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Supplement Manufacturing Responsibilities: Brand Owner v. Manufacturer

<p>The responsibilities for supplement manufacturing vary for the brand owner and manufacturer. The brand owner focuses on the formula, ingredients and testing, while manufacturers are concerned with formulation and manufacturing, as well as optional and mandatory testing.</p>

As anyone who has experienced the process of bringing a supplement to market (as either a brand owner or a contract manufacturer) would likely tell you, dietary supplement manufacturing is a unique process. Thus, it also comes with a well-established catalog of considerations and challenges.

For most dietary supplement products, the foundation of the journey from concept to consumer can be made or broken by the conversations that pass between the company or brand owner, and its contract manufacturer in the days and weeks leading up to a production run.

While the process for creating any two supplement products will never be identical, there are certain factors players on both sides of a manufacturing partnership are likely to encounter during each manufacturing run.

Ultimately, it is the ability to recognize, evaluate and delegate responsibility for each of these factors (and others) that distinguishes the strongest, healthiest supplement contract manufacturing partnerships from the most troubled ones.

Key Contract Manufacturing Responsibilities for Brand Owners

Along with developing the remainder of their business plan, several vital components of the supplement manufacturing process are often the responsibility of the supplement company or brand owner.

The Formula—Arguably one of the most important components of any nutraceutical or nutritional product is the formula. While many industry contract manufacturers may offer suggestions or guidance concerning some aspects of a prospective formula, it is the client’s responsibility to provide its manufacturer with a completed and finalized product formulation.

That said, a supplement company’s responsibility to its product formulas rarely ends at finalizing an ingredient list. Along with providing a completed formula prior to the start of the production run, companies are responsible for verifying, among other factors, both the efficacy and the safety of their supplement formula.

Similarly, ensuring key components of the final product—namely any packaging, structural and/or functional claims—are accurate and compliant with federal or local regulations becomes the responsibility of the brand owner.

This is one of several instances where companies and brand owners are encouraged to seek professional legal counsel, even if a contract manufacturer partner may offer suggestions or guidance.

Ingredients and Testing—Particularly for new brand owners, it is important to understand the ingredient/raw material variations that impact a formula, as well as the test and certifications the product or its formulation are expected to undergo or receive.

Before testing can be considered, a supplement product’s formula must be completed. To help ensure a formula is manufactured to the desired efficacy and levels of safety, it’s critical the proper form or variant of a listed ingredient is used. Specifying such a variant is a brand owner’s responsibility. Once a formula has been finalized, conversations concerning testing and certifications are rarely far behind. While GMPs (good manufacturing practices) and standard operating procedures (SOPs) have established a “baseline" of purity and efficacy tests that must be performed during manufacturing, a number of popular tests and certifications must be requested prior to the start of a dietary supplement product’s production run.

Allergen testing is one of the best and most common types of “add-ons" to fall into this category. All supplement manufacturers should have the ability to test for the eight major allergens (i.e., dairy, eggs, fish, shellfish, tree nuts, peanuts, gluten and soy), but more often than not, a company looking to run its product through one or more of these tests must request them explicitly.

Key Contract Manufacturing Responsibilities for The Manufacturer

Though it may go without saying, dietary supplement contract manufacturers with experience and who are compliant with the most current nutraceutical industry rules and regulations should have a clear understanding of what their responsibilities are during the supplement manufacturing process.

Formulation and Manufacturing—Where it’s the client’s responsibility to provide and finalize a supplement products formula prior to manufacturing, it’s the contract manufacturer’s responsibility to ensure the final supplement product meets each of the pre-established specifications. Often, meeting these specifications will included testing raw ingredients for purity, identity and efficacy, as well as ensuring the final product contains all of the required ingredients at the appropriate ratios.

Not surprisingly, if errors or deviations from the established product specifications are discovered during quality control (QC) and assurance (QA) testing, it is the manufacturer’s responsibility to make the necessary corrections.

Optional and Mandatory Testing—It is the responsibility of the contract manufacturing partner to ensure all the components of its facility, as well as any and all SOPs, are FDA and GMP-compliant.

In addition to any tests or special certifications that have been requested and incorporated into the supplement product’s specification sheet, current regulatory standards dictate a full panel of mandatory QA and safety tests that include, but are not limited to, tests for microbial organisms and heavy metals.

Making the Most of the Supplement Manufacturing Journey

Each dietary supplement product is unique. In turn, each dietary supplement run is unique. Often, making the most of any given production run comes down to effective communication between the brand owner and contract manufacturer. Taking the time to establish each party’s responsibilities from the start (and in detail) can and should make all the difference.

Melissa DellaBartolomea is a content marketing specialist for NutraScience Labs (nutrasciencelabs.com). Based in Farmingdale, New York, NutraScience Labs is dedicated to providing companies and brand owners with excellent customer service and a full suite of dietary supplement manufacturing.

 

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