Nutrition Industry Executive turned to Mark LeDoux, founder, CEO and chairman of the board of directors of Carlsbad, CA-based Natural Alternatives International, and asked him the following question: In terms of quality control, what role does the contract manufacturer play, and how does this relate to responsibility for ensuring quality up and down the supply chain?

“The main burden associated with compliance for adherence to the good manufacturing practices (GMPs) espoused in Federal Law 21 CFR 111 lies with the manufacturer,” said LeDoux.

“Distributors of own-label products also share in that liability, but in essence the burden is on the manufacturer to verify the identity and purity of the components used in the finished product, including the packaging components, and the labels or containers, showing suitability for use, preservation of potency and absence of illegal compounds or contaminants.

“DSHEA (Dietary Supplement Health and Education Act of 1994) governs this, in addition to components of subsequent laws such as Food Safety Modernization Act, but at the end of the day, it is the responsibility of the manufacturer to verify that the substances being procured to make the product are safe, unadulterated, and free of contaminants, and that they meet the potency requirements established by GMPs or monographs.

“Finished products must also be tested to verify that at the end of the process of manufacturing there is a product which meets label requirements for the period of time that the product remains in commerce, e.g., verification of shelf life stability—and remember stability, if a best by label is on the label (and it should be), all in the chain: the manufacturer, the brand, the distributor have a role to play in that. As an industry, we don’t want products without a best by.

“Nothing that comes from nature lasts forever. The consumer knows that, and that is part of the reason they trust our industry the way they do.”

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