What are the regulatory differences between FDA’s ‘Natural Cosmetics’, ‘Adulterated Cosmetics’, and ‘Drug’

In order to understand the relative meaning of ‘adulteration’, we naturally need to initially understand the meaning of the term ‘natural’. According to the Food and Drug Administration standards, “adulteration” of a product generally refers to different degrees of violations involving the composition of products. The violation can result from contaminants, ingredients, packaging, to processing, handling, or shipping.

What is ‘Natural Cosmetics’, and what is so “natural” in it

Interestingly, the FDA did not yet define the word ‘natural’ in the term ‘natural cosmetics’, like it has for many other products. However, on 5 November, 2019, Sean Patrick Maloney, Congressional representative (NY-18), had introduced the landmark Natural Cosmetics Act in Washington with an aim to give legal definitions to the terms ‘natural’ and ‘naturally-derived ingredient’ that are often used in cosmetic products related to personal care.

As defined by this bill, the cosmetic products that are commercially sold, bearing the label or represented to be “natural” must contain a minimum of 70% “natural substances, excluding water”, to use the term about the products in question.

In order to maintain accountability, the proposed bill requires cosmetics suppliers to go through Carbon-14 testing that needs to be submitted to the manufacturers. This bill will also give independent power to the Food and Drug Administration authority to issue cease distribution orders when necessary, as also, publish public notice on their website, and recall the authority of any of such products that would be deemed misbranded under this act.

Now that you are informed about the updated status of ‘Natural Cosmetic’, you will easily be able to understand its relational difference with an ‘adulterated’ cosmetic, and a ‘drug’ in the eyes of law.

The FD&C Act declares a cosmetic as ‘adulterated’ under several conditions and circumstances.

A cosmetic product is said to be ‘Adulterated’ if:

• “it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labelling thereof, or under conditions of use as are customary and usual” (except for coal-tar hair dyes);
• “it consists in whole or in part of any filthy, putrid, or decomposed substance”;
• “it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health”;
• “its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health”; or
• “it is, or it bears or contains, a colour additive which is unsafe within the meaning of section 721(a)” of the FD&C Act. (FD&C Act; section 601) (with exception to coal-tar hair dyes).

FDA stamps a product as ‘Drug’ if:

The Food and Drug Administration has defined a guideline to define the term ‘drug’. It explains that, any product that has officially been recognized by a formulary or pharmacopoeia, or else, if it has been manufactured for use against some disease with the motive of “diagnosis, cure, mitigation, treatment, or prevention”, then it is termed as ‘Drug’.

Again, a product (other than a food item), that has been formulated with the purpose of affecting the structure of the body, or any of its functions, or as a component of a medicine, is a ‘drug’.

However, the definition of ‘drug’ set by FDA focuses on biological products that mostly fall under those laws and regulations that are defined above. The primary points of differences that exist between them are based on the procedures of manufacturing them (that is, the biological process vs. the chemical process.)