How to register nutritional supplements for athletes?

Before starting the process of registering nutritional supplements with ANVISA, it is essential to understand the basic requirements. ANVISA classifies nutritional supplements for athletes into different categories, such as protein supplements, hypercaloric supplements, energy supplements, among others. Each category has specific regulations. Here are the general requirements:

1. Complete documentation: A dossier must be submitted containing detailed information on composition, labeling, stability and safety studies, among other documents required by ANVISA.
2. Good Manufacturing Practices (GMP): The manufacturing company must follow Good Manufacturing Practices (GMP) and have certification of conformity. This certification guarantees that the product has been manufactured under suitable and safe conditions.
3. Proof of Efficacy and Safety: The company must present studies proving the efficacy and safety of the nutritional supplement. These studies may include clinical trials, microbiological and physical-chemical analysis reports and other tests that prove the quality of the product.
4. Appropriate labeling: The labeling of nutritional supplements must follow ANVISA standards, including clear and precise information about the product, its ingredients, mode of use, warnings and permitted nutritional claims.

The process of registering nutritional supplements for athletes with ANVISA involves several steps. Below, we detail each of them:

1. Identifying the Type of Supplement: The first step is to identify the category of nutritional supplement (protein, energy, hypercaloric, etc.) and understand the specific rules applicable to that category.
2. Preparing the Documentation: Organize all the documentation required for registration, such as the product's technical data, analysis reports, safety and efficacy reports, stability studies, and labelling information.
3. Registering the company with ANVISA: The company must be registered with ANVISA as a “Producer Establishment”, “Importer”, or other applicable category, and have an Operating Authorization (AFE).
4. Submitting the registration dossier: After gathering all the documentation, it's time to send the complete registration dossier to ANVISA via the agency's electronic system, Solicita. Make sure that all the documents comply with ANVISA's requirements.
5. Payment of Sanitary Inspection Fees (TFS): The registration of nutritional supplements involves the payment of fees, known as Sanitary Inspection Fees (TFS). The company must generate and pay the fee in order for the registration process to officially begin.
6. Analysis by ANVISA: ANVISA will analyze the registration dossier. During this phase, the agency may request additional information or clarifications. It is crucial to be prepared to respond to these demands quickly.

Publication in the Federal Official Gazette (DOU): After approval by ANVISA, the registration of the nutritional supplement will be published in the Federal Official Gazette (DOU). From that moment on, the product is officially registered and can be marketed.

• Hire Specialized Consulting: Regulatory consulting firms, such as Stone Okamont, can help simplify the process of registering nutritional supplements, ensuring that all steps are completed correctly and in an agile manner.
  
  
• Keep up to date with ANVISA regulations: Regulations for nutritional supplements can change over time. It is essential to keep up to date with the rules and regulations to avoid problems with product registration and marketing.
  
  
• Invest in Good Manufacturing Practices: Compliance with Good Manufacturing Practices is crucial to guaranteeing product quality and consumer safety. In addition, it is a mandatory requirement for registration with ANVISA.

At Stone Okamont, we are experts in regulatory affairs and are ready to help your company navigate the complex requirements of ANVISA and other regulatory bodies. We offer customized solutions, agility in the registration process, and expertise to ensure that your nutritional supplements are always in compliance with current regulations. Let our experts take care of all the registration steps and free up your time to focus on what really matters: the growth and success of your business. Contact us and find out how we can help you conquer the market for nutritional supplements for athletes!