This is
beauty law.

Frequently Asked Questions

Does MoCRA apply to my small beauty brand? +

MoCRA applies to anyone who manufactures, processes, packages, or holds cosmetics for US distribution. There is a small business exemption for businesses with under $1 million in average annual gross sales of cosmetics (and that do not regularly sell products that come into contact with mucous membranes), but this exemption only covers facility registration and product listing. It does not exempt you from safety substantiation requirements, adverse event reporting, or Good Manufacturing Practice (GMP) regulations. Understanding whether and how the exemption applies to your business requires looking at your specific revenue, product categories, and distribution model.

What does FDA label review actually involve? +

FDA label review for cosmetics involves evaluating your product labels against the requirements of the Fair Packaging and Labeling Act (FPLA), FDA cosmetics regulations, and, for products introduced after MoCRA, any additional MoCRA-driven labeling requirements. This includes reviewing the ingredient list (using INCI nomenclature, listed in descending order of predominance), required label elements (net quantity, responsible party name and address, directions for use where necessary), and marketing claims. If your label makes a claim that crosses from cosmetic territory into drug territory, such as claiming your product treats or prevents a skin condition, that creates a regulatory compliance issue that can result in FDA enforcement action.

I run a beauty salon or spa. Do I need contracts with my clients? +

Yes. For service-based beauty businesses, client agreements protect you from liability disputes, clarify what services you are providing, address refund and cancellation policies, and can include limitation-of-liability provisions. If you have employees or independent contractors performing services, those relationships also need to be properly documented. Misclassifying a worker as an independent contractor when they are legally an employee exposes you to significant liability. The contracts that protect a service-based beauty business are different from those that protect a product-based business. Antonella works with both.

What is the difference between a cosmetic and a drug under FDA regulations? +

The distinction matters enormously. A cosmetic alters the appearance. A drug is intended to diagnose, cure, treat, mitigate, or prevent disease, or affect the structure or function of the body. Products that fit both definitions (like anti-dandruff shampoos or sunscreens) are regulated as both cosmetics and drugs, which means they must comply with both regulatory regimes, including drug labeling requirements, OTC monograph requirements, and in some cases New Drug Application requirements. Where your product falls in this spectrum affects everything from your label to your safety data requirements to your FDA registration obligations.

How is Colella Legal Studio different from other firms when it comes to beauty industry law? +

Most attorneys who handle beauty business matters approach it as general business law. Antonella specifically focuses on the intersection of business law, trademark, and the beauty and cosmetics industry. She understands the specific regulatory landscape (MoCRA, FDA cosmetics and OTC drug regulations, FTC guidelines for influencer marketing), the industry's IP landscape (crowded trademark space, trade dress, trade secrets in formulation), and the business realities that beauty brand founders face. She is not learning your industry while billing you.