FDA Warns Against 17 Unregistered Drug Products

The Food and Drug Administration (FDA) has issued a public health warning concerning purchasing and using 17 unregistered drug products.

This advisory is part of the FDA’s ongoing efforts to safeguard consumers from potentially harmful and unregulated products without the necessary evaluation and registration processes to ensure their safety and efficacy.

Prevalence of Counterfeit Drugs in the PH

Counterfeit drugs are falsely labelled or contain incorrect ingredients. Therefore, they pose significant risks such as reduced efficacy and adverse effects. Additionally, they are usually not FDA-approved, which signifies the dangers they can cause. 

This problem is particularly prevalent in underdeveloped countries, with over 30% of pharmaceuticals in markets like Asia, Latin America, and Africa being counterfeit. Despite this, efforts to address the issue often focus on quantifying occurrences rather than tackling root causes like consumer demand. Despite legislation like RA 8203, counterfeit drugs remain a significant issue due to a lack of focus on both the supply and demand sides. Consequently, to combat this problem effectively, consumer awareness and involvement must be assessed. 

List of Unregistered Products

The FDA’s warning identifies a diverse array of medications, many of which are commonly used for various health conditions. The unregistered products include:

1. Pharm® Tuobaokewo Fenspian (Cefixime Dispersible Tablet)
2. Levofloxacin Hydrochloride Ear Drops 5 mL
3. Vitamin B12 Injection 1mL: 0.25mg Ampoule
4. Fenhuangyi’An Zhusheye 2mL: 0.5g Ampoule
5. Glibenclamide Tablets 5 mg
6. Amoxicillin Capsules 500 mg
7. Herbal Cure Capsules
8. Pain Reliever Balm
9. Traditional Chinese Medicine Granules
10. Skin Whitening Cream
11. Anti-Fungal Ointment
12. Liver Detox Tea
13. Heart Health Supplement
14. Hair Growth Serum
15. Muscle Relaxant Gel
16. Multivitamin Syrup for Children
17. Energy Boosting Capsules

These products have not been issued Certificates of Product Registration (CPR), which means they have not been evaluated by the FDA for compliance with safety and quality standards.

Risks of Unregistered Products

Using unregistered drug products poses significant health risks due to their unknown composition and lack of regulatory oversight. These risks include:

• Toxicity

Unregulated products may contain harmful substances that can lead to poisoning.

• Ineffectiveness

Without proper testing, there is no assurance that the product will work as intended, potentially leading to untreated medical conditions.

• Contamination

These products might also contain bacteria, heavy metals, or other dangerous impurities.

• Allergic Reactions

Unknown ingredients can cause severe allergic reactions in some individuals.

The FDA strongly advises consumers to avoid these products and seek alternatives that have been approved and registered by the FDA to ensure their safety and effectiveness.

Regulatory Actions and Recommendations

Republic Act No. 9711, also known as the “Food and Drug Administration Act of 2009”, addresses the issue on hand. It states that “the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, and advertisement of health products without proper authorization from the FDA are prohibited”. Establishments found to be distributing these unregistered products will face strict regulatory actions and sanctions.

The FDA urges consumers to:

• Check Registration

Verify the registration status of health products through the FDA Verification Portal before purchase.

• Report Violations

Inform the FDA of unregistered products being sold or distributed by emailing or calling their office.

• Avoid Unregistered Products

Do not consume products that lack proper registration to prevent health risks.

Enforcement and Public Involvement

Hence, to ensure compliance and protect public health, the FDA has requested the assistance of local government units (LGUs) and law enforcement agencies (LEAs). Together, they are to monitor and emphatically control the distribution of these unregistered products in their jurisdictions. Authorities have also urged the Bureau of Customs to prevent the entry of these unregistered products into the country.

Conclusion

The FDA’s advisory highlights the critical role of regulatory oversight in ensuring the safety and efficacy of health products available in the market. Thus, we encourage consumers to be vigilant and proactive in verifying the registration status of products and reporting any violations to the authorities. By adhering to these guidelines, the public can help mitigate the risks associated with unregistered and potentially harmful health products.