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leaving out ingredients on the label
I know CA passed the law that says harmful ingredients must be disclosed on the label but what about unharmful ingredients? I am creating a product that I don’t want people to steal the ingredient deck. How can I legally hide some of the ingredients?
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25 Replies
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You can’t … you must disclose every single ingredient in the product regardless of how little you use. The only work-around is if you apply to the FDA for a trade secret, but you must have a valid reason for requesting the trade secret and the chances of you receiving one are very, very slim.
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Thank you @MarkBroussard
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esthetician922 said:How can I legally hide some of the ingredients?You are aware of the 1% rule? Where you can jumble the ingredients that are used below 1%. This is about the only way to make life a little more difficult for copy-cats.
But any good formulator…should be able to knock off your formula…in say…an afternoon.
You’ll find….it is all about the marketing…and not nearly as much about your formula as you think….Sorry.
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MarkBroussard said:@esthetician922
You can’t … you must disclose every single ingredient in the product regardless of how little you use. The only work-around is if you apply to the FDA for a trade secret, but you must have a valid reason for requesting the trade secret and the chances of you receiving one are very, very slim.
@MarkBroussard But I have seen some brand , they do not disclose as a brand name BIOTIQUE, that produce all kind of hair, skin products. A label of face wash showing only some herbal extract in% and rest water only and everyone knew only water can’t make any face wash product. BIOTIQUE is very popular brand name in natural products( as they claim). Another well known name is Arial; developed by P&G. Its liquid detergent not mentioning single ingredient except instructions to use it.
So why they didn’t do this? -
MarkBroussard said:@esthetician922
You can’t … you must disclose every single ingredient in the product regardless of how little you use. The only work-around is if you apply to the FDA for a trade secret, but you must have a valid reason for requesting the trade secret and the chances of you receiving one are very, very slim.
So while intentionally concealing ingredients is obviously unacceptable, what would you think about the following cases?- Carrier solvents, such as the alcohols in fragrances, flavors, etc.
- Process ingredients, such as residual isopropyl alcohol from sanitized equipment that has not fully dried.
- Impurities in larger amounts, such as up to 8% diethylene glycol monophenyl ether in cosmetic grade phenoxyethanol. (I’ve only seen this mentioned in the 1990 CIR review for PE. Maybe not a great example anymore since no Phenoxyethanol COA I’ve seen has this.)
- Impurities/additives in small or minute amounts, such as 0.04% Silicone Dioxide (anticaking?), and 1ppm Arsenic in MakingCosmetics Titanium Dioxide.
I’m unsure about 1 and 2.For 3, I think it is too significant not to list.For 4, it seems unnecessary. -
MarkBroussard said:@esthetician922
You can’t … you must disclose every single ingredient in the product regardless of how little you use. The only work-around is if you apply to the FDA for a trade secret, but you must have a valid reason for requesting the trade secret and the chances of you receiving one are very, very slim.
Will you have to show your ingredients to FDA if you want to apply for a trade secret?
Is there any product in market who is legally hiding the ingredients because he has applied for a trade secret?
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@drjayseesunish
Those brands are sold in India. Perhaps they are in complicance with the labeling laws in India or they are simply not in compliance.
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As I suspect you already know, you are not required to list processing aids on your LOI, but you must use the INCI of the ingredient. All of the examples you raised are covered in the regulations.
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Abdullah said:Will you have to show your ingredients to FDA if you want to apply for a trade secret?
Is there any product in market who is legally hiding the ingredients because he has applied for a trade secret?
Yes, of course and you would have to have an extremely good reason for seeking a trade secret. I am only aware of a couple of ingredients that have some sort of trade secret component.
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Graillotion said:You are aware of the 1% rule?
Personally, I would like to see the 1% rule done away with and you just list all ingredients in declining order of inclusion. When reverse engineering a formula, I usually ignore most ingredients below the 1% line except for the obvious like chelating agents, etc.
Correct, it’s more marketing than formula. I seriously doubt that @esthetician922 has come up with something uniquely new, but a variation on a theme. Most reverse engineering requests are also made with some variations, so people are more interested in using the bones of the formula, but then adding their own twist to it.
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In US, you can pursue trade secret protection. You’re very unlikely to find a product on the market with that exemption.
FDA comments
“Review time varies. You will receive at least an interim response within 180 days, but not necessarily a final decision at that time. For the one request granted in the last twenty years, our complete review process took about one year.”
(emphasis added)https://www.fda.gov/cosmetics/cosmetics-labeling/trade-secret-ingredients
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For other potential ingredients exempt from labeling
Definition:
Any processing aid added and removed or converted to a declared ingredient
or
Any ingredient of another ingredient or processing aid present at an insignificant level and having no technical or functional effecthttps://www.fda.gov/cosmetics/cosmetics-labeling-regulations/cosmetics-labeling-guide#clgl9
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PhilGeis thank you for pointing out that section.@drjayseesunish said:Another well known name is Arial; developed by P&G. Its liquid detergent not mentioning single ingredient except instructions to use it.Laundry detergent is not a cosmetic product, so cosmetic labeling regulations do not apply. Unless I’m mistaken, neither is dish detergent. From FDA.gov:The Federal Food, Drug, and Cosmetic Act
(FD&C Act) defines cosmetics by their intended use, as “articles
intended to be rubbed, poured, sprinkled, or sprayed on, introduced
into, or otherwise applied to the human body…for cleansing,
beautifying, promoting attractiveness, or altering the appearance”
[FD&C Act, sec. 201(i)].This article mentions that other regulatory agencies have their own rules that apply to noncosmetic chemical formulations depending on their intended use (OSHA/EPA/etc.).
With respect to BIOTIQUE… From their website, it appears they are an Indian company subject to India’s regulations and birthed from Indian business culture[1]. They do not appear to have retail stores in the US or the EU. Have you seen their products sold on store shelves at your location? From their site:
All Domestic & International orders shipped from our New Delhi warehouse and will take their respective time in delivery.Globally they seem to operate by direct-to-consumer ecommerce, which would make it difficult for the FDA to regulate imports of these products. It’s up to the Indian authorities to enforce their own regulations, and what they are doing now is what they can get away with in their regulatory environment.
[1]: If you want to be scared to ever again take generic drugs, listen to this podcast episode about Ranbaxy’s fraud in the pharmaceutical industry. If blatant fraud was occurring on this scale in pharma, I expect the Indian cosmetics industry would be worse. No offense intended to those individuals and companies in India who produce safe, high-quality products, and do not engage in such fraudulent practices.
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you can hide ingredients in very specific cases, like fragrance, extracts and also for example when you have different grades of the same substance for example I have seen a lot of raw materials with different properties, yet the CAS NUMBER and name is the same “corn starch” or ” modified corn starch” etc
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In India, there is something called AYUSH (dept for Ayurveda, Siddha, Unani, Homeopathy, Naturopathy, etc). If you make a product (personal care products or drugs) using ayurvedic/siddha herbs, you don’t necessarily have to get an FDA licence. You can go for an AYUSH license. Like how Biotique (and many other brands) has done.
Here, you only have to mention the herbs and its percentage on label, and base/excipients.
What many brands do is that they use just one or two herbs (not even according to ayurveda/siddha principles) in a product, and get it licensed under AYUSH, just so they won’t have to mention ingredients. -
Ariel P&G - liquid detergent - If I’m not mistaken, Indian regulation for powder and liquid detergent use the word active ingredients “should” be listed in declining order of inclusion. So they left out LOI as so other big brands in India. (may have to wait for members from India to clarify this again)
But their versions for other countries have listed active ingredients.As for BIOTIQUE, they simply violate the rule. You should look for a good example not a bad one, Himalaya is doing great with proper product, isn’t it.
MarkBroussard said:Graillotion said:You are aware of the 1% rule?Personally, I would like to see the 1% rule done away with and you just list all ingredients in declining order of inclusion.
@MarkBroussard - I have to disagree with you on this. How do we supposed to list our star dusts then lol.Mayday said:It’s up to the Indian authorities to enforce their own regulations, and what they are doing now is what they can get away with in their regulatory environment.[1]: If you want to be scared to ever again take generic drugs, listen to this podcast episode about Ranbaxy’s fraud in the pharmaceutical industry. If blatant fraud was occurring on this scale in pharma, I expect the Indian cosmetics industry would be worse. No offense intended to those individuals and companies in India who produce safe, high-quality products, and do not engage in such fraudulent practices.
From my humble experience, when dealing with Indian counterpart, if you are a newbie, it might be safer to go through government representatives or trusted third party organizations. With all respects, India is the land full of opportunities but also full of fraudulences.
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Pattsi said:MarkBroussard said:Personally, I would like to see the 1% rule done away with and you just list all ingredients in declining order of inclusion.
@MarkBroussard - I have to disagree with you on this. How do we supposed to list our star dusts then lol.
LOL! … look at all the money you can save by not putting star dusts in products .. fewer ingredients to buy for no benefit other than having the name on your LOI.
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Padmavathi said:In India, there is something called AYUSH (dept for Ayurveda, Siddha, Unani, Homeopathy, Naturopathy, etc). If you make a product (personal care products or drugs) using ayurvedic/siddha herbs, you don’t necessarily have to get an FDA licence. You can go for an AYUSH license. Like how Biotique (and many other brands) has done.
Here, you only have to mention the herbs and its percentage on label, and base/excipients.
What many brands do is that they use just one or two herbs (not even according to ayurveda/siddha principles) in a product, and get it licensed under AYUSH, just so they won’t have to mention ingredients.This is a crazy. The equivalent would be that if you use certain plant extracts in cosmetic products in the US, then you would not need to list all the other ingredients in the product? Do I understand this correctly?
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@MarkBroussard Yes! plant extract that comes under ayurveda/siddha.. like turmeric or sandal, you can just mention their percentages and leave everything out.
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Actually, the more flexible law for traditional local products is quite typical. From what I understand, such products need to get a special Ayush license / certificate?
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Well… here in Switzerland, though we have some of the strictest regulations in some regards, pharmaceuticals still don’t need to list excipients but only actives (with amount). If you want to know more, you have to contact the manufacturers. Fortunately, this will change soon and several companies started to list all ingredients (maybe because they already have to if they want to sell to the EU). However, the list of possible excipients is rather short and includes only ingredients from the EU and CH pharmacopoeas.
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@Padmavathi - Thank you for AYUSH information, I didn’t know it is also cover personal care, I thought it only licensed to pharmaceutical manufacturer.
May I trouble you with one question, can personal care under AYUSH license be sold across states?
@Pharma - Good thing they are changing but I’m curious how will you write prescription, Neomycin 3.5 mg cream w/ aaaaa, bbbbb, ccccc, dddd, not w/ xxxxx, yyyyy, zzzzz, that one, Ah Ahr not that one, yeah that one, like this? Sorry, just try to be funny. -
@Pattsi It can be sold across India.
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@Pattsi It will be prescribed as usual:- Proprietary drugs: Brand name of original, sometimes generic brand name, and less often active ingredient with % and galenic form- Stuff which has to be made in a pharmacy: Super rare… usually active ingredient with %, the rest is up to the pharmacist or you give the doc a call and he/she tries to sound smarter than you but both know what’s really going on. There are actually a few rare cases, mostly old dermatologists from Germany, which really write a recipe (and you think that they could have done it easier by mentioning the reference work such as DMR, FH or DAB).
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@Padmavathi - Thank you Padmavathi, my marketing brain is blinking again.
Pharma said:he/she tries to sound smarter than you but both know what’s really going on.@Pharma - It’s funny that it happens everywhere I guess, there always will be some doc trying to act like they know more than pharmacists, in my humble life, there’s only one time that I had to correct an intern pharmacist but he’s sooooo (with million o) cocky, wanted to show off in front of a pretty intern and forced two completely messed up drugs on me, so I had to call for his supervisor. - well this is too off topic sorry.
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