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Premix regulatory challenges

Premix regulatory challenges.jpg
The use of premixes in dietary supplement contract manufacturing requires disclosures, quality and a shared responsibility of compliance.

Every natural products brand will, at one time or another, consider whether to purchase individual components of its product or to purchase a premix. The convenience of having to purchase a single premix, as opposed to locating, purchasing and maintaining inventory of multiple individual components, is often simple math. The calculus to proceed, however, often does not include regulatory compliance.

This type of product must be considered from the supplier and the brand owner. Some suppliers’ entire business is to produce and sell premixes, which is good a business. The challenges often occur at the brand’s end with its compliance obligations.

A supplier’s role may be simple blending, granulation, microencapsulation or some other form of activity before delivering the product to the manufacturer or brand. The supplier is required to manufacture the product according to existing regulations. The manufacturer is required to have or generate specific information about the premix. This includes all ingredients and subcomponents as well as disclosure of potential allergens and potencies, and all this information must be gathered with documented specificity.

The supplier may hold some of the information close without disclosing everything about the product. The manufacturer must comply with what is likely a different set of regulations than the premix supplier. Unfortunately, it’s common that manufacturers operate without complete information of the components of a premix; sometimes, they don’t ever receive the order listing showing which ingredients are dominant in the mix.

Requirements that the manufacturer and the brand owner must meet may only be achieved with complete information. Suppliers may justify nondisclosure with claims of “proprietary information,” but mechanisms can alleviate that concern. Supply agreements with specific definition(s) of what components will be used can address cases where the manufacturer wants the blending or other processing done on its behalf. Agreements that specify materials/components in the specific amounts should not be overlooked.

Dietary supplement manufacturers that receive the premix on a customers’ behalf—especially in cases where the premix is a combination of dietary ingredients—must positively identify the premix every time it is received. The accomplishment of that seemingly simple task is challenging when the received material is a blend.

The manufacturer must disclose the complete list of ingredients as well as the means to properly assay the premix for identify. This can be exceptionally challenging depending on the nature of the blend and may not simply be resolved by a Fourier-transform infrared spectroscopy (FTIR) scan alone. Everyone in the supply chain that uses a premix needs this information. The supplier should consider the requirements of its customers and assist with the development and understanding of the necessary specifications.

Dietary supplements brands must test for the identity, purity, strength and composition of the product, and it must be within acceptable limits for contamination. Demonstration of these aspects is challenging when the received material is not quantified by the supplier, and the complete information about the material is not disclosed. Additionally, the material may not have been tested for potency. This fundamental requirement is too often not met, and the downstream consequences are significant.

These are challenges that more heavily weigh on the brand owner than the supplier or manufacturer. Quality agreements, documentation of the composition of the premix and verification that the blend can be identified to the satisfaction of the regulations help address these concerns.

The use of premixes in manufacturing is commonplace and not likely to change. The convenience and efficiency weigh heavily on manufacturers that provide products with complex combinations. The solutions are agreements and open and direct communication aimed to address the regulatory requirements.

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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