Marie Gale Answers Your Questions

Hey Marie, I have tried to look this up and have gotten several different answers so I thought I would ask the expert. When making products that have well-researched benefits like magnesium, turmeric, or even some oils can we add those facts to posts or sales descriptions without crossing that line into the drug category? In no way do I want to make a medical claim about my product but like my buyers to understand why I have added it into my recipe.  -- M.S.

Any statements that the product or the ingredients can/will/might alter the function or structure of the body gives the product the intended use of a drug ... thereby making it an unapproved new drug. If you added those ingredients because of potential benefits that could alter the function or structure of the body, then your original intention for the product was such that it IS an unapproved new drug.  

Only cosmetics can be made without prior approval from the FDA.  I strongly suggest that you review the intended use of your product and the definition of a cosmetic and make sure you stay within the legal limits.  

On the other hand, there is nothing saying you can't include those ingredients --- you just can say that they (or the product) will alter the function or structure of the body.  You could say something along the lines that you have "carefully selected" your ingredients top create the best possible product... but you have to rely on your customers knowing or looking up the benefits somewhere else.

Hi Marie, I started my soap making business this year and thought I had all my bases covered. Until I posted a label that I'm working up on Face Book and asked for feed back. I called "Deer Tallow Soap". I had a person post that it was illegal to name a soap based on it's ingredient(s). Is that true. It is true that I can only call it "Handmade or Handcrafted Soap"? Other items on the front of the label are my logo and sometimes pictures and net weight. I also list the ingredients, in descending order by amount, on the back along with the Business name, city, state, zip and lot number, my labels wrap around my soap. Am I OK? What should I change? Thank you, Paulette  -- P.L.

There are two parts on the front of the label which often get confused (and often are just plain confusing):  NAME of the product and the INDENITY of the product.

The NAME is what it's called - usually something unique to make it stand out from other products in the same category, or from other similar products by the same company.  Tide laundry detergent.  Kleenex tissues.  It is the name that could, theoretically, get a trademark.

The IDENTITY is what it IS.  Tide laundry detergent. Kleenex tissues. Aveno hand soap. Method dishwashing liquid.

Where it gets a little tricky is that for cosmetics, the FDA says that the name cannot contain an ingredient (if there are two or more ingredients in the product).  So something like "Magic Shea Butter hand cream" wouldn't fly.

Then the FTC (which governs soap that is exempt from the definition of a cosmetic) says that an ingredient can't be included in the IDENTITY of a product unless it's present at "functional amounts" (which is not defined).  

The term "Deer Tallow Soap" could be interpreted to be the NAME or the IDENTITY or BOTH --- depending on how it's presented on the label.

My general suggestion is to skip all the confusion and put the ingredient(s) you want to highlight on the front as MARKETING TEXT --- not part of either the name OR the identity.  This is made up, but:  Woodland Wonders natural handcrafted soap made with Deer Tallow.

  • NAME: Woodland Wonders 
  • IDENTITY: natural handcrafted soap
  • MARKETING: made with deer tallow (could have more explanation or marketing)

The key is to make sure that the marketing text is CLEARLY not part of the name or identity by placement, font, color, etc.  I asked an FDA agent about that and he said "it would be evaluated on a case by case basis - there are no specific standards".

We are making a hand sanitizer with the following ingredients: 62% Organic Cane Alchol, Glycerin and Essential Oil. As far as labeling, can we call it "hand sanitizers" or should we avoid that phrase even if we make no claims as to its 99.9 effectiveness. What can we get away with without having to pay for special federal regulations, etc. Thank you!  -- K.C.

Hand sanitizers and other anti-bacterial products are considered over the counter drugs. they must be manufactured by a licensed and inspected drug manufacturing facility and meet specific requirements (and testing) to verify their effectiveness against multiple different types of microbes. 

As a small manufacturer, you are not qualified nor licensed to make any type of sanitizer for sale to the public. Any product you make cannot be labeled in any way that indicates that it is an antimicrobial of any kind.

Hi Marie, I'm a cp soap maker opening a zero waste store. On my quest to source liquid shampoo, body wash, conditioner, pet wash and baby wash I found a company that provided me with, in my opinion, an unacceptable list of ingredients. I asked for clarification. Here is the list of two of their products: Distilled water, Organic* Oil Blend including Sunflower* and Olive*, Kosher Certified Vegetable Glycerin*, Soy Protein*, Cetearyl Alcohol, Vitamins A/B3/B5/C/E, Aloe*, Jojoba*, Glyceryl Stearate, Panthenol, *, Plant Based gel agent 100% paraben-free, Rosemary Seed Extract Distilled Water, Organic Hemp Oil, Organic Sunflower Oil, Coco Betaine, Cetearyl Alcohol , Soy Protein, Vitamin E, Xanthan Gum*, Aloe Vera*, Citric Acid*, Plant Based gel agent 100% paraben-free, Rosemary Seed Extract My biggest quip, aside from the extra *, is that they list ALOE in one and ALOE VERA in the other- from doing my own sourcing I have not been able to find aloe..anything that does not have a preservative like sodium benzoate or something else added to it. I asked for the proper INCI name of the MSDS or whatever document they have for that ingredient. This is their response to my request for transparency: All ingredients are on the web site or in the file I sent you. However, soap is not regulated by the FDA so we do not wish to be under stringent guidelines of any sort. If that is the case, then we might not be the best match for you. We make everything by hand and when we use aloe, that's what it is - aloe. That said, we occasionally buy 'systems' of raw materials that are added and we can not always vouch for them, except to say we do our best. QUESTION ONE: Am I being unreasonable? Our mission for this store is based on our feelings around the importance of transparency and we want to present a list of ingredients in the store that is compliant as well as honest. QUESTION TWO: Are they correct in regards to what they say about the FDA? Is shampoo considered soap in the same way CP soap is? Conditioner is a cosmetic, right? I have tested the product and I like it. It's the most natural thing I've found white label on the market, and I would like to carry it. Any advice would be greatly appreciated. Thank you so much.  -- M.M.

Good questions!

First, SOAP MAY be exempt from the definition of a cosmetic IF the bulk of it is the alkali salt of fatty acids (lye/oil) AND the detergent properties come from the alkali salt of fatty acids AND it is only marketed and sold as "soap".

Conditioner, shampoo (even "soap" sold as shampoo) and baby wash (even if "soap) are cosmetics.  Soap, if any claims to beautify or improve attractiveness are made, is a cosmetic.

From a professional manufacturer, I would expect a complete list of ingredients for the product, correctly identified according to the cosmetic ingredient dictionary.  "Plant based gel agent 100% paraben free" is not a suitable ingredient name. You can check for the correct name in the Ingredient Lookup on the HSCG website.

From the response you received, I would gather that they purchase some sort of bulk base to which they add additional ingredients, and they may not get all the data or know how to put there ingredients into the correct order.  Not that that makes it acceptable, but it might be understandable.

As you expand your business, my advice would be to ensure that each step in both your business and product development practices is set up in a way that makes it so you can (and do) follow the existing regulations now, and can also expand and still do so. 

As an example, it is legal to sell soap (that is exempt from the definition of a cosmetic) and not put an ingredient declaration on it.  But down the road, what if you want to repackage or remarket that soap in a different way (maybe claiming that it is "moisturizing")?  THEN you would need to have all the ingredients, in compliance with the cosmetic regulations.  If you don't have the correct ingredient declaration, then you would be limited in how you market the product.

For example, if you decide to sell soap that is ONLY soap (and therefore doesn't require



Marie, Is it legal to use the words "Aromatherapy Oil" on the label? I am concerned about the word "aromatherapy," as the FDA has mentioned that word on their site in a dubious manner (in quotes), but I couldn't figure out if that actual word is taboo or if the manner in which some aromatherapy products are described is the actual problem. Thank you!  -- J.V.

"Aromatherapy" is a  broad term with no real specific claim.  The FDA is, I think, concerned about the "therapy" part of it.  Within the field of aromatherapy it is very easy to fall over into the therapy part and end up claiming that the product is intended to treat, cure, mitigate, prevent or diagnose a disease or the alter the function or structure of the body (which causes the product to be an unapproved new drug).

The word "aromatherapy" or "aromatherapy oil" is unlikely to be a drug claim on it's own.

Remember though, that the claims for the product don't have to be on the label itself. they could be on any accompanying material including signage, brochures, verbal statements, website copy ... even a book placed on your table in your craft booth.

Marie, Does your labeling book contain a list of words that cosmetic makers should and should not use when naming/labeling and describing their products ? For example, Don't say: healing. Do say: calming. Or are you aware of another resource that would help me get the terminology correct? Thank you!  -- J.V.

There is no set of words that is always correct.  It comes down to the intended use - are you saying the product will change the function or structure of the body (that's a drug), or saying that it will just improve the appearance (cosmetic).

"Healing" nearly always implies that it will alter the function or structure of the body somehow.  "Moisturizing" is usually considered to be only surface appearance change.  "Calming" could be a general descriptive word (more cosmetic) ... unless you are referencing calming someone who is in a psychotic rage, or calming in order to overcome insomina, or calming red inflamed areas of the skin. All those would be claims that the product would alter the function or structure of the body (making it an unapproved new drug).

It's not about the actual words themselves, it's about what your consumer thinks your product it intended to be used for after they have read those words.

Hi Marie, Years ago I saw a loophole for using the word organic on the hair products (I make hair gel, shampoo, etc.). As long as I market less than $5000 worth of product annually and adhere to all of the certification standards in the production with the ability to pass a random inspection at any point, you could use the word organic on your labels. What I have never figure out is what they mean by "marketing." For example, I have the same all my products on two websites. For eas lets say they all cost $20 and I have 10 products on each site, so $400 worth of products with the word organic on it. Am I getting this correctly or am I totally missing the mark here? Heres the resource I found: Thank you! April  -- A.S.

The wording on that website page is a little deceptive.  When they say "market less than $5,000", they actually mean that the company has an annual revenue from organic sales of less than $5,000. The actual code for that is here:  - 205.101(a) - which says:

"(a) Exemptions. (1) A production or handling operation that sells agricultural products as “organic” but whose gross agricultural income from organic sales totals $5,000 or less annually is exempt from certification under subpart E of this part and from submitting an organic system plan for acceptance or approval under §205.201 but must comply with the applicable organic production and handling requirements of subpart C of this part and the labeling requirements of §205.310. The products from such operations shall not be used as ingredients identified as organic in processed products produced by another handling operation."

So it is a loophole, just not quite as big as you might have thought.

Hi Marie, I was wondering if Fizzy Bath Bombs have any special labeling requirements, or are they just treated as regular cosmetics? I would assume so, since I don't seem them listed in your labeling book (3rd edition). Also, do you think Shower Steamers would be treated as a cosmetic too (as far as labeling is concerned), even though it's not something that is intended to contact your skin? Thanks in advance!  -- L.N.

Fizzy Bath Bombs don't have any special labeling requirements UNLESS it would be considered a "foaming detergent bath product".  In that case, it would need a bubble bath warning.  I think if the fizzy is using a surfactant that creates bubbles (not just a citric/soda reaction) then it might be a bubble bath and need the warning.

I would think that a shower steamer would be a cosmetic ... the idea is that the STEAM is coming in contact with the body and doing something.  That's a little different than a room freshener or a potpourri.  To be on the safe side, I'd suggest labeling as a cosmetic (which really means only putting the ingredient declaration on it) ... all other labeling requirements apply either way.

Thank you Marie for this common sense answer. A vaguerie for sure. To all, I did mention that big stores will not accept an old label if you're wholesaling, I know this firsthand.  -- V.C.

Hi Marie, no research has turned up any answers to this question: I have moved my business (and myself) to a new location. I have money invested in old labels (over $1500) with previous business address. Is there ANY possible use for packaging with an old label or is this just outright violation? Can I clearance those soaps, etc? Inquiring minds... I do want to be compliant and I would never sell to stores with old labels. Just wondering before I dump the $$$ in the trash. Thanks, Vanessa  -- V.C.

There isn't anything specific in the regulations, but there seems to be a general agreement that there should be a certain amount of time to use up old labels.  WORST case is that some inspector is going to tell you that you can't use them; BEST case is that you can use them up quickly, so it's not an issue.  While you are using up the labels, be sure there is a forward or some way for people to get ahold of you if they contact you at the previous business address.

I make and sell a Magnesium Oil that is applied topically and contains magnesium chloride, water and an essential oil blend. Does this product qualify as a nutritional supplement and if so what regulations apply to this? Lately, I've been worried that maybe I am not in compliance with this particular product. Here is my product:  -- A.C.

Your page says that magnewium benefits the body in many ways.  Everything you listed is a physical issue and involves treating, mitigating or preventing disease or altering the function or structure of the body.  That definitely disqualifies it from being a cosmetic.

I don't know if it could be considered a nutritional supplement (since it is topically applied) and nutritional supplements are normally ingested.  IF it does qualify as a nutritional supplement, there are many, many requirements for supplements and limitations on what you can and can't say.  There are also required GMP regulations, facility licensing and approval and other requirements. (Nutritional supplement requirements are a hybrid of the food regulations and the drug regulations.)

Finally, the HSCG insurance doesn't cover nutritional supplements.

You might want to rethink the way you are promoting the product.

Hi Marie- I am curious to learn more about regulatory requirements when it comes to labeling our soaps. For example, in this recipe (Olive Oil, Sustainable Palm Oil, Water, Coconut Oil, Lye, Shea Butter, Fragrance, Kaolin Clay, Salt), do we have to call out water and lye on the label even when saying saponified oils of...? Thanks, Tom  -- J.H.

If the soap is being marketed and labeled ONLY as soap (that is there are NO claims that it will do anything else such as moisturize or soothe), then the cosmetic ingredient declaration requirements don't apply. In that case, you are free to use whatever terminology you want to describe the product and its ingredients, provided only that the information isn't false or misleading. 

If the soap is being marketed as a COSMETIC, then the cosmetic regulations DO apply. For cosmetics, the ingredients must be correctly identified.  You can list what goes INTO the pot, which would be oils (not "saponified ___"), water, sodium hydroxide and any other additives.  Or you can clist what comes OUT of the pot, which would be the saponified oils - which must be identified as sodium ___ate (ie sodium oliveate, sodium palmate, etc), and the additives.

If you are listing the ingredients for a soap exempt from the definition of a cosmetic in a way that is NOT in accordance with the cosmetic regulations, I suggest present it differently so the consumer doesn't assume to understand it in the same way as a cosmetic ingredient declaration

Hi..I bought your book bundle at the conference and watched your video on soap math. I am planning on taking the basic certification and on practice tests and am having difficulty on the math problems. Do you have any video on this or a book I can buy or do you have a class etc? Where are you located?? Sarina  -- S.A.

I am located in Washington State, near Seattle.  At present I don't offer any classes.

The basic CP/HP Soapmaker certification test requires two kinds of math:

First, calculating the right amount of lye. You aren't required to know the SAP values, they are provided.  You just need to know how to do the multiplication and move the decimal point.  But first you need to understand what the SAP value is - and that should explain what needs to be multiplied and why.  My recommendation: study up on what the SAP value is and how it is used.

Second, calculating the amounts of an oil when you have the percentage and the total (or the amount of another oil for which you know the percentage). For these questions, study up on what percentages are and how to use them to caluclate relative amounts.

Until we get more tutorials up on the website, I am sure you can find something online.


I need to create a Material Data Safety Sheet for one of my Customers. I have one for each ingredient in our file, but is there a template that you can create one with your own recipe?  -- S.B.

Generally a Safety Data Sheet is for occupational safety and health.  It's not for the consumer, but to provide safety information for someone that is working with a chemical or substance in a manufacturing type environment. For finished products, you shouldn't need to provide an SDS.  Consider Amazon. They don't require SDS sheets for all of the products they are selling!

If your product is one that the customer is using to make something else, you may need to provide a safety data sheet. Wikipedia has an excellent article on Safety Data Sheets that lays out the requirements SDS sheets (and you can see that they are geared to chemical substances).  

If you are wholesaling a product for retail sale, it may be that you need to educate your customer rather than actually make an SDS for your product.

I should have been more specific. Our soaps always weigh more than the weight on the box. What the NJ weights and measures are giving our customer grief over is that it varies, and is not exactly what is on the box on every bar. 1. Do they have the ability to even govern this, i cannot find anything that gives them legal power over soap. 2. Where is the federal law that specifies soap labeling that i can provide to the client? I cant find that.  -- J.T.

Generally the Department or Division of Weights and Measures is the one that has authority over the measurement of what it in a package, and the labeling of the packages.  New Jersey adopted the Uniform Weights and Measures Regulation and the Uniform Weighmaster Law suggested by the National Insitutes of Standards and Technology Handbook 130. The 2019 version can be found here, but according to the NIST website, they adopted an earlier version. So, in answer to your first question, the NJ Weights and Measures does have legal power over soap because it is a consumer commodity.

The New Jersey packaging and labeling regulations, which can be found here (see page 5).  The NJ regulations are easy --- they say to see the NIST Handbook 130, 2018 edition, at IV.A.6 and IV.A.7.   The actual text (as of 2019) can be found here, on pages 63-74.  The key provisions that apply to your question are :

  • 6.3: A declaration of the net quantity shall appear on the principal display panel.
  • 6.12: Quantity declaration cannot have supplemental statement (such as "miminum" or "when packed")
  • 6.15:  The average quantity of contents in the packages of a particular lot, shipment, or delivery shall at least equal the declared quantity, and no unreasonable shortage in any package shall be permitted even though overages in other packages in the same shipment, delivery, or lot compensate for such shortage.

As for the federal regulations for labeling soap - they are found in 16 CFR 500.  The paragraphs applicable here are probably 500.25 and 500.26. 

I hope that helps you work it out with the NJ Weights and measures and your customer.


We have a 3 store health food chain in nj that carries our bar soap. We have our bar weight listed on our box, but as you know with soap, that weight changes based on cure, cut, etc. So no 2 bars are exactly alike in weight,  and our listed weight has to be a blended average. I need help in how to address this, as its jeopardizing our account. I cannot find anything in the NJ weights and measures that even says they can govern this. Help!!!!  -- J.T.

The "blended average" is not allowed in the US. That's sort of what the "e" estimated symbol is used for the the EU, but we don't have that option in the US.

The weight on the box is supposed to be the actual and accurate net weight of the product, but there is provision of "reasonable variance" due to evaporation, manufacturing practices, and the like.  But even so, the stated net weight CANNOT be more than the actual weight of the product.

With soap, because of the evaporation issue and the unknown variable of how long it will stay on the shelf until purchased, you'll need to calculate the LOWEST weight it COULD be when the consumer purchases. 

You can make that calculation mathematically by adding up the weight of all the ingredients EXCEPT the water (for the batch and then divide by the number of bars in the batch).

You can also make that calculation empirically by figuring out the longest amount of time until the product is sold, and then measuring the weight of a bar that has been sitting around in a similar environment for at least that long.

Hi Marie - Can you point me to the Florida statute that states that home based businesses cant make any product other than soap? For example - no lotions, scrubs, etc. Thanks. Joan King  -- J.K.

It's Florida Statutes (here:

499.01 Permits:  Says "Prior to operating, a permit is required for each person and establishment that intends to operate as: .... a cosmetic manufacturer"

499.012(1)(a) which says "An establishment that is a place of residence may not receive a permit and may not operate under this part."

Cosmetic is defined in 499.003(13)(a): "an article, with the exception of soap, that is intended to be rubbed, poured, sprinkled, or sprayed on; introduced into; or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance."

The cosmetic manufacturing laws apply to making any type of cosmetics, which includes lotions, scrubs, fizzies, lip balm, lotion bars, cream, etc.  It also includes soap that is marketed as a cosmetic (that is, it claims to do more than just clean, such as moisturize, etc.).

If you are manufacturing soap that is exempt from the definition of a cosmetic (which means that it is the alkali salt of fatty acids and is labeled and marketed only as "soap"), then the cosmetic manufacturing laws don't apply. 


I recently started to use lake colors in my bath bombs, and I am having trouble finding a correct answer on how to properly label them. Can I simply use "RED 40" or do I need to label "FD&C Red 40 Aluminum Lake" or someone had even recently told me I needed to put "FD&C RED 40 LAKE BATCH #12345678. It's safe to say I am more than confused. Any insight you have will be GREATLY appreciated!  -- K.K.

You can just use Red 40.  You don' tneed to specify the batch number (that is only necessary for manufacturers who are providing the ingredient, not for consumer products).

I am surprised that you are using lakes in your bath bombs since lakes, by definition, are not water soluable.  

Marie, Enjoyed your class. Trying to implement GMP and can't find recommendations re: how long to retain samples of soap, lip balm, bath bombs, lotion, and salts. The only thing I found was a European recommendation that said 1 year after expiration, which makes soap and salts problematic, and we don't usually put expiration dates on the other products. What is your best recommendation? Thank you. Anne  -- A.R.

General rule is that retain samples should be kept for 1 year past the end of the shelf life.

For soaps that can last a pretty long time, I'd say keeping 1 year past the reasonable time that a person would hold on to them or use them should be okay.

Nearly all other cosmetic products - particularly those that could be affected by environment/humidity (bath bombs, bath salts), that contain preservatives (lotions, creams), or that have other potential degradation over time (scent dissipation) SHOULD have an expiration date.  Even if you don't put it on the package (which I would recommend doing), you should have a standard within your GMP. Kep the retain samples 1 year past that date.

What's the best way to incorporate batch numbers on products? A separate label or should it be on the product label itself. Is it okay if it is handwritten? Sheri  -- S.V.

In big companies, the batch number is included on the label or stamped onto the container when it is filled.  For handcrafters, you have several options...

If you make the labels yourself and only print enough for each batch when it is done, then including the batch number when you print should be relatively easy.  That looks the cleanest.

If you have labels printed in advance and you have room, you can leave a space for the batch number and then either stick on a label with the batch number or write in the batch number.  Keep in mind that if the labels are printed professionally and are on glossy paper or have a UV coating, you won't be able to easily write on the label.

In either case, another option would be to print little stand-alone labels that say "batch number 12345" and stick those on the container/package somewhere.  

Handwriting the batch number is fine, so long as it is readable.  If you are thinking about taking that option, take into consideration whether a handwritten addition to the label would be appropriate for your brand and your selected target customer base.

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