Is the FDA certification compliant? Did the TriPollar agent exaggerate the publicity?

When it comes to "FDA certification", many consumers will be familiar with it, but do not have a detailed understanding of it. The FDA (U.S. Food and Drug Administration) is a government department that supervises and manages food, drugs, cosmetics, medical devices and other products in the United States in accordance with relevant laws and regulations. Among them, according to the medical purpose and possible harm to the human body, the FDA divides medical devices into categories I, II, and III. The higher the category, the more supervision.

Some self-media introduced in the article that only products with the highest risk level of Class III or above that are not exempt from 510K, applying for FDA registration are called FDA Approved. The TriPollar Stop product, that is, the radiofrequency beauty instrument, should be classified as a Class II medical device, and it should have obtained a marketing authorization (FDA Cleared) rather than a certification, so it is suspected of false advertising.

Nanjing Jaguar explained that if it is a brand-new technology that has no technical endorsement or approval from the FDA before, and pre-market clinical trials prove that it is safe and effective, it will be FDA Approved. If other products use the same technology, they will be FDA Cleared after proving to the FDA that the ingredients, technology, parameters and other elements of the product are as safe and effective as FDA Approved products.

Therefore, Nanjing Jaguar believes that the radio frequency technology used in the TriPollar Stop series of products has been FDA Approved in previous products, so it will be FDA Cleared (marketed) in the description of this series of products. Licensing) is said to have obtained technical certification. There is no problem. The company believes that the ambiguity in the relevant description is a matter of academic debate and translation, and is not an intentional distortion of facts.

In recent years, the demand for beauty devices in my country has been booming. Due to the characteristics of the products, it is conceivable that merchants attach great importance to various test reports, qualifications, certifications and other data. In all kinds of dazzling advertising campaigns, it is inevitable that controversial voices will appear.

In fact, professionals have been paying attention to the statement of "FDA certification" on the market. In October this year, Dongwei Chengdu Law Firm issued an article explaining this.

The law firm introduced in the article that most of the FDA certifications obtained by the home beauty equipment promoted on the market refer to the marketing authorization obtained through the 510K route and become a Class II medical device. The household beauty instrument has passed the FDA Class II medical device certification through the 510(k) route, which only means that the instrument is consistent in safety and efficacy compared with existing instruments, constitutes substantial equivalence, and is therefore allowed to be used as a medical device. Identity and Purpose For sale in the United States.

In other words, if the FDA obtains marketing authorization (FDA Cleared) through the 510(k) route, it can only explain in the promotion that the device is consistent in safety and efficacy compared with existing devices. ?and ?allowed to be sold in the U.S. market? ?Therefore, if a merchant's promotion of a product's FDA certification exceeds the scope of the above explanation, and if the promotional terms are inconsistent with the records in the application materials submitted to the FDA, it is suspected of false promotion. ?Called by Dongwei Chengdu Law Firm.

So, TriPollar-related products are advertised on the Tmall platform with the slogan "Our products have 13 technical certifications from the authoritative FDA". Is there any suspicion that it exceeds the scope of the above explanation?

In response, "China Economic Weekly" called Nanjing Jaguar on the afternoon of December 28 and sent an interview letter. As of press time, no response has been received from the other party.

If Nanjing Jaguar’s FDA certification is officially deemed as exaggerated propaganda, what measures can consumers take?

Article 8 of my country's "Consumer Rights Protection Law" stipulates that consumers have the right to know the true situation of the goods they purchase and use or the services they receive; Article 55, paragraph 1, stipulates: If an operator engages in fraudulent behavior in providing goods or services, it shall increase compensation for the losses suffered by the consumer at the request of the consumer. The amount of increased compensation shall be three times the price of the consumer's purchase of goods or the fee for receiving services; the amount of increased compensation shall be less than 5 For one hundred yuan, it is five hundred yuan. If the law provides otherwise, such provisions shall prevail.

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According to the above provisions, if the "exaggerated publicity" is established and the consumer purchases TriPollar StopVx at the price of 4,482 yuan on Tmall on December 30, the merchant should refund the consumer 4,482 yuan and additional Compensate consumers 13,446 yuan.