How to Regularize Weight Loss Products with ANVISA?

Weight loss products can be classified into different categories, each with specific regularization requirements:

1. Dietary Supplements: Products that provide additional nutrients and may contain ingredients that aid in weight control.
2. Foods: Food products that claim to assist in weight loss through calorie control or specific ingredients.
3. Cosmetics: Topical products that claim to help reduce body measurements.

Regularizing weight loss products with ANVISA is essential to ensure the safety and efficacy of products available on the market. Unregulated products may contain dangerous substances or be ineffective, putting consumers' health at risk. Additionally, regularization is a legal requirement for the commercialization of these products in Brazil.

1. Product Classification The first step is to determine the correct classification of the product. The classification affects the documentation requirements and the regularization process.
• Dietary Supplements: Must follow the guidelines for functional foods and novel foods.
• Foods: Must comply with the standards for specific and controlled foods.
• Cosmetics: Must follow the guidelines for cosmetic products with slimming claims.
2. Preparation of Documentation The necessary documentation varies according to the product category, but generally includes:
• Petition Form: Detailed information about the product and the company.
• Product Composition: A complete list of ingredients and their concentrations.
• Safety and Efficacy Studies: For cosmetics and some dietary supplements.
• Label and Packaging: Must comply with ANVISA regulations, including health claims, usage instructions, warnings, and manufacturer details.
3. Submission of the Petition The petition must be submitted through the Solicita system, available on the ANVISA website. It is crucial to follow all instructions and ensure that all documentation is complete and accurate.
4. Payment of the Union Collection Guide (GRU) Submission requires payment of the Union Collection Guide. The fee amount varies depending on the product category and the size of the company.
5. Petition Review by ANVISA ANVISA reviews the petition and submitted documentation to verify compliance with regulations. There may be requests for additional information or clarifications during this phase.
6. Obtaining the Registration If the petition is approved, ANVISA will issue the product registration, allowing its commercialization in Brazil. The registration has a determined validity and must be renewed periodically.

• Complete Preparation: Gather all necessary documentation and ensure it is complete and accurate before starting the submission process.
• Compliance with Regulations: Ensure the product's label and packaging comply with ANVISA regulations.
• Specialized Consulting: Consider hiring a specialized consultancy in regulatory affairs to speed up the process and ensure everything is in order. Stone Okamont, for example, offers complete support in preparing documentation and submitting the petition to ANVISA.
• Process Monitoring: Regularly monitor the submission status and be prepared to respond to any additional information requests from ANVISA.

Regularizing weight loss products with ANVISA can be a complex and challenging process. Stone Okamont is a company specialized in regulatory affairs that can assist your company in all stages of the process.