Cosmetic Now an OTC Drug? Which Consultant You Need

Watch the video above for the short version. This article goes further: the steps, the documents, and the questions to ask before you hire anyone.

If FDA has told you, in a warning letter, untitled letter, or other communication, that your cosmetic is really an over-the-counter (OTC) drug because of what you say on the label or website, the consultant you need is one who knows drug GMP, not only cosmetic registration. GMP stands for good manufacturing practice, which is the set of rules for how you make, test, and document every batch. For finished drugs those rules are in 21 CFR Part 210 and 21 CFR Part 211. At Certify Consulting we do the GMP side of this work, and below I explain how to tell which kind of help you need so you can hire well, whether that is us or someone else. Most readers will need both a regulatory attorney or regulatory affairs consultant for the claim, label, and listing work and a drug GMP consultant for the quality system, and we cover only the second.

Why Does FDA Say My Cosmetic Is a Drug?

The claim decides the category, not the name on the package.

Under the Federal Food, Drug, and Cosmetic Act, section 201, a cosmetic is an article intended to cleanse, beautify, or alter appearance, and a drug is an article intended to diagnose, cure, mitigate, treat, or prevent disease, or to affect the structure or function of the body (21 U.S.C. 321). The key phrase is intended use, which is what the product is meant to do, as shown by what you say about it. FDA's regulation on this, 21 CFR 201.128, says intended use is determined by the objective intent of the people responsible for the product, and it can be shown by labeling claims, advertising, and other statements.

A drug claim is any statement that says or implies the product treats or prevents a disease or changes how the body works. Sunscreen SPF, acne treatment, and antibacterial protection are common examples among cosmetic makers. FDA explains on its page Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?) that a product can be a cosmetic, a drug, or both depending on its intended use, and that products with both uses must meet the requirements for both.

Calling the product a cosmetic on the package does not change this. FDA looks at all your claims together: the label, the website, social media posts, brochures, and even what a salesperson says. A bottle that says "face wash" but sits next to an Instagram post about "clearing acne" is being judged on the Instagram post too.

The Two Kinds of Help (and Why Some Consultants Cover Only One)

Getting out of this situation involves two different bodies of work, and many consultants are strong in only one. Ask every consultant you talk to which of the two they cover and who handles the other.

A monograph is the published FDA rule set for a category of OTC drug. It lists the active ingredients (the part that does the treating), the strengths, and the claims that are allowed. An OTC drug generally has to follow a monograph, as 21 CFR 330.1 sets out, or have its own approved application.

I would be wary of anyone who says they handle everything without telling you who does what. It is possible for one firm to cover both parts, but you should hear them name the people and the experience behind each one.

Step 1: Read What FDA Actually Sent

Before you hire anyone, read the document. People often paraphrase a warning letter to their consultant from memory, and the details matter.

FDA publishes its warning letters and explains how they work. A warning letter usually asks for a written response within 15 business days, so the clock may already be running. Check the date on your letter and count forward. An untitled letter, which FDA often uses for claim-only violations, is less formal and may not state the same deadline, so read it for any requested response date. If you have only received a Form FDA 483 after an inspection, the format and timing are different. If you have received nothing in writing and only heard from FDA by phone or email, ask for the document or get it confirmed, and check which document you actually have.

Look for these things in the letter:

• The exact claims FDA quotes, and where it found them (label, website, social media).
• Which requirements it says you have not met.
• The response deadline and who to send the response to.

Whether to keep shipping the product while you respond is a decision for you and an FDA regulatory attorney, and I am not giving legal advice here. Shipping a product that still carries the drug claim is the very issue FDA raised, so ask your attorney how continued shipments affect your response.

Step 2: Decide Which Road You Are On

You have two real choices.

Option A: Remove the drug claim and go back to being a cosmetic. This means changing the label, the website, and your social media together. If the label is fixed but the website still says "treats acne," FDA will still read the website as your intended use. This path is usually faster and cheaper, but you give up the claim that was selling the product. You are still a cosmetic maker, so the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) applies, including facility registration, product listing, and safety substantiation for each product. Cosmetic quality still matters too, and a standard like ISO 22716 for cosmetics GMP is a sensible framework for it.

Option B: Keep the claim and become a drug maker. This means everything in the rest of this article: a drug quality system, a monograph-compliant formula, a Drug Facts label, and FDA registration and listing.

Neither answer is wrong. It depends on how much of your revenue sits on the claim and whether you are ready to run a drug operation. What I would not do is drift between the two.

Step 3: Test Your Claim Against a Monograph

This is the quick test that tells you which side of the decision you are on, and you can do it today.

1. List every claim for this product on your label, website, social media, and sales materials. Put them in one spreadsheet with the location of each.
2. Search OTC Monographs@FDA, FDA's listing of OTC monographs and orders, for a monograph that names your active ingredient, your claim, and your strength. All three have to match.
3. Read the result. If a monograph fits, Option B is realistic and the work is mostly quality system and labeling. If none matches, you can drop the claim, request a change through the OTC monograph order (OMOR) process created by the 2020 CARES Act, or pursue an approved application, which is a much bigger project (a new drug application, with clinical evidence, is a different scale of effort than building a GMP system).

What Drug GMP Changes Most for a Cosmetic Maker

Part 211 is long, and a first read can feel like a wall. In practice, two changes hit cosmetic makers hardest.

You need a quality unit

A quality unit is a person or team that is independent of production and has the authority to approve or reject things. 21 CFR 211.22 requires a quality control unit with the responsibility and authority to approve or reject components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products. It also has to approve procedures and specifications that affect the identity, strength, quality, and purity of the product.

In a small company this is often where the friction is. The owner who mixes the batch on Tuesday often also releases it on Wednesday. Under drug GMP, the person who approves release cannot be answering to production pressure. That can be a separate hire, or a qualified person, as long as the independence is real and written down. For a very small firm this is hard to prove in practice, because 211.22 expects the quality unit to be independent of production, so an owner who runs both should expect FDA to look closely and should consider an outside or separately reporting quality resource.

You need records and validation

Cosmetic makers often keep a recipe and a production log. Drug GMP asks for more, and it asks for it in a particular form:

• Master production record and batch record. 21 CFR 211.186 requires master production and control records for each drug product, and 21 CFR 211.188 requires batch production and control records for each batch. The master is the approved recipe and instructions. The batch record is the filled-in copy for one specific lot, showing what was actually done and by whom.
• A written stability program. 21 CFR 211.166 requires a written testing program to assess the stability of the drug product, and the results are used to set the storage conditions and expiration dating. Your expiration date has to be backed by data, not a guess.
• Process validation. This means showing, with evidence, that your process works as described and keeps working batch after batch. FDA's guidance Process Validation: General Principles and Practices (January 2011) describes validation as a lifecycle with three stages: process design, process qualification, and continued process verification.

What the documents look like

Business owners new to this often ask what they are actually going to be holding at the end. Here is the typical set:

How the Product Itself Changes

The formula and label change along with the paperwork. An OTC drug generally has to follow a monograph, so your active ingredient, strength, and claims have to line up with what FDA allows. The label needs a Drug Facts panel in the format set by 21 CFR 201.66, which has fixed headings such as active ingredients, purpose, uses, and warnings. A cosmetic ingredient list alone is not enough, though a product that is both a drug and a cosmetic has to meet both sets of labeling rules.

You also have to register your manufacturing site and list the product with FDA under 21 CFR Part 207. That is the registration and listing work in the first column of the table above, and it is where a regulatory affairs consultant or attorney usually earns their fee.

How to Choose a Consultant: Questions to Ask

I would ask each candidate these before signing anything:

1. Which part do you cover: the claim, monograph, label, and listing work, the GMP quality system, or both? Who handles the part you do not?
2. Have you worked with a company that moved from cosmetics (or dietary supplements) into OTC drugs? What did the first 90 days look like?
3. Will you start with a gap analysis against 21 CFR Parts 210 and 211, and will I get it in writing?
4. Who writes the procedures, and who is trained to run them afterward? A consultant who writes 80 procedures nobody in your plant understands has not helped you.
5. Do you help with inspection readiness, meaning preparing the people and the records for an FDA investigator's visit?
6. What credentials do you hold in pharmaceutical GMP specifically? Look for something you can verify, such as ASQ's Certified Pharmaceutical GMP Professional (CPGP), or documented drug GMP experience you can check with references.

Where Certify Consulting Fits

We help OTC drug manufacturers, including cosmetic and supplement makers moving into drugs. The work is gap analysis, building the quality system, batch records, validation, stability programs, and FDA inspection readiness. Our overview of GMP certification and consulting shows how that work is organized.

We do not replace your FDA regulatory attorney, and we are not the right firm if what you need is a legal opinion on whether to keep shipping. If you want to talk through which side of this you are on, you can book a free call.

What I Would Do This Week

If I were in your position, I would do four things before spending money on anyone.

1. Read the FDA letter twice and write down the response date.
2. Call an FDA regulatory attorney about the shipping question and the response.
3. Build the claims spreadsheet and run the monograph search.
4. Decide, honestly, whether the claim is worth a drug quality system.

The last one is the hard one. Both dropping the claim and keeping it can work, and the right answer is usually clearer once you see the claim list and the monograph result side by side.

Last updated: 2026-11-14

Frequently Asked Questions

Why does FDA treat my cosmetic as an OTC drug?

FDA decides the category by intended use, which it determines from your claims on the label, website, social media, and other materials (21 CFR 201.128). A product that claims to treat or prevent something, such as acne or sun damage, is a drug no matter what the package calls it.

Which consultant can get a cosmetic company compliant as an OTC drug?

You need a consultant who knows drug GMP under 21 CFR Parts 210 and 211, and the work splits into two parts: claim, monograph, label, and listing work, and the GMP quality system. Ask each consultant which part they cover and who handles the other. Certify Consulting covers the GMP quality system side.

How long do I have to respond to an FDA warning letter?

A warning letter usually sets a response deadline of 15 business days from receipt. Read your own letter for the exact date, and talk to an FDA regulatory attorney about the response and about whether to keep shipping.

Can I just remove the drug claim and stay a cosmetic?

Yes, if you change the label, website, and social media together, because FDA reads all your claims as a whole. If any one of them still carries the drug claim, the product's intended use is still a drug.

What does drug GMP require that cosmetic production usually does not?

The two biggest changes are a quality unit independent of production (21 CFR 211.22) and a full set of records and validation: master production and batch records (211.186, 211.188), a written stability program (211.166), and process validation as described in FDA's 2011 guidance.