Cosmetics Legal & Compliance
Guidance
Guidance
Under the Federal Food, Drug, and Cosmetic Act (FDCA), dietary supplements and cosmetic ingredients (except for color additives) are not subject to FDA premarket approval. However, the Food and Drug Administration (FDA), the Federal Trade Commission (FTC), and other state agencies can take legal action against companies, distributors, or individuals who fail to comply with regulatory requirements regarding product labeling, advertising claims, good manufacturing practices, or overall safety.
Cosmetics companies can make claims for their products, provided they are mindful of the way FDA and FTC laws and regulations shape the marketing environment.
Our Focus on Cosmetics Companies’ Legal Needs
Our legal team’s focus on cosmetics, dietary supplements, and medical devices gives us the expertise to help clients navigate FDA and FTC issues. We advise a range of clients on FDA and FTC legal questions, including:
Advertisers
Distributors
Importers
Manufacturers
Resellers
Our expertise includes products targeted to:
Beauty
Overall Health
Weight Loss
We excel at helping clients make claims that pack as much marketing power as possible, without intruding on FDA and FTC legal boundaries.
What Is the Legal Definition of a Cosmetic?
In the beauty and personal care industry, terms like “cosmeceutical” and “nutraceutical” are often used to describe products with hybrid qualities. For example, a cosmetic or dietary supplement that also claims therapeutic benefits.
However, the Food and Drug Administration (FDA) does not officially recognize or regulate products under these names. Instead, companies must determine whether their product will be regulated as a cosmetic, dietary supplement, drug (either prescription or over-the-counter), food, medical device, or medical food.
This distinction is critical because the way a product is marketed and the claims it makes will dictate how it is regulated. For example, if a shampoo is promoted solely to cleanse hair, it falls under the cosmetic category. On the other hand, if that same shampoo claims to treat psoriasis, it may also be considered a drug and must comply with drug-related regulatory requirements.
Under the Federal Food, Drug, and Cosmetic Act (FDCA), the FDA defines a cosmetic as an article 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. This definition also extends to any material that is intended for use as a component of a cosmetic product.
Cosmetics include skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup, shampoos, permanent waves, hair colors, toothpastes, and deodorants. Importantly, while cosmetics generally do not require premarket FDA approval, drugs, biologics, and medical devices do.
What Are The Federal Agencies That Regulate The Beauty and Wellness Industry?
The beauty and wellness industry is regulated by several federal agencies, each overseeing different aspects of compliance, safety, and marketing. The Food and Drug Administration (FDA) enforces the Food, Drug, and Cosmetic Act, monitoring issues such as product labeling, good manufacturing practices, product recalls, and FDA warning letters.
The Federal Trade Commission (FTC) regulates advertising claims and ensures that marketing claims are not false or misleading. The Consumer Product Safety Commission (CPSC) has authority over certain consumer products to ensure they meet safety standards.
In addition, the Environmental Protection Agency (EPA) regulates chemicals and substances that may impact both health and the environment, particularly for personal care products and hair care products. Together, these agencies play a critical role in protecting consumers and ensuring that companies in the cosmetic industry meet all compliance matters and avoid costly litigation or legal action.
How Can Cosmetics Misbranding Affect Your Business?
Improperly labeled or deceptively packaged products are considered misbranded and subject to regulatory action. Under the Food, Drug & Cosmetic Act, a cosmetic is considered misbranded if:
- The label contains any false or misleading information or is false and misleading by failing to include all the required information.
- The label lacks required information.
- The required information is not sufficiently conspicuous and prominent.
- The packaging is misleading.
- There is improper packaging and labeling for color additives, and
- The packaging has deficiencies that require special packaging under the Poison Prevention Packaging Act.
The FDA has severe penalties for misbranding. This is why claims review is so important.
FTC Legal Issues
While the FDA mainly oversees the labeling, safety, and quality of food, dietary supplements, medical devices, and cosmetics, the Federal Trade Commission (FTC) makes sure that advertising and marketing claims are honest, clear, and backed up with evidence. Thus, we address both FDA and FTC legal issues for our clients.
Who Is a Cosmetics Patent Attorney?
A cosmetics patent attorney is a specialized legal professional who helps cosmetic companies, beauty brands, and personal care product manufacturers protect their innovations through intellectual property law. Generally, a cosmetics patent attorney guides clients through the patent application process, advises on licensing agreements and distributor agreements, and helps prevent product liability claims or infringement disputes.
Beyond securing patents, these attorneys often counsel clients on broader regulatory compliance matters. They ensure that new products and marketing claims comply with the Food, Drug, and Cosmetic Act (FDCA), the Fair Packaging and Labeling Act, and other regulatory requirements.
Legal Services for Cosmetics Companies
Our scope of legal services includes:
- Defense of FDA Inspections, Investigations & Administrative Detentions
- Drafting
- Distributor Agreements
- Licensing Agreements
- Marketing Agent Agreements
- Sales Representative Agreements
- FDA Regulatory Compliance Advice
- FTC Regulatory Compliance Advice
- Guidance Regarding Product Substantiation (Clinical Studies, etc.)
- Labels and Labeling
- Response to FDA Warning Letters
- Reviewing:
- Advertising (Print and Online)
- Infomercials
- Labeling
- Marketing Claims
- Retail Displays
- Testimonials and Endorsements
- Websites
The claims made about a product, whether in advertising or labeling, can determine whether the FDA regulates the product as a drug, a cosmetic, or both. Contact our experienced attorneys for FDA legal guidance regarding your product.
Need Cosmetic Legal Representation Services?
The cosmetic industry is highly competitive and heavily regulated, with agencies such as the FDA, FTC, EPA, and CPSC closely monitoring cosmetic products, dietary supplements, medical devices, and other personal care products. If businesses don’t follow the strict rules of the Food, Drug, and Cosmetic Act and other federal and state laws, they can face serious problems with things like product labeling, advertising claims, regulatory compliance, product recalls, and lawsuits.
Our experienced team provides strategic counsel to cosmetic companies, manufacturers, distributors, and beauty brands on all aspects of regulatory compliance, intellectual property, licensing agreements, distributor agreements, and claims review. With extensive knowledge of the cosmetic industry and the laws that govern it, we help clients protect their businesses, reduce liability, and maintain compliance with federal and state agencies.