Homme Skin Cosmetics

FDA Requirements for Cosmetics

When it comes to your skin, you deserve the absolute best. Purchasing products from a company that partners with brands that design products for men’s skin care with nothing but the finest ingredients in mind is crucial. You want products that are sustainable, efficient, and safely sourced and imported. As with any product that will be placed on your body, it’s important to know that your product is meeting all the necessary guidelines set forth by the FDA to be properly imported.

What is Considered a “Cosmetic?”

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Let’s start with the basics. According to the FDA, cosmetics are “a product (excluding pure soap) intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance.”

Sometimes, there are products that brands may produce that cause you to question, “is this a cosmetic, or a drug?” If you’re unsure about whether the products you’re using or being recommended are classified as a drug or cosmetic, the FDA takes it one step further to provide clarification to ensure all cosmetic products are being correctly imported.

The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as ‘articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance.’"

However, a drug is defined as, “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and articles (other than food) intended to affect the structure or any function of the body of man or other animals.”

There are some products that fall into both of these categories. Take a shampoo for example. Shampoos are created with the intention of washing and cleansing the hair, and most are considered a cosmetic. But say you purchase an “antidandruff shampoo,” this specific shampoo would fall under the drug category as well, because it was formulated to “treat” dandruff. Several other types of products may also fall into both categories including things such as moisturizers or makeup that are marketed with SPF and claim “protection from the sun,” deodorants that are also antiperspirants, as well as fluoride containing toothpastes.

For products such as these, they will have to comply with the regulations and requirements of both cosmetics and drugs in order to be imported.

How are Cosmetics Regulated?

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While not all cosmetic products are individually examined prior to being imported, those not being pulled for review, must still meet all of the legal requirements set forth by the FDA. Both imported, and domestically produced products must comply with the same laws and regulations.

The FDA states that all products, “must be safe for consumers under labeled or customary conditions of use, and they must be properly labeled… Firms and individuals who manufacture or market cosmetics are responsible for ensuring that their products are in compliance with U.S. law.”

To ensure cosmetic products are safe for use, the FDA conducts special physical examinations of the products based on trends, which test and analyze every aspect of the product, verifying the product is not spoiled, contaminated, created through questionable conditions or practices, improperly stored, contains non-permitted color additives, and meets label compliance.

If a cosmetic does in fact need to use a color additive, the company must be verified by the FDA, ensuring that the additive has the proper certification to be used.

In addition to that, all product labels are reviewed by trained FDA entry reviewers, who are trained specifically for this task. Once a product is vetted and completes a rigorous review, if it meets all of the requirements set forth, it will only then be allowed to be imported. Customs and Border Protection also assist in setting forth rules and regulations, as well as enforcing those rules.

While it may seem strange, according to the law, cosmetic products, as well as their ingredients, don’t need FDA premarket approval, aside from color additives. That said, the FDA can enforce legal action if products go on the market and do not comply with the law.

Ingredients Not Allowed in the U.S.

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If a brand or company is importing products, it is critical for them to know and be aware of any and all ingredients that are banned or prohibited in the U.S. Not all countries have the same restrictions on ingredients, so it is on the importer to know what is and isn’t allowed. In addition, the FDA also states, “Any ingredient is prohibited if it causes the finished cosmetic product to be unsafe for consumers under labeled or customary conditions for use, even if there is no regulation specifically prohibiting or restricting its use in cosmetics."

A few ingredients prohibited in the U.S. include:

  • Bithionol
  • Chloroform
  • Mercury compounds
  • Vinyl chloride

For a complete list of all prohibited ingredients, you can click here. In the meantime, if you’re looking for high-quality products with only the finest and properly imported ingredients for men’s skin care, Homme Skin has everything you need!