For lotion crafters, have you ever submitted your cosmetic as a drug to fda?

[mikvahnrose]

So i understand soap does not fall in the drug category as it's only purpose is to "clean"

People however put ingredients in them to help "mitigate" conditions like acne making it a drug. And thus falls under the fda.

Anyone here ever go through the process of actually submitting their product
(soap, lotion, cleanser, scrub etc) as a drug?

I know i'm probably going to be pounced on "don't make claims, don't make claims, too much of a hassle"

But i want to grow my business and venture into markets that eventually love to see at dermatologists offices. In the future when i'm ready i'd rather go through that hassle than to deal with the ramifications later.

 

[Dahila]

I am in Canada and subbmitting something as druga or NHP Natural healing product, it is a long process with on site inspection and requirements, It took 8 months of paper work for one lady in my group. I would guess that is very similar in US

 

[DeeAnna]

An over-the-counter product does not have to be approved by the FDA, but you do have to do your homework so you can substantiate your claims if challenged. Why not check out the FDA website and learn about this? A 5 minute search found this --

"Bringing Nonprescription Drug Products to the Market Under an OTC Monograph

"OTC drugs can be brought to the market following the NDA process as described above or under an OTC monograph. Each OTC drug monograph is a kind of "recipe book" covering acceptable ingredients, doses, formulations, labeling, and, in some cases, testing parameters. OTC drug monographs are continually updated to add additional ingredients and labeling as needed. Products conforming to a monograph may be marketed without FDA pre-approval...."

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/default.htm

If you think your products might be prescription drugs, then that's a whole other story. In this case, the real issue is the deep pockets needed to do efficacy testing. And that testing doesn't necessarily guarantee FDA approval.

 

[Catastrophe]

Subscribing, been seeing lots of claims on soaps, etc in my travels during the holidays and have been wondering how they are getting away with it in light of the cracking down.

 

[DeeAnna]

Many people make claims and get away with it because the FDA can do only so much and people know that.

Even in countries where there are much stricter controls over soap and other bath and beauty products, some people still try to "fly under the radar" and make outrageous claims or sell without the proper approvals. I'm thinking of a lady in the UK who was making some pretty amazing claims awhile back for the health benefits of her soap.

 

[mikvahnrose]

It seems it is very labor intensive and alot of paper work. I will give the FDA a call to ask them more about it. Like what's needed and cost's etc etc. :]

 

[HappyGoNaturally]

If the ingredients you are using are botanicals, minerals, or ingredients which are already approved, I've been under the impression that it's mostly a matter of having the proper labeling. This includes the listing of the ingredients and specific sizes of labels regarding container size, etc., plus specific statements that must appear. Although my knowledge is limited, I thought most of the qualifications have to do with proper labeling, but perhaps that is only when natural ingredients are used, or ingredients which are commonly used in skin care.