Post-COVID, the world has become more aware of the importance of health and wellness. People are purchasing exercise programs, adopting whole food diets, and leaning on supplements to boost their quality of life. With supplements growing in popularity among consumers, it becomes increasingly more important to focus on ensuring that quality supplements are on the market. Dietary supplement brand holders often rely on supplement contract manufacturers to produce quality products.Concern about dietary supplement quality is increasing as manufacturing companies and the ingredients they source may not be up to standard. The Food and Drug Administration (FDA) plays a role in regulating dietary supplements; however, the FDA will regulate primarily after the product enters the market. This leaves it up to the supplement brand to evaluate manufacturing quality, and to choose a partner they can trust to ensure their consumer receives a safe and effective product. To support with that evaluation, we offer the following key categories for the brand to consider as they evaluate their manufacturing partners:
Regulatory Compliance. Dietary supplements are regulated by the Food and Drug Administration (FDA). The Dietary Supplement Health and Education Act (DSHEA) was established in 1994 to provide access to a variety of dietary supplements and provide a strong regulatory framework to ensure safe products enter the market. The implementation of DSHEA provided supplement contract manufacturers and consumer brands with laws to follow.
Often referred to as current good manufacturing practices (cGMPs) for dietary supplements, the code of federal regulations 111 (CFR 111) is an outline that both dietary supplement contract manufacturers and consumer brand holders must adhere to ensure the safety and quality of their products. There are several sections of these standards, but a few commonly discussed in relation to dietary supplements on the shelf are purity, potency, identity, and safety.
The following article published by the New Hope network can serve as an additional resource for brand holders to learn more about DSHEA: https://www.newhope.com/regulatory/dshea-10-things-emerging-supplement-brands-should-know?_mc=NL_DR_EDT__20231218&cid=NL_DR_EDT__20231218&utm_campaign=NWHPNTWK_News_Natural%20Business%20Today_NL_20231218&utm_emailname=NWHPNTWK_News_Natural%20Business%20Today_NL_20231218&utm_medium=email&utm_source=eloqua&utm_MDMContactID=05771b88-95d8-4c63-8e85-d5b75b834997&utm_campaigntype=Newsletter&eM=5624292d9f3cc6badd34a82bec6a203a2693ea67b7e866cb2b431cbd1a754ede&eventSeriesCode=ES_NWHOPEDGTL&eventEditionCode=HLN00NHN&sessionCode=S_NTRBUZTDY&sp_eh=5624292d9f3cc6badd34a82bec6a203a2693ea67b7e866cb2b431cbd1a754ede
Ingredient Sourcing. For a dietary supplement contract manufacturer to produce a quality product, it is imperative that the ingredients used to make the product are of high quality. Before going to market, the supplement contract manufacturer must design a specification to outline the requirements of the material, based upon the finished product specification.
Once the ingredient and/or component specifications have been designed, the supplement contract manufacturer must start by qualifying the supplier, to ensure that they are following current good manufacturing practices (cGMPs).
Once the supplier has been qualified, the contract manufacturer should provide the ingredient/component specification to the supplier. A sample of the ingredient should be sent out to confirm purity, potency, and identity prior to utilizing any of the ingredients in the manufacturing process. These ingredients are what the dietary supplement is comprised of, therefore if one poor ingredient is placed into the product, it will be detrimental to the quality of the entire product.
Manufacturing Process. Depending on the dosage form of the dietary supplement, manufacturing is an intricate process that is an art, as much as it is a science. Quality should be integrated into every step of the process to ensure that the consumer receives a safe, quality product.
These Quality checks begin before the production batch paperwork is released to the manufacturing floor. The production batch paperwork should be reviewed against the Master Manufacturing Record (MMR). Next, and before any production is started, a quality control (QC) technician must examine the room and equipment to ensure it is properly cleaned and sanitized. The QC technician also reviews any ingredients or components against the batch paperwork to ensure it matches the requirements. If requirements are met, the machine operators move forward with manufacturing. During the manufacturing process, the machine operators perform in-process quality checks to ensure the product meets quality requirements. Each step has a quality control check before it moves forward to the next manufacturing step.
Testing and Certification. Testing the final product manufactured ensures that the supplements bound for the shelf are in fact quality products. Common testing includes purity and potency. This will help provide confidence that consumers are receiving supplements that have what they say in them and nothing else. A common challenge is ensuring that the proper analytical testing method was used for the supplement product. Partnering with a reputable, experienced, third-party lab to help determine the appropriate method for the product matrix is important.
Third-party testing and product certification demonstrates to the consumer that the supplement was independently tested and meets label claim. A few reputable dietary supplement product certifications include NSF for Sport, USP, and Informed Manufacturer. Ask your manufacturing partner if they have the certifications and processes in place to support on-pack claims for your brand of NSF for Sport, Informed Manufacturer, USP, and others. Please note that there are no FDA certified dietary supplements.
Customer Complaints and Adverse Event Reporting. As a dietary supplement brand, it is important to track, monitor, and investigate customer complaints. Supplement brands should partner with their contract manufacturer to evaluate the root cause of any complaints. From the root cause, a preventative action and/or corrective action may be determined to reduce the root cause. This will provide an opportunity for continued improvement for both the supplement brand and contract manufacturer, which will elevate the consumer experience. If the any complaints are related to a serious adverse event, they must be reported to the FDA.
Transparency. Transparency has become a popular term used in the dietary supplement industry. While it is popular, not all supplement contract manufacturers truly practice it. Before a supplement brand chooses a contract manufacturing partner, the brand should visit the facility. There are companies that claim to be supplement manufacturers, yet they outsource to several contract manufacturers and merely operate as a broker. This is a sure way to pay more and lose visibility to if the supplement is a quality product. Supplement contract manufacturers should be willing to provide consumer brands with batch paperwork, testing results, and certificate of analyses that relate to their specific product.
While regulatory compliance, ingredient sourcing, the manufacturing process, testing and certifications, and customer complaints and adverse event reporting are a few of the considerations that must be made, this is short snap-shot of each of these considerations.
Consumers: If the supplement is not third party certified by a reputable certification body, ask dietary supplement brands how they qualify their manufacturers. Do you have access to the supplement certificate of analysis, and if you do, does it make sense?
Consumer brands: Establishing a partnership with a supplement contract manufacturer that values quality is one of the most important steps to ensuring quality products are on the market. By doing so, it’ll help you create a stronger brand. Visit your manufacturing partners!
Contract manufacturers: Encourage consumer brands to visit your facility, educate brands about your manufacturing process, partner with brands to investigate complaints, share relevant product information so brands can feel confident that you are providing quality products. It is what is right for the industry, brands, and the consumer.
About the Author Brea Viratos:
Appointed CEO of Columbia Nutritional in December 2020, Brea joined the company in 2018, working first as director of quality and then as vice president of quality. Prior to her time at Columbia, she worked at a large nutraceutical contract manufacturer in quality management for five years, and before that spent six years at Bayer managing a high-throughput food science laboratory.
