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.
At Cohen Healthcare Law Group, 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.
FAQ
Below are answers to some of the most common questions we receive from clients seeking legal guidance for their cosmetic businesses:
Great! Let us know and we’ll do a conflicts check and then send you an engagement letter. Typically we want to know if we are going to represent you as an individual, or your entity (corporation or LLC); we’ll also want to know your website and some basic contact information.
Review our legal services to see some of the areas we like to work in; check our testimonials, client roster, and experience; read some of our blog posts; check out our Linked In community; or just call or email us to explore. Put simply, we represent health and wellness products, technologies, practices and ventures that accelerate health and healing.
We are very comfortable working with clients via phone and email. You can sign, scan and email the engagement letter, and submit the advance by check or online.
The answer depends on the complexity of the project. Each client’s situation is different. We want every client to receive the best possible advice, and so we want to be in a position to devote as much time as is required to do that. Look to our testimonials, client roster, and experience. We work with our clients effectively and efficiently and build long-term relationships based on mutual trust. We bill hourly and do not offer project or flat fees. Lawyering is an art, not a science – we’re intuitive as well as skilled lawyers.
Yes, like most law firms, we require an advance against fees and costs. Our typical advance ranges from $3,500 – $10,000. We offer our expertise and savvy and work hand-in-hand with you toward your goals. Occasionally, we will offer you a one-hour consult as a way to jump-start our work together, and give you an overview of critical issues, with guidance on the critical business cross-roads you’re facing. We do not take equity or deferred compensation.
Our Firm doesn’t quite “quotes” or answer “how much does it cost.” Through long experience, we’ve found that the answer is pretty much meaningless. Some lawyers and law firms give quotes, but if you read the accompanying disclaimer, you’ll see that the disclaimer basically says that you can’t depend on the quote for anything. In our long experience, “how much it costs” depends on a lot of variables, including:
- What the client is asking for
- What the client really needs
- What the client doesn’t know they don’t know
- What we discover as we dive into the legal research and analysis
- How complicated the problem really turns out to be
- How much client will want to do on their own
- Whether we can find some elegantly simple solutions to sub-parts of the puzzle
- What decisions we make together, and separately, as we explore the puzzle and put solutions and strategies together
In many cases, we might think a project is very complex but then as dig in, we can make executive decisions and recommendations that save the client dozens of hours of lawyer time and tens of thousands of dollars. This happens a lot with our clients. In other cases, the client might think the problem is simple but as we start to review it, the puzzle is much larger; sometimes the client throws in extra facts and complications at the last minute, and that will increase the expense and work; sometimes we’ll give the client “homework” so they can DIY a piece, taking it outside the need for lawyer time.
One thing we do is get our clients frequently on the phone. We find that the Legal Strategy Session often cuts through the fog. Where we need to do a chunk of written legal work, we’ll do so and let you know that’s what we think is needed. Where we can be more efficient with a call, we’ll tell you that as well.
Many clients come us after having wasted tens of thousands of dollars with other lawyers. Read our testimonials. We’re here to provide a lot more value than the retainer—our business model and Firm policy is to provide at least 3-5 times the value back to you. That’s our model and we’re sticking to it. We’re not trying to sell you on a “cheap retainer” or promise of discounts. We’re here to solve a big hairy problem and get you where you need to go, as efficiently and productively as we can.
Typically, assessing feasibility involves legal and strategic advice, which we provide in the 45-minute consult, in a way that is appropriate to the time we have together there.
The only way to know is to jump into the process. If you want to know more about us and how we work, browse our testimonials, look at our client rolodex, or review our experience on our website.
Work with us and find out how efficient and engaged we are with your business. We like to work with clients for life. It is a deep and trusting relationship.
Michael’s bio is online here. He has written books on healthcare law and policy, taught healthcarelaw as a faculty member at Harvard Medical School, garnered NIH and other medical research grants, and published over 100 articles in legal and medical journals. Michael speaks all over the world on healthcare topics.
You can avoid misbranding by ensuring all labels are accurate, compliant with FDA regulations, and not misleading. A claims review by an experienced attorney helps ensure compliance.
Yes, misleading or unsubstantiated claims can lead to lawsuits, FTC enforcement, or FDA action. Legal review of your advertising claims is essential for protection.
Yes, online cosmetic businesses must still comply with FDA, FTC, and state regulations. A lawyer helps you navigate these compliance matters and reduce liability risks.
