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The FDA (U.S. Food and Drug Administration) has enacted Import Alert 53-06 as part of a serious initiative to prevent consumers from being harmed. This notice calls out to importers of general use cosmetics that are contaminated or mislabelled because of a violation related to colour additives in cosmetics. These are products that contain non-permitted, uncertified, or unidentified colour additive ingredients and are then detained without physical inspection upon arrival on U.S. shores. The sweep of the alert classifies certain products as generally unsafe, and they can be refused entries if under the alert. [1]

FDA Recall of Mercury- and Hydroquinone-Containing Skin Whitening Products with Unlabelled Mercury and Hydroquinone

Recall , July 24, 2025

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Summary of Import Alert 53-06

The FDA (U.S. Food and Drug Administration) has enacted Import Alert 53-06 as part of a serious initiative to prevent consumers from being harmed. This notice calls out to importers of general use cosmetics that are contaminated or mislabelled because of a violation related to colour additives in cosmetics. These are products that contain non-permitted, uncertified, or unidentified colour additive ingredients and are then detained without physical inspection upon arrival on U.S. shores. The sweep of the alert classifies certain products as generally unsafe, and they can be refused entries if under the alert. [1]

Recall Summary

Recall instant pertains to CRLAB Hair Spray with a point of manufacture by ADVIHAIR SpA at Via Benini 11, Zola Predosa, Bologna, Italy. The product is being held under FDA Import Alert 1184 due to the presence of dichloromethane or methylene chloride, a toxic chemical. The product is considered noncompliant since it is unsafe for consumer use and is being recalled.

Product Information

Product Name: CRLAB Hair Spray (Aerosol Fixatives)

Product Category: Hair Preparations (Non-coloring)

Manufactured By: ADVIHAIR SpA, Italy

Violation: Methylene chloride (dichloromethane) is listed in the ingredients [2]

Reason for Recall

Dichloromethane (Methylene Chloride)

Methylene chloride is a solvent that is a serious health risk to those who meet it, including skin irritation, respiratory deception, central nervous system depression, and it is included in hair spray products that is noncompliant with the FDA suggesting certain consumer products are unsafe to individuals since the aerosolized vapor is harmful to the consumer.  

FDA Import Alert

The product is now under FDA Import Alert 1184, meaning the product is presently detained at ports of entry in the United States and is not permitted for trade. The product is considered to have toxic effects due to the ingredient being dichloromethane, as such, this hair spray product is unsafe for consumer use.

CRLAB Hair Spray Recall blog

Regulatory Issues, Public Health

Health Risks

Inhalation of methylene chloride can cause dizziness, headaches, and nausea. Prolonged or excessive exposure can cause worsening symptoms up to neurological impairment and death in extreme cases.

Regulatory Non-compliance

The inclusion of methylene chloride in this product breaches the guidelines established by the FDA for cosmetics, specifically those that can be inhaled or topically applied to the skin. Also, the product does not comply with FDA regulations on safety testing and labeling. It also puts consumers in a difficult position as they may be unaware of the risks involved.

Manufacturer Recommendations

Immediate Action:

 ADVIHAIR SpA, should stop the distribution of CRLAB Hair Spray internationally immediately, and initiate a full product recall of any remaining inventory.

Testing and Replacement:

Testing all remaining inventory against FDA safety tests in the US and redesigning the formulation of the product replacing methylene chloride with a safer alternative if necessary.

Certification:

Manufacturers must provide certifications that product does not contain harmful substances, and documentation that conform to global regulations.

FRL Commentary

As a leading partner in cosmetic product safety and formulation, Food Research Lab, emphasizes the importance of compliance with regulatory standards and ingredient transparency in any personal care product. Methylene chloride is an unnecessary risk in this scenario and manufacturers must be sure their formulations are created from FDA approved ingredients. Brands must remain diligent on their responsibility to regulations on ingredients and third-party testing to assure consumer safety.

Stay Informed:

 Instructions for Consumers at Risk

Consumers using CRLAB Hair Spray must:

  • Stop use immediately
  • Consult healthcare provider for adverse effects
  • Report problems to the FDA or local regulatory authority
  • Dispose of the product safely according to appropriate disposal directions

Conclusion

The incident involving CRLAB Hair Spray and methylene chloride recall, reminds us that vigilance is the personal care industry is ongoing, and immediate action must be taken by manufacturers to protect consumer health and safety by compliance with regulatory standards. ADVIHAIR SpA must show their commitment to safe and effective formulations for their products, and provide appropriate testing, labeling and education to consumers.

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