FDA would have significantly greater authority over cosmetic products under the Personal Care Products Safety Act. The Personal Care Products Safety Act would increase regulation over many aspects of the cosmetics industry, including:
- registration of cosmetics facilities
- registration of cosmetic ingredient statements
- review of ingredients
- good manufacturing practices
- adverse events reporting
- records inspection; mandatory recall authority
- animal testing alternatives
This represents significant expansion of regulation over cosmetic products.
At the moment, for example, registration of cosmetics facilities is voluntary. FDA currently notes: “The VCRP (Voluntary Cosmetic Registration Program) applies only to cosmetic products being sold to consumers in the United States. It does not apply to cosmetic products for professional use only, such as products used in beauty salons, spas, or skin care clinics. It also does not apply to products that are not for sale, such as hotel samples, free gifts, or cosmetic products you make in your home to give to your friends.” Under the bill, cosmetics establishment registration would be mandatory.
Under the bill, companies must report both serious and non-serious adverse events. Serious events include: death; life-threatening experience; inpatient hospitalization; persistent or significant disability or incapacity; congenital anomaly or birth defect; or significant disfigurement, including serious and persistent rashes and infections; or events that require a medical or surgical intervention to prevent any of these outcomes.
Currently, many cosmetics companies run into regulatory trouble by confusing the line between cosmetics and drugs. For this reason, we recommend legal review of all marketing materials, including website, to ensure that no therapeutic claims are being made. In some cases, consumer products may be classified as a medical device. Again, legal review of claims is important to assess the intended use, which is what FDA reviews to assess the categorization of the consumer product. More stringent regulation generally applies to drugs and medical devices than to cosmetics, so it is better for manufacturers if they can remain within the “cosmetics” category.
In any case, cosmetics cannot be misbranded or adulterated; nor can drugs or medical devices.
These existing prohibitions remain, but the bill adds new safeguards.
In the proposed legislation, if FDA determines that a cosmetic product manufactured in a registered facility “has a reasonable probability of causing serious adverse health consequences or death to humans,” FDA may suspend the registration of the cosmetics facility or suspend the cosmetic ingredient statement of the product.
As mentioned, the proposed federal legislation also requires FDA to evaluate a number of ingredients commonly found in cosmetics products, for safety.
Our FDA attorneys and healthcare lawyers track FDA developments so we can counsel our clients on their FDA compliance legal obligations. Contact our FDA cosmetics legal team for laws and updates relevant to your situation.