Beyond Compliance: Current Challenges in Quality Testing of Dietary Supplements


The regulatory climate in the dietary supplements industry has heated up recently in the wake of enforcement actions by State Attorneys General, as well as some negative media attention; many companies are allocating bigger budgets to Quality Control departments and expanding testing programs.  As business models increasingly trend toward being less vertically integrated, diversification and globalization of the botanical supply chain has led to significant challenges to assure Quality products for consumers. This separation of the farmers and the fresh herbs they grow from the botanical supplement manufacturers has led to a situation where the traditional established methods for identification of plants, such as macroscopic and microscopic evaluation, often cannot be implemented.

In practice in the modern industry companies are often dealing with powders or extracts, as opposed to crude plant material, which has necessitated the need for newer methods, such as HPTLC, to establish botanical identity. The language in the Code of Federal Regulations (21 CFR part 111) is subject to differing interpretations among the gamut of stakeholders around establishing appropriate identity and potency specifications and test procedures.  One of the biggest challenges is that many companies are setting specifications without including a scientifically valid method to support that specification as is required by 21 CFR part 111. The complex nature of botanical dietary supplements and the proliferation of myriad finished product formulations and complex label claims present challenges regarding fit-for-purpose scientifically valid methods to support compliance with specifications for each unique matrix. There is also a need for well characterized reference materials as well as efficient broadly applicable standard analytical methods.

Consumers are becoming more savvy, demanding detailed information about their supplements, and are increasingly willing to pay more for a high-quality product. I see the industry already responding by investing more resources in Quality, including establishing more rigorous and appropriate testing programs and consulting more scientific and regulatory experts. As the expectation of transparency and the role of Quality Control testing in the supplements world evolve, perhaps there will be a bifurcation in the market where these challenges will be widely addressed and consensus on what constitutes a Quality product will become apparent. Stay tuned.


Holly E. Johnson, Ph.D.
Laboratory Director, Alkemist Labs,
Costa Mesa, CA, USA



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