The new law places new requirements on cosmetics packagers, and gives FDA new powers over them. It’s a massive strengthening of FDA oversight over these products, and is the culmination of years of efforts by advocates for more FDA power, who asserted that FDA’s limited powers had resulted in safety issues.
Cosmetics companies will, starting December 29 of 2023, be required to register their facilities with FDA, and list with FDA the products they make (and update the list each year) including a list of their ingredients. They’ll also have to keep on hand records substantiating the safety of the ingredients they use in their cosmetic products, and report adverse reactions to its products. FDA gains new power to suspend a company’s facility registration if it thinks a product made there could be a danger to health, and can order a company to recall a product if it thinks there’s a “reasonable probability” that it’s adulterated and might be a danger to health and the manufacturer refuses to recall it. The new law calls on FDA to develop Good Manufacturing Practices regulations for cosmetics as well, and take steps to address asbestos in talc and PFAS in cosmetics.
Also, state and local governments are preempted by the new law from imposing other requisites relating to topics including those mentioned above, though they will maintain some powers over cosmetics, such as the ability to restrict some uses of specific ingredients.
The law’s definition of a “cosmetic” stays the same as it has been for decades:
The term “cosmetic” means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.
What you see here is a definition that incorporates one of the core concepts in FDA law, namely the packager’s or manufacturer’s intended use of a product.
What you also see here is that cosmetics’ intended use is all about making superficial changes to the body, not, for example, changing its structure. So, cosmetics include “skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup, cleansing shampoos, permanent waves, hair colors, and deodorants,” says FDA.
As noted, cosmetic products don’t need FDA approval before being marketed (except for the color additives in them), and the companies marketing the cosmetic can choose the ingredients they use, but have been responsible for assuring they are safe and must avoid the relatively small number of ingredients that are forbidden or restricted by FDA. It’s long been the rule that, as long as the ingredient and the cosmetic it’s in are “safe under labeled or customary conditions of use,” the product is “properly labeled,” and using the ingredient “does not otherwise cause the cosmetic to be adulterated or misbranded,” FDA says, the ingredient can be used.
Now, the packager will need to have proof of ingredients’ safety. What’s more, cosmetics labels had long needed to list the product’s ingredients on packages for retail customers, and also needed to include any material facts that would make use of the product safe, such as directions and relevant warning or caution statements, in addition to the common label elements for consumer products, which are a statement of identity, a statement of the net quantity of contents, and the name and place of business of the manufacturer, packer, or distributor. Now, companies will need to submit their ingredient lists to FDA each year.
Over my years practicing food and drug law, I have often found myself saying something to the effect that, of all the product types FDA regulates, it had the lightest touch on cosmetics packagers. It was a reflection primarily of FDA’s relatively limited legal powers over cosmetics, as opposed to drugs, foods, medical devices, biological products, animal foods and drugs, radiation-emitting articles, and tobacco.
And I sometimes wondered if saying that gave the false impression that cosmetics weren’t regulated at all, the same way too many people mistakenly think dietary supplements are not regulated simply because individual dietary supplement products aren’t specifically approved by FDA before they go to market. The reality is that supplement makers must, for example, follow Good Manufacturing Practices, comport with a range of labeling requirements and restrictions, and face important procedural steps when they decide to make “structure or function” label claims. That sure doesn’t seem ‘not regulated’ to me.
And in some ways, it was the same with cosmetics. For many years, cosmetics have been regulated in a variety of ways, even though individual products didn’t have to get FDA approval. The new law still doesn’t require premarket approval, but it sure does add lots of new requirements, such as those mentioned above. So, I think I will get out of the habit of using the expression “light touch” when describing FDA regulation of cosmetics.
Eric Greenberg can be reached at [email protected]. Or visit his firm’s website at www.ericfgreenbergpc.com.
INFORMATIONAL ONLY, NOT LEGAL ADVICE.
