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As a soap Marketeer you do not need any License from FDA unless you want to market Soaps under Drug License.

Your manufacturer will however need a product permission from FDA for each & every variant of the soap you want manufactured. For this Product permission either he can get it as an additional product under his own manufacturing License or You can take out a Loan License on him.

In case of Loan License you become the manufacturer at his premises. He is only Loaning the premises to you , so all responsibility of compliance will fall on you . You will have to provide him all RM, PM and get it converted from his people .
Your name will come as the manufacturer on the pack and your address will be the address where the soaps are actually manufactured.

In case of additional product , the factory owners name & address will come on the pack & responsibility for compliance will be his.. This is also a faster process in terms of Govt approval.

TFM means Total Fatty Matter.
As all soaps are made from saponification of Fatty Matter ( Oils ) , TFM % becomes an indication of % Actives.
Bath Soaps ( correct generic name as per BIS – Toilet Soaps ) are divided into 3 grades based on TFM
GrI – TFM Over 76%
Gr II -TFM min 70%
Gr III – TFM min 60%

Bathing Bars is the correct Generic name for soaps with at least 4% synthetic surface active agents. These are synthetic actives which are not saponified Fatty Matter. Bathing bars thus have lower TFM.

They are required to have Min 40% TFM as per BIS

These are synthetic soaps that have PH 5.5 ie same PH as the human skin. These soaps can also be called soap less soaps.

They fall into the Bathing Bar category of BIS

A hand made soap is a customized soap where all the ingredients are hand-picked by the maker.

Many people buy a ready-made soap blend, melt it, make soaps at home and call it handmade chemical free soaps. This is a misrepresentation as they may be making the soaps by hand and not adding any chemicals, but the chemicals would already be there in the blend!

A true Handmade soap is the one where the maker starts with the various oils and saponifies it himself & then adds essential oils for fragrance.

Transparent soaps generally do have a higher glycerin content than other soaps.
However Glycerine content has nothing to do with Transparency.
You can have regular ( non-transparent ) soaps with equally or even higher Glycerin content.

These are soaps containing one or more APIs at therapeutic levels. These can necessarily be manufactured only at a Facility having License to manufacture Drugs ( Drug License ) .

Currently the FDA is not giving permission for any new combinations and only the combinations already present in the market are being approved.

Unlike Cosmetics these require only a Formula Approval and not a brand name Approval from FDA.

Most countries have a requirement of registration Of soaps in their country before import. You will have to check on these.

The Importing country health authorities may ask you for a Free Sale Certificate for the soaps that you intend to sell there.

This essentially means that these soaps should be allowed to be freely sold in the country of manufacture ie our own country.

Indian FDA is obliged to issue this certificate if valid product permission exists.

The labelling rule keeps changing, so please check with your legal person.


The answers to these FAQs are to be taken as a general guideline.
Pls check with your legal team before taking any business decision.

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