How do I Know if I Can Use Certain Dyes in the US?

I just wanted to clear up a couple of things regarding dyes and the fda as there seems to still be a lot of confusion surrounding what is and isn’t allowed when it comes to cosmetic products.

1. The regulations differ for importers of colourant additives, suppliers of colourant additives and users of colourant additives so make sure you look up the appropriate regulations depending on what your intentions are regarding the dye. When you speak with the FDA regarding regulations, it’s very important that you have an understanding of what you are talking about and are SPECIFIC because there are a lot of fda regulations and it’s very easy for there to be miscommunication as a result.

2. Anyone can import dyes. ANYONE. As long as they follow fda procedure any rando person can import fda certified colourants into the USA from manufacturers outside the country.

3. Anyone can sell dyes. Again, as long as they follow fda procedure for selling and labeling any rando person can start up a colourant business, import fda certified dyes and sell them in the USA. Anyone can set up a dye business in another country and sell to people in the USA. It’s also important to note that Batch Certification regulations don’t apply to people selling the dye to the public. That being said, anyone selling dyes should familiarise themselves with the regulations of the countries they are posting them to. If they have customers who intend on selling their products they really should know the ins and outs of Batch Cert regs and what dyes are approved and banned in those countries.

4. Anyone can purchase dyes. Some rando wanting to dye a shirt can purchase dyes with no issues whatsoever. A person in the business of making cosmetics intended for sale, however, needs to make sure that what they are purchasing is not only FDA approved but is also batch certified. If the dye is not batch certified it CANNOT BE USED IN PRODUCTS INTENDED FOR SALE PER FDA REGULATIONS. (see below for links) I don’t care what someone else tells you. I don’t care who they’ve spoken to. Chances are if someone is telling you they’ve spoken to the fda and have been told they don’t need to worry about batch certification – they haven’t asked the right questions in the first place.

5. If you live in the USA, make products intended for sale and purchase your dyes from overseas you need to be very careful about what you are buying. Suppliers in countries other than the US aren’t required to follow fda regulations unless they are exporting to the US. If they regularly sell to the US they should be listing their dyes by the FDA approved name if that’s what they are. If you see a dye listed by it’s regular name or colour index number then chances are it’s not approved for use in the USA. For example, if a supplier is selling C.I. 42090, we know that’s the colour index identifier for Blue #1. But it’s NOT Blue #1 unless it’s called FD&C Blue #1. I know it seems like a technicality, and it is really, but if a colour is not listed by it’s FDA certified name you shouldn’t be buying it if you are in the USA and are making products intended for sale.
Some suppliers may not realise this and may be listing their colours by the CI number even though they are technically FD&C. If you want to double check you can always ask the supplier if their blue is FDA certified or not. They should have proof if it is. The bottom line is that in other countries it’s cheaper to buy the regular dye and not pay extra for FDA approved versions of the dye, so don’t just assume that blue 1 is blue 1 is blue 1 because most suppliers in other countries aren’t going to bother buying the fd&c version.

6. FDA approved dyes will be listed with their approved name: FD&C or D&C (Food, Drug & Cosmetic Act). Followed by a colour and a number. For example “FD&C Blue No. 1” or “D&C Red No. 33”. This does not always mean the colour is safe for use in any old cosmetic you want. You need to go research the dye you are looking at and make sure it’s approved for use in the product you intend to make. You also need to double check it can be used in cosmetics at all. There are a couple of dyes that are fda approved and are still named FD&C despite the fact they aren’t actually allowed in Cosmetics anymore. So do your research, don’t just assume based on the name that something is allowed to be used.

7. When a supplier imports fda approved dyes, they come batch certified from the manufacturer. Now, usually these are in pretty large containers, these are manufacturers after all so they tend to work in large amounts. Some manufacturers however are happy to repackage their dyes into smaller containers for a fee as long as the supplier purchases a decent amount of the containers. When they come repackaged into smaller containers straight from the manufacturer, the supplier knows that they are batch certified and can resell them as such. This means that each of those little containers will have a batch certification number that shows that they haven’t been opened, tampered with or altered in any way. They are straight from the manufacturer and the manufacturer details will usually still be on the packaging.

These can be purchased and used by people in cosmetic products intended for sale. 

8. When a supplier buys a large bucket of dye and decides to repackage into smaller containers themselves, however, this is when the end user needs to ask more questions and find out if that dye is still batch certified.
For example: Supplier A buys a 5kg bucket of FDA Approved Batch Certified dye with the intention of splitting the dye into baggies and reselling. This is fine. There is nothing wrong with a supplier doing this because they have no idea what their customers will be using the dye for. HOWEVER, claiming those baggies of dye are fine for anyone to use is categorically false. A person making products for personal use can use them with no issues. A person making products intended for sale CANNOT. Unless breaking the law is the way you roll, of course, in which case have at it.

Supplier A needs to request and pay for repack certification from the FDA. Then, and only then, are those small baggies of dye Batch Certified. If Supplier A splits her dye into those baggies without gaining repack certification and tells her customers the dye is still batch certified, she is lying.

The bottom line is that anyone can sell dye powders. Anyone can import or export. Anyone can split up batches and sell them on. Problems arise when sellers aren’t being clear about what they are selling and a lot of the time this is due to the fact the seller doesn’t actually understand the regulations themselves and are passing on bad information to their customers.

If you are someone selling to the public it’s your responsibility to know what you are putting in your products. It’s your responsibility to know the regulations in your country regarding cosmetics and make sure YOU aren’t breaking the law. I know it can be difficult when there are suppliers popping up on facebook every five seconds who don’t even understand the product they are selling but it’s your responsibility as someone selling to the public to ASK QUESTIONS. Make sure the ingredients you are purchasing are what they claim to be and if you aren’t getting a satisfactory response it’s time to look for a new supplier.

FDA Batch Certificationhttp://www.ecfr.gov/cgi-bin/text-idx…
Batch Certification Limitationshttp://www.ecfr.gov/cgi-bin/text-idx…
My explanation of the limitations regulationshttp://bodybonbon.com.au/FDA%20Colorant.pdf
My first email to the FDA regarding batch certificationhttp://www.bodybonbon.com.au/fdaemail1.png
My second email to the FDA regarding batch certificationhttp://www.bodybonbon.com.au/fdaemail2.png

Speak Your Mind