¿Los vaporizadores RAZ están aprobados por la FDA? Lo que necesitas saber (Guía 2026)

Introducción

If you’re considering buying a RAZ vape or have seen them in stores, you might be wondering: are RAZ vapes FDA approved? With growing concern about the safety and legality of disposable vapes, especially popular brands like RAZ, it’s important to understand how the US Food and Drug Administration (FDA) regulates these products.

In this detailed guide, we’ll break down what “FDA approval” actually means for vaping products, whether RAZ vapes have received it, and what implications that has for consumers.

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What Does FDA Approval Mean for Vape Products?

Before we answer the main question, it’s crucial to clarify what FDA approval involves:

• The FDA regulates tobacco products, including e-cigarettes and vapes, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Administración de Alimentos y Medicamentos de los Estados Unidos
• Most vaping products are considered “new tobacco products.” For these to be legally marketed in the U.S., manufacturers must obtain premarket authorization from the FDA. Administración de Alimentos y Medicamentos de los Estados Unidos
• Products without required authorization are considered unauthorized and may not be legally sold. Administración de Alimentos y Medicamentos de los Estados Unidos

Note that “FDA approved” is slightly different from “FDA authorized.” In tobacco regulation, the agency typically issues marketing authorization rather than full pharmaceutical-style approval seen with drugs.

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Are RAZ Vapes FDA Approved?

No — RAZ vapes are not FDA approved or authorized for marketing in the United States.

According to an FDA warning letter to the company responsible for RAZ Vape products (FUNCOOL Technology Co., Limited d/b/a RAZ Vape), several RAZ vape devices, including popular models like the RAZ DC25000 y RAZ TN9000, were being sold without the required FDA marketing authorization. Administración de Alimentos y Medicamentos de los Estados Unidos

The FDA determined these products are “new tobacco products” and cannot legally be marketed because:

• They were not on the U.S. market before February 15, 2007.
• They do not have a premarket authorization order from the FDA.
• They have not been granted exemption or substantial equivalence status. Administración de Alimentos y Medicamentos de los Estados Unidos

Because of this, these RAZ vape products are considered adulterated and misbranded under federal law. Administración de Alimentos y Medicamentos de los Estados Unidos

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Why Many Disposable Vapes Lack FDA Authorization

Disposable vape brands like RAZ often do not receive FDA authorization before being sold for several reasons:

1. Complex Application Process: The FDA’s premarket authorization involves detailed scientific data on safety, public health impact, and manufacturing quality. Administración de Alimentos y Medicamentos de los Estados Unidos
2. Youth Appeal Concerns: Products with sweet flavors or marketing appealing to young people have faced intensified scrutiny and enforcement. Administración de Alimentos y Medicamentos de los Estados Unidos
3. Market Flooded with Imports: Many disposable vapes are imported without proper documentation or compliance, prompting FDA enforcement actions. Administración de Alimentos y Medicamentos de los Estados Unidos

Only a limited number of vaping products have successfully obtained FDA marketing authorization so far. digitalmedia.hhs.gov

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Does “Not FDA Approved” Mean RAZ Vapes Are Unsafe?

Not necessarily—but it’s important to understand the difference:

• A product being unauthorized simply means it has not gone through the FDA’s required review process for marketing clearance.
• It does no automatically prove the product is unsafe, but it hace mean its safety and public health impact have not been evaluated and approved by the FDA. Administración de Alimentos y Medicamentos de los Estados Unidos

Whether or not a disposable vape has FDA authorization, nicotine-containing products carry health risks and are addictive.

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What Happens to Unauthorized Vape Products?

The FDA can take enforcement action against unauthorized vape products, such as:

• Issuing warning letters to distributors and manufacturers. Administración de Alimentos y Medicamentos de los Estados Unidos
• Detaining or seizing shipments at the border. Administración de Alimentos y Medicamentos de los Estados Unidos
• Ordering products removed from the market.

Selling unauthorized vape products in the U.S. can lead to legal consequences for companies.

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How to Check If a Vape Has FDA Marketing Authorization

To verify whether a particular vape product is authorized:

1. Visit the FDA’s Searchable Tobacco Products Database.
2. Enter the product name or manufacturer.
3. If it’s authorized, you’ll see a marketing order listed.
4. If not, the product is considered unauthorized. Administración de Alimentos y Medicamentos de los Estados Unidos

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FAQs About RAZ Vapes and FDA Approval

1. Are RAZ vapes FDA approved?

No, RAZ vapes currently do not have FDA marketing authorization in the U.S. and are considered unauthorized. Tobacco Insider

2. Does “not FDA approved” mean they are banned?

Products without authorization are not legally marketed in the U.S., and the FDA can take action to remove them. Administración de Alimentos y Medicamentos de los Estados Unidos

3. Are any vapes FDA approved?

Only a limited number have received FDA marketing orders; most disposable flavors have not. digitalmedia.hhs.gov

4. Can RAZ vapes be sold in other countries?

Yes—FDA authorization applies to the U.S. market; other countries have their own regulations. Wikipedia

5. Does FDA authorization mean a product is safe?

Authorization means the FDA evaluated data on health risks, but vaping still carries health risks. Administración de Alimentos y Medicamentos de los Estados Unidos

6. Why hasn’t RAZ obtained FDA authorization yet?

The premarket process is costly and time-consuming, and many manufacturers delay or avoid it. Administración de Alimentos y Medicamentos de los Estados Unidos

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Conclusión

Así que.., are RAZ vapes FDA approved?
👉 No. RAZ disposable vapes lack FDA marketing authorization and are considered unauthorized products in the United States. Administración de Alimentos y Medicamentos de los Estados Unidos

This doesn’t necessarily mean they’re inherently dangerous, but it hace mean they haven’t been reviewed or cleared by the FDA for sale based on scientific evaluation. If FDA authorization matters to you as a consumer, check the agency’s official tobacco products database before buying or using any vaping device.