When developing your supplement brand, focusing on every detail of the supplement manufacturing production process can be tedious, but necessary. Providing your consumers with quality supplements is an important factor in growing brand loyalty. In your quest to find a supplement or vitamin manufacturer to create your product, finding one that is compliant with government regulations and industry standards should be considered a top priority. Working with a manufacturer that is FDA registered and is cGMP compliant displays the ability to produce a quality product and to cultivate and sustain long-term relationships with their customers. With so many elements on which to focus, how can you ensure your supplement brand is compliant? If you choose the right company, compliancy is one less area for you to focus on.
For many years, the legitimacy of supplements and their effectiveness have come under scrutiny. To address this, it became necessary to compose and enact regulations to not only hold supplement manufacturers accountable for the products they create, but to also educate their consumers on the ingredients of said products. This has been a progressive measure since the Food, Drug and Cosmetic Act of 1938, which focused on defining dietary supplements and their claims of effectiveness. The introduction of the Dietary Supplement Health and Education Act of 1994 began to address safety and labeling from health claim perspective. As recently as 2010, the Food & Drug Administration (FDA) has developed new regulations for the dietary supplement industry, aimed specifically to eliminate consumer concerns and health risks associated with these products. Below are the guidelines your supplement manufacturers are required to follow in order to be compliant:
- Laboratory Controls – Demonstrating the specifications of the supplements can be verified and accurately tested for authenticity.
- Manufacturing Operations – Having a system in place to thoroughly keep records of batches manufactured.
- Packaging and Labeling – Proven ability to characterize contents of packaging and demonstrate that it lines up with specifications.
- Holding and Distribution – Managing the supply chain by developing a process for retaining samples and handling products. Also, making certain products are identifiable and are not mislabeled.
- Handling of Returns and Salvage – Instilling a process to oversee the proper handling of defects and deviations that are not aligned with regulations.
- Product Complaint – Instituting quality control to oversee how products are handled and mitigated.
- Formal Procedures and Training Documentation – Implementing a process to maintain documentation of everything from complaints to formula deviations.
- Quality Control – Implementing a department to oversee all procedures are in line with FDA and cGMP regulations and extensive analytical testing is in place.
While the guidelines set for nutraceutical manufacturers appear strict, they are necessary for accountability purposes. Having a quality management system in place to monitor regulations set by the FDA confirms that the supplement manufacturer you choose generates products that are compliant to government standards. These regulations provide manufacturers the opportunity to take responsibility for ensuring quality dietary supplements for companies to distribute to their consumers. Furthermore, consumers should find comfort in knowing your company is providing supplements that are free of contamination and are accurately labeled to solidify its purity, potency, and composition.
Establishing your company supplement brand can be challenging; however, collaborating with a manufacturer that commits to developing quality, standardized goods can ease the stress of ensuring your product is compliant. A reputable supplement manufacturer will not only have measures in place to ensure every product is high-quality and meets legal requirements, but will also be able to advise you on effective labeling, marketing, and distribution to develop a business that is compliant with all regulatory agencies.