Six Emerging Trends and Their Influence on Dietary Supplement Manufacturing Practices
This article looks at six emerging trends in dietary supplements—and what they mean for dietary supplement manufacturing. As this market shifts and grows, staying compliant and competitive means staying ahead of your competition. We’ll break down the key changes influencing supplement manufacturing, along with what to consider when it comes to how 21 CFR Part 111 compliance and quality are impacted.
1. Consumer Demand for Ingredient Sourcing Transparency
Consumers are more informed than ever about the products they buy. It’s not enough to just list ingredients; people want to know the source. Along with ingredient origins, processing, and whether these practices are deemed ethical and sustainable are top factors in choosing dietary supplements. This has led manufacturers to focus on:
- “Clean” ingredients that require minimal processing
- Sustainable and ethically sourced raw materials
- Organic, non-GMO, and allergen-free formulations
Key Considerations – This growing demand for clean, high-quality ingredients that are accurately represented on the label greatly impacts dietary supplement manufacturing. It requires brands and manufacturers to seek new sources and committing to more strict supplier qualification programs, detailed documentation, employee training, and regular supplier audits. Production teams must learn to work with minimally processed, organic, and non-GMO materials. These ingredients can be more sensitive, so teams need to tweak how they’re formulated, handled, and stored. On top of that, using allergen-free or certified ingredients might mean setting up dedicated lines or tightening controls to prevent cross-contamination.
2. Heightened FDA Enforcement
Since the FDA has increased oversight over dietary supplement regulations, compliance with 21 CFR Part 111 is more essential than ever. Recent trends include:
- More frequent inspections of dietary supplements manufacturing facilities
- Increased Form 483 observations and warning letters for non-compliance
- Thorough evaluation of label claims to ensure product safety and guarantee that consumers get what they pay for
Key Considerations – To stay ahead, companies must ensure both raw materials and finished products meet identity, purity, strength and composition claims that the label states. Also, proactively conducting internal audits, identifying and implementing corrective and preventive actions (CAPA), and ensuring comprehensive documentation of their quality control (QC) processes will help maintain regulatory compliance and lessen or eliminate regulatory action.
3. Rising Popularity of Exotic Ingredients
Consumers are increasingly looking for unique and exotic ingredients in dietary supplements in categories such as:
- Plant-based and herbal extracts
- Fungi and adaptogens
- Nootropics and bioactives
- Fermented and postbiotic ingredients
Key Considerations – These novel ingredients offer differentiation but can also bring considerable regulatory issues to the forefront. If an ingredient wasn’t marketed in the U.S. before October 15, 1994, it’s considered a New Dietary Ingredient (NDI). Seventy-five days before market introduction, an NDI notification with safety data must be submitted to the FDA. Many companies aren’t aware of this rule or they supply insufficient data which could put them at risk for FDA enforcement action.
Also, manufacturers must work closely with laboratories and develop acceptable identity testing. Botanical and exotic extracts can often be adulterated or misidentified, especially if sourced without proper vetting.
4. Personalized Nutrition & Custom Formulations
Demand is rising for supplements tailored to individuals, whether that be genetics, age, gender, lifestyle, or health goals. Meeting this demand requires:
- AI-driven personalization: Using AI and other tools to analyze genetic data, biomarkers, and customer data and requests to recommend specific supplement formulations
- Subscription-based delivery: Ongoing, customized supplements delivered regularly, often with adjustments provided by the consumer
Key Considerations – Unlike mass-produced products, personalized supplements often need micro-batching or single-unit production. This raises the bar on the need for operational precision and recordkeeping. Manufacturers must maintain master manufacturing records (MMRs) and batch records (MBRs) and be able to trace lot numbers and match labels to individual orders. This is critical in all manufacturing but much more detailed and cumbersome with customized products.
To succeed with this offering, companies must invest in flexible systems that can handle high SKU complexity while still upholding quality and regulatory standards required by 21 CFR Part 111 and 21 CFR Part 11.
5. Eco-Friendly Packaging
A shift toward eco-friendly packaging is creating both opportunities and challenges for dietary supplement manufacturers. To uphold the highest standards of product quality and compliance, manufacturers must adapt their packaging lines, quality systems, and material sourcing – just like raw materials – to accommodate these sustainable formats.
- Increased use of biodegradable, recyclable, and refillable packaging
- Carbon-neutral and eco-conscious manufacturing practices
Key Considerations – Using alternative materials like compostable films or recycled plastics can impact equipment, shelf-life stability, and a host of other factors. Manufacturers may need to invest in new packaging technologies, adjust sealing and labeling processes, and conduct additional testing on these new materials. Supporting these types of initiatives often involves strengthening supply chain relationships and watching energy usage and waste management practices.
6. Advanced Bioavailability & Delivery Systems
New supplement formats are designed to help the body absorb vitamins and nutrients more effectively. These delivery systems can be more sensitive than traditional pills or capsules to manufacture and handle. They may need special storage conditions (like refrigeration or protection from oxygen) and extra care during packaging to keep them stable and effective through their shelf life.
These innovations offer real benefits to consumers and can open market opportunities but they can also complicate the manufacturing and handling of supplements.
- Development of liposomal, nano-emulsified, and micellized nutrients for better absorption
- Growth in gummies, soft chews, dissolvable strips, and liquid supplements over traditional pills
- Encapsulation technologies to protect sensitive or volatile ingredients and ensure efficacy
Key Considerations – The popularity of alternative delivery forms creates new manufacturing challenges. These forms typically involve more complex manufacturing processes, such as gelatin or pectin cooking systems, high-shear mixers, and molding or extrusion equipment. They can also introduce new quality concerns, like testing water activity, texture, flavor masking, and ingredient degradation. Encapsulation technologies require precise conditions and multi-step processes to maintain the potency and time-release functionality of the ingredient. To comply with GMP, these processes will need to be validated and their equipment qualified.
Conclusion: Staying Ahead in a Regulated Market
To succeed in today’s dietary supplement industry, manufacturers need to acknowledge stronger quality systems, technology advancements, and newer manufacturing practices that keep up with customer demand. By continuously aligning and training on 21 CFR Part 111 and other supplement standards and guidelines, companies can build trust and credibility in the market.
Contact us for more information on dietary supplement compliance.
