The reality of the FDA for henna artists

You may have heard that using henna in the United States is illegal. This is absolutely NOT true. You may have heard that the FDA does not approve of the use of henna on skin. That IS absolutely TRUE. How can that make sense? Let me try to explain.

Let’s start with what the FDA actually says about henna. Here is the regulation pertaining to henna quoted verbatim. The most important bit is emphasized with blue text.

[Code of Federal Regulations] [Title 21, Volume 1] [Revised as of April 1, 2013] [CITE: 21CFR73.2190] PART 73 — LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
Subpart C–Cosmetics
Sec. 73.2190 Henna.
(a)Identity. The color additive henna is the dried leaf and petiole of Lawsonia alba Lam. (Lawsonia inermis L.). It may be identified by its characteristic odor and by characteristic plant histology.
(b)Specifications. Henna shall conform to the following specifications:
It shall not contain more than 10 percent of plant material fromLawsonia alba Lam. (Lawsonia inermis L.) other than the leaf and petiole, and shall be free from admixture with material from any other species of plant.
Moisture, not more than 10 percent.
Total ash, not more than 15 percent.
Acid-insoluble ash, not more than 5 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
(c)Uses and restrictions. The color additive henna may be safely used for coloring hair only. It may not be used for coloring the eyelashes or eyebrows, or generally in the area of the eye.
(d)Labeling. The label for henna shall bear the information required by 70.25 of this chapter and the following statements or their equivalent:
“Do not use in the area of the eye.”
“Do not use on cut or abraded scalp.”
(e)Exemption from certification. Certification of this color additive for the prescribed use is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

There it is! The FDA said it! Henna on skin is against the law! Right? NOPE. There’s more. We also need to discuss the jurisdiction and limitations of FDA regulations. What is the FDA’s reach?

The FD&C Act prohibits the marketing of adulterated or misbranded cosmetics in interstate commerce.
Under the FD&C Act, color additives, except for coal tar hair dyes, are subject to FDA approval before they may be used in cosmetics.
A product is adulterated if: it contains an ingredient that is harmful, putrid, or
decomposed; if it manufactured in insanitary conditions; or if it is not a hair dye and contains a non-permitted color additive.
A product is misbranded if its labeling is false or misleading, if it doesn’t bear the information required by the FPLA, or if the container is made or filled in a deceptive manor.

As we learned above, henna is a color additive, and not approved for use on skin, which means it is, in fact, adulterated by FDA definition. How is applying henna to clients OK?

It is not INTERSTATE COMMERCE or manufacturing.
Also the FDA does not have authority over products applied by professionals, including henna vendors. (see more here)

If you are not selling, labeling, manufacturing, or importing henna NONE of this applies to you. There are no actual local laws on the books in the US prohibiting the use of henna on skin. It is not a criminal action. These FDA regulations are all the law says about the use of natural henna paste.

But how are we going to get our henna?!? That’s not really as big of a deal as it seems either. There has been a lot of inflammatory rhetoric lately, but in all actuality NOTHING has changed. About a year ago customs decided to tighten up on refusing or impounding henna shipments that do not comply with FDA regulation. The regulation did not change. Its just been an increase of enforcement at customs. When customs says “hey check out this non-compliant thing!” The FDA is obligated to follow through. Almost every henna importer I know has had this happen. Almost all of those have been able to jump through the prescribed hoops and get their shipment back. Almost of those have been able to receive later shipments with no problem. So yes, it is a pain, and a risk to get henna in the US, but knowledgable people have been able to navigate the land mines and they will continue to be able to even if they have losses from time to time. Fear mongering to the contrary serves only to increase sales with panic hoarding, or to attempt to push henna substitute products for henna art.

The fact of the matter is that the FDA absolutely knows what is wrong with the current regulation. They are unable to make changes until some reliable academic research is compiled to petition the FDA regulation. (Private corporate research would be great too, but unfortunately the corporations prefer to keep using cheap dangerous chemicals and are uninterested in completing such research.) Meanwhile all that is happening! Slowly over the course of literal decades. And in the meantime the FDA puts out the outreach material below. If you click through the slide show you can see that they understand which “temporary tattoos” are dangerous, which are not, and which need more research. They even give people the tools they need to tell the difference between dangerous PPD paste and the real thing! They point out the regulation because they have to, but their understanding of the reality is clear.

http://www.fda.gov/downloads/AboutFDA/Transparency/Basics/UCM396649.pdf

Please don’t worry. Everything is fine. Nothing has changed recently and very little has changed in the last year. There is nothing to fear for henna artists. Importers and suppliers are taking the risk for you and learning to navigate the bureaucratic waters.

Relax and enjoy this instead of worrying.