Supplement Perspectives
FDA

This Regulatory Chasm

NPA’s Dr. Corey Hilmas and Viviane Brett explore why ingredient suppliers must bear the burden of cGMPs.

The health food and dietary supplement industry is experiencing profound growth thanks to increasing demand in healthy living and lifestyle options. However, this also comes with higher expectations in product quality, including manufacturing and testing procedures.

In recent years, manufacturers have attracted the ire of the FDA and media following the release of the Current Good Manufacturing Practice (cGMP) final rule in early 2007. Since then, manufacturers and label distributors in the industry have taken significant measures to implement quality control standards, consistent with the dietary supplement cGMPS, and become cGMP certified through a third-party vendor.

If we take one step further up the supply chain to ingredient suppliers, this sector of the industry is on notice but has yet to attract the enforcement attention of the FDA with regards to identity, quality, and safety. While manufacturers are subject to the cGMP final rule and certification requirements, ingredient suppliers remain exempt. This introduces a level of uncertainly to the production process as manufacturers often receive bulk ingredients from both local and international sources and it is not always immediately obvious as to the purity and quality of the entire batch.

cGMPs require manufacturers to test a sample of incoming ingredients. However, this selective testing may not be representative of an entire batch. The exemption of ingredient suppliers could potentially put manufacturers in a difficult position should any undetected impurities affect the quality of the final product. Implementing cGMPs and obtaining certification for ingredient suppliers ensures the quality and effectiveness of the product from top to bottom of the supply chain. From the ingredients to manufacturers to the shelves, a high quality, pure and safe product can be achieved.

This regulatory chasm affects everyone including our U.S. importers of record who receive foreign-sourced ingredients, our U.S. manufacturers who rely on overseas ingredients for further processing into finished products, our retailers who sell these products on their store shelves, and the U.S. consumer who wants access to innovative products designed to maintain and improve their health.

Even when "trace-back" analysis of adulterated ingredients exonerates the U.S. manufacturer, packer, distributor or retailer, the harm to the U.S. firm and industry reputation is long-lasting and often irrevocable. Further damage comes from civil lawsuits over adulteration or defects in the products because of our current product lability laws.

With the New York Attorney General’s Office casting their eye on ingredient suppliers and their exemption from the 2007 cGMP ruling, it is time for ingredient suppliers to give consumers greater transparency and confidence when it comes to quality and safety in the supply chain. Manufacturers continue to pay the freight and carry the burden for the industry. Ingredient suppliers should begin planning and preparing for the Food Safety Modernization Act’s preventive controls for human food. 

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