Want to know the FDA labeling requirements for Cosmetic Products? Let's discuss

Manufacturers and sellers of cosmetic products know that their product label is an important aspect influencing the customer's purchase decision. 

However, before printing labels for your cosmetic products, it is crucial to review the rules and specifications set up by the Food and Drug Administration (FDA). 

What are cosmetics, according to the FDA?

"Products, except soap, intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance are termed cosmetics."

It may include shampoo, makeup, other hair products, tanning products, scrubs, nail products, deodorants, other skin products, some oral care products, perfumes, and others.

A peek into FDA regulations

FDA's stringent regulations governing the labeling of cosmetic products serve as a critical foundation for ensuring consumer safety and transparency within the beauty industry. These labeling requirements dictate the essential information that consumers must accurately convey. It is also applicable to manufacturers of soap and aromatherapy products. 

So, why are these rules so important to follow?

• The FDA's main purpose is to protect human health and ensure the products rolled out are safe for consumer health.
• These rules ensure that products are suitably labeled and can be used safely for the purposes they are being manufactured. 
• FDA rules ensure that labeling and packaging are clear and contain the required directions or steps. 
• The FDA regulations protect consumers from unsafe, deceptively labeled, or packaged products and restrict the movement of adulterated or misbranded cosmetic products.

 

FDA regulates cosmetic labeling under the authority of two separate acts. The Fair Packaging and Labeling Act (FPLA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FD&C Act was created in 1938, authorizing the FDA to supervise food, drugs, and cosmetics safety. 

As per the FDA, all labels must be legible and applied to containers properly. The labels should remain in place and be properly legible during the customary distribution, storage, and use conditions. It also mentions that other labeling that contains user instructions should remain legible during customary storage and use. Refer to the summary of the Cosmetics Labeling Guide from the FDA for comprehensive details.

FD&C and FPLA

The definition of the term' label' varies for the FD&C and the FPLA. FD&C considers a label "a display of written, printed or graphic matter upon the immediate container." FPLA defines a label as a "written, printed or graphic matter affixed to any consumer commodity or affixed to or appearing upon a package containing any consumer commodity."

Let's discuss some pointers highlighted by the FD&C and the FPLA.

• Except for the ingredients the FDA has listed as restricted, manufacturers are free to use any ingredients in their products. Additionally, when adding color additives, it is important to ensure they have proper approval from the FDA. 

• The FDA doesn't prohibit manufacturers from creating cosmetic products outside their homes. However, ensuring that all other rules and regulations are followed is important. For good manufacturing practices (GMP), there are no specific rules. The FDA gives a GMP checklist that lists the things that an FDA investigator would inspect.

• In the case of cosmetic products manufactured for retail store purposes or online orders, they must meet the FPLA labeling requirements and the FD&C Act requirements. The FDA and the Federal Trade Commission (FTC) are directed by the FPLA to issue label regulations for all consumer commodities. 

• The labels on the packages should provide consumers with information about the quantity of contents, which must be accurate.

• It should also show the commodity's identity and the name or place of the product's manufacturer. There are additional regulations to restrict other forms of consumer deception because of labeling. 

• FD&C requires that any information on the immediate container's label must also be visible through the outside container of the retail package or on the immediate container's label. 

Misbranding and Misleading Labels

As per the FD&C, a cosmetic product is considered to be misbranded if 

• Its labeling is false or misleading.
• The label does not state (a) the address and name of the manufacturer, packer, or distributor and (b) the net quantity of contents.
• The required information is not provided in an obvious way, is conspicuous, and is not easy for consumers to read and understand under purchase conditions and use situations. 
• The container or its contents is misleading.

As per the FD&C, a cosmetic is considered to be misleading when

• A label statement is deceptive, and a material fact is not revealed to the consumer.

• A fact may be relevant if it clarifies a statement made on a label or if using a product as advised leads to certain consequences.

Understanding the placement of information on labels

FP&L requires that information related to ingredient labeling and a statement of the net quantity of contents appear on the label of the outer container holding the inner (immediate) container. If a cosmetic product is not displayed in a box, folding carton, etc., then the outer container holding the cosmetic product is the immediate container. The outer container can be a box, folding carton, wrapper, etc.

The part of the label that is most likely displayed or checked under customary conditions of display for sale is the principal display panel. This part must state the product's name, nature, or use, and the package's net quantity of cosmetic contents. The quantity should be mentioned as a measure, numerical count, weight, or a combination of the numerical count. 

 

The declaration must be legible, placed in the panel's bottom area, and the container's size as prescribed. The firm's name and place of business marketing the product must be stated. It should be mentioned on the information panel of the label along with the address, including the street address, city, state, and zip code. 

Label Warnings

Cosmetics that may harm consumers when misused must contain adequate directions for safe use and appropriate label warnings. The statements must be conspicuous and prominent. Some cosmetics, such as cosmetics in self-pressurized containers (aerosol products), feminine deodorant sprays, and children's bubble bath products, are examples of products that must have label warnings or cautions prescribed by regulation.

The FD&C Act does not require cosmetic manufacturers or marketers to test their products for safety. However, the FDA strongly urges cosmetic manufacturers to conduct toxicological or other appropriate tests to substantiate the safety of their cosmetics. Suppose the safety of a cosmetic is not adequately substantiated. In that case, the product may be subject to regulatory action or may be considered misbranded unless it bears the following statement: Warning: The safety of this product has not been determined. 

Some products consist of alkali salts of fatty acids and can be used only for cleaning. Such products fall under the Consumer Product Safety Commission (CPSC). Hence, they aren't considered cosmetic under the law. This product won't need to meet the FDA's cosmetic labeling requirements.

If the aromatherapy products are used for the user's looks or only to cleanse the body, they are cosmetic. But if aromatherapy products treat disease or affect the body's function, they are drugs. Hence, these products do not meet the FDA's cosmetic labeling requirements.

Here are some of the most important points for labeling cosmetic products.

• The label has to be large enough so that the required information is prominently displayed and is easy to read.
• Labels must have the information displayed legibly.
• The label should include the product's name, net quantity, safe use directions, any warnings, a list of ingredients, and information about the business.
• The FDA guidelines require that the ingredients be listed in weight order. Heaviest to lightest must be the order. 
• The label must have a warning and/or directions for the safe use of products. 

The label on a cosmetic product is more than a marketing tool and is a way to convey essential details regarding ingredients, usage, and potential risks. Manufacturers must familiarize themselves with the FDA's regulations before working on cosmetic labels. By following the rules, manufacturers meet the legal requirements and create a transparent and accountable cosmetic brand. 

Beast Branding offers custom and stock blank roll labels for various products across different industries. You can also check out our ready-for-label packaging collection to stock up on packaging supplies.