and re-certification ensures the implementation of the regulations while, ideally, addressing the operation to an increasing depth with each re-certification effort.

The strength and simplicity of that message is what makes for the continuing success of certifying agencies.

For decades, industry has spoken of “self-regulation” where the industry can police its own kind. The consistent demonstration of the inability of the industry to truly self-regulate has created a cascade effect that runs through the certification business. The marketing approach began to work as more retailers listened to their customers’ confusion over which brand was best or which product they should use and why. Moreover, consumers became increasingly concerned with products' quality issues through deliberate adulteration or unintentional contamination often overplayed in the media. Ultimately, it is the consumer who has driven the certification business forward, but it is the whole of the industry that is responsible for the direction this has taken. The industry’s lack of coalescence around the most fundamental self-regulatory issues and compliance with the regulations, and its inability to present that information to the consumer and the regulatory agencies is the parent of the certification business.

The use of certifying agencies is an important and unfortunately necessary part of the industry. Those certifying agencies that affirm the compliance of the manufacturing operation to provide the right, safe and meaningful products to the consumer perform this service. The ancillary certifying agencies are recognizable and potentially meaningful to a specific market segment. Whether they are valuable to individual organizations is an internal determination. Brand should recognize that the regulations offer adequate means of communicating this information to the consumer, and affirmation is in the brand’s practices that conform with those regulations. These additional certifications should be approached cautiously.

The natural products industry is governed by regulations, and a many of those involve the composition, manufacture and overall safety of the food supply. Certification bodies’ role is becoming increasingly important to show a brand’s compliance they are required by law to have, but certifications are not a guarantee, and more importantly, they do not satisfy the government's requirement for daily compliance. The reason for the importance is unfortunate, but to address continuing compliance, they do perform a needed service, and a resulting certificate is commonly thought of as a “nice to have,” rather than a “need to have” from a regulatory perspective, regardless of whether organizations downstream in the supply chain require such a certification in order to do business.

As chief operating officer, Jim Lassiter oversees all consulting operations at REJIMUS, formerly Ingredient Identity. He has more than four decades of experience in quality control (QC), and government and regulatory affairs throughout the pharmaceutical, dietary supplement and natural product industries with organizations such as Nutrilite, Robinson Pharma, Irwin Naturals, Chromadex, the American Herbal Products Association (AHPA) and the Council for Responsible Nutrition (CRN). A respected author and speaker, Lassiter has served on numerous industry and trade boards.

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