Making Cosmetics in Pennsylvania

Pennsylvania is another state that has specific requirements for cosmetic manufacturers (like Florida and Ohio). These laws have been on the books for a number of years (at least partially) but apparently haven’t been enforced until recently. The information available online is somewhat contradictory, but it looks like they do expect all cosmetic manufacturers to register.

Registrations are under the Pennsylvania Department of Health, Drug, Device, and Cosmetic Program. The home page of the program located here, says:

Any business in the Commonwealth of Pennsylvania who is manufacturing, distributing or retailing drugs, medical devices, and/or medicated cosmetics must register with the Department of Health unless otherwise noted as a designated exemption.

It says “medicated cosmetics,” which is an oxymoron. There’s no such thing as a “medicated cosmetic.” A product could be a cosmetic AND an over-the-counter drug or a prescribed drug. However, it seems the statement is being interpreted to mean that all cosmetic manufacturers must register, regardless of whether the cosmetic is also a drug or not.

The registration form

The registration form is straightforward. There’s also an online application form which can be filled out and submitted (here). In order to submit the online version your business name must be registered with the Department of Corporations and you need to have a pin number already assigned.

All that is really needed is to fill in the form with your business contact information, check off that you’re a cosmetic manufacturer and send in the $100. It doesn’t appear that any pre-approval or inspections are needed prior to issuing the approval.

Cosmetic manufacturer expectations

There are, however, some expectations of standards you should uphold as a cosmetic manufacturer.

First, comply with labeling requirements.

Second, good manufacturing practices. These include (very, very generally):

  • Keeping batch and lot records
  • Maintaining clean facilities free of dirt, debris, pets/animals, etc.
  • Having appropriate written policies and procedures to ensure the safety of products and preventing the distribution of adulterated or misbranded products.
  • Setting up recall procedures.

Third, your business name (if other than your personal name) needs to be registered with the PA Department of Corporations.

Inspections, including unannounced inspections

As part of the registration, you agree that your facility may be inspected by the Department of Health. They don’t have to announce that they are coming; the inspector could just show up at your door one day.

There isn’t any indication if, when, or why an inspection would take place. Unlike some other states, there is no indication that there is a fee for an inspection. (At least I didn’t find anything in the materials I looked at.)

Actual Laws & Regulations

The Pennsylvania LAW covering cosmetics is The Controlled Substances, Drugs, Device, and Cosmetic Act (here). It does cover some things about cosmetics (adulterated or misbranded cosmetics are not allowed, and specific color additives), but other than that it doesn’t actually mention cosmetics much. It doesn’t actually say that cosmetic manufacturers need to register. All the parts about registration have to do with drug and device manufacturers:

Section 6. Registration.-(a) No person shall operate within this Commonwealth as a manufacturer, distributor or retailer of controlled substances, other drugs and devices nor sell, offer for sale nor solicit the purchase of controlled substances, other drugs and devices nor hold them for sale or resale until such person has registered under this act with the Secretary.

The Pennsylvania REGULATIONS covering cosmetics are from the Pennsylvania Regulations (Title 28, Chapter 25), Controlled Substances, Drugs, Devices and Cosmetics (here). Again, it has some regulations specific to cosmetics, but the portions on registration all specify drugs and devices, not cosmetics:

§ 25.113. Requirements for registration.
(a) Every person who manufactures, distributes or retails drugs or devices within the Commonwealth or proposes to engage in the manufacture, distribution or retail sale of drugs or devices within the Commonwealth shall obtain annually a registration unless exempted under § 25.114 (relating to persons exempt from registration).

The bottom line

The officials of Pennsylvania Department of Health, Drug, Device, and Cosmetic Program have determined and implemented registration for cosmetic manufacturers in the state of Pennsylvania. The registration is fairly simple, doesn’t require advance approval, and only costs $100.

The expectations for a cosmetic manufacturer are reasonable, and in line with what you should be doing anyway (labeling, cleanliness, written procedures, etc.).

Whether they have expanded or exceeded the actual letter of the law is a question for another day.

Navigating the Rules and Regs book by Marie Gale

Besides labeling, there are many other laws and regulations that apply to handcrafters. To find out which ones apply to you and how to comply with them, buy my book and keep it handy!

Comments

13 responses to “Making Cosmetics in Pennsylvania”

  1. Is there a law (I can’t find it) regarding making roller ball scents in the home for sale at craft shows in PA?

    1. Marie Gale

      Roller ball scents are cosmetics, so all of the cosmetic laws and regulations apply.

  2. There is no information about being to be able to make cosmetics in clean home space. Are we able to do that in PA or find a commercial space to make it at?

    1. As far as I could see in the law and regulations, there is nothing specifically prohibiting making cosmetics in a home.

  3. I am thinking about opening my cosmetic eyebrow tattoo business at home. am I allow to do this in the state of Pennsylvania? If yes. what are the things i will be inspected on?

    1. The regulations that are likely to apply are those for tattoo businesses, not manufacturing cosmetics. You should check on those regulations.

  4. Kimberly everson

    Does Making organic body scrubs considered a cosmetic in PA

    1. Marie Gale

      Body scrubs of any kind are considered a cosmetic.

      Be watchful of generally claiming “organic” without proper organic certification.

  5. Does this include soap that is labeled soap with no cosmetic claims?

    1. Marie Gale

      Soap that is the alkali salt of fatty acids (lye/oil soap) and for which there are no cosmetic claims is not a cosmetic, so cosmetic regulations do not apply.

      1. Trish Novelli

        Thank you! This is what I was looking for.

  6. Angelique Churilla

    So if I am making cosmetics in my own home but don’t technically have a business just selling them under my name do I have to register with somebody in Pennsylvania??

    1. Marie Gale

      If you are selling, then you are a business. It just means that your business name is your own personal name. Technically, it does appear that you should register as a cosmetic manufacturer. Your business name is your personal name (as that is the name you are doing business under). Keep in mind that your personal name is also the name that is required on your labels as the business name (or the name of the responsible party).

      If you are planning to actually make some money doing this, then you might want to consider registering a business name (as a “doing business as” or “ficticious name”—whatever they call it in PA) so you can use that as your business name. You’ll also need that if you want to open a business bank account.

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