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Dietary Supplement Regulations: 21 CFR 117 vs 21 CFR 111

September 16, 2023

In the complex and comprehensive area of FDA regulations, understanding the distinctions between different sections can be the key to compliance and the production of safe products for consumers. Two essential parts in the Code of Federal Regulations that often get discussed in the realm of food and dietary supplements are 21 CFR 117 and 21 CFR 111. While both play crucial roles in ensuring product safety, they serve different areas of the market.

21 CFR 117: A Focus on Human Food

Title 21, Part 117, commonly referred to as 21 CFR 117, deals with “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.” At its core, this regulation aims to ensure that human foods are produced, packed, and held in a manner that ensures their safety and compliance with hygiene standards.

Highlights of 21 CFR 117 include:

  1. Preventive Controls: Requires facilities to evaluate the hazards that could affect food safety, specifying preventive steps or controls to ensure these hazards are minimized or prevented.
  2. Facility Inspections: Periodic inspections are mandated to ensure facilities maintain sanitary conditions.
  3. Safety Management: This regulation emphasizes proactive measures, asking manufacturers to anticipate potential hazards and implement preventive controls.

21 CFR 111: Tailored for Dietary Supplements

21 CFR 111, “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements,” zeroes in on the specific requirements for dietary supplements. Its goal is to ensure that dietary supplements are produced in a quality manner, preventing adulteration and ensuring accurate labeling.   The FDA is especially interested when manufacturers make claims about their product related to weight loss, sexual enhancement or nutrition.

Key components of 21 CFR 111 encompass:

  1. Facility and Personnel Standards: Specific sanitary standards are mandated for places where supplements are manufactured, packaged, or held. There are also standards that apply specifically to personnel regarding hygiene, training, and qualifications to ensure safe product handling.
  1. Product, Process and Quality Control: For every product and batch, there are requirements for quality control, including establishing a master manufacturing record for each product and batch production record for each batch of product.
  2. Holding and Distribution: Rigorous guidelines are established for storing and transporting both raw materials and final products.
  3. Labeling Accuracy: The content of dietary supplements must be accurately reflected on their labels. Standards are set for ensuring product packaging and labeling don’t lead to product adulteration or misbranding.  Most labs will require laboratory testing to develop the supplement label to ensure accuracy.
  4. Handling Complaints: Detailed procedures are put in place for documenting and investigating product-related complaint including guidance on how to handle products that are either returned or recalled.

So, Why the Distinction?

While there is an overlap in the intent of both regulations – ensuring product safety – the nuanced differences lie in their scope and details. For manufacturers, distributors, and other stakeholders in the food and dietary supplement sectors, understanding the specifics of both 21 CFR 117 and 21 CFR 111 is paramount. Compliance is not just about adhering to regulations; it’s about ensuring the safety and well-being of consumers. By understanding the nuances between these two sections, businesses can better navigate the regulatory landscape and maintain the highest standards of product safety.

Dietary supplements, as products that people consume for health benefits, have their unique challenges, from ensuring that they contain the correct ingredients in the right amounts to ensuring no contaminants or adulterants are present. 21 CFR 111 ensures that supplements meet these specific challenges.

On the other hand, 21 CFR 117 addresses a broader range of foods and emphasizes risk-based preventive controls, focusing on a more comprehensive approach to food safety that takes into account the many different types of products and processes in the food industry.

How to Ensure Compliance?

In the intricate web of regulations that govern the dietary supplement industry, navigating the complexities of compliance can often be overwhelming for manufacturers. This is where professional partnerships become invaluable.

  • Expertise in the Field: RL Food Testing has a 5-Star customer service model with an established reputation in the areas of food, pet food and supplement testing. Their team of experts is well-versed with the nuances of both 21 CFR 117 and 21 CFR 111, ensuring that your products meet the required standards.
  • State-of-the-Art Analysis: With evolving technology and continuous research, the methods of analyzing dietary supplements for safety and efficacy are continually advancing.  Calibration of equipment and age of equipment can play a big part in the outcome of lab testing.  ISO certification is one-way labs can communicate the quality of their work
  • Accurate Labeling: One of the significant challenges in the dietary supplement sector is ensuring accurate labeling. RL Food Testing provides comprehensive labeling services, ensuring that every ingredient, nutritional fact, and claim on your product label is precise, compliant, and consumer friendly.  We insist on laboratory testing to produce supplement labels and encourage lab testing for food labeling as well.
  • Proactive Approach: FDA regulations are always being updated. As science progresses and more becomes known about nutrition and health, these regulations adapt and change. Partnering with a lab partner with years of experience means you’re always a step ahead, as they proactively monitor and adapt to regulatory shifts.
  • Trust and Credibility: In an industry where consumer trust is paramount, displaying a partnership or certification from a recognized entity like RL Food Testing can boost your brand’s credibility. It signifies to your consumers that you prioritize their health and well-being above all.

While 21 CFR 117 focuses on general human food, 21 CFR 111 specifically governs the manufacturing and handling of dietary supplements. Manufacturers and stakeholders in the dietary supplement industry should familiarize themselves with these regulations to ensure compliance and safeguard public health. Partnering with trusted lab partners can provide the services you need to be in compliance with government regulations and, in most cases, retailer requirements.

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