Understanding The Regulations For Teeth Whitening Strips In Different Countries

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Understanding The Regulations For Teeth Whitening Strips In Different Countries

23 December 24.

Teeth whitening strips have become an incredibly popular at-home cosmetic treatment over the last few decades. But while they offer an easy way to brighten your smile in the comfort of your own home, they are subject to different regulations depending on the country you're in. In order to choose the safest and most effective products, it's important to understand the basic regulations for teeth whitening strips where you live.


The Regulations For Teeth Whitening Strips


North America


United States

Teeth whitening products in the United States are regulated by the Federal Food, Drug, and Cosmetic Act (FD&C Act). Teeth whitening strips are considered Class I medical devices, meaning they don't require pre-market testing.  However, they do have to be registered with the FDA and must comply with regulations that prohibit the use of unsafe ingredients or misleading claims in marketing.


Canada

Health Canada regulates teeth whitening strips under the Cosmetic Regulations and Natural Health Products Regulations. This requires teeth whitening strips that contain more than 3% hydrogen peroxide to be administered by a dental professional.


South America


Brazil

Brazil's health regulatory agency ANVISA classifies teeth whitening strips as cosmetics as long as they contain less than 6% hydrogen peroxide. Anything over the threshold requires professional supervision. Most South American countries have similar regulations on teeth whitening products.


Europe

In the EU, teeth whitening products are considered cosmetics, which means they have to comply with the EU Cosmetics Regulation (EC) 1223/2009. Whitening strips containing 0.1% hydrogen peroxide or less are available over the counter, while anything between 0.1-6% hydrogen peroxide can only be sold to and administered by licensed dental professionals.


Asia


China

Teeth whitening products are classified as special cosmetics if they contain active whitening agents like hydrogen peroxide. This means they require pre-market approval from the National Medical Products Administration.


Japan

If teeth whitening strips contain hydrogen peroxide, they will usually need to be professionally administered according to the Pharmaceutical and Medical Device Act.


Australia

The Therapeutic Goods Administration (TGA) requires products with over 6% hydrogen peroxide or 18% carbamide peroxide to be administered by a dental professional.


The Importance Of Certifications In Teeth Whitening Products


Teeth whitening strips contain chemicals that can pose a safety hazard if not manufactured correctly. This is why compliance with regulatory standards is such an important factor when buying and using teeth whitening strips.  If you're a dental clinic or a salon that's selling teeth whitening strips, you want to make sure your products are safe, effective, and compliant with your local regulations. The quality of your teeth whitening strips has a direct impact on your customers' experience.


Here are a few of the benefits of choosing certified teeth whitening strips:


Higher consumer trust.  Seeing the proper certification proves that the product is both safe to use and effective. Your customers will know that they're getting their money's worth and avoiding scams.

Easier to obtain.  If you're buying questionably made teeth whitening strips from overseas, don't be surprised if they have a hard time getting through customs. You may end up facing import restrictions or legal challenges if you try to import and sell products that don't meet the necessary certifications.

Lesser safety risk.  The last thing you want to risk is damaging your customers' gums or teeth with unsafe products. Choosing certified teeth whitening strips will ensure their safety during the teeth whitening process, which will keep them coming back as loyal customers.

Avoid damaging your brand.  If you sell OEM strips that have your business' branding on the label, then you want to make sure what you're selling is up to par for your business. Your business and brand will take the blame if the whitening strips are ineffective or unsafe.


Where To Find Certified Teeth Whitening Strips


Manufacturers like Onuge ensure that every one of our products is safe, non-irritating, and complies with the various regulatory requirements of global markets. We take teeth whitening strips' safety seriously, which is why our products are rigorously tested to ensure they're effective without compromising safety. You can browse through our website to find teeth whitening strips with various strengths and ingredients, from Non-Peroxide Teeth Whitening Strips to full-power 6% HP Teeth Whitening Strips


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