This article is to provide and define the U.S. Food and Drug Administration (FDA) regulation governing misbranded and adulterated nail care products. To illustrate how a brand’s non-compliance may negatively impact the health and wellness of your business, I will share independent chemical analysis result of products that utilize harmful (prohibited) ingredients that are not disclosed on the products’ ingredient lists, as is required by the FDA regulation.
It is important to know that marketing misbranded and adulterated products is illegal. The FDA makes accountable not only manufacturers, but also the businesses promoting and selling illegal cosmetic products. Let’s explore more.
What defines a cosmetic?
The Federal Food, Drug, and Cosmetic Act of 1938 defines a cosmetic as "a product, except soap, intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance."
A cosmetic is not intended to alter the physiology (the chemistry and physics behind how a living organism functions) of the human body and its parts. For decades, cosmetics were viewed as ‘hope in a jar or bottle.’ In the late 1990s, however, consumers were clamoring for cosmetics that work as claimed, and with technology, product developers delivered them as cosmeceuticals. In the United States, the FDA does not recognize ‘cosmeceuticals’ as cosmetics. Any product that claims to cause a ‘physiological effect’ is a drug (pharmaceutical) per the Federal Food, Drug, and Cosmetic Act’s definition, subject to the drug (pharmaceutical) regulations.
MYTH: Cosmetics are not regulated.
FACT: The cosmetic industry has been self-regulated for almost a century following the Federal Food, Drug, and Cosmetic Act of 1938 guidelines. Unfortunately, this law had no teeth because the FDA had limited resources and authority to enforce the regulations. Uninformed entrepreneurs would build manufacturing companies, and marketers promoted their brands, seemingly without compliance concerns. Because of this, the public perceived cosmetics as unregulated and convinced their representatives to enact a law to tighten regulations by expanding the FDA’s authority. This law, called the Modernization of Cosmetics Regulation Act or MoCRA, was enacted in 2022.
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) expands FDA’s authority to regulate cosmetics. This became the first update of the Federal Food, Drug, and Cosmetic (FD&C) Act since it was passed in 1938. This new law aimed to help ensure the safety of cosmetic products by giving the FDA more teeth to enforce the regulations. From Sec. 301 of the Federal Food, Drug, and Cosmetic Act: “The FD&C Act prohibits the marketing of adulterated or misbranded cosmetics and their adulteration or misbranding while in interstate commerce.”
What defines a misbranded cosmetic?
Per Sec. 201(n), FD&C Act, 21CFR 1.21 a cosmetic labeling is false or misleading if:
- A label statement is deceptive if a material fact, such as consequences that may result from the recommended use of a product, is not revealed;
- The label does not state: the name and address of the manufacturer, packer or distributor; and the net quantity of contents;
- The required information is not stated prominently, with conspicuousness, and in terms that it is read and understood by consumers under customary conditions of purchase and use.
- The container or its fill is misleading.
Per 21 CFR 740.10, a cosmetic is also considered misbranded if its safety has not adequately been substantiated and it does not bear the following conspicuous statement on the principal display panel (PDP), "Warning: The safety of this product has not been determined."
The safety of a cosmetic may be considered adequately substantiated if experts (qualified by scientific training and experience) can reasonably conclude from the available toxicological and other test data, chemical composition and other pertinent information that the product is not injurious to consumers under conditions of customary use and any ‘reasonably foreseeable’ conditions of misuse.
The safety of a cosmetic can adequately be substantiated by:
a) Reliance on available toxicological test data on its ingredients and similar products, and
b) Performance of additional toxicological and other testing appropriate in the light of the existing data.
Even if the safety of each ingredient has been substantiated, some toxicological testing is usually still needed of the ‘formulated product’ to assure adequate safety substantiation of its collective ingredients.
What ingredients are prohibited or restricted by FDA regulations?
Example: Methylene chloride.
It causes cancer in animals and is likely to be harmful to human health, too (21 CFR 700.19).
Use of methylene chloride as an ingredient of cosmetic products.
(a) Methylene chloride has been used as an ingredient of aerosol cosmetic products, principally hair sprays, at concentrations ranging from 10 to 25 percent. In a 2-year animal inhalation study sponsored by the National Toxicology Program, methylene chloride significantly increased in benign and malignant tumors of the lung and liver of male and female mice. Based on these findings and on estimates of human exposure from the customary use of hair sprays, the Food and Drug Administration concludes that the use of methylene chloride in cosmetic products poses a significant cancer risk to consumers, and the use of this ingredient in cosmetic products may render these products injurious to health.
(b) Any cosmetic product that contains methylene chloride as an ingredient is deemed adulterated and is subject to regulatory action under sections 301 and 601(a) of the Federal Food, Drug, and Cosmetic Act. [54 FR 27342, June 29, 1989]
How do noncompliant cosmetic products continue to be marketed?
Unfortunately, the existence of the law does not prevent unscrupulous companies from marketing noncompliant products. Here, I cite two examples of independently tested products* that, for purposes of this article, will remain unnamed:
Example 1: Adulterated and Misbranded Gel Remover
Table 1 compares our independent lab analysis of the gel remover with that of a paint remover. The brand owner's ‘declared ingredient list’ differs from our own lab analysis of the product, which determines for us that the gel remover’s composition contains methylene chloride and is ‘similar to’ that of a paint stripper:
The gel remover is an ‘adulterated’ product because it contains an ingredient prohibited in cosmetics due to its significant cancer risk to consumers who use it. It is a ‘misbranded’ product because the owner's labeling is false and deceptive.
Example 2: Adulterated and Misbranded Odorless Polish Remover
We purchased a polish remover online because the brand advertised that it is odorless, removes polish quickly and is made only with minerals and water. The brand claims it can also be used to remove nail fungus, cuticles, corns, bunions and calluses. We were curious to find out if the ingredient declaration was truthful.
We found that the label had no ingredient list. Our thermogravimetric analysis (TGA) showed the volatile components boiled off at 100 degrees C and below. Methanol boils at 65 degrees C, and nitromethane boils at 100 degrees C. Our infrared analysis is consistent with mostly methanol and nitromethane, solvents that are unapproved for cosmetics, and little or no nonvolatile residue.
This product is ‘adulterated’ because it contains nitromethane, methanol and sodium hydroxide, listed as prohibited in Annex III of the FD&C Act. Polish remover is not one of the Act’s allowed use exceptions. Furthermore, the product contains sodium hydroxide at twice the permitted concentration. It is also ‘misbranded’ because the information on the label is incomplete, false and misleading.
What can beauty professionals do to help stop the marketing of noncompliant cosmetic products?
Most brands are scrupulous, but some are not. It’s important to arm yourself defensively. Familiarize yourself with the FD&C Act of 1938 and MoCRA. It’s content in entirety is readily available online. Knowledge is power, and only we can mandate what we choose to tolerate. Place your trust in industry proven professional brands. Interrogate the brand’s ingredients, accept no imposters and shop like you shop for your own family because it’s that important.
About the Author:
Vivian Valenty, Ph.D. (@nailpolishdoc), is the founder and president of VB Cosmetics, the creator and manufacturer of Dazzle Dry. She is also a member of Nailpro’s advisory board. She obtained her doctorate in chemistry from Penn State University, and, for the past 33 years, has been creating products for the professional nail industry.