Regulatory Compliance for Supplement Manufacturers: What You Need to Know

Introduction  

• Myth❌: Dietary supplements are not like medications, so they are unregulated.
• Fact✅: Dietary supplements comply with numerous regulations, from production to marketing.

As consumer health commodities, dietary supplements are subject to various regulatory compliance requirements to ensure their safety, efficacy, and reliability for users. Various international statutes regulate the ingredients, formulas, manufacturing process, labeling and packaging, and marketing claims of dietary supplements.  

These regulations are implemented and enforced by prominent international authorities such as the U.S. Food and Drug Administration (FDA) and the European Food Safety Authority (EFSA). The enforcement also includes sanctions for non-compliance.  

According to the FDA, about 25 supplement brands have been recalled between 2023 and 2024, impacting millions of product units, for failing safety or transparency requirements.  

Similarly, in the first quarter of 2023, dietary supplements and fortified foods were the third-highest product category impacted by EFSA recalls in the EU, affecting about 109 brands. 

Hence, regulatory compliance in the nutraceutical industry is an established legal obligation for brand and business success. Whether you are a new or established nutraceutical manufacturer or brand owner, understanding and implementing the knowledge of regulatory compliance for your business is critical. 

Understanding Regulatory Compliance for Supplement Manufacturers  

The dietary supplement industry is guided by many laws. Some notable ones include: 

• Dietary Supplement Health and Education Act of 1994 (DSHEA.
• Current Good Manufacturing Practices (cGMPs).
• Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006.
• Fair Packaging and Labeling Act (FPLA), among other regulations.

The DSHEA empowers the FDA to regulate the manufacture and sale of dietary supplement products in the United States. The Act effectively defines what classifies as a dietary supplement and its ingredients, giving the FDA the power to adjudicate claims relating to any supplement ingredient or product. Additionally, the DSHEA stipulates the compliance requirements for dietary supplements Good Manufacturing Practices under the 21 CFR Part 111 of the Act.

For the EFSA, Directive 2002/46/EC and Regulation (EC) No 1925/2006 empowers the body to regulate the use of vitamins, minerals, and ancillary health substances in the manufacturing of food supplements and nutraceuticals in 24 countries of the EU.

The cGMPs are a popular encompassing regulation in the manufacture, quality control, testing, packaging, labeling, storage, and distribution of food, medications, and nutraceuticals. All domestic and foreign companies in the U.S. involved at any stage in the supplement value chain are expected to comply with cGMP and put compliance auditing mechanisms in place. Here, the goal of the cGMPs is to ensure that supplement products consistently meet quality standards in their identity, purity, strength, and composition.  

The Dietary Supplement and Nonprescription Drug Consumer Protection Act prescribes guidelines to manufacturers for the correct labeling of dietary supplements and provides consumers with the mechanisms for reporting adverse events with supplement use.   

The Fair Packaging and Labeling Act (FPLA), which encompasses all consumer commodities marketed in the U.S., requires brands to label their product to disclose net contents, the identity of the commodity, and the name and business address of the product’s manufacturer and distributor. This Act, which seeks to protect against consumer deception, also applies to dietary supplements. 

Other consumer preference and protection bodies such as Halal, Kosher, and Vegan society also have statutes to comply with to secure their certification. 

Key Certifications Needed for Supplement Manufacturing  

As a supplement manufacturer, holding or presenting relevant certifications lends credence to your claims to quality processes and can boost your standing. 

If you are a brand owner who uses a contract manufacturer, these certifications should be checked before issuing a purchase order.  

Suppliers of your starting ingredients and critical formulation materials (e.g. empty capsules) should also present key certifications affirming their quality and expertise.

Moreover, informed consumers, many of whom are frequent supplement users, often seek and recognize certain certifications on your product, which can help secure their interest, loyalty, and recommendation.  

That said, there are quite several certifications to secure or prioritize with potential suppliers or contract manufacturers. These include: 

1. cGMP Certification 

This certification indicates that the infrastructure, quality control, documentation, personnel training and conduct, and standard operating procedures (SOP) of a manufacturing facility are in tune with best practices, i.e. current Good Manufacturing Practices (cGMP) guidelines. It implies compliance with Hazard Analysis Critical Control Point (HACCP) food safety standards or the International Organization for Standardization (ISO) 9001 principles for manufacturing.  

cGMP certification assures consumers that products from the facility are of the highest accessible quality, do not contain dangerous levels of any contaminants, and contain only what is stated on the label.  

2. Informed Manufacturer Certification  

The Informed Manufacturer is a quality assurance and manufacturing facility certification program for manufacturers of dietary supplements and sports nutrition.  

Offered by LGC Assured, the certification is globally recognized. A facility is certified after the evaluation process confirms that it is free of contamination with substances that are banned by the World Anti-Doping Agency (WADA) in sports.  

3. NSF’s Certified for Sport® 

This is another essential quality certification to have if you are into sports supplements and nutrition. The NSF is a product-focused certification that assures that the tested products are free of banned substances in sports.  

The ‘NSF Certified for Sport certification is well recognized by athletes, dietitians, coaches, and consumers around the world.  

4. Specific dietary/ethical preference certifications 

Depending on your target market, you might also need to possess additional certifications to address the dietary preferences and ethical concerns of your customers.

Examples of such certifications include:  

• Halal: issued by the Halal Certification Authority to affirm a product’s suitability for adherents of Islamic laws globally.  
• Kosher:  Rabbinic stamp of approval affirming that a product is suitable for consumers following the Jewish Kosher laws. 
• Certified Organic: Based on the National Organic Program and supervised by the US Department of Agriculture (USDA), the certified Organic certification protects the confidence of consumers who prefer purely organically prepared supplements or products. Certified products may be classified into 3 tiers of  claim based on their organic content: 100% Organic, USDA Organic (95% organic content), and ‘Made with Organic Ingredients’ (75% organic content) 
• Vegan Trademark: Issued by the Vegan Society to support the vegan credentials of brands worldwide.  

Regulatory Compliance: What it means for us at Capsuline

Formulating your supplement as capsules offers many advantages. From flexibility and elegance in delivery to promoting consumer acceptance with aesthetic appeal, capsules can give you an edge in the market.  

Yet, it is also desired that your product’s capsule contributes to your meeting the regulatory requirements. And to that, we say — “Yes, it can”. That is why you should choose a regulation-compliant empty capsule supplier to manufacture your supplements.

At Capsuline, we are a leading supplier of high-quality empty capsules that can help your nutraceutical product meet regulatory requirements from authorities and target market demands.

Our empty gelatin capsule range is made from 100% bovine gelatin, and our vegetarian capsules are from plant-derived HPMC. We manufacture our empty capsules in our state-of-the-art, cGMP-compliant facilities with a top-rate quality control process that meets international standards.

We are proudly Kosher and Halal certified! Each batch of our capsule supplies has its certificate of Analysis (COA) and Material Safety Data Sheet (MSDS). On top of that, our supply chain is fast and seamless.  

To learn more about how we can support your brand in meeting all relevant regulatory requirements for your products, contact us today. Our doors are always open. 

Conclusion

Building a successful and trusted brand in the highly regulated and competitive nutraceutical space demands adherence to regulatory standards and communicating that to consumers. That requires understanding and adapting to regulations in the industry, securing key certifications, maintaining unwavering dedication to standards of quality and safety in supplement production, and a clear communication of this commitment to consumers.