Navigating FDA Regulations for Cosmetics: A Comprehensive Guide for Beauty Brands
by Jack Li · Updated May. 04, 2023
The FDA regulations for cosmetics do not approve cosmetics or authorize them unless they contain specific ingredients, except for color additives. Additionally, the FDA doesn’t mandate that cosmetics be produced under good manufacturing practices, nor does it require manufacturing facilities to register with the FDA or demand product listing. The FDA regulations for cosmetics do require that cosmetic manufacturers guarantee their products are neither adulterated nor misbranded. It falls upon cosmetic companies to market safe, accurately labeled products, refrain from using prohibited ingredients, and comply with restrictions on limited ingredients.
Table of Contents
1. What Exactly Falls Under the Category of "Cosmetics" According to the Law?
The Food, Drug and Cosmetic Act defines cosmetics as “items intended for cleansing, beautifying and/or enhancing attractiveness, or modifying the appearance.” This includes skin moisturizers, perfumes, lipsticks and nail polishes, as well as any substance meant to be used in a cosmetic product. However, it does not cover soap.
2. How Can You Determine Whether Your Products are Cosmetics and Not Drugs or Another Product Category?
The intended use of a product will be influenced by factors like the claims made for the product and customer expectations. A product is classified as a cosmetic if its purpose is to cleanse the human body, enhance a person’s attractiveness, or alter their appearance.
If a product aims to influence the functioning of a person’s body or treat or prevent diseases, it’s considered a drug. However, some products are classified as drugs even though they work as cosmetics. Drugs must adhere to different regulations.
The Food and Drug Administration regulates certain personal care products as medical devices or dietary supplements, while the Consumer Product Safety Commission regulates other types of soap.
3. What is the Difference in International Definitions of Cosmetics and Drugs?
Various countries define drugs and cosmetics differently compared to the United States. For instance, in some nations, sunscreens are regulated as cosmetics, while in the U.S., they fall under the category of drugs. Some examples of products that could be classified as drugs in the United States include hair restoration and skin protection products, pain relief products, anti-aging products that work on the skin structure or function, acne treatment products, dandruff products and eczema treatment products.
4. How Does the FDA Oversee Imports?
The Food and Drug Administration works closely with the U.S.Customs and Border Protection in an effort to keep imported cosmetics from being misbranded or adulterated.If foreign cosmetics seem to be misbranded or adulterated, they may be denied entry into the United States.Such products must either be brought into compliance, destroyed, or re-exported. The FDA’s website lists import refusals and updates them monthly.
5. Where Can I Find a List of FDA Refusals?
The Import Refusals Report (IRR) provides a list of refusals organized by country/area and product based on the industry code. The FDA created the IRR to provide the public with information about shipments that seem to violate FDA laws and regulations. The IRR is updated monthly.
6. Is the FDA Able to Address Inquiries Regarding U.S. Customs Requirements?
Unfortunately, no. To acquire information about Customs requirements pertaining to your imports, you’ll need to get in touch with U.S. Customs and Border Protection (CBP) directly. The CBP website has a wealth of helpful resources, including for example a guide entitled “Importing into the United States: A Guide for Commercial Importers.“
7. Are All Imported Cosmetics Inspected and Sampled?
Not every cosmetic product is scrutinized or sampled upon entering the country. To optimize inspection efforts, the FDA issues Import Alerts to inform inspectors about trends in violations. Import Alerts touch on a variety of cosmetic products, including those that are sold in the United States with therapeutic claims, which are classified as unapproved new drugs under the law; cosmetics that are adulterated due to microbial contamination; and bulk shipments of high-risk bovine tissue from BSE countries. Additionally, the fact that a product hasn’t been detained in the past doesn’t exempt it from future detention if it appears to violate U.S. law.
While most imported products are subject to inspection at the time of entry, products that aren’t are still subject to all legal requirements enforced by the FDA.
8. Is FDA Approval Required Before Importing Cosmetics?
Cosmetic companies are not required by the FDA to get permission to use any ingredient in their products before they become available on the market. However, any company or individual marketing a cosmetic must ensure its safety and labelling under labeled or customary conditions of use.
Please be aware that some personal care products are classified as both drugs and cosmetics under U.S. law. If your product’s ingredients are considered drugs under U.S. law, it is subject to drug-related requirements such as premarket approval from FDA before it can be sold in stores nationwide.
9. Does the FDA Require Registration with Them in Order to Import Cosmetics?
The FDA does not require cosmetic companies to register with the agency, but the agency encourages companies to register their establishments and store information regarding their ingredients in a database called the Voluntary Cosmetic Registration Program (VCRP).
While participation in this program is voluntary, not mandatory, it is one way to ensure that cosmetics already on the market in the United States are safe.
The VCRP accepts statements for cosmetics already on the market in the United States only and can accept only for cosmetics. If your products are classified as drugs or both cosmetics and drugs under U.S. law, they are subject to drug registration requirements.
10. Why is it that Cosmetics are Sometimes Refused Entry into the United States?
Some of these include:
Mislabeling: The U.S. Food and Drug Administration (FDA) enforces stringent labeling requirements for cosmetics, which encompass accurate ingredient listings, net quantity declarations, and suitable warning statements. If a cosmetic product is found to be mislabeled or does not meet the FDA’s labeling requirements, it may be refused entry.
Adulteration: Adulteration refers to the presence of harmful or unsafe ingredients in a cosmetic product. The FDA bans certain ingredients in cosmetics because of their potential hazards to consumer health. If a product is found to contain prohibited or harmful ingredients, it may be considered adulterated and refused entry.
False or Misleading Claims: If a cosmetic product’s labeling or promotional materials contain false or misleading claims, the FDA may refuse entry. This includes claims about the product’s safety, efficacy, or intended use that are not supported by scientific evidence.
Failure to Meet Import Requirements: Importers are responsible for complying with various import requirements, such as filing Prior Notice with the FDA, providing accurate information on the product’s country of origin, and meeting any applicable customs requirements. Noncompliance with these requirements may lead to the denial of entry for the cosmetic products.
In order to avoid these issues and ensure the successful import of cosmetics into the United States, it is crucial for manufacturers and importers to be familiar with and adhere to the FDA’s regulations and guidelines. This includes understanding labeling requirements, using approved ingredients, making substantiated claims, and following GMP guidelines.
11. What Ingredients are Prohibited or Restricted?
When importing cosmetics, make sure to familiarize yourself with the ingredients that are prohibited or restricted by the FDA. The country of origin might have different restrictions than the United States, but any ingredient that causes a finished cosmetic product to be unsafe for consumers under labeled or customary conditions of use is considered prohibited. For more information about ingredients that can’t be used in cosmetics, see “Ingredients Prohibited or Restricted by FDA Regulations.“
12. What are the Labeling Requirements for Cosmetics?
The cosmetics labeling requirements differ from country to country, but the FDA regulates them in the United States under the FD&C Act and FPLA. Here are some key labeling requirements for cosmetics in the U.S.:
The principal display panel (PDP) of the label must include the identity of the cosmetic product (e.g., “shampoo” or “lipstick”) and its net quantity, expressed in terms of weight, measure, or numerical count
Ingredient List: Cosmetics must have an ingredient list, which should be placed on the information panel (usually found on the back or side of the packaging). Ingredients should be listed in descending order of their predominance by weight. Ingredients present in amounts of 1% or less may be listed anywhere after ingredients present in greater amounts. The proper nomenclature for ingredients should be used, as specified by the International Nomenclature of Cosmetic Ingredients (INCI) system. List ingredients in descending order by weight. Color additives and ingredients present in amounts of 1% or less may be listed after the ingredients present in greater amounts.
Name and Address of Manufacturer/Distributor: The label must include the name and place of business of the manufacturer, packer, or distributor. If the company’s name is listed in a city directory or telephone book, the street address may be omitted.
Warning Statements: Cosmetics must include appropriate warning statements when necessary. For example, products containing certain ingredients known to be harmful if misused, such as certain hair dyes or sunscreens, must have appropriate warning statements on their labels.
Language: All required label information must be presented in English. If the product is intended for distribution in a non-English speaking market within the U.S., the required information must also appear in the predominant language used in that market.
Claims and Advertising: Any claims made on the cosmetic product’s label or in its advertising must be truthful and not misleading. The FDA may take action against products making false or unsupported claims, including removing the products from the market.
These are some of the primary labeling requirements for cosmetics in the United States. It is essential for cosmetic manufacturers and distributors to familiarize themselves with these regulations to ensure compliance and avoid potential penalties or product recalls. Other countries may have different labeling requirements, so it is crucial to research the specific regulations for each market in which a cosmetic product will be sold.
13. Are Cosmetics that are "Natural" or "Organic" Required to Receive Certification?
In the United States, there is no legal definition or specific regulation for the terms “natural” or “organic” in cosmetics. The U.S. Food and Drug Administration (FDA) does not strictly regulate the term “natural” for cosmetics, and there is no official certification for “natural” cosmetics.
However, the FDA does monitor cosmetic labels for false or misleading claims, and a product claiming to be “natural” should not contain any artificial or synthetic ingredients that would make the claim misleading.
As for “organic” cosmetics, the term is regulated by the United States Department of Agriculture through the National Organic Program. While the USDA primarily focuses on food products, cosmetic products can also be certified as organic if they meet the NOP standards.
To display the USDA Organic Seal on a cosmetic product, the product must be certified by an accredited certifying agent and meet the following criteria: It must contain at least 95% organic ingredients (excluding water and salt), with the remaining ingredients consisting of approved non-organic ingredients or synthetic substances from the USDA’s National List. Additionally, the product must be overseen by a USDA National Organic Program-authorized certifying agent and adhere to all USDA organic regulations.
Please note that the FDA does not have specific regulations for “organic” cosmetics either. The USDA certification is voluntary and not a requirement for cosmetics to be marketed as “organic.” However, having USDA Organic certification can provide credibility and assurance to consumers that the product meets the established organic standards.
In conclusion, “natural” cosmetics do not require certification in the United States, and the term is not strictly regulated by the FDA. However, “organic” cosmetics can be certified by the USDA if they meet the National Organic Program standards, but this certification is not mandatory for marketing a cosmetic product as “organic.”
14. The FDA Regulations for Cosmetics Final Thoughts
In conclusion, it’s essential for us to know how cosmetics are regulated to make informed choices about the products we use. Keep in mind that companies are responsible for ensuring their products are safe and properly labeled. Thus, it’s always a smart move to conduct some research before trying out a new cosmetic product!