Ohio Regulations – 2021

In Ohio, cosmetic manufacturers must be inspected prior to start of operation.

NOTE: This post supercedes our Cosmetic Regulations – Ohio post from 2015.

The Ohio Department of Agriculture recently published (June 2021) a Cosmetics webpage containing the requirements for a cosmetic manufacturer to get their facility inspected. There is also downloadable pdf1The pdf linked to in this blog post is stored on my website. There is a link to the downloadable pdf on the Ohio Cosmetics webpage. available from the Cosmetics page.

Inspection Overview

The inspection must be completed prior to the start of operations.

The inspection is to determine if the site is compliant with good manufacturing practices.

Cosmetics may be produced in a home or commercial setting.

NO pets are allowed in the facility.

There is no fee for the inspection.

There is no license or registration issued.

The request for an inspection can be downloaded here.

Laws and Regulations

The Ohio laws for cosmetics follow the federal laws as covered in the Food, Drug and Cosmetic Act. They allow for inspections of cosmetic facilities (although the federal law doesn’t require inspection before the facility starts operations for cosmetics).

When it comes to cosmetics, the Food Drug and Cosmetic Act mainly requires that cosmetics cannot be adulterated or misbranded. The regulations specify the labeling requirements.

Ohio’s labeling rules are found in the Ohio Administrative Code, primarily 901:6-30-01 through 901:6-3-12.  The rules are  almost identical to the Uniform Packaging and labeling Regulations provided by the National Institute of Technology in their handbook.

Adulterated / Misbranded

An adulterated or misbranded cosmetic is prohibited.

Adulterated

A cosmetic can be considered adulterated for four main reasons:

  • It may be injurious to users under normal use because it contains a potentially harmful substance.
  • It contains filth.
  • It contains a non-permitted, or in some instances non-certified, color additive.
  • It is manufactured or held under insanitary conditions whereby it may have become injurious to users or contaminated with filth.

For a more complete disculssion of adulterated cosmetics, see What does ADULTERATED mean?

Misbranded

A cosmetic can be considered misbranded for:

  • False or misleading labeling.
  • Failure to state prominently and conspicuously any required information.
  • Misleading container presentation or fill.

Good Manufacturing Practices

Following  good manufacturing practices is considered the best way to ensure that a product isn’t – and doesn’t become – adulterated or misbranded. In general, good manufacturing practices involve:

  • Suitable buildings and failities
  • Well maintained and clean equipment
  • Personnel adequately trained and maintaining adequate cleanliness
  • Raw materials are stored and handled so they don’t get mixed up or contaminated.
  • Production has established and written instructions and procedures.
  • Laboratory controls are in place as needed
  • Records are kept on lots of raw materials & manufacturing batches
  • Products are correctly labeled
  • Complaint procedures are documented and in place.

Obviously, the implementation of these different factors is unique to each manufacturing facility. How they are adapted to manufacturing in a home would be very different than how they are adapted to a commercial facility.

The following resources have more information on implemeting GMP guidelines:

Other Ohio Regulations

The Ohio Small Business Development Center has a page about starting a business in Ohio which includes checklists for a whole bunch of different businesses. One of those is the 1st Stop Checklist for Cosmtic Sales / Manufacturing.  The document is quite short and lists out only a few points under the Requirements and Regulations:

  • Comply with the Ohio Food, Drug, Cosmetic and Device law
  • Comply with Ohio’s labeling rules
  • If you sell in-home (door-to-door), you must comply with the Ohio Home Solicitation Sales Act.
  • If you sell via mail, telephone or Internet, you must comply with the Ohio Telephone Solicitation Sales Act.

Note that it doesn’t mention getting the facility inspected.

Sales Tax

If you sell products in Ohio, you must have a Vendor’s License, collect sales tax, file tax returns and keep compelte records of transactions. The Ohio Department of Taxation can help with that (or go to http://www.tax.ohio.gov).

And an Odd Quirk

In looking through the regulations, I did find one small item in the prohibited acts of the Ohio Food, Drug, Cosmetic, and Device law, about selling products at a flea market (the excerpt below only contains the pertinent sections):

(1) No person at a flea market shall sell, offer for sale, or knowingly permit the sale of any of the following products:

(b) Any drug, cosmetic or device;

(2) [This] does not apply to a person who keeps available for public inspection an identification card identifying the person as an authorized representative of the manufacturer or distributor of any drug, cosmetic or device, as long as the card is not false, fraudulent or fraudulently obtained.2ORC 3715.52(B)

So apparently you could sell your OWN products (if you have a valid card showing you are an “authorized representative”), or could sell products for a company that you representated (maybe Avon or Mary Kay, for example), but you couldn’t just go to the Dollar Store, buy a bunch of cosmetics and then resell them (since you wouldn’t be an “authorized representative” of the companies that made the products).

close

Sign up for my newsletter to get notifications of new blog posts and occasional newsletters with general information.

I don’t spam! Read the privacy policy for more info.

Like this? Please Share!
RSS
Follow by Email
Facebook
Twitter
Pinterest
LinkedIn

References

References
1 The pdf linked to in this blog post is stored on my website. There is a link to the downloadable pdf on the Ohio Cosmetics webpage.
2 ORC 3715.52(B)

Discussion

10 responses to “Ohio Regulations – 2021”

  1. This doesn’t look like it’s a new law. If you look at this page: https://codes.ohio.gov/ohio-revised-code/section-3715.70 it appears that this has been the case since 1998, at least.
    The only thing that looks like it’s new is the web page and, maybe, the startup inspection. Which isn’t terribly surprising given the explosion of people making cosmetics in their homes. I wouldn’t even think that the startup inspection is anything new. I can certainly tell you that the chemical factory I worked in had to be inspected before they started operation.
    I’m certainly not any kind of legal expert but it doesn’t really look like this is a new law.

    1. Yes, that’s my understanding as well. The right to inspect and the oversight of cosmetics has been on the books for a long time.

      1. I’d also add that we’re homeschoolers and every single year the local homeschool, “coordinator (as they title the job), asks for all kinds of information that we aren’t legally required to give them. It doesn’t actually say anything about what the actual legal requirements are, it just asks for more than we’re legally required to provide the state with. This is extremely common according to other homeschooling parents.
        The web page strikes me as being a similar case of asking for something in hopes of getting it even if it’s not actually required. My wife said that she looked all over in the sections above and couldn’t find anything about an actual _legal_ requirement to get an inspection before starting cosmetics manufacturing. She is not a lawyer, either and that certainly isn’t proof that there isn’t any legal requirement to get an inspection before starting cosmetics manufacturing. It is just to say that, if there is a legal requirement, she couldn’t find it in the laws. (Finding anything in the laws is pretty difficult, though. Which is what happens when the lawyers are the ones writing the laws, isn’t it? “How do we make sure no one can do anything without paying one of us?” LOL)
        One of the important things people need to be aware of with this, I think, is that they don’t appear to need any kind of a search warrant to enter your home if you’re manufacturing cosmetics in your home. The law says that they have the right to enter during reasonable business hours and inspect. Also… If you’re making cosmetics in your home, you’re not supposed to have any pets. (Though I doubt they’d have much to say about a fish tank. Unless they wanted to be unreasonable.)

        1. Yes – that’s my observation as well. I also couldn’t find anything in the actual regulations requiring a pre-inspection. Ohio – like most states – does have laws/regulations allowing inspections.

  2. Any thoughts on how this would apply to someone who was in operation before these rules were put in place? I could only find that inspections were required before start of operations.

    1. The Ohio Cosmetics page says, “Subsequent inspections will be conducted on a routine, unannounced basis.” So I assume that event if you didn’t get inspected at the start, you could get inspected at any time.

  3. Do you believe the new Ohio requirements
    are coming to the rest of the state’s?

    1. I hope not! There are a few other states that have special requirements for cosmetic manufacturers, not most still do not.

  4. So there cosmetic rules don’t apply to soap as long as we don’t mislabel it to having other health benefits. Is this correct?

    1. In order to be exempt, the soap must be made from lye/oils (“the bulk of the soap is the alkali salt of fatty acids”) and it can only claim to be “soap”.

      If you use an MP base with other sufactants, add surfactants to a CP soap, or make any statements that the soap will do more than “clean” (ie moisturize, exfoliate, etc) then the soap is a cosmetic.

      If it’s a cosmetic, you have to follow the cosmetic manufacturing requirements (inspection). If it’s a soap, you don’t have to.

Leave a Reply

Your email address will not be published.