The U.S. Compliance Guide for Supplement & Skincare Founders

Most founders discover U.S. product rules the hard way: a label reprint after the first order, a paused ad account, or a lawyer's email that lands the week before launch. It doesn't have to go that way. The rules that govern supplements, cosmetics, and the claims you make about them are knowable, and once you understand the logic behind them, they stop feeling like traps and start feeling like guardrails. This guide walks through the three frameworks that matter most, DSHEA, MoCRA, and the FTC's advertising standard, in plain English, so you can build a brand that markets with confidence instead of crossing its fingers.

One thing to settle up front: nothing here is legal advice, and none of it replaces qualified regulatory counsel before you launch. The goal is to make you a fluent, informed client: someone who can read a claim and sense whether it's inside the line or over it.

Three agencies, three questions

Almost every compliance question a founder faces comes down to three overlapping authorities, each asking a different question about your product.

• The FDA, under DSHEA, asks: is this a properly formulated, honestly labeled dietary supplement, or are you quietly selling an unapproved drug?
• The FDA, under MoCRA, asks: is this cosmetic safe, is its maker registered, and can you back up what's on the label?
• The FTC asks a simpler and broader question about everything you say in marketing: is it truthful, non-misleading, and substantiated?

Get comfortable with those three questions and most of your day-to-day decisions answer themselves.

Supplements: the DSHEA framework

The Dietary Supplement Health and Education Act of 1994 (DSHEA) is the law that defines how supplements are regulated in the United States. The single most important thing to internalize is this: supplements are not approved by the FDA before they go on sale. There is no pre-market approval process for a dietary supplement the way there is for a drug. That is exactly why the phrase “FDA-approved supplement” is not something you can ever claim. No such thing exists, and using it is itself a compliance problem.

Responsibility sits with you

Because there's no pre-market gate, the responsibility shifts to the manufacturer and brand owner. You are responsible for ensuring your product is safe, that it's produced under current Good Manufacturing Practices (cGMP), that its ingredients are permitted, and that everything on the label is accurate. The FDA's role is largely post-market: it can act after a product is on shelves if there's a safety issue or a labeling violation. This cuts both ways: no one signs off for you, so your documentation and your manufacturer's quality systems are the real backbone of compliance.

Structure/function claims: the language you can use

DSHEA lets you make what are called structure/function claims: statements describing how an ingredient is designed to support the normal structure or function of the body. “Supports a healthy immune response” or “designed to support restful sleep” are structure/function claims. What you cannot do is cross into disease claims: any statement that the product can diagnose, treat, cure, mitigate, or prevent a disease. The moment a claim implies a disease effect, the FDA can treat your supplement as an unapproved (and misbranded) drug, which is a category no founder wants to be reclassified into.

The disclaimer and the 30-day notification

Two procedural pieces travel with structure/function claims. First, when you make one, your labeling must carry the standard FDA disclaimer: that the statement has not been evaluated by the FDA and that the product is not intended to diagnose, treat, cure, or prevent any disease. Second, you generally must notify the FDA within 30 days of first marketing a product with a structure/function claim. These aren't obstacles. They're the normal cost of speaking about benefits, and they're easy to handle when they're planned into your launch rather than discovered after it.

Cosmetics and skincare: the MoCRA framework

For years, cosmetics were among the most lightly regulated consumer products in the U.S. That changed with the Modernization of Cosmetics Regulation Act (MoCRA), which introduced meaningful, drug-adjacent obligations for cosmetic makers and brand owners. If you're launching skincare, beauty, or personal-care products, MoCRA is now part of your operating reality. Its core requirements are worth knowing by name.

Facility registration and product listing

Facilities that manufacture or process cosmetics generally must register with the FDA, and brand owners are responsible for listing their cosmetic products, including their ingredients. This creates a paper trail the agency can follow, and it means the manufacturer you choose needs to be handling their side of registration correctly.

Safety substantiation

MoCRA requires that there be adequate substantiation of a cosmetic product's safety. In practice, that means you need a documented, defensible basis for believing the product is safe for its intended use: not a hunch, but records. This is where responsible development pays for itself: the substantiation file is something you build during formulation, not something you scramble to assemble later.

Adverse-event reporting and recordkeeping

Brand owners must keep records of and report serious adverse events associated with the use of their cosmetic products. You're expected to have a way to receive, log, and act on reports of harm. It sounds intimidating, but it's mostly about having a simple, reliable process in place before you need it.

Labeling and FDA recall authority

MoCRA tightened labeling expectations (including contact information for adverse-event reporting and, over time, fragrance-allergen disclosures) and, importantly, gave the FDA mandatory recall authority over cosmetics for the first time. The agency can now order a recall of a cosmetic it believes is unsafe. The lesson for founders is the same one that runs through this entire guide: safety documentation and honest labeling aren't box-checking, they're your protection.

A word on the cosmetic/drug boundary. If a skincare product is intended to affect the structure or function of the body, or to treat a condition like acne or eczema, it may legally be a drug, not a cosmetic, and a different (much heavier) pathway applies. That's why cosmetic claims should describe appearance and the senses (“helps skin look smoother,” “supports the appearance of hydration”) rather than promising to heal or treat.

The FTC: everything you say, everywhere

DSHEA and MoCRA govern the product and its label. The Federal Trade Commission governs your advertising: your website, your ads, your emails, your social posts, your influencer partnerships. The FTC's standard is short and unforgiving: claims must be truthful, not misleading, and substantiated before you make them. “Substantiated” means you have a reasonable basis (competent and reliable evidence) for a claim at the time you make it, not evidence you hope to gather after it goes viral.

Two traps catch founders most often. The first is the implied claim: you never literally say the product cures anything, but the before-and-after photo, the testimonial, and the headline together imply it. The FTC reads the net impression, not just the literal words. The second is the unqualified typical-results promise. If results vary (they always do), your marketing can't present an exceptional outcome as what a typical customer should expect.

Safe wording vs. wording to avoid

Here's the practical translation. None of these are magic phrases (context and substantiation always matter), but they illustrate which side of the line language tends to fall on.

Language that tends to be defensible

• “Designed to support” a normal function, not “will fix.”
• “Supports wellness goals,” “supports a healthy [function],” “helps maintain [normal process].”
• “Science-informed formulation,” “formulated with [ingredient] studied for [function].”
• For skincare: “helps improve the appearance of,” “supports skin's look and feel,” “hydrates the skin's surface.”
• “Built to” and “intended to” instead of “guaranteed to.”

Language to avoid

• “FDA-approved supplement”: supplements are not FDA-approved before sale, and the phrase is off-limits.
• “Clinically proven to cure,” “treats inflammation,” “prevents disease,” “reverses aging.”
• “Heals eczema,” “treats acne,” “repairs” a medical condition, “regenerates tissue” (unless you are intentionally on a drug pathway).
• “Guaranteed results” and any promise of a specific, certain outcome.
• Naming a disease anywhere near your product, even in a customer story or a hashtag.

Building compliance in from the start

The founders who never have a compliance scare are almost always the ones who treated claims and documentation as part of formulation, not as a marketing afterthought. That means deciding your product's regulatory category early (supplement, cosmetic, or a deliberate drug pathway), building the safety and quality documentation as you develop, and drafting a claims map (a documented view of what you can responsibly say) before the copywriter ever opens a blank page. This is the same order we work in on the supplement product development and skincare product development tracks: category and claims strategy live inside the development process, not bolted on after. For a deeper look at supplement claims specifically, see our companion piece on making supplement claims in the USA.

Compliance done this way isn't a brake on your marketing. It's what lets you market boldly, because you know exactly where the line is, and you've built a product that stays comfortably inside it.

This guide is educational and is not legal or regulatory advice. DSHEA, MoCRA, and FTC requirements are detailed and change over time; have your labels, claims, and advertising reviewed by qualified regulatory and legal professionals before you launch.