Cosmetic Regulations – Louisiana

Louisiana is another state that has some regulations for cosmetic manufacturers, over and above what the FDA requires. I recently did some looking into the laws and regulations for Louisiana; this post details what I found.

Dept of Health and Hospitals

The Food and Drug Unit in the Office of Public Health under the Louisiana Department of Health and Hospitals seems to have jurisdiction over not just food and drugs, but also cosmetics and cosmetic manufacturers. They have published a document, Basic Requirements for Prospective Cosmetic Manufacturers, which details (in pretty official language) what you should know and the applicable regulations.

Cosmetics … and Soap

The definition of a cosmetic in Louisiana law is very similar–but NOT the same as–the definition used by the FDA.

“Cosmetic” includes all substances and preparations intended for cleansing, altering the appearance of, or promoting the attractiveness of a person. The term includes soaps only when medicinal or curative qualities are claimed by the use thereof.

There’s a notable difference between Louisiana and the FDA when it comes to the definition of soap, and when it is or is not exempt from the definition of a cosmetic. However, for either one, if there aren’t any cosmetic claims made, then soap isn’t considered a cosmetic. That being the case, if you are ONLY making soap, and are ONLY calling it “soap” and are NOT making any cosmetic claims for it, then you probably don’t need to register as a cosmetic manufacturer in Louisiana.

Permits

Anyone operating a facility engaged in manufacturing cosmetics in Louisiana must have a permit to operate. Permits are issued by the State Health Officer though the Food and Drug Unit of the Office of Public Health. It took a little searching, but I found a packet of information which contains the forms that need to be submitted. It looks like the forms for cosmetics are the same as (or very similar to) the forms for food and drug manufacture—so they are detailed and complicated.

There is a fee of $175 for businesses with less than $500,000 gross annual sales. The permit must be renewed annually.

The required forms (which are described below) may seem like overkill for a handcrafter or home-based business, but they do make sense for a full-on manufacturing factory. Protecting the water and sewer systems is extremely important. When you are trying to figure out how to get through the paperwork, remember that it is designed for big companies, so try not to get too frustrated.

Form FD-1B Plans Review Questionnaire

This is the general overview form (name, address, contact, etc.). It requests a set of plans and specifications for the facility be made available to the inspector. I expect that this is primarily to ensure that good manufacturing practices are being (or can be) followed. The form also requires the name of your water, sewer, and garbage/refuse disposal companies. I didn’t see anything that indicates that manufacturing can’t take place in a home or residence.

Form FD-1E Parish Utility Letter

You are required to get a “Utility No Objection Notice” completed by the local utility company saying that they have no objection to your manufacturing facility. It mostly has to do with wastewater disposal and potable water source. If you are dealing with a person from the utility company that is not familiar with making soap or cosmetics, you may need to explain about what may go down the drain. You may need provisions for ensuring that un-neutralized lye doesn’t end up in the sewer system.

Inspection

It appears that an inspection is likely in order to have your facility approved for manufacturing cosmetics. The information on their website is somewhat confusing, but it looks like you can find your local office on this page. The main concern seems to be that there are sufficient procedures in place to ensure that your product(s) won’t become contaminated or adulterated. The FDA GMP Inspection Checklist and the FDA Cosmetic GMP Draft Guidance would be good places to start to make sure you are ready for the inspection. The local inspector may have more information about what is expected, especially from small, home-based businesses.

A Temporary Permit to Operate is issued once the plans have been reviewed, approved, and a pre-operational inspection is passed.

Product Registration

Louisiana requires that all cosmetic products be registered. Before a full Permit to Operate is issued, all products must be registered, which includes submitting the labels for review to ensure they are correct.

Form FD-9 Application for Registration

The Application for Registration form requires basic contact information, which must be EXACTLY AS IT APPEARS ON THE LABEL of the product(s).

A product list and electronic or paper copies of labels or label proofs must be attached to and submitted with the form.

There is a fee of $27 per product, with a maximum of $270. Payment must be made by check or money order (no online or credit card payments). Registrations must be renewed annually.

Adulterated and Misbranded Cosmetics

Similar to the federal regulations, cosmetics manufactured in Louisiana may not be adulterated or misbranded. The definitions are basically the same as the federal definitions and the requirements for cosmetic product labels for Louisiana are the same as for the FDA.

Good Manufacturing Practices

Good Manufacturing Practices (“GMP”) are defined the Title 51, Public Health-Sanitary Code, Part VI. Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics, but the regulations only seem to have specific GMP requirements for food and drugs. Like the FDA, even though GMP are not in the regulations for cosmetics, there are obviously standards which should be met to ensure that products are not adulterated or misbranded.

The FDA GMP Inspection Checklist and the FDA Cosmetic GMP Draft Guidance are good places to start learning about GMP.

Good Manufacturing Practices cover

Every handcrafter’s situation is different. To work out the good manufacturing practices that will work for you, get my book from Amazon and use it.

Records

Cosmetic manufacturers engaged in interstate commerce (in other words, if you are selling across state lines), must keep records showing what was shipped and to whom. I expect that your invoices or other sales documentation would be sufficient. The department has the right to inspect your records.

Inspections / Penalties

There is a provision that “in order to prevent commerce in adulterated or misbranded food, drugs, devices or cosmetics and to safeguard the public health and to prevent deceit upon the purchasing public” the Department has the right to enter any establishment where cosmetics are manufactured, processed, packed or held, or any vehicle used to transport them, and to inspect the factory, establishment, vechicle and all pertinent equipment, materials, containers, and labeling. And no owner or operator may refuse a reasonable request.

In other words, the state has the right to enter and inspect any place where you manufacture cosmetics.

Where product is found to be adulterated or misbranded, the department can seize the product or tag it so it can’t be sold. Normally, though, they would (like the FDA) provide notice and allow the person/manufacturer to correct the issues. However, where there are uncorrected major violations that involve gross deception or imminent danger to health, there are potential penalties of a fine of not more than $1,000 and/or not more than 1 year jail time. For subsequent offenses, it’s up to $3,000 and 2 years or both. Of course, with handmade cosmetics you’d have to work very hard to make products that caused imminent danger to health AND you’d have to be in blatant disregard of all attempts to get it corrected.


Summary

  • If you are making cosmetics in Louisiana, you need a permit for your “manufacturing facility” BEFORE you start making products. It costs $175 per year.
  • Each cosmetic product you sell needs to be registered with the state BEFORE you start selling it. $27 per product (maximum of $270) per year.
  • The Food and Drug Unit of the Office of Public Health has the right to inspect your facility upon request.
  • You are responsible for ensuring that your products are not adulterated.
  • Products must be correctly labeled (and the labels must be included with the product registrations).

Actual Experience

updated March 27, 2016

After writing and publishing this post, I was contacted by a woman who has worked with the Louisiana Small Business Development Center to get her business set up in New Orleans. They helped her get through all of the basic steps (getting an EIN, registering her business with the Louisiana Secretary of State, getting a sales tax ID, etc.). She specifically stated that she would be making home-made cosmetics—and was never referred to the Food and Drug Unit to get registered.

So, either the regulations for cosmetic manufacturers are not well known, or they are intentionally not being applied to home-based businesses—at least in this case.

Your Experience?

If you are from Louisiana and are making cosmetic products, I’d like to hear about your experience. If you’re comfortable with sharing, tell us your story in the comments. If you’d rather your story remain private, please email me and tell me about it.

Comments

25 responses to “Cosmetic Regulations – Louisiana”

  1. Dede Chat

    I am just starting out. We are starting a cosmetic line the first up in the line is lip gloss. Does anyone know where to start? We are so lost.

    1. Marie Gale

      Start by downloading the Cosmetics Plan Packet (link in the post above). It contains several documents, you’ll have to download the whole file and then view it in Adobe Reader. (Download that from the link provided, if you don’t have it).

      The first document lists out the documents in the packet.

      The LAST document is form FD-1E, the Utility No Objection Letter. Probably best to start with that, since your manufacturing won’t go anywhere without it. You’ll need to go to your Parish and get it signed. Basically it says that potable (drinkable) water and the wastewater system for your operation are okay. If you’re making products in your house you may need to show that you are not going to overwhelm either the drinking water or the sewer system with your manufacturing. Likely not an issue for you – but you can see how it would be an important point for a big manufacturing facility.

      Once you get that, the next thing you need to do is the third document – form FD-1B. You’ll need to fill that out. It’s a fillable pdf, so that makes it easier. Keep in mind that it is designed for large companies, so some of the questions may not be applicable. There doesn’t seem to be any restriction on making cosmetics at home – but again, it’s all about water and waste. If you are making in your house, just provide all of the pertinent information about the space you are using.

      You’ll need an inspection – that comes after the forms have been submitted.

      The documents reference a “program coordinator assigned to your region/district.” You might be able to contact that person and ask for guidance or assistnace.

      If you would like some one-on-one consulting to help you get through it, I’m available. See Consulting for details.

  2. So as far as soaps go….if I create a list that lists all the benefits of a specific ingredient within the soap….but I do not claim that the producy( soap) itself does anything other than clean….is this permissable? For instance…..if I sell turmeric and honey soap …and list all benefits of honey for the skin…( If that makes sense).

    1. Claims for the ingredients are considered claims for the product (otherwise why mention them?)

      So if you make cosmetic-type claims for the ingredients in a soap (cleansing, improving attractiveness, altering appearance), the soap would become a cosmetic.

      If you make drug-type claims (healing, curing, altering the function or structure of the body), the soap would become an unapproved new drug.

  3. If I have been making lip balms, lotions, bath bombs, and sugar scrubs already without knowing any of this… what would happen? I can’t afford these prices. I’m still the red for gods sakes. But my bath bombs sell way more than anything else.

    1. In theory, you could be shut down if your facility and products are not correctly registered. The reality may be a little different than the regulations. So far, I haven’t heard of any enforcement for handcrafters.

      The good news is that the pre-emption clause of the new federal cosmetic regulations MAY provide some relief.

  4. Laqueena Marshall

    How are people getting around legal practices? I’ve been dreaming this dream for 3 years only to have them crushed today because I want to follow the law. Ive wasted lots of time and money and I am completely broken.

    1. Marie Gale

      I’m sorry to hear that.

    2. Just for clarification, in Louisiana, if making soap with no stated claims, you do not need a facility registration nor the other permits? Does this also apply to candles? Does lotion require the registration and permits?

      If for soap and candles, nothing additional is needed, the standard local and state taxes along with stare and local business registration are the only needed thungs?

      1. Marie Gale

        In Louisiana, soap isn’t a cosmetic if you don’t make any claims. Candles aren’t a cosmetic because they aren’t appied to the human body. Massage candles would be a cosmetic, but not a regular room candle. If you are only making soap and candles, you aren’t manufacturing cosmetics, so a cosmetic license is not needed. You do, of course, need the regular business registration for state and local taxes, business name filing, etc.

  5. Suzette LeBlanc

    Hi Everyone, I live in Louisiana and am in the early stages of getting my permit to make cosmetics other than soap. As my mini building stands, I can make soap. Anything else is a cosmetic and requires rules and regulations. Sent off labels and preliminary pictures and was told: I need a 3 compartment sink, floors must be lighter, and my packet would be sent off to the supervisor for final recommendation review. I’ve read the guidelines and I must be missing some parts, I see nothing about what materials can be used or not. I will be emailing the supervisor and asking for more information that my area inspector couldn’t give me. I haven’t set up water, electricity, or sewage yet. Not sure what can be done, when I know I will update

    1. Marie Gale

      This document https://www.fda.gov/media/86366/download from the FDA contains a draft GMP guidance for cosmetic manufacturers. It has a section on buildings and facilities; not terribly specific, but at least a general guide.

    2. Can we get an update on your business? I live in Louisiana and am trying to start a lip balm, soap, and candle business. I have a building bit I am confused on what to do to it to get it approved.

      1. Marie Gale

        I haven’t heard anything else about requirements in Louisiana. I did look at the most updated packet of information for cosmetic manufacturers and noticed the “last updated” dates for the documents are 2020 and 2021, so they are valid now. You should contact the State of Louisiana Department of Health to get your specific questions answered.

        Keep in mind that CANDLES are not cosmetics and SOAP is not a cosmetic (provided no statements are made that it will do anything more than clean), so no cosmetic permit or approval is needed to make or sell those products. Lip balm, however, is a cosmetic and could require a permit and product registrations.

    3. Heather McGehee

      Hi, I’m a beekeeper in Louisiana and am wanting to set up my business to make lotions next, how did the process go for you?

  6. I would like any updates you may have on this topic. Thank You!

  7. I need more info on this privately

    1. Marie Gale

      Feel free to email me at [email protected]

  8. I want to sell cosmetics at home. But I want to work with a private labeling company. Do I need a permit to sell lipstick and lipgloss after purchasing and labeling my products with private labeling company?

    1. Marie Gale

      The “Basic Requirements for Prospective Cosmetic Manufacturers” document linked to above, says “No person shall operate a facility engaged in “manufacturing, processing, packing or holding of drugs or cosmetics within Lousiana without a valid permit to operate … ” Since you will be “holding” the cosmetics (and maybe packing or labeling), then you would need a permit.

      Even if you get the cosmetics packaged and labeled (and ready for resale), you would still need a permit AND would need to register the product. The document also says ” … each manufacturer, processor, packer or private-label distributor of drugs or cosmetics in package form must register each separate and distinct product annually.

      1. Kyra Jean

        Do bath bombs fall under the same category as soap? Its not a cosmetic and used for cleaning.

      2. Marie Gale

        A bath bomb is a cosmetic. So all the cosmetic regulations apply.

  9. Maria Carroll

    I was wanting to start making bath bombs to sell out of my home and when I called Dept of Health and hospital they told me I could not make these in my home. I also called the local FDA office and they also said the same thing. I’m totally devastated because I know for a fact there are many that make them and sell from their home. March 26, 2018

    1. Marie Gale

      It’s true that there are people out there who are violating the law. Unfortunate. Very unfortunate, because it reflects so badly on all of us who want to avoid more industry regulations to corral the non-complying people/companies.

      I’m sorry that you won’t be able to go ahead with your plans at this time.

      If you are more interested in selling than in making, you might consider purchasing product from another handcrafter (out of the state) and then repackaging private label. See the article Private Labeling in the How-To Library of the Handcrafted Soap and Cosmetic Guild. It might give you some ideas.

  10. Annalisa

    I contacted the Dept of Health and Hospitals and they said that Louisiana law does not allow production of cosmetics by home businesses.

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