Shampoo (hair care products) FDA registration cycle and cost

Shampoo (hair care products) FDA registration cycle and cost

Shampoo, also known as shampoo and shampoo, is the most widely used shampoo and one of the most commonly used hair cosmetics. It is used to wash the body's secreted oils, sweat stains, scalp cells and foreign dust, microorganisms, styling product residues and bad smells attached to the scalp and hair, and keep the scalp and hair clean and beautiful.

There are various types of shampoos, and the commercially available shampoos are mainly liquid shampoos. Most liquid shampoos have the following structural ingredients, in which surfactants, foam stabilizers, thickeners, preservatives and flavors are the basic ingredients. Other ingredients depend on consumer needs and cost-effectiveness.

1. Primary surfactant

Anionic surfactants are the most commonly used main surfactants in shampoos, such as lauryl alcohol sulfate (AS), laureth sulfate (AES), sulfosuccinate, etc.

2. Co-surfactant

Such as amine oxide, alkanolamide, imidazoline and so on.

3. Conditioner

Such as cationic guar gum, emulsified silicone oil, etc.

4. Thickener and dispersion stabilizer

Such as electrolytes (sodium chloride, ammonium chloride), water-soluble polymers, etc.

5. Pearlizing agent: ethylene glycol (mono) distearate

6. Chelating agent: EDTA-Na2, EDTA-Na4

7. Acidity regulator: citric acid, lactic acid

8. Others: pigments, flavors, preservatives, functional raw materials, etc.

product category

There are many types of shampoos, and their formula structures are also diverse. According to the form, there are liquid, paste, powder, etc.; according to the function and performance, it is divided into ordinary shampoo, conditioning shampoo, anti-dandruff and anti-itch shampoo, children's shampoo, and washing and dyeing shampoo. Therefore, in the market, consumers can choose different types of shampoos according to their hair quality, such as shampoos suitable for different hair types such as normal hair, dry hair, and oily hair; or have different properties such as anti-dandruff and nutrition. The product.

All cosmetics sold in the United States, whether made locally or imported from abroad, must comply with the Federal Food, Drug, and Cosmetic Act, the Fair Packaging and Labeling Act, and the regulations promulgated by the management committees of these laws.

The "Federal Food, Drug, and Cosmetic Act" defines cosmetics as articles that are specially used on the human body for the purpose of cleaning, beautifying, enhancing attractiveness, or changing the outer surface of the human body without affecting the structure or function of the human body.

Products that fall under this definition include skin creams, lotions, perfumes, lipsticks, nail polishes, eye creams and creams, shampoos, permanent curling agents, hair dyes, toothpastes, deodorants and any ingredients used as part of cosmetic products. Soap is mainly composed of It is composed of alkali salts of fatty acids, and the label only needs to declare the cleansing power of the human body, so the Act considers that soap is not a cosmetic.

Cosmetic FDA certification regulations:

1. Labeling requirements: US FDA 21 CFR 701&740

Section 701 and 740 of Chapter 21 of the Federal Laws of the United States Food and Drug Administration

2. Regulations on chemical composition or cosmetic composition: US FDA 21 CFR73, 74, 84

Articles 73, 74 and 82 of Chapter 21 of the Federal Laws of the United States Food and Drug Administration

Product FDA registration classification:

Ordinary cleansing shampoo is registered according to FDA, the registration period is 2-3 weeks

Shampoo with special effects (anti-dropping, anti-dandruff) is registered according to OTC-NDC, the registration period is 2-3 weeks