On January 3, 2021, the 117th Congress was sworn in. The House of Representatives includes some new faces and more women. In the Senate, where a January 6 runoff decided whether the Democrats took control, or the Republicans maintained the majority, the numbers will be closer (Happi went to press December 24). Why does the makeup of the 117th Congress matter to the cosmetics industry?

For the past several years, legislation has been introduced in the House and the Senate that would modernize the Food and Drug Administration’s oversight of the cosmetics industry, something that the Independent Beauty Association (IBA) has worked hard to help craft and agrees is long overdue. Many of our industry’s most successful entrepreneurs weren’t even alive when the cosmetics oversight laws were written in 1938!

So, reform of the laws governing the cosmetics industry should be a breeze, right? How often does the industry agree with the government on regulation?

Unfortunately, the legislation that has been proposed would overregulate and punish an industry that has had a remarkable safety record and has been responsible for innovation in all facets of the industry. It would also disproportionately impact the industry’s entrepreneurs, many of whom make up IBA’s membership. 

Many brands started out in the founder’s garage and are now household names. These show the power of innovation in the cosmetics industry. The legislation that is being proposed would unnecessarily put all of this at risk and adversely impact many of the smaller, independent companies that make up the heart of the industry, companies in many cases started by women and minorities.

It doesn’t have to be this way. There is a way forward that would allow the industry to continue to innovate and create jobs, continue to ensure consumer safety and give the FDA the tools to regulate the industry. We can do it all.


Keep Moving Forward

The new OTC bill is a good model. That legislation encourages innovation and adoption of the latest technologies to expand and enhance the OTC industry. It fosters innovation and creativity and takes advantage of the trickle-down effect of some of the new technologies from the pharmaceutical industry as well as technologies that support sustainability and respect for the environment. 

The questions we should be asking is: do we want our industry to move into the 21st Century or do we want to keep looking in the rearview mirror? It was the cosmetics industry and not the drug industry that introduced the use of sunscreens in non-beach products, addressing the concern that an epidemic of skin cancer would ensue in this country.  The introduction of a sonic brush is but one of the many innovations and advancements that have been made by the cosmetics industry.

Had the regulatory approach being advanced by any of the recent bills been in place when sunscreens were introduced into non-beach products or when the sonic cleansing brush was introduced, neither of these important advancements would have been marketed; the provisions are just too onerous.  In the case of the inclusion of sunscreens in non-beach products, the heightened enforcement tools being advocated by these bills would have precluded the challenge that the marketing company made which resulted in the FDA changing its position to allow for the inclusion of sunscreens in non-beach products. The lotion many people use every day has an SPF because of the cosmetics industry’s fight.

The enforcement tools proposed in these bills are so draconian and the means to challenge so limited the threat of action by the FDA will probably be sufficient to discourage the kind of challenges which sometimes need to be made to get the best public outcome, including SPF in your daily lotion.

Many innovative and disruptive advances which have been made by the smaller companies may not have happened for a different reason and that is the extraordinarily high user fees that these bills are proposing; user fees that would force the smaller companies to pay a disproportionate share. 

Between the user fees and the enhanced enforcement tools, IBA believes new barriers to entry will discourage new entrants who tend to be the innovators and disruptors. Why enter a new field which imposes high user fees on small companies with a regulatory body that has overarching authority? Don’t believe me; just ask our members who overwhelmingly oppose both provisions.


An Excellent Safety Record

Let’s address another one of the main tenants of the proposed legislation, consumer safety. All of the bills are based upon the food safety amendments which were designed to address significant health risks resulting from food borne illnesses which caused hundreds of thousands of deaths and serious illnesses each year. The cosmetics industry, in contrast, has an excellent safety record. Most of the issues that have arisen in the last few years have been dealt with effectively and efficiently by the FDA. As one Senator noted at a Senate HELP Committee meeting on cosmetics, “the FDA has significant enforcement authority over the industry.” When real safety issues have been presented, the FDA has worked quickly to address these issues through the tools which are currently within its authority. For example, the Brazilian blow out problems were addressed very quickly, and the FDA took a number of actions against asbestos and the “bad actor” companies involved. The FDA has reported all of these actions on its website including the studies it conducted on the safety of parabens in cosmetics. The FDA has over the years proved a competent and diligent regulator. 

Can we, as an industry, always provide more confidence to consumers about safety? The answer is YES and that is why IBA and its sister organizations support legislation that would do just that instead of creating a false narrative about the industry.


Preemption Is Critical

There is another issue critical to the proposed legislation that would help the industry and consumers alike, and that is preemption, a national standard that would preempt a patchwork of state regulations. While the bills all profess to support a strong FDA by providing enhanced enforcement and supporting the FDA with large user fees, they all fall short of actually supporting a strong FDA, a singular national program. None of these bills provide preemption from state laws and regulation by state agencies. So, while these bills all purport to support a strong FDA, in fact they all specifically undermine the FDA’s authority by permitting states, which are underfunded and do not have the developed knowledge base and expertise of the FDA, to continue to regulate in this area and undercut the FDA’s authority.

State legislatures are all busy passing laws to regulate cosmetics and cosmetic ingredients and they are all inconsistent. For example, with the legalization of CBD from hemp, we have seen significant state activity, some of which ignores the science and the positions taken by the FDA. Passage of any cosmetic bill without strong preemption can result in 50 different state laws in the area of cosmetic regulation. It may be fine for the big guys with big regulatory operations, but for the little guys, it may make selling products nationally a thing of the past.

As noted, the bills all call for significant annual industry user fees, in some cases as much as $46 million annually. IBA is not opposed to sensible user fees, but the legislation proposes to tax the industry to conduct a review of ingredients whose safely has already been independently established by numerous different accredited bodies including the EU. Let’s instead use the funding from user fees to review NEW ingredients and direct the funds to scientific advancement. This would be beneficial for all stakeholders including, most importantly, consumers.


Working Together

IBA is hopeful that the new Congress will look at these issues as it considers cosmetics reform legislation. We look forward to working with members of the House and Senate in crafting new, more forward-thinking legislation that supports innovation and encourages entrepreneurial endeavors in an industry where woman and minorities have been able to succeed at every level. While our products may not cure diseases, throughout the COVID pandemic, despite the hit our industry took, we stepped up and helped fill the shortage of hand sanitizer and have been developing products which can add further protection from the virus. As an industry, we are committed to continually improving our product offerings to benefit our consumers and promote beautiful healthy skin and hair.

The Independent Beauty Association stands ready to work with the new Congress and our partners in the industry to craft sensible cosmetics reform legislation that is good for consumers and for the industry. Without a seat at the table, we will see punitive bills like Pallone, Schakowsky or Feinstein Bills that seek to overregulate and punish the industry for alleged safety infractions which are largely based upon questionable studies and innuendo. While there have been issues, as a whole, the industry has a remarkable safety record which is why when the FDA went to a risk-based system for all of its programs it identified the cosmetic program as a low-risk area.

Contrary to the “fake news” disseminated by some, the FDA has brought enforcement actions against cosmetic products that contain asbestos. The FDA conducted significant validated studies on the question of excessive amounts of lead in lipstick testing a very large cross section of popular lipsticks and found there were negligible amounts of lead in lipstick. One of the uses of these funds will be to conduct a serial review of not just cosmetic ingredients but of nonfunctional constituents in these ingredients as well. There are new accepted scientific methods for conducting these reviews, but inclusion of these processes has been rejected. The fact that the safety of these ingredients has been independently established has also been rejected. Ignoring sound science, each of these proposals advocates spending rapacious amounts of money, going over old ground and avoiding what has been scientifically substantiated. These funds could and should be directed to scientific advancement.

Another example of these bills being anti-innovation is the fact that none addresses the question of new ingredient review which was included in both the new dietary supplement bill and the new OTC bill.

Cosmetic industry stakeholders should seriously question the need for the excessive users’ fees when no user fees were levied on the dietary supplement industry, an industry that has, unlike the cosmetic industry, annually experienced significant numbers of serious adverse events each year. Perhaps the purpose for collecting these large fees from the cosmetics industry is to support other programs in the center, namely dietary supplements and foods.

The registration requirements proposed in these bills will not enhance the FDA’s product or facility information or result in enhanced product safety, it is just one more element of cost that will be loaded onto these products with no safety benefit, merely additional costs and reduction in innovation all of which will be to the detriment of the consumer who will pay more and have fewer choices. 

---

About the Author
Dr. Ken Marenus is currently president and CEO of the Independent Beauty Association. Advocacy@independentbeauty.org