In many parts of the world, countries are now starting to treat cosmetic products as if they were a consumer drug (paperwork, approvals, certificates, etc.). Here in the United States, the FDA doesn’t have a direct hold or regulation on what “cosmetics” are being sold to the public. Do note, the FDA defines “cosmetics” as…
“Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance” (FD&C Act, sec. 201(i))
But, if the product is intended for a therapeutic use, such as treating or preventing disease, or to affect the structure or function of the body, it’s a drug (FD&C Act, 201(g)), or in some cases a medical device (FD&C Act, 201(h)), even if it affects the appearance. Other “personal care products” may be regulated as dietary supplements or as consumer products.”
Even though some of these products are already regulated by the FDA, the commonly defined “cosmetic” may just be treated the same as a drug/medical device. With new laws and legislations coming from across the world, is it time that the FDA will step in and regulate the cosmetic industry? With ALL cosmetics being regulated similarly to a drug or medical device, will we see more of a rise in “therapeutic use” cosmetics from small businesses (example: sunscreen lotions)?
As of now, late 2015, this vision may become a reality soon for all the cosmetic companies. Currently, many cosmetic companies and groups are attempting to unify the US cosmetic regulation with the world. The act that is being pushed right now is called the Personal Care Products Safety Act. The Personal Care Products Safety Act (PCPSA), a bipartisan bill introduced by Sen. Dianne Feinstein (D-CA) and co-sponsored by Sen. Susan Collins (R-ME), has been the latest chapter in unifying cosmetic regulations. With little national uniformity of cosmetic regulation in the United States, the PCPSA bill hopes to finally implement federal regulatory oversight to ALL cosmetic products.
“Why do we need to implement this act so badly?”
While regulations for drugs and medical devices see some minor global differences, their basic concepts are similar. But, for cosmetic regulations, the rules are extremely different from country to country. These regulated differences are getting beyond out of control to the point where we now see states have their own cosmetic rules (California’s Proposition 65 chemical list). Not only is it frustrating for the companies to comply with all these different country standards, it’s going to eventually frustrate the consumer when a certain cosmetic won’t be able to reach a specific country/state due to regulatory differences. The lack of a universal understanding of the risks cosmetics can pose to the consumer and or the environment will continue this issue.
“What will the PCPSA do to cosmetics and companies?”
Although this can be seen as a great revolution for cosmetics, people still need to look at both sides of what this act can pose. President and CEO of the Independent Cosmetic Manufacturers and Distributors (ICMAD), Pam Busiek, states that “ this legislation places too large a burden on small business, stifles innovation in the cosmetic and personal care industry, and does not provide appropriate and significant national uniformity”. It’s argued by several companies that this bill still needs work since it does not state any information in regards to assisting small cosmetic manufacturing businesses that don’t have the resources/employees to comply with the bill’s requirements. It will be difficult to know what exact role the FDA would play here in future cosmetic products and formulation, as so much worldwide focus already exists on the safety of cosmetic products. It’s true that the United States can benefit from a federally regulated system, like most other countries in the world. What the bill doesn’t reveal is the overwhelming amount of diligence that will need to go into cosmetic safety from both within and outside of the United States.
Will the cosmetic industry one day have harmonizing global regulations, such as the drug and medical device industry? Will small cosmetic businesses be able to survive the regulatory requirements that may come? We may get that answer soon if the PCPSA becomes a reality. Right now we are living in a period of cosmetic revolution, where technology has taken cosmetics far enough to the point where there is a need of regulation across the globe.