Just over one year ago, the NY Attorney General sent cease-and-desist letters to four major retailers: GNC, Target, Walgreens and Wal-Mart, after laboratory testing suggested that certain dietary supplements pulled from each of the retailers’ shelves contained little-to-none of the active botanical ingredient(s) listed on the product label. The products were considered adulterated or contaminated, and as result, the retailers were forced to pull the products from their shelves.
Many industry advocates criticized the DNA barcode testing method utilized by the Attorney General’s office as being “not fit for purpose,” meaning that the tests used may not have been the most appropriate for the identification they were working on. However, these complaints failed to garner significant media coverage and proved additionally confusing for customers.
Instead of dwelling on the potential errors by the NY Attorney General or focus on the media coverage, it is time for the industry to act proactively and address the greater issues at hand.
Botanical Identity Basics
One of the primary requirements of the Dietary Supplement GMPs (21CFR Part 111) is that manufacturers of dietary supplements must ensure the products are “100% identified.” Further, the GMPs require that the manufacturer use at least one “scientifically” valid test for identification. However, the reality has been, especially in the case of botanicals, that there are few agreed-upon standards and methods that cover this requirement completely. Manufacturers are left to use “best practices” and are subject to defending their practices.
The reality has been, especially in the case of botanicals, that there are few agreed-upon standards and methods that cover this requirement completely. Manufacturers are left to use “best practices” and are subject to defending their practices.
The big question for the industry is how to develop and adopt an identity program that meets the requirements and utilizes best practices. There is considerable debate on this topic that surrounds the use of different testing technologies, including DNA. Last November, the United Natural Products Associations sponsored a summit to discuss this very topic. Significant progress is being made and industry leaders have put forth great ideas.
At RFI, we developed an internal program for identity, and it was in place long before the NY Attorney General got involved.
Identity = Traceability + Testing/Analysis
Pardon the pun, but compliance with cGMP and other quality programs are part of our DNA as a company. We have always taken these efforts very seriously. From the beginning, we have been building an identity testing program that we feel suits our diverse product platform.
Our identification program is roughly divided into two major parts: Traceability and Testing/Analysis.
- Verification by means of documented records of each component from farm to finished product
- Purchasing history
- Cultivation location
- Manufacturing processes
- Testing and Analysis
- Validated methods and analytical equipment
We begin by verifying the raw material supply chain.
We then look at every step of the process: extraction, drying, milling, etc., and when necessary, perform incremental analysis to measure changes that occur to the material. By using a variety of analytical tools, we can then describe with full confidence what happens to an ingredient, from raw material on through to the finished product.
We use testing methods that are “fit for purpose.”
The analytical tools used should align with what is being tested for. Confused about the term “fit for purpose?” We will explain…
You wouldn’t use a sledgehammer to remove a safety pin from a blouse, right? In this case, a sledgehammer would not be the proper tool for the job. Well, the same thought should be applied to marker compound measurements!
DNA testing has a particular purpose, but it is not the best tool for every purpose. Depending on the starting material, the more a product is processed to achieve a desired end result, the more likely that serious DNA degradation will occur. So, only using DNA marker points when looking at a material that has gone through multiple steps of processing—as opposed to a fresh leaf of the same material—is not “fit for purpose.”
While DNA testing is part of a larger program, it cannot be the only tool used to verify botanical identity.
We use distinctly different testing methods.
The GMP requirement is to perform one appropriate or qualified test. There is no definition or standard for which test to perform and instead it leaves this up to the manufacturer to use best practices.
At RFI, we break down each product category and look at the best set of tools to use for each one, which is how we build quality and transparency into our identity program.
Additionally, the use of distinctly different test methods to analyze the same product may also lead to stronger results. This approach, known as “orthogonal testing” (defined in Wikipedia as: “In analytical chemistry, analyses are “orthogonal” if they make a measurement or identification in completely different ways, thus increasing the reliability of the measurement.”) offers a great deal of promise when feasible, as it allows the analyst to reach the same result, but from distinctly different paths.
In closing, the industry should take this opportunity to focus in on the GMP requirements, especially product identity, purity and content. Doing so will improve consumer and regulatory confidence, while effectively weeding-out the manufacturers who are unwilling to assure product safety and efficacy to this degree.
In Good Health,
Paul Altaffer – Chief Innovation Officer, RFI Ingredients