5 Ways Cosmetic Product Companies Can Comply with FDA Labeling Requirements & Help Avoid FDA Enforcement.

Cosmetic products do not require Food and Drug Administration (FDA) approval unless they have color additives or unless the qualify as a drug, medical device, or dietary supplements. There are two laws, however, that regulate the entry of cosmetic products into interstate commerce. Since most cosmetic companies sell their products through the Internet and through regional, national, or international distributors; companies that make, pack, distribute or market cosmetic commodities need to understand these laws and how to comply with them.

The cosmetic product laws apply to manufacturers, packers, distributors, importers, advertisers, resellers, and others in the supply chain. Experienced cosmetic lawyers can help guide you through the maze of cosmetic laws and regulations.

The Key Cosmetic Industry Laws

The Food, Drug, and Cosmetic Act (FD&C Act) enacted in 1938 gives the FDA the authority to regulate the safety of food, drugs, and cosmetics. The law provides for civil and criminal remedies for violations of the Act.

The Fair Packaging and Labeling Act (FPLA) which became law in 1967, authorizes the FDA and the Federal Trade Commission (FTC) to issues regulations covering consumer products. The FDA and FTC require that the cosmetic labels properly disclose the identity and contents of the package; the quantity of the products (how much the consumer is getting); and the identity of the makers, packers, and distributors of the cosmetic products. Labeling cannot be deceptive and should promote value comparisons.

Cosmetic companies must comply with these laws and any relevant regulations passed so these laws can be detailed and enforced. The Center for Food Safety and Applied Nutrition (CFSAN) is the cosmetic product agency, within the FDA, that monitors cosmetic safety and cosmetic labeling.

What products qualify as “cosmetic products?”

Common cosmetics include eye and face makeup, perfumes, shampoos, deodorants, lipsticks, skin moisturizers, hair colors and any product that is 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”

Cosmetics are also intended to “exert a physical as well as a physiological effect.”

Soap is generally not considered a cosmetic if the labeling refers to ability to cleanse. When the labeling includes references to moisturizing, skin softening, and other comparable claims; the soap may be considered a cosmetic.

Cosmetic products that are intended for any therapeutic use including helping remedy diseases or to affect the body’s structure or function can qualify as – either a drug or even a medical device. Some individual care products may qualify as a dietary supplement. Examples of cosmetics that can qualify as drugs are fluoride toothpastes and antidandruff shampoos. Many cosmetics that are drugs are sold over the counter.

See our prior blog post:

Five key things that cosmetic manufacturers and other companies involved in the making, sale, and promotion of cosmetic products must understand are:

1. Understand what the FDA can do if a cosmetic commodity fails to comply with the federal laws or regulations

The term “cosmetics” is a legal term of art. They are specifically defined in the FD&C Act and interpreted by the courts.

As your FDA cosmetics lawyer can explain, the FDA has extensive enforcement authority, including the authority to:

• Conduct and inspect sample products and inspect the places where the products are made.
• Work with the U.S. Customs and Border Protection agency to refuse to allow the products to enter the United States.
• Have the products taken off the market by requesting, with the help of the U.S. Department of Justice, that a federal district court enjoin the further manufacture or distribution of the product
• Begin criminal proceedings against violators
• Request a product recall if the manufacturer or other cosmetic commodity doesn’t conduct a voluntary recall – though the FDA can’t order a product recall

2. Understand what FDA means by “adulteration” and “misbranding” and why FDA takes this seriously

The FD&C Act regulates cosmetics sold through interstate commerce in two fundamental areas:

• Adulterated cosmetics. Cosmetics cannot be adulterated (tainted) in any way including the ingredients themselves or through the packaging, shipping, or handling of the products, or how the cosmetic product is handled. A cosmetic is adulterated if:
  • It includes a poisonous or dangerous substance which can cause injury through standard use or the use detailed in the label.
  • It has any putrid, filthy, or decomposed substance.
  • It was made or packaged under insanitary conditions
  • Its container has a toxic of deleterious substance which can cause harm.
• Misbranded cosmetics. Even if the product is valid, the FD&C Act, considers that cosmetic misbranding has occurred if:
  • The labeling is untrue or misleading in any way
  • The labeling omits required information such as warning statements or instructions on safe usage.
  • The requisite information is not “prominent and conspicuous.”
  • The container is itself misleading such as suggesting that there is more content than there really is
  • The label or package violates the Poison Prevention Packaging Act of 1970.

The FPLA requires that the cosmetic ingredients be listed in a precise order.

3. Understand the steps required to comply with product safety requirements

The cosmetic products must be safe. The safety of cosmetic products is largely up to the individual manufacturer.

FDA does not require that specific tests be taken or met. Companies should, however, create established procedures to test and verify the safety of their ingredients and products – to ensure that the products are indeed safe and to prove, if violations are asserted, that proper precautions were taken. Cosmetic product safety factors include:

• Reviewing existing toxicological test data on similar products
• Conducting independent toxicology tests
• Not using prohibiting ingredients such as mercury compounds, methylene chloride and other chemicals listed in the Code of Federal Regulations 21 CFR 700 and other sections.
• Providing warning statements for ingredients with known concerns – in conformity with the Code of Federal Regulations.
• Complying with any safety laws if color additives are being used

21 CFR Part 700 Subpart A (Section 700.3) – Cosmetics — General Provisions

21 CFR Part 700 Subpart B (Sections 700.11 Through 700.35) – Requirements for Specific Cosmetic Products

4. Comply with the cosmetic labeling requirements and ingredient listing requirements

Labels must meet strict cosmetic labeling requirements. Your FDA lawyer understands the Code of Federal Regulation (CFR) rules that dictate the precise label and ingredient requirements.

Labels include graphic images as well as text and information on both the inside and outside of the packing wrapper. The part of the label that consumers normally read is called the principal display panel. It should have the product name; usually has a descriptive name or picture; and lists the product’s quantity such as its weight, a number, or some other calculable figure. The display panel or other information panel should include the name and address of the marketing company, maker, packer, and/or distributor. also require that the information be easy to read and understand.

Labels should be in English, be conspicuous, and prominent. With some exception (products meant to be sold to professionals and not consumers), the ingredient list (in addition to the label) must also be conspicuous and likely to be read by the consumer. The list can appear on the outer container or on a tag or item securely attached to the product. There are strict size (height) requirements that must be met. The ingredient list should include the most predominant ingredient first and the least used ingredient last – in descending order. Ingredients that compose less than one percent can be at the end. Ingredients that are also drugs should be listed first.

Other key cosmetic labeling requirements that must meet CFR standards include the need to have proper statements about hazardous products such as aerosol products and that some products must be secured in tamper-resistant packaging.

5. Practical strategies for complying with the FD&C Act and the FPLA

Some of the most important suggestions for cosmetic makers, packers, distributors, marketers, importers, resellers, and other cosmetic commodities, in addition to a complete understanding of the federal laws and regulations, are:

1. Safe facilities. The facilities and equipment should be in great working order to reduce or eliminate the risk of contamination, charges of unsanitary conditions, or other safety violations. The building, walls, and ceilings should be easy to clean. The ability of ducts and pipes to cause leaks or condensation should be minimized. The plumbing and electrical utilities should comply with federal and local health and safety laws.
2. Proper equipment. The equipment and tools to make the cosmetic products should be designed and maintained with product safety and quality as a top priority. These items should be regularly sanitized.
3. Proper handling of raw materials. The ingredients and packing materials should be stored and used so that they can’t be contaminated or allowed to decompose due to exposure to the elements or other conditions. The materials and packaging should be properly labeled and controlled. Products should be tested properly before they are used.
4. Use experienced and educated personnel. The team of people managing the design and manufacture of the product should be properly trained and educated and have proven experience in the cosmetic industry. Staff should be educated as to the proper gloves and garments to wear and the hazards to avoid while making the products.
5. Utilize a controlled production process. The manufacturer of the cosmetic products should use approved materials, should regularly test samples, and have multiple checks by different people. Cosmetics that are returned should be properly discarded or inspected for contamination. Water supplies and other resources should also be routinely inspected. Proper records should be kept verifying the production process, testing process, and all phases of production.
6. Proper concern for customers. There should be a system in place to handle all customer complaints about injuries and medical treatment including the identity of the local poison control center.

Another suggestion is to participate in the FDA’s Voluntary Cosmetic Registration Program (VCRP). While manufacturers do not have to register their company or file formulas with the FDA, voluntary registration can help your company show that it is making the effort to comply with the laws.

See our prior blog post:

Your FDA cosmetic product attorney can also explain how the FDA’s Cosmetics Labeling Guide helps manufacturers, packers, distributors, marketers, importers, and resellers get answers to questions about labeling requirements.

Experienced FDA cosmetic labeling requirement attorneys do more than just help you understand and comply with the relevant laws and regulations. They help you prepare in advance and help protect you when complaints arise. 

We have counseled many cosmetics manufacturers, distributors, importers, and others with respect to FDA and FTC compliance requirements – both preventatively, when getting their product to market, and after on receiving an FDA warning letter or other enforcement action.  Contact our healthcare law and FDA attorneys for legal advice on cosmetic product safety and labeling requirements