If so, would I need to clearly specify in the products listing on my website that these items were made/manufactured in the state of Arizona? Kari that would be fine, as our effort needs to learn more how and to what extent Florida soapmakers have gotten ensnarled Floridas complex and burdensome cosmetic regulations. If I sell soap can I give away other products (bath) with a purchase of soap? I can make soap (water, lye oil) and add whatever I want to it & bypass all of this mess just by labeling it as soap, making absolutely no claims. Section 499.012(1)(b) states An establishment that is a place of residence may not receive a permit and may not operate under this part.. Of all the subjects I get asked about, Florida cosmetic regulations is close to the top of the list because they have the most stringent regulations for cosmetic manufacturers. What is repackaging? So, I always recommend that people voluntarily follow the law and regulations DESPITE what others may be doing. Maybe somebody can help me to start my hair cosmetic company or knows someone who can be partner entering with low budged. Getting a professional third-party text of your final formulation to verify the preservative system is a very good idea. The florida business buys finished goods and resells them. There are many important factors to consider when launching a new sugar scrub business.. Since you have a registered business in Florida, you probably already have your basic business requirements in place (taxes, filing, accounting, business registration and all that). When someone gets a product and you get money its a sale. We need your stories and accounts ( all confidential) of how tough and confusing it is to be a cosmetic manufacturer in Florida. That includes scent bombs that could be used in the tub with a person, or any product that is applied to the body for scent/perfume purposes. I just have a question in regards to soap making/selling. just not sure about the other products. They probably dont have proper licensing. What license and legal document do I need as a Floridian. So even if you make no claimes whatsoever, even if its just called skin cream or just sugar scrub.. its a cosmetic? In researching there were at over 100 businesses at events Ive attended in the last six months who sold what are considered cosmetics and resided in the state of Florida .when asked said they whipped it up in the kitchen or something to that effect. Learn how to turn your passion into profit with these 11 easy steps to start a successful YouTube channel business. (If yes, an Over-the-Counter Drug Manufacturer permit is required). And GMP requires logs of incoming ingredients and batch records with ingredients tracked. Also, where does dog or pet soap fall within these regulations? Theres legislation in the works, but no changes to the cosmetic laws or regulations at this time. Whipped soap, so long as it fits the definition of a soap to be exempt, is still soap. [] The guidelines for how they go about enforcing are somewhat vague, and are supposed to take into account the level of the violation, if there have been previous violations, whats being done to resolve the issue(s) and other factors. If its not within city limits, check with the county. I would be purchasing bulk dry items (flour, sugar, frosting) and sending them in a box with a recipe. For example, a 16 oz container holds 2 pounds of sugar scrub which might sell for around $10 retail (or wholesale if sold to a store). Do I need to have my cosmetic products or ingredients approved by FDA? The same way that a kitchen can be authorized for commercial purposes, a home can qualify to be in compliance with GMP (I know what Im talking about). I currently make handmade soap in Florida and was wondering if I can sell whipped soap legally in Florida if I dont make any other claims other than that it is soap in a whipped form. Also, there are very specific rules about Made in the USA so if the product is made outsside the US or using ingredients from outside the US, then you should be careful of the Made in the USA claim. I just provide the materials so they can make it. Thanks in advance! Ready to make a splash in the waterproofing industry? Thank you again for this blog!! If you are unfamiliar with the requirements for good manufacturing practices, they are covered in detail in Good Manufacturing Practices for Soap and Cosmetic Handcrafters (link to Amazon). If the cream was used only during the massage, it is covered. I am so confused. Sugar scrubs can probably be classed as moisturizers which would fit under the exemption. Are they two different businesses, one selling to the other in which case you probably need business registration in EACH state, with taxes and such (and the Florida business buying from the Arizona business)? If so, consider starting a sugar scrub business! Thanks, Vit. Will I be able to make and sell sugar/salt scrubs if I market it as a moisturizer? Social Media: Social media has become a major source for both personal and professional interactions over the past decade or so - make sure to keep up with your accounts! Before sharing sensitive information, make sure you're on a federal government site. Glycol, Coconut Oil and Triethanolamine are the largest percentage ingredients. Do I need to get a license from FDA to manufacture or market cosmetics? Also, was going to sell bubble bars but they have Cocamidopropyl Betaine ( Coco Betaine) which is made from coconuts and is for bubbles. It would be a cosmetic. Also, where in South Florida can I have my products made, since I cant make it at home. Remember, however, that not all. The state searches for you, or competitors would report you to the state, then you get that knock on the door, and I had a separate facility. Thank you Marie for being so knowledgeable and sharing it with us. I dont specify WHERE in the USA, but after reading through this article and all the comments, I might just move back to California. I dont exactly know how Florida interprets their laws in this case. Or setting up a totally new business with a different name for manufacturing is acceptable? Well just the fact that I have to purchase them instead of making them myself is soooo wrong! For a lip scrub business, you are looking at two different issues. They are tablets that release aromas in the shower, but are not intended for the human body. If you manufacture elsewhere, you can still sell within Florida as far as I know. So a bath tea, since it is used in the bath, is applied to the human body. Hello I live in Florida I want to make a face oil for myself and friends and give it away just to see how well it does. Shower steamers are somewhat questionable I dont know how the State of Florida interprets them generally. Discover the 11 essential steps to launch your own successful yoga mat business and turn your passion into a profitable venture. I attended the Batch versus Manufacturing class. how i just learn alot just by finding your page! I would be sure to document it all so that theres evidence that its not being done in FL whatsoever. My best advice if you plan to have a cosmetic making business in Florida is to take the time start out right. The law does not require cosmetic products and ingredients, except for color additives, to be approved by FDA before they go on the market. Youll have to check locally. For extra hydration and smoother skin, let the scrub sit on your body for a couple of minutes before rinsing thoroughly. Here in Ga I have a separate studio but it is attached to the house. That means the only claim can be that it cleans no claims that could make it a cosmetic (moisturizing, soothing, otherwise changing the appearance) for the product itself OR any of the ingredients. What I found interesting was these two requirements; Add that to the label content if you want to explain. We just moved to Florida, my mom & brother own a craft beer/wine shop and have been wanting me to make beer soap and other products for sale. The facility cant been in a residence, although it looks like it MIGHT be acceptable if it is on a residential property, but in a separate building. I did notice that the forms they had (not sure if they are still using them) were for both cosmetics and pharmacies. E.g. Melt the oils, butters, and waxes over a double boiler (or in the microwave, if you prefer). A complete GMP program for your new facility can be created in 1 month if you have some technical writting skills and background in Quality. P.S.S.S If all else fails I just might write my own soap and cosmetic bill thats logical, doable, and sensible for all the handcrafted entrepreneurs and then press the politicians with it, and to boot a simple comprehensive internet tax plan to keep the IRS off our backs. The biggest threat is the high cost of operating a home-based soap-making business IMHO. Like buy 3 bars of soap and get a bubble bar free? They have their own quality control, but of course you can and should always inspect your own product. Before investing a lot of MONEY, Id suggest you invest all the TIME needed to thoroughly research what it would take in terms of financial investment and time committment. If you are making soap that fits that definition, then it does not fall under cosmetic registration requirements in Florida. You must get a Certificate of Free Sale for each cosmetic product you make in Florida to sell. I know that will not work in the state of Florida. If youre making a massage oil, youre making a cosmetic so in Florida you need a registered cosmetic manufacturing facility unless you fall under the new exemption. It says cosmetics must have a separate facility, but does not address location of soap making, which leads me to think a clean kitchen is acceptable. Claims to make you feel better (like (a walk in the garden, fun in the tub like going to a spa) are either cosmetic claims (better feelings which would make you look better) or they are just plain marketing claims and dont affect the intended use at all. If it meets those criteria, then it falls under the definition of soap that is EXEMPT from the definition of a cosmetic (its not considered a cosmetic) so you wouldnt be a cosmetic manufacturer, so no cosmetic manufacturer permit and license is required. Maria-have you heard anything about Cottage industry being set up in Florida for soaps, lotions and the like? Just like any other state, Florida has business and tax regulations that apply to all businesses. I did not find the exact information, please tell me. Does this mean that the cosmetic manufacturers have to post a bond as well as a fingerprint card? Cosmetics include scrubs, creams, lotions, serums, bath fizzies and bombs, oils, bubble bath, shampoo, make-up, bath salts, bath milk, bath tea, masks, etc. The GMP is at the level that would be required to manufacture ANY drugs so as you can imagine they are very detailed and exact. I then asked about homemade deodorant, she has to get back to me on that. Your email address will not be published. Therefore, the cosmetic regulations dont apply. (1) The bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the detergent properties of the article are due to the alkali-fatty acid compounds; and If you have any questions about setting up your accounting system, talk to your accountant orfinancial advisor. Manufacturing in Florida is not for the faint of heart. Hi, Easy Emulsified Sugar Scrub - Oh, The Things We'll Make! I am unfamiliar with the workings of the State of Florida with regards to the cosmetic facility inspections, but heres some info that should help. That includes signage, website, facebook, brochures, (and, yes, even verbal statements). Im not sure what the regulations are for those who teach in Florida; the regulations I was discussing have to do with cosmetics manufactured for sale. First thank you so much for putting this information together and responding to everybody so thoroughly. A free gift must be a FREE gift. Can I say using it feels like going to a spa or feels like a walk in a garden? From manufacturing to emergency response. If you receive the containers of the haiar and body oil ready to label, and all you do is apply the label, they you arent considered a cosmetic manufacturer. If I were to create solely soap, the lye and oils definition, would I still need to have the safe practices in place ie. I intend to read your good manufacturing practices book, but I wasnt sure if that would give me info on what they are looking for in the inspections? Have you heard anything new since the original post? I just dont know how they would consider a food truck whether it would be considered part of your home if you use your home address. No cosmetic claims for the product OR the ingredients. They dont cover cosmetics (although the names are very similar). Also, would the person making them in the other state need any permits etc? (without making medical claims) First, you want to make sure the name is memorable and easy to spell. Youll need your good manufacturing practices in place and probably a location outside the home to manufacture. Probably not too risky right now its the long term effect on all of us that is really the issue. Hello everyone! The Florida definition of a cosmetic is just about the same as the FDA definition. Great information, thank you for this. Whether they fall within the allowed products under the new exemption for lessthan $25,000 annual sales is still a question. You should check with the state for the requirements. Maybe they were based on a good idea at the beginning but it rarely stays that way. Dont use terms such as natural as part of an ingredient statement, because ingredients must be listed by their common or usual names, without additional description. You should put together an expense list and figure out how much money you need to spend in order to produce your product, market it, reach customers and get paid. Thank you so much for your knowledge and tutelage. I expect they use the same definition that the FDA uses [21 CFR 701.20(a)]: (a) In its definition of the term cosmetic, the Federal Food Drug, and Cosmetic Act specifically excludes soap. I want to make & sell bath scrubs, salts & bath bombs. i would list everything thats put into the soaps and other products My question is If I buy my finished oil (for hair and body) just label them in my home and sell them online only. No other claims about what it will do (moisturize, soothe, etc). 3. Had to refund everyone and move my home, my facility, my family out of state. It does meet the exempt requirements. You may run into a BUSINESS issue (for which you may need accounting and/or legal assistance) having to do with your corporate structure and taxes. So long as your soap is true soap that is, the bulk of the product is the alkali salts of fatty acids, AND it is identified and marketed only as soap then it is exempt from the Florida cosmetic regulations. Third, you cant make any claims that the soap will do anything more than clean (otherwise the intended use would be as something different than soap, which puts you under the Florida cosmetic laws). One state just said you needed a mail order certificate. Only in FL, you can make soap at home and sell it, no permit is needed. The (federal) Food Safety Modernization Act that went into effect several years ago DOES have some provisions for small businesses and farms that make food products (especially from produce they grow), but it doesnt apply to cosmetics at all. I have been soaping as a hobby and many of my friends have encouraged me to start selling but Im not sure what is all required. 2. However, manufacturers & marketers of a lot of products for application to the human body that arent for those purposes including massage oils, sexual lubricants, some aromatherapy products, some bubble baths have voluntarily been complying with cosmetic regs in the knowledge that: (1) theyre not very onerous; The full definition is the bulk of the non-volatile portion is the alkali salt of fatty acids. Note, Ive only included items relating to cosmetics and have removed references to drugs and devices, to which all of these items also apply. I am wanting to start a handmade vegan soap business, but am confused on how it legally has to be packaged or what licenses I need. (the people buying the empty lip gloss tube will more than likely make their own products). Conversely, every time someone is caught, it gives the regulators one more reason to put stricter laws in place. I was so excited to start fresh here in FL and actually build my business but its sounding like the $$ involved in the uber expensive permits/licenses and the added expense of outside (the home) workspace on top of the cost of starting a business and product costs Im feeling like this is the end of the road, before it truly ever started. Do I Need A License To Sell Body Scrubs Part Three 3 Of 6 Body Scrubs Seems to me the easiest thing to do for someone who doesnt want to open a factory in Florida would be to contract for your products manufacture. These are important questions to answer before you start creating any visuals for your brand. if I am rebottling and relabeling sample sizes of essential oils and fatty oils to be included in a class, not selling them individually? Do they fall under soap. A wax candle that is promoted for use in massage becomes a cosmetic because the intended use (or at least one of them) is for it to be applied to the human body it becomes a massage oil. Since they cannot be made in the state of Florida. Can I give them away instead of selling them and not need a permit? However if I wanted to start selling privately to friends and family only how would I go about doing that? I am so surprised of Florida rules because, so many people are now selling lip gloss and lip gloss base and its all over the internet, you tube and Esty. For cosmetics, you do not need any FDA registration. Then the products would be sold wholesale to a company in Florida for retail resale. If a product is intended to alter the function or structure of the body its a drug and the FDA regulates animal/veterinary drugs the simiarly as they do human drugs. A smooth ceiling requirement can FDA approved ceiling tiles that are waterproof which can simply replace the common used the suspended ceiling tiles, and be bought online. I saw you suggested not calling it like peppermint soap so what would you be allowed to call it? Does any of this still pertain if you are only selling at farmers markets? Thank you so much Marie Gale for your knowledge and for you to take the time to share them with us. Do I need to have a registration with the FDA, because my manufacturer told me there is no pre-market FDA approval process, so there are no FDA certificates for cosmetics? You should (mind you, this is my un-lawyer opinion) be fine. Cosmetic Manufacturer Permit A person who manufactures cosmetics and has annual gross sales of $25,000 or less is exempt from the permit requirements of this paragraph. Please contact me to learn more about this important initiative. Im pretty sure that if you charge extra for a massage with take home products then it would be considered charging for the products but if all your massages of the same kind and length were the same price (regardless of take home products) then it wouldnt be considered charging for the take-home products. Unless you call it something other than soap (shampoo bar, exfoliating bar, etc) OR you make cosmetic claims for it, it should still be classed as soap, not a cosmetic. Also wondering if I have any more range in how I market it as any claims would be in the area of metaphysical benefits not physical healing or body claims? Any other business or trade names used by the person. In terms of soap businesses, this happens often if you sell online. Hello Marie. With the ingredients of beer, lye, oils and clay. Hello Marie Gale, Packaging and labeling must not be deceptive. I dont know about the liability as a distributor of a manufactured product. I would have jars of different oils and essential oils for them to mix themselves with a percentage recipe for them to follow. Helping soap and cosmetic handcrafters navigate the rules and regs. In determining if the large company in Florida is licensed, keep in mind that they might be getting the products made for them by a contract manufacturer that is VERY common. The cosmetic products would need to be manufactured and packaged out-of-state by an out-of-state company. I am just starting out my business in Florida. I guess its more complicated for them to figure out how much is sufficient to cover the costs of administering the program. Did I get this right Marie? So, Im thinking I can drive to Georgia, rent a motel room for a few days. in Florida without all the proper requirements. If youre going to try to get tricky in going around the laws, you should consult an attorney to ensure you are staying on the right side of the law and regulations. Bath bombs, lotions, scrubs, and bath salts are all cosmetics. Wow my nephew just opened a bakery here in Florida and did not have to go through half of this and we eat that stuff, not even all natural or organic, but sure is good Thank you so much Marie for sharing all of this! 1. (See the. Hair products are considered cosmetics. 1.Define your sugar scrub company's purpose and values. Living near the GA border I plan to take my RV across state lines to manufacture, package, and label my products before bringing them back to Florida. I expect it would be up to the inspector to determine if it is still residential or not. How do I know if my products are regulated as cosmetics, and not as drugs or some other product category? Can I use a Post Office (P.O.) See Florida 2021-Changes to Cosmetic Manufacturers Law for the most current info. So would moisturizing salt/sugar scrubs as they are also cosmetics. A commercial kitchen covers many of the requirements but not all. Yes all those things are cosmetics they are applied to the human body and are intended to cleanse, improve appearance or beautify. Bath salts are a cosmetic. I would suggest contacting the state agency and seeing if you can get a helpful person to talk to you about whats needed. Now, add in 2 tablespoons (29.6 ml) of honey. Since salves are applied to the human body, they are either a drug or a cosmetic in Florida and everywhere else. Its not worth it. and let me know what happens! Makes you wonder how and why they came up with that nonsense. (a) A person who prepares, derives, manufactures, or produces a drug, device, or cosmetic; Repackaging, such as when you purchase in bulk and repackage it into smaller containers, still qualifies as a manufacturer.. Thats what I cant find a clear answer on. Will required records be computerized, automated or stored electronically. Hopefully I am understanding this correctly? FDA Rules & Regulations For Selling Handmade Goods A shampoo bar is generally considered a cosmetic because it is shampoo not soap. 2. A felony conviction under federal, state, or local law. Lets assume Im making and selling soaps from home, following all guidelines that exempt me from registering as a cosmetic manufacturer. Join me on my mission to make entrepreneurial success easier. Again, the soap and bath bombs will not be considered cosmetic or drug; cleansing purposes only. Ficticious name filing with the state is required if you are doing business as something other than your personal name. I allow $1.00 for the cost of each tin itself plus the paper and ink to label it. Can I make it out of my own house? Drugs must meet different requirements. Also, a bath bomb is probably primarily other ingredients than the soap, so it wouldnt be exempt from the definition of a cosmetic because of that as well. Fla is the hardest place to try to work from I think. IRS.gov also has a wealth of information for small businesses, nonprofits, and other special groups. Ingredients arent required for soap (although they may be included); they are required for cosmetics. Would I need a license if I decide to make my own lip gloss or lip scrub and sell them online? Checking Account:The most common type of business bank account is a checking account. Start making waves today! Is that also considered a cosmetic? How to Use a Sugar Scrub in 5 Simple Steps - WikiHow Its intended for more than just cleansing that makes it a cosmetic. Here are some examples: Cosmetic ingredient suppliers often have safety data on their products. Thank you Marie! Generally, the rule is that if purchase is required to get the free gift then the gift is actually purchased. There are contract manufacturers wholl use your formula confidentially to make and package what you want. I have heard that it has gone both ways.