1. “A cosmetic by any other name”: situations in which the cosmetic products marketed are considered to be drugs
The FDA regulates drugs and cosmetics differently, with the latter subject to significantly lower regulatory requirements. Cosmetic manufacturers can sometimes break the law by marketing a cosmetic product with a drug indication or by marketing a pharmaceutical product as a cosmetic, failing to comply with regulatory requirements for drugs. In determining whether a product is a “cosmetic” or a “drug”, the US Food and Drug Administration (“FDA”) examines the “intended use” of the product.
Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), cosmetics are defined as “articles intended to be scrubbed, poured, sprinkled or sprinkled, introduced or otherwise applied to the human body … for cleaning, beautifying, promote attractiveness or alter appearance.1 Products recognized as cosmetics by law include skin moisturizers, perfumes, lipsticks, nail polishes, eye and face makeup preparations, cleansing shampoos, hair colors and deodorants. In contrast, drugs are defined as “articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the human or other animal body. “2
The FDA determines the “intended use” of a product by analyzing the claims made on the product’s labeling, its advertisements, and other promotional materials. The FDA also looks at consumer perception and the use of certain ingredients that have established therapeutic uses to determine whether a product is a “drug” or a “cosmetic”.
In some cases, a product can be considered both a drug and a cosmetic. This occurs when a product has two intended uses. For example, a moisturizer with a sun protection factor (SPF) indication is considered to be both a drug and a cosmetic. The moisturizer is a cosmetic because its use is to beautify the skin while the SPF component is a drug because it uses it to protect the skin from ultraviolet rays A and B. Consequently, the product must comply with both regulatory and cosmetic requirements. than on drugs.
It is important for cosmetic manufacturers to understand the distinction between cosmetic and drug claims. In addition, it is imperative that these companies take into consideration claims about the labeling of their products, advertising (including on the Internet) and any other promotional materials. This is especially true when they market sunscreen products that are regulated by the FDA differently than they are in Europe by European authorities.
2. There are two sheriffs in town: Cosmetic product labels are subject to both FDA and FTC requirements
The FDA and the Federal Trade Commission (FTC) are both authorized by federal laws to regulate the labeling of products. Under the FD&C Act, the FDA has the authority to regulate cosmetic labeling claims while the FTC has the authority to regulate cosmetic product advertising claims under the Federal Trade Commission Act (“FTC Act”).
While the FD&C law does not require the FDA to review or approve cosmetic product labeling, the FDA can take enforcement action against companies whose cosmetic products are mislabeled. As mentioned above, this generally occurs when a cosmetic product is marketed with “drug” claims such as the treatment or prevention of a disease. The FDA often issues warning letters to these companies, stating that these marketed cosmetic products are “new drugs” that need prior approval from the FDA to market these products as drugs.
The FTC regulates advertising claims for cosmetic products and requires these claims to be true and not misleading. The FTC generally issues administrative complaints to companies that engage in misleading advertising. The FTC often files complaints to cosmetic companies after the FDA has issued warning letters to these companies.
Cosmetic manufacturers should be aware of both FDA and FTC regulations and enforcement actions (e.g., warning letters, seizures, and injunctions) related to cosmetics and develop compliance programs to ensure that their labeling and advertising claims are in line with the regulations of both agencies.
3. Be aware of state requirements relating to cosmetic products
In addition to FDA and FTC regulations, almost all states have laws and regulations that apply to cosmetic products. Most of these states have their own Food, Drug, and Cosmetic Act which closely mirrors federal FD&C law. Some states like Florida and Louisiana have additional requirements for cosmetics manufacturers such as facility registration, product registration, licensing / authorization, and / or inspections. For example, Florida requires in-house cosmetic manufacturers to obtain a cosmetic manufacturing permit from the state.
In 2005, California passed the California Safe Cosmetic Act. This law applies to all cosmetic products sold in California. This law requires the manufacturer, packager and / or distributor of cosmetics listed on the product label to provide the California Safe Cosmetics Program (CSCP) with a list of all cosmetic products that contain ingredients known or suspected of causing cancer or developmental damage or other reproductive damage.
Cosmetic manufacturers should be aware of applicable state requirements for their products in addition to federal regulatory requirements.
4. News on talc
Recently, the FDA published a white paper titled IWGACP Scientific Opinions on Testing Methods for Asbestos in Cosmetic Products Containing Talc (includes Talc Intended for Use in Cosmetics). The white paper outlined scientific advice on testing cosmetic products containing talc for asbestos. The IWGACP white paper follows the February 2020 FDA public meeting on asbestos testing.
Any cosmetic manufacturer that uses talc as an ingredient should be aware of the recent FDA guidelines on product testing.
5. The proposed law could change the structure of the current cosmetics regulations
Since the passage of the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) in 1938, the FDA’s oversight of cosmetics has generally remained unchanged.
Last summer, Senators Dianne Feinstein (D-Cal.) And Susan Collins (R-Me.) Reintroduced the Personal Care Safety Act (S. 2100). This bill would substantially expand the FDA’s authority on cosmetics. Under the proposed legislation, the FDA could issue mandatory recalls in some cases involving cosmetic products that could cause serious adverse health consequences, and companies have refused to voluntarily withdraw these products. As of now, the FDA does not have this authority. The bill would also require companies to register with the FDA and disclose the ingredients they use in their products. Additionally, under the proposed bill, companies must report serious adverse events, including death and hospitalization, to the FDA within 15 days. Additionally, companies must report an annual summary of all adverse events, including non-serious adverse events such as rashes.
This legislation would require the FDA to enact regulations for good cosmetic manufacturing practices. The FDA would also be authorized to seize counterfeit cosmetic products. Finally, similar to drugs and medical devices, the bill would authorize the FDA to collect user fees from manufacturers.
Currently, there has been no action since the introduction of the bill and we do not expect the bill to be passed this year. However, there continues to be some support for this proposed legislation and we will continue to monitor the changes.
NOTES ON FOOT
1. See DFCA §201 (i); 21 USC §321 (i).
2. See DFCA §201 (g) (1); 21 USC §321 (g) (1).