Many people, including soap manufacturers, retailers, sellers, and of course, consumers, often face various questions regarding how a widely-used and important product like soap is regulated by the Food and Drug Administration, and what are the laws, regulations and standards related to its production and usability. This article discusses a handful of important questions that will throw light to all your probable questions and queries.
In order to determine whether a product is a soap or a synthetic detergent, it is necessary to understand how the products in question is regulated. The FDA has set its standards to define what ‘soap’ means. Let’s take a look at it.
In order to be considered as a ‘soap’ in the eyes of FDA’s law, a product has to satisfy three conditions:
To be termed as ‘soap’, a particular product must compose, or at least has the base of “alkali salts of fatty acids”. This means, the ingredient materials should combine together to give the desired result (fats or oils mix with an alkali, such as lye, with the property of cleaning).
Again, in order to be considered as “soap”, the “alkali salts of fatty acids” mentioned above needs to be the only ingredient used in the product to deliver the resultant action of cleaning. On the contrary, if the product has synthetic detergents as an ingredient, then it would be termed as ‘cosmetic’, and not a soap in the eyes of FDA. Nonetheless, however, the pack or label of the product can still carry the word ‘soap’ when it’s ready to be sold in the market.
Finally, the product in question needs to be labeled and marketed only to be used as soap. For instance, if the product is intended for other purposes including skin moisturising, helping the skin smell nice, or deodorize the body of the consumer, etc., then it would be considered as a cosmetic. Even if the product is intended for the treatment or prevention of diseases with the ability or claim to kill germs, or even cure or treat dermatological issues, e.g. eczema, acne, pimples, rashes, etc., then the product will be regarded as a drug. However, the manufacturer can still mention the word “soap” on the label of the product.
As we all know, ordinary body soaps meant for human use is formulated by combining an alkali with fats and/or oils. In the olden days, soaps were domestically made by people combining lye derived from wood ashes with animal fats.
At present, the oily and the fatty ingredients that are used in soap usually come from either organic or natural sources, including animal and vegetables, or else, from minerals. They are then degenerated into free fatty acids and are finally mixed with the alkali, after which, crude soap is formed from this combination.
The lye (alkali) chemically reacts with the oily ingredients, forming block soaps by converting them from the previous liquid state. If proper procedures are followed, the end product does not contain any trace of alkali.
At present, very limited number of true soaps is available on the market. We mean, most of the products that we find today commercially are usually solid and liquid body cleansers, and these products are basically synthetic detergents. Most of these are marketed with the label of ‘soap’, and are popular since they mix with water easily, forming suds, and moreover, do not form gummy depositions. However, these detergent cleansers are not true soap and do not satisfy the conditions or parameters mentioned in the regulatory definition of the word by FDA.
The Food and Drug Administration did not clarify the terms ‘natural’ or ‘organic’ in its laws and regulations, thus leaving their standards and differences vague or obscure. Hence, no matter whether your soap is made of ingredients from animal, plants, minerals, or have synthetic ingredients, the same requirements apply to it. So, you should never presume that using ingredients derived only from plants will make your product safe for use.
