Unifying U.S. Cosmetic Regulation: The Challenges of the Personal Care Products Safety Act

If you stand in a room of regulatory professionals, you can’t mistake the confident demeanor of colleagues who work in prescription drugs and medical devices. Much is the same for foods and sometimes even dietary supplements. If in a room like this you admit that you work in cosmetics, they might just look down their noses, wondering why you didn’t make it into the big leagues.

The truth is, however, that in most jurisdictions, regulators don’t approve cosmetics the way they do drugs and medical devices. In these latter categories, suppliers get all kinds of help from regulators, from the formulation to how it’s manufactured to how it’s labelled. Regulators are known to write volumes to petitioners for these sophisticated kinds of products in order to guide them to approval.

Cosmetics don’t get this kind of help. Cosmetics land in most markets on the basis of professional advice from any number of sources. Input can come from the marketing department, the R&D team, regulatory affairs, legal, outside consultants and yes, even the art department. Cosmetics don’t dredge through any regulatory checks and balances until products are on the shelf or trying to cross international borders. Beyond that, there is no global harmonization of cosmetic regulations.

While regulations for drugs and medical devices see some global differences, the basic concepts are similar. We’ve often shaken our heads as to why cosmetic rules are so different from country to country. Now we look throughout the United States and wonder why they are so different state to state. Infuriating as this condition is, it gives us some serious bragging rights in a room full of our pill-pushing regulatory colleagues.

But it really makes you ask, in a world that knows how to regulate serious products like drugs, why can’t regulation get done for much simpler products like cosmetics? A majority of the answer to this question lies in the fact that cosmetics have not historically had anywhere near consistent interest by regulators.

Challenges of Regulation

Much of today’s serious cosmetic regulation has been set just in the past 20 years. Prior to that, the cosmetics category was a very lightly regulated. As different jurisdictions have become aware of the importance of cosmetic regulation, they have often relied on their own concepts and biases to develop their regulations, leading to the disjointed cosmetic regulatory world in which we live.

Another enormously important fact about cosmetics is the lack of a universal understanding of the risk they pose to consumers or the environment. It is fairly straightforward to appreciate and clinically assess the risk of a drug. But for cosmetics, to some stakeholders, they have no risk. To others, they are massively risky and get blamed for all manners of human and environmental damage.

The Personal Care Products Safety Act

No greater example of the challenges posed in regulating cosmetics exists than what is happening in the United States today. The Personal Care Products Safety Act (PCPSA), a bipartisan bill introduced this past spring by Sen. Dianne Feinstein (D-CA) and co-sponsored by Sen. Susan Collins (R-ME), has been the latest chapter in the challenges faced in regulating cosmetics. With so little national uniformity of cosmetic regulation in the United States, the PCPSA or Feinstein bill hopes to finally implement federal regulatory oversight to this often chaotic and confusing regulatory environment.

In a recent question/answer session, the Personal Care Products Council’s (PCPC’s) executive vice president of public affairs and communications, Lisa Powers, acknowledged the non-uniformity within the current regulatory framework and stated, “it is mutually beneficial to all stakeholders to harmonize regulatory oversight and create a greater role for the [U.S. Food and Drug Administration] (FDA) in assessing the safety of cosmetics and personal care products.” She added that a “patchwork regulatory approach with potential varying state bills does not achieve this goal.”

Specifically, the Feinstein bill is composed of two titles: Cosmetic Safety and Fees Related to Cosmetic Safety. Within Title I-Cosmetic Safety, the major elements include the mandatory registration of cosmetic facilities and cosmetic ingredient statements with the FDA.1 Manufacturers and processors will be required to register within 60 days of the law’s enactment and will face user fees based on average gross annual sales.¹

A cosmetic ingredient statement will make the FDA legally authorized to request information on products and suspend facilities if reasonable belief is present that a product has the potential to cause serious health effects to humans.¹ Cosmetics will also be subject to Good Manufacturing Practices (GMPs), with large businesses subject to GMPs after 180 days, and small businesses to be governed by GMPs two years after the published final rule date.¹ Another change the bill includes is the requirement to report serious adverse effects within 15 days following an event and an annual report summarizing all adverse events.¹

The FDA will also report annually to Congress on the progress of the bill.¹ A mandatory annual review of at least five cosmetic ingredients that have not been reviewed in the prior three years will also occur, with the list determined in consultation with industry and consumer groups.¹ Review of cosmetic ingredients may also take place without any specific conditions.¹

The bill also will increase labeling requirements for vulnerable populations and require Internet sales to include the same labelling of cosmetics as on packaged products sold at retail.¹ The FDA will also have the authority to cease distribution of a cosmetic if a supplier refuses voluntary recall of an unsafe product.¹

What the PCPSA Means for Cosmetics

This bill, affecting both large and small companies, specifically comments on small businesses in SEC. 619, of Title-I Cosmetic Safety.¹ The FDA is required to give assistance and expertise to small businesses to comply with the PCPSA.¹ Although this bill intends to improve regulatory oversight for all sizes of companies, some associations disagree with the approach it takes.

Pam Busiek, president and CEO of the Independent Cosmetic Manufacturers and Distributors (ICMAD), stated that the legislation, “places too large a burden on small business, stifles innovation in the cosmetics and personal care industry, and does not provide appropriate and significant national uniformity.”²

When discussing the concern for small businesses being negatively affected, PCPC’s Powers stated that the bill still needs work. Its members, “are supportive of the process and seeing it to a successful conclusion. In that regard, we believe additional provisions, which can help smaller cosmetic manufacturing businesses comply with the new requirements, should be added to the bill…

“We will continue to work with all relevant stakeholders, including ICMAD, to find common ground and further strengthen the bill,” Powers said.

In a statement, Feinstein said, “Europe has a robust system, which includes consumer protections like product registration and ingredient reviews. I am pleased to be introducing this bipartisan legislation with Senator Collins that will require the FDA to review chemicals used in these products and provide clear guidance on their safety.”³

It is difficult to know what role the FDA would play here, as so much worldwide focus already exists on the safety of cosmetic ingredients, with the Cosmetic Ingredient Review already playing a role similar to the one proposed for the FDA. What many industry and association leaders seem to agree on is the need for national uniformity. Will this be achieved by the proposed bill? In an online post discussing the PCPSA, the Environmental Working Group (EWG) pointed out that, “states would largely retain the authority to act on their own.”⁴

Interestingly, the bill is not the first attempt to amend the Federal Food, Drug, and Cosmetic Act. The 2012 Lance Act included similar measures to reform regulations and increase the safety of cosmetic products.⁵ Including provisions for mandatory manufacturer registration, ingredient disclosure and adverse effect reporting requirements, it had widespread approval among the industry and called for an increase in the FDA’s oversight of the industry.⁵ However, the bill made little progress in committee and no votes were taken on it.⁶

NGOs’ Influence

To Non-Governmental Organizations (NGOs), cosmetic ingredient safety seems by far their priority. Heather White, EWG’s executive director, said, “The fact is that companies can put potentially dangerous ingredients into the products they sell without ever having to prove they are safe. We are grateful for the leadership of Senators Feinstein and Collins on trying to improve the safety of the products that families use every day.”⁷

Further, Scott Faber, EWG’s vice president of government affairs, added, “Cosmetics are sort of the last unregulated area of consumer products law. I can’t overstate how little law is now on the books. The FDA virtually has no power to regulate the products we use every day.”⁸

Making the PCPSA Reality

It’s true that the United States would benefit from a federal system, like most other countries in the world. What these statements don’t reveal, however, is the overwhelming amount of due diligence that goes on regarding cosmetic safety both within and outside of the United States. How could it possibly be a good business model for a company to harm its valued consumers?

Reading through the Feinstein Bill begs the question: What has changed to allow the PCPSA to become law when previous attempts have failed? To see the bill be enacted into law, the Senate, House of Representatives, and Health, Education, Labor and Pensions (HELP) Committee, along with the NGOs and other relevant stakeholders, would have to find common ground that simply has not been found before.

The optimist in us hopes that the United States will find a pathway to federal cosmetic regulations, and that the world will become more harmonized in such regulations. Will we ever have a global regulatory world more like drugs or medical devices? Who knows? But the next time we’re standing in that room with our colleagues from drugs and medical devices, we will stand tall, hoping we may get some unspoken respect as we brave the complicated and fascinating journey through cosmetic regulation.

References

1. congress.gov/bill/114th-congress/senate-bill/1014 (Accessed June 10, 2015)
2. cosmeticsdesign.com/Regulation-Safety/Feinstein-bill-could-be-bad-for-business-ICMAD-claims (Accessed June 17, 2015)
3. feinstein.senate.gov/public/index.cfm/press-releases?ID=89ff88b8-5fb1-4617-b96a-c46547ca14ef (Accessed June 18, 2015)
4. ewg.org/enviroblog/2015/04/new-cosmetics-framework-provides-path-forward (Accessed June 26, 2015)
5. pharmamedtechbi.com/publications/the-rose-sheet/36/17/feinstein-bill-lacks-crucial-national-uniformity-assurance--icmad (Accessed June 16, 2015)
6. govtrack.us/congress/bills/112/hr4395 (Accessed July 16, 2015)
7. ewg.org/release/feinstein-collins-bill-would-improve-cosmetics-safety (Accessed June 26, 2015)
8. medicaldaily.com/personal-care-products-safety-act-plans-ensure-regulations-168-chemicals-women-use-331194 (Accessed June 16, 2015)