FDA Cosmetic Regulations

Mar 24, 2021

What is the FDA’s Definition of a Cosmetic; and Why Does it Matter?

Now more than ever, cosmetics consumers are aware of every ingredient in their products. Therefore, cosmetics manufacturers need to be aware of exactly what ingredients they are using and be transparent to the consumer. And not only for the consumer’s benefit—manufacturers must comply with the regulations that the U.S. Food and Drug Administration (FDA) has established for this market.

The personal care market is inclusive of many different types of products, however, not all are defined as cosmetics. The FDA has different regulations for drugs and cosmetics, as well as for personal care products. Since cosmetics are used on the skin and hair, the FDA has a strict definition about which products qualify as a cosmetic.

A product can be classified as a drug or cosmetic, or a combination of them, depending on what the product claims are. It can be difficult to determine what types of claims should be used for cosmetics because they might have multiple applications. This is especially true for those products that address conditions such as aging, acne, and rosacea. However, correctly defining a product and its primary uses is important.

What is the FDA Cosmetic Definition?

If you asked a consumer to define a cosmetic, they might say a product applied on their face or body to enhance their appearance. The FDA has a more detailed and stringent definition.  The Federal Food, Drug, and Cosmetic Act (FD&C) defines cosmetics by their intended use: “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.” Products in this category include:

  • lipsticks
  • nail polish
  • eye and facial makeup
  • cleansing shampoos
  • skin moisturizers
  • hair color and perms
  • deodorants

While there are regulations on cosmetics on the market by the FDA, unless they contain certain ingredients such as color additives, they do not require FDA pre-market approval. The agency states that cosmetic companies do have a legal responsibility for the safety of their products.

The law does not require cosmetic products and ingredients, other than color additives, to have FDA approval before they go on the market, but there are laws and regulations that apply to cosmetics on the market in interstate commerce.

Per the FDA website

Examples include makeup that has built-in sunscreen and acne treatments.  These types of cosmetics either need to be pre-approved by the FDA or must adhere to certain regulations.  Cosmetic companies must ensure that they are meeting the standards as put forth by the FDA cosmetic or drug definition for each product they manufacture.

FDA Cosmetic Regulations

The FDA’s regulations differ for drugs and cosmetics. Cosmetics must abide by the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act and must be labeled according to these labeling regulations. For example, the principal display panel (the front of the box or package) should have the name of the product, its net quantity in weight, measure, or numerical count, and its use. The list of ingredients must be clear and visible.  While the FDA does not authorize recalls of cosmetics, they are able to inspect cosmetic manufacturing companies and can pursue charges through the Justice Department if necessary.

The FDA does not approve cosmetic labels before the products are available for sale, but the FDA does have criteria that must be met when companies make claims about what their products can do. Cosmetic brands must be honest and truthful about the claims they make for their products.

FDA Drug Definition

A drug is a substance that diagnoses treats, or cures a health condition. The FDA drug definition is as follows, “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.”  Some examples are:

  • hand sanitizer
  • products that treat acne
  • sunscreen
  • shampoo that treats dandruff
  • anti-aging products

Drugs are regulated by the FDA so the business must register the product by submitting items such as the ingredient list and all product packaging to the FDA for approval. They must be labeled according to OTC drug regulations.  For example, if a product is both a cosmetic and a drug, the drug ingredients must be listed alphabetically as “Active Ingredients” followed by cosmetic ingredients listed in order of predominance under “Inactive Ingredients”.  Every cosmetic manufacturer should understand the FDA drug definition prior to going to market with the product.

Claims About Products That are Cosmetics and Drugs

There are some products that have two intended uses so they are characterized as both a cosmetic and a drug. For example, a facial moisturizer that also contains sunscreen or a foundation that also treats acne. These types of products need to comply with the requirements for both cosmetics and drugs.  The classifications are based on the claims that are made so if a cream is moisturizing, it is considered a cosmetic.  If it treats acne, it is classified as a drug.  Note:  Soap is considered its own category by the FDA.

Any claims made about a product, either on the label, through advertising or marketing, must be backed. So language like “may help fight dandruff” may be considered to be making a claim, and the product will be treated like a drug. Terms for cosmetics are not allowed to make the claim that the product cures or treats any health conditions, otherwise they are no longer defined as cosmetics. Therefore terms like moisturizing, cleansing, calming, conditioning, and hydrating are all acceptable. The following language cannot be used for claims for common cosmetic issues:

Examples of claims to fight the aging process: collagen production, decreasing melanin production, increasing cell turnover, treating aging.

Examples of claims to prevent acne: breakouts, reducing oil production, unclogging pores, and killing bacteria.

Examples of claims that provide sun protection: SPF protection or can heal from sunburn.

It is important for cosmetic manufacturers and brand owners to research the Food and Drug Administration’s regulations so the correct categorization for drugs and cosmetics takes place.  From there the manufacturer can determine which regulations apply and what needs to be included on the label. It should also be noted that associated costs and lead times from your manufacturer, whether Evora or otherwise, can be very different when dealing with drugs vs cosmetics.

Why It Matters to Cosmetic Manufacturers & Brand Owners

The FDA looks at how a product is marketed and advertised when making sure that a claim is valid.  The agency also considers consumers’ perceptions about the ingredients.  This means that how the product is labeled and described online is important. If a claim on a cosmetic is misrepresented, the FDA will issue a Warning Letter with a corrective action based on the violation.

In order to avoid violations, cosmetic manufacturers need to make sure that they comply with the regulations that the FDA puts forth for cosmetics and drugs. The FDA cosmetic definition, as well as the FDA drug definition, should be considered when creating the labeling and promotional materials for each product in this category.

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