Hero Skin Care FDA Requirements and Regulations to Know Before Opening Your Business

Industry • Best Practice

Skin Care FDA Requirements and Regulations to Know Before Opening Your Business

Complying with FDA guidelines for skin care products means applying accurate labels and keeping contaminants out of your cosmetics

Selling skin care products is an easy way to raise client satisfaction and shore up your bottom line. Why? Because they give your providers a chance to personalize each client's experience. Clients want to maintain their skin as best they can, even when they're not visiting your business. The providers you hire can lend their expertise by recommending products that fit each client's specific needs. And wouldn't you know it: Those products are sitting right here on the shelf, convenient as you please. Will that be credit or debit?

But the prospect of putting products on the shelf may raise some pressing questions for business owners. Do you need a license to sell skin care products? What are the FDA guidelines for skin care products being sold and marketed? What if I’m making my own cosmetics? And what is a cosmetic, exactly? Luckily, these questions are (mostly) simpler to answer than they seem.

Do you need a license to sell skin care products?

Let’s start with the big one: Do you need FDA approval to sell skin care products? The short answer is no. Skin care products fall under the FDA’s definition of cosmetics, which is anything meant to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body’s structure or functions. Generally, that means makeup, moisturizers, hair dyes, perfumes, colognes, nail care products, permanent waves, straighteners, and removers.

The Food and Drug Administration does not license cosmetic firms for product sales. However, some states and localities may have different standards.

For example, the California Safe Cosmetics Program dictates that if your company makes more than $1 million in annual revenue and any skin care product you sell contains a chemical agent known or suspected to cause cancer, congenital disabilities, or reproductive harm, you must submit to specific reporting requirements. The list of offending ingredients appears on the California program’s site. It’s best to check your state’s website or get in touch with local representatives to find similar laws affecting you.

So, if my state has no licensing requirements, I can already sell cosmetics?

That’s right. If your plan is simply to put moisturizers, shampoos, or other retail products on the shelf, you’re good to go. But if you’re making, marketing, or distributing those cosmetics, there’s more to consider.

Regulations for skin care products

The basis for the FDA’s work in cosmetics comes primarily from two laws: the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act.

The first of the two sets the definition of cosmetics we discussed earlier. The latter sets standards for proper labeling. All labels should contain a principal display panel and an information panel. The principal display panel should include:

  • An identity statement including the product’s name and what it’s used for

  • An accurate statement of the net quantity of contents, whether that be in weight, numerical count, or some other form

The information panel should dig into further details, including:

  • The name of both the manufacturer and the distributor

  • The address of either the manufacturer or distributor, though the exact street address can be omitted if it’s available in a current phone or city directory, either in print or online

  • Material facts such as directions for safe use

  • Prominent and conspicuous warning and caution statements

  • Ingredients in descending order of predominance

Labeling should be in English, and additional labels in other languages must contain all the same information. Because the FDA doesn’t approve labeling, products should never say “FDA Approved.” FDA doesn’t have regulations for the terms “natural” and “organic” with regard to cosmetics, but it recommends avoiding “natural” when describing ingredients.

The FDA also has a list of prohibited labeling tactics:

  • Labels cannot be false or misleading

  • Labels cannot omit required information

  • Labels cannot be improperly displayed

  • Labels cannot violate the Poison Prevention Packaging Act of 1970, which means they can’t interfere with packaging that stops children from opening the product

You can see the full list of rules for labeling on the FDA’s website. The site also hosts plenty of other resources, including a step-by-step guide to making sure your labels are up to code.

Do you need a license to sell a skin care product that’s also medicinal?

Cosmetics are just one of three categories of goods related to skin care that the FDA regulates. The other two are drugs and soap, and neither requires a license to sell. Labeling requirements for those products are slightly different from cosmetics.

According to the FDA, a drug is a product intended to treat or prevent disease or otherwise affect the structure or function of the human body. Some cosmetics are also drugs. Anti-dandruff shampoo, for example, cleanses and promotes attractiveness but also treats a medical condition. You can learn more about label requirements for drugs on the FDA site

Soap is a product that consists primarily of an alkali salt of fatty acid with no label claim other than the cleansing of the human body. Learn more about soap here.

Unsure whether your product is a cosmetic, a soap, a drug, or some combination of the three? This guide from the FDA will help you figure it out and label it accordingly.

Does the FDA approve ingredients or products?

The FDA does not approve specific products or ingredients except for this list of color additives. Color additives not on that list shouldn’t be used when making cosmetics. Neither should any ingredients from this list of restricted and prohibited ingredients maintained by the FDA. To ensure compliance, the administration regularly inspects cosmetic manufacturing and distribution facilities to ensure products aren’t being contaminated, adulterated, or mislabeled.

Until March 2023, businesses had the option to voluntarily register their cosmetic products with the FDA through the Voluntary Cosmetics Registration Program. That changed after Congress passed the Modernization of Cosmetics Regulation Act of 2022, and the FDA has shut down registration while it overhauls the system to meet the requirements of the new law. Once the new system is live, anyone who owns or operates a manufacturing or distribution facility for cosmetics will have to register it with the FDA. The administration says it will share more info about the new system as it becomes available.

What regulations for skin care products affect manufacturing?

You don’t need a license to make cosmetics, but that doesn’t mean manufacturing is a free-for-all. Whether you do it at home or your business, you must manufacture your cosmetics in an environment that avoids adulteration. What does that mean? It means avoiding prohibited or restricted ingredients and color additives, using safe packaging, and keeping microbial and other contaminants from the product. Although the FDA guidelines for skin care products don’t include manufacturing rules per se, they do offer a checklist of things FDA inspectors look for when they come knocking.

As the manufacturer, you’re also responsible for ensuring your product is safe. The FDA doesn’t provide specific tests for products, but it does point to a collection of safety data maintained by the Cosmetic Ingredient Review. By comparing your formulation to a similar one in that data set, you can get a baseline understanding of its safety. FDA recommends toxicological testing to fill in any gaps, and it has resources for finding a lab to do the testing.

What happens if I violate the regulations for skin care products?

The FDA also performs routine inspections of cosmetic manufacturing facilities to ensure product safety. The Modernization of Cosmetics Regulation Act significantly expanded the FDA’s ability to penalize businesses that don't meet its standards. The administration can now access and copy a violating business's records, issue mandatory recalls of a product, demand reports on how the product negatively affects consumers, and suspend a manufacturer's facility registration so that it can no longer distribute or sell its products.

Getting on the FDA’s bad side isn’t a risk worth taking. So long as you ensure the products in your skin care business meet proper labeling standards, you’ll be able to safely enjoy the revenue boost retail sales can provide.

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