Cosmetics Legal & Compliance
Guidance
Guidance
Cosmetics companies can make claims for their products, provided they are 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.
Definition of Cosmetic
Cosmeceutical” and “nutraceutical” are industry names for products that present hybrid qualities—for example, a cosmetic or a dietary supplement with therapeutic properties. However, the FDA does not regulate a product as a cosmeceutical or nutraceutical, per se. Typically, we counsel clients to distinguish whether their product will be regulated as a:
- Cosmetic
- Dietary Supplement
- Drug (prescription (Rx) or OTC)
- Food
- Medical Device
- Medical Food
The FDA notes that if a product makes therapeutic claims (for example, a shampoo whose intended use is to treat psoriasis), then it may fall into multiple regulatory categories and have to meet the requirements of both (for example, cosmetic and drug).
In Are Some Cosmetics Promising Too Much, ” the FDA gives very limited examples of claims cosmetics may make:
- Cleanses skin
- Enhances beauty
- Promotes attractiveness
- Alters appearance
Moisturizing has traditionally been considered a valid claim for a cosmetic product.
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 and the parts of such an article. The term cosmetic includes skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, toothpastes, and deodorants, as well as any material intended for use as a component of a cosmetic product. Under the federal Food, Drug & Cosmetic Act, drugs, biologics, and medical devices require premarket FDA approval.
Cosmetics and Misbranding
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 of 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 to important.
FTC Legal Issues
While the FDA has primary jurisdiction over labeling, safety, and purity of a given food, dietary supplement, medical device, or cosmetic, the Federal Trade Commission (FTC) enforces advertising and marketing regulations to ensure that claims are truthful, not misleading, and adequately substantiated. Thus, we address both FDA and FTC legal issues for our clients.
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 be the difference between whether the FDA regulates the product as a drug, a cosmetic, or both. Contact our experienced attorneys for FDA legal guidance regarding your product.
FAQ
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.
