The guidance, titled "Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND”, looks to clarify for developers which products are subject to IND requirements.
Originally published in September 2013, the FDA has now increased the deadline for comment submission until 7 April, giving room for cosmetics brands to query the guideline’s inclusion of beauty products.
The potential impact of a requirement for IND upon cosmetics development will be increased expense and delay on product development within the US.
What is an IND?
An IND allows researchers to move an experimental drug across state lines (i.e. to their clinical trials) before a marketing application for the drug has been approved.
The FDA checks an IND application for safety to ensure trial participants will not be subjected to ‘unreasonable risk’. It typically reserves regulation for food and drug products, but the proposed IND guideline looks set to include cosmetics.
“Studies of ingredients or products marketed as cosmetics require an IND if the study is intended to support a cosmetic claim about the ingredient or product’s ability to cleanse, beautify, promote attractiveness, or alter the appearance, rather than a structure/function claim,” the FDA states.
Inclusion of cosmetics
The FDA’s inclusion of cosmetics is an unusual move for the regulatory body. The guideline states:
“With the exception of color additives and a few prohibited ingredients, a cosmetic manufacturer may use almost any raw material as a cosmetic ingredient and market the product without an approval from FDA.”
Despite this, any product which makes a ‘beautifying’ claim will require an IND approval pre-clinical trial according to the new guidelines:
“For example, a study of the effect of a cosmetic product containing human or animal biological material (such as placenta) on skin repair mechanisms would require an IND, even if the study is intended only to support a claim of younger looking skin.”