Overview
This Blog addresses the intensified inspection efforts by the Brazilian Health Regulatory Agency (ANVISA) against the marketing of products without proper sanitary authorization. We analyze recent seizure cases involving Unregistered Hair Cosmetics (Botox and Straightening products) and Irregular Medicines/Herbal Supplements, highlighting how the absence of registration, notification, or proper listing exposes consumers to serious health risks and the industry to severe penalties.
Introduction
Brazil boasts a vast consumer market eager for quick and innovative solutions in both the beauty and health sectors. However, this demand is often exploited by companies that ignore or circumvent regulatory requirements, placing unauthorized products into circulation.
The lack of sanitary registration signifies that the product has not undergone the mandatory safety, efficacy, and quality assessment. ANVISA’s recent actions, which have resulted in the seizure and prohibition of several lines of popular hair cosmetics and supplements, reaffirm an undeniable truth: saving time and cost on compliance translates into an unacceptable risk to public health.
The Targets of Inspection and the Nature of the Risk
Sanitary inspection has concentrated on two major product groups that are widely marketed but frequently irregular:
- Unsafe Hair Cosmetics: “Organic” Botox and Straightening
In the beauty sector, ANVISA focuses on miraculous promises that mask irregularity and the use of prohibited substances.
The Problem: Lines of “hair botox” and “organic” or “vegan” hair straightening/sealing products without registration have been removed from the market. The lack of registration indicates no documented proof that the formulation is safe and that its manufacturing follows Good Practices (GMP).
The Hidden Risk: What is often marketed as “organic” may conceal prohibited ingredients, such as formaldehyde (in concentrations above the allowed limit) or other undeclared allergens and irritants. Chronic or acute exposure to these substances can cause everything from hair loss and scalp irritation to serious respiratory problems for both the consumer and the salon professional.
The Regulatory Point: Claiming chemical straightening or hair modification is complex and requires a Tier 2 Registration with ANVISA. Simple notification (Tier 1) is insufficient and illegal for products with this purpose.
Irregular Supplements and Herbal Products: The False Cure
The market for natural supplements and compounds is also a constant focus of seizures, leading to the removal of popular products like “Xarope da Vovó” (Grandma’s Syrup) and other irregular herbal products.
The Problem: These products have been suspended due to the lack of registration, notification, or proper listing, or because of misleading therapeutic claims. In the case of herbal products, the absence of registration implies that the origin and concentration of the plant extracts have not been verified, and the extraction and handling process may be contaminated.
The Hidden Risk: Many irregular supplements contain undeclared active ingredients (spiking), which can interact with continuous-use medications, cause liver damage, or kidney dysfunction. When a product is falsely sold as a “cure” (therapeutic claims), it may induce patients to abandon proven medical treatments.
The Regulatory Point: Brazilian legislation is clear: any product claiming to treat, cure, or prevent diseases must be registered as a Medicine, undergoing a rigorous clinical efficacy process.
Key Aspects for the Industry
For health and beauty companies striving for excellence and responsibility, it is essential to observe:
Mandatory Certification: It is the duty of the manufacturing or importing company to ensure that all products (medicines, cosmetics, and supplements) possess valid registration, notification, or proper listing with ANVISA.
Chain Penalization: Responsibility is not exclusive to the manufacturer. Distributors, retailers, and even e-commerce platforms selling unregistered products can be jointly penalized for sanitary infractions.
Transparency and Labeling: The formulation and marketing claims must be 100% transparent and compatible with what ANVISA has approved. Omission of hazardous ingredients or false therapeutic claims are immediate grounds for interdiction.
Severe Penalties: In addition to multimillion-dollar fines (which can reach R$ 1.5 million) and interdiction, publicizing a seizure by ANVISA destroys consumer trust, impacting long-term sales.
Conclusion
The recent wave of seizures of unregistered hair cosmetics and supplements confirms that ANVISA is vigilant and acting strategically to curb informality. For GRP Brazil and the entire productive chain, the only sustainable strategy is the continuous and rigorous investment in sanitary compliance.
Operating with registration is not just about obeying the law; it is an ethical commitment to consumer safety and a competitive differentiator in the market. The absence of a regulatory document transforms a simple product into a potential threat to life.
GRP Brazil
If you are interested in registering your products in Brazil, GRP is ready to help. Our team of experts can simplify the process of registering products in Brazil and make it easier to schedule meetings with Anvisa more efficiently.
GRP can act as your local Agent & Register your product in U.S
Contact our team today to Inquire!
Email: info@globalregulatorypartners.com
Telephone : (+1) 781-672-4200
References
Learn more about Anvisa.
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.