Green Circle Talks About Cross-Border - Is it a drug or a cosmetic? Toothpaste Ingredients Determine FDA Classification

Toothpastes exported to the United States are regulated by the FDA, with specific requirements depending on whether they are classified as a drug or a cosmetic. Toothpastes that claim to have anti-cavity or whitening effects, or contain ingredients such as fluoride, are usually categorized as OTC (over-the-counter) and are subject to drug registration requirements. This requires the toothpaste to go through the new drug approval process to ensure the safety and efficacy of the product.

If the toothpaste does not contain any of the above ingredients and does not claim the above effects, it will be registered as a general cosmetic product. For products with both cosmetic and pharmaceutical functions, they should be registered according to the higher standards for pharmaceutical products.

The presence of certain specific ingredients in toothpaste may cause it to be recognized by the FDA as a drug rather than a cosmetic, especially if those ingredients are used in the prevention or treatment of oral diseases. Here are some of the ingredients that would cause a toothpaste to be considered a drug:

1) Fluoride: e.g. Sodium fluoride, Stannous fluoride, Sodium monofluorophosphate, etc. These ingredients are used for caries prevention.

2) Triclosan: Used for antibacterial and gingivitis prevention.

3) Hydrogen peroxide: Used as a bleaching agent to whiten teeth.

4) Sodium bicarbonate, which is used as a dental cleanser in some cases.

5) Special anti-sensitivity ingredients: e.g. Potassium nitrate is used to treat tooth sensitivity.

6) Histatins: Used in some toothpastes, they have antifungal properties that may help prevent oral candida infections.

When a toothpaste contains any of these ingredients and is labeled as having a therapeutic or preventive effect, it is typically classified as an OTC drug. Toothpastes exported to the U.S. market must comply with stringent regulations including product testing, approval, manufacturing standards and labeling requirements.

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