As the world was enjoying the Christmas season last year, the US Congress quietly passed the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), its first major update to the US cosmetics regulations in nearly a century. While some people feel it was overdue, it is quite clear to many US industry insiders that the authors of the Act know very little about the US beauty industry, and this is clearly reflected in the short comings of MoCRA. Those of us who have been in the industry for a few decades believe that this regulation will end up having several unintended, negative consequences that will leave the US with some of the same issues that existed in the European Union (EU) pre-2009 and were the impetus for the passing of EC No. 1223/2009. It also disproportionately impacts small and medium-sized brands while favoring large brands, multinationals, and the Environmental Working Group (EWG). More on this to follow. Ultimately, it will negatively impact the consumer, particularly those who are lower income.
To make matters worse, there are many myths swirling around this regulation creating fear in the global cosmetic industry. One of the primary reasons for so many misconceptions is that the US Food and Drug Administration (FDA) has not yet published the final regulations and the actual details are unknown. Just to provide perspective, in the US, Congress passes laws and acts that are then given to the federal agencies to write the regulations. To date, we only have MoCRA which is the Act and FDA, the agency, is developing the regulations. There are many consulting companies claiming to know the FDA’s thinking behind the regulations and therefore are propagating these myths with the goal of profiting from MoCRA.
There is one myth that will be debunked throughout this article and that is that MoCRA is inspired by the EU regulations and is very similar to EC No. 1223/2009. I will provide examples of how MoCRA is very different than the European regulations. I will also debunk additional myths as I address the deficiencies of MoCRA.
So where has this Act fallen short and what are the untended, negative consequences? While there are three primary areas, preemption, raw material and product safety and regulatory definitions, they are all intricately intertwined.
Preemption and State’s Rights
previous versions of this bill, some industry experts were able to get a federal preemption clause included to ensure one single federal cosmetics regulation that would sunset any existing state regulations. However, this was rewritten in MoCRA’s final draft, with input from EWG, allowing states to establish any new law or regulation related to cosmetics so long as it is not in conflict with the requirements of MoCRA related to registration and product listing, good manufacturing practice, record retention, recalls, adverse event reporting or safety substantiation. What that means is that if every US state put a reporting requirement in place like the FDA’s, a brand would have to register all their products 51 times. Someone who may be questioning how it is possible to have a patchwork of cosmetic laws in a single country when there is federal regulation is asking an important question. The US’ founding fathers, to get the original 13 colonies to buy into a centralized, federal government, created the concept of federalism providing for state rights. Federalism gives the states the right to address policy areas under the First Amendment that are not addressed by the national government. This miss in the drafting of MoCRA will make compliance in the US potentially much more difficult. As an industry, our only hope is to try to influence the regulations both at the state and federal levels. Now, to further illustrate the first potential unintended, negative consequence, state regulation proliferation, let’s look at California more closely.
As anyone who has sold products in the US knows, not only do brands need to comply with the FDA, but also with California’s many onerous regulations. Despite having several federal regulations, the state of California has passed mirror image regulations but with different requirements from the US (federal) regulations.
Currently cosmetics are regulated under FDA’s Food, Drug and Cosmetics Act (FD&C Act) because MoCRA has not been fully enacted. Over the last few decades, California has passed three Acts, The Food, Drug, and Cosmetic Law (Sherman Act) which regulates the packaging, labeling, and advertising of cosmetics, drugs and devices; The California Safe Cosmetics Act which established the requirement to report cosmetic products containing “hazardous” ingredients through an on-line portal; and The Cosmetic Fragrance and Flavor Ingredient Right to Know Act which requires the disclosure to the state of fragrance or flavor ingredients in cosmetics and professional salon products.
In addition, despite the existence of the US Environmental Protection Agency’s (EPA) Clean Air Act, which California has never been able to fully meet, the California Air Resources Board (CARB) has passed the Consumer Products Regulation to limit the amount of volatile organic compounds in consumer goods, including beauty products. The EPA also administers the Toxic Substances Control Act (TSCA) which requires reporting, record-keeping and testing requirements, and restrictions relating to chemical substances and/or mixtures and bans substances accordingly. Again, California has its own scheme –Proposition 65 (Prop 65), officially known as the Safe Drinking Water and Toxic Enforcement Act of 1986, which identifies chemicals known to the state of California to cause cancer, birth defects or other reproductive harm, and requires warnings on products containing these chemicals.
California is just one state in the US. Now imagine, that the other 49 states had all these same regulations, and all had different approved use levels, definitions, or requirements. Then add in the MoCRA requirements. A brand would need to make a formula that is compliant with 51 potentially different regulations and have several formulas just to sell in the US. Having 51 separate regulations would not only make compliance difficult, the quality, price and creativity of products could be impacted, making it harder for small and medium-sized brands to compete and ultimately affecting the consumer. This is the first major difference between the US and the EU and in my opinion, and as I stated previously, is the reason that EC No. 1223/2009 was passed in the EU.
Raw Materials and Product Safety
Going hand in hand with preemption is product and raw material safety. MoCRA is vague on the requirements to prove that a brand’s products are safe. There are two big myths in this area – an EU-style safety assessment can be used to support product safety in place of testing and brands need to hire a US Responsible Person to substantiate safety and report adverse events to the FDA. Both myths highlight two more differences between the US and EU regulatory schemes.
In 1976, the then Cosmetics, Toiletries and Fragrances Association (CTFA) now the Personal Care Products Council (PCPC) established the Cosmetic Ingredient Review (CIR) with the support of the FDA and the Consumer Federation of America. Although funded by CTFA/PCPC, the CIR, the Expert Panel for Cosmetic Ingredient Safety, and the review process are independent from PCPC and the cosmetics industry. In some ways this is no different than the EU Scientific Committee on Consumer Products (SCCS) opinions except that to date, the FDA has not used CIR data to create regulations. The CIR program has worked effectively for the last 47 years and is largely, in my opinion, one of the reasons why the FDA does not have restricted and prohibited lists like the EU Annexes, and another major difference between the two regulatory schemes.
There is an additional key reason for the FDA’s vagueness. The FDA requires that all products placed on the market in the US must not be adulterated or misbranded. The regulatory definition of unadulterated is that a product is safe for consumers under labeled or customary conditions of use. The FDA does not have a list of required tests that must be conducted on raw materials or products. In their guidance documents, the FDA suggests to first conduct a review of the safety data provided by the raw material manufacturers, CIR, PubMed, and Toxnet and FDA acknowledge that they do take CIR reviews into consideration when evaluating cosmetic ingredient safety, another affirmation that the CIR program is working. They also suggest that toxicological testing may be needed on newer ingredients or where data gaps exist. The FDA does explicitly identify microbiological testing as a mandatory requirement to prove that a product will not be cross contaminated during normal use.
Many brands have interpreted FDA’s vague guidance in two ways. First is, if the product is “natural” or “botanical” that it is safe, and therefore does not have to be tested, which the FDA explicitly states is an incorrect assumption. The second interpretation and a popular myth is that an EU-style safety assessment is all that is required. This, however, is wishful thinking. The regulations in 21 CFR 740.10 state the following,
a) Each ingredient used in a cosmetic product and each finished cosmetic product shall be adequately substantiated for safety prior to marketing. Any such ingredient or product whose safety is not adequately substantiated prior to marketing is misbranded unless it contains the following conspicuous statement on the principal display panel:
“Warning – The safety of this product has not been determined.”
(b) An ingredient or product having a history of use in or as a cosmetic may at any time have its safety brought into question by new information that in itself is not conclusive. The warning required by paragraph (a) of this section is not required for such an ingredient or product if:
(1) The safety of the ingredient or product had been adequately substantiated prior to development of the new information;
(2) The new information does not demonstrate a hazard to human health; and
(3) Adequate studies are being conducted to determine expeditiously the safety of the ingredient or product.
Clearly, this means that raw materials and products must be tested for safety. Misbranded means that false and/or misleading information is presented to the consumer about the product. So, if the safety of a product has not been substantiated and is missing the warning (see left), it is both adulterated and misbranded and will likely be recalled. This debunks the myth that cosmetic products are not regulated in the US as stringently as in the EU. While the US doesn’t have the Annexes, the requirement to prove product safety involves testing and data review and is, at a minimum, the same level of review as the EU. Conversely, in the EU, it is the calculation and review of daily exposure limits (paper toxicology) and minimal testing. That said, despite MoCRA’s vague language, the FDA has stated publicly that nothing has changed as it relates to the substantiation needed to prove the safety of a raw material or a product. And considering that now the FDA has recall authority and expanded adverse event oversight, it is in a brand’s best interest to conduct rigorous testing to ensure that their products are safe. My personal opinion is that the FDA was intentionally vague on safety to force brands to conduct testing if they have not done so previously.
Following California’s lead, states have begun to pass laws to regulate or ban chemicals used in cosmetics sold in their state. Washington, New York, Nevada, Illinois, Oregon, Maryland, Maine, and a few others either have passed laws or have bills in the hopper. Some states have bills related to asbestos in talc or PFAFs, both of which will be covered under future regulations and hopefully, industry will only have to comply with one federal regulation.
For example, Washington State’s Toxic-Free Cosmetic Act effective January 1, 2025, bans Ortho-phthalates, PFAFs, Formaldehyde, Formaldehyde donors (list yet to be defined), Methylene Glycol, Mercury and Mercury compounds, Triclosan, m-Phenylenediamine and its salts and o-Phenylenediamine and its salts. Further after January 1, 2025, any product containing intentionally added lead or lead compounds or having lead or lead compounds as a contaminant above 1ppm is banned. This regulation was written by Washington’s Department of Ecology, so therefore, not by anyone with cosmetic chemistry experience. State regulations tend to be written by state environmental agencies with very little knowledge of the cosmetic industry, including federal regulations, and we tend to see that most are either not scientifically feasible or there is no viable replacement for the newly banned substance or in direct conflict with federal regulations – more on this to follow.
Another example of this is a recent law that went into effect in Maine. Maine defines PFAFs as “Perfluoroalkyl and polyfluoroalkyl substances” or “substances that include any member of the class of fluorinated organic chemicals containing at least one fully fluorinated carbon atom.” This means that HFC 152A, a cleaner alternative aerosol propellent can no longer be sold in Maine. (38 MSRA 16 §1614). To date, there is no feasible replacement.
To further illustrate the challenges with the proliferation of state regulations and creating one formula for the US, see the definition for PFAFs in Maryland. Maryland’s bill defines regulated PFAFs of concern as Perfluorooctane Sulfonate (PFOS)/Heptadecafluorooctane–1–Sulfonic Acid, Potassium Perfluorooctanesulfonate/Potassium Heptadecafluorooctane–1–Sulfonate, Diethanolamine Perfluorooctane Sulfonate, Ammonium Perfluorooctane Sulfonate/Ammonium Heptadecafluorooctanesulfonate, Lithium Perfluorooctane Sulfonate/Lithium Heptadecafluorooctanesulfonate, Perfluorooctanoic Acid (PFOA), Ammonium Pentadecafluorooctanoate, Nonadecafluorodecanoic Acid, Ammonium Nonadecafluorodecanoate, Sodium Nonadecafluorodecanoate, Perfluorononanoic Acid (PFNA), Sodium Heptadecafluorononanoate and Ammonium Perfluorononanoate, thus allowing the use of HFC 152A.
Some states, however, have crossed the line into FDA territory without realizing it because the authors do not know federal cosmetic regulation as discussed previously. Some states have begun to regulate ingredients used in OTC products (sunscreens, antiperspirants, acne, etc.). OTC products are extensively regulated at the federal level, and as discussed earlier, states cannot create regulations that contradict the federal regulations. This will now provide a conundrum for the states. For example, if Titanium Dioxide is permitted for use up to 25% as an OTC sunscreen active ingredient and a state regulates it either through restriction (cannot be used above 5%) or prohibition, they have infringed on FDA’s regulations. Another example is around hair colorants. While MoCRA is silent on most ingredients, it specifically calls out coal tar hair colorants as the one class of chemicals with federal preemption. Yet, Washington state explicitly bans the use of
m-Phenylenediamine and its salts and o-Phenylenediamine and its salts. Again, this shows the lack of understanding of federal cosmetic regulations. It is our hope that once the FDA completes the regulations, they will begin to address these conflicting state regulations.
The last area that may be troublesome for states is around colorants. A state may ban an impurity that is used in a colorant that FDA has approved. MoCRA has not yet addressed colorants and it is likely going to become a bigger issue with respect to heavy metals. As background, every batch of synthetic colorant (think Red 6/CI 15850) that will be sold in the US is required to be tested and certified by the FDA. So, if the FDA certifies a batch of Red 6, and that batch of Red 6 contains lead above 1ppm, it will not be permitted for sale in Washington state for example because of their limits on lead as discussed earlier. The newly created FDA Office of Colors and Cosmetics will hopefully sort this out.
Non-governmental organizations like EWG are encouraging states to pass laws to force the FDA to pass more regulations, particularly on raw materials. Excessive legislation will either put small brands out of business or drive down their purchase price, which only further helps the bigger brands looking to buy these brands for expansion. Further, smaller brands cannot afford to have multiple versions of packaging and formulas in inventory, particularly, in the current economic conditions. We are seeing small and medium-sized brands going out of business weekly in the US and the trend is likely to accelerate with the addition of more state regulations. What EWG and others pushing for more regulations do not take into consideration is the cost to small and medium-sized brands and would lead one to believe that there is an incentive to help the larger brands and multinationals. Unfortunately, EWG’s primary motivation is dishonest as they have a financial incentive to push for more state regulation. As they say, fear sells.
Does this situation sound familiar? Think about the European Union pre-1223/2009. Back then countries would ratify the Directives at different times and sometimes even change the status of ingredients for their country without following the Directive. In 2005, France added Vitamin K1 to its prohibited list based on 5 cases of undesirable effects (allergic reactions) between December 2003 and June 2004 from 3 products and a further 6 cases were identified between March 2004 and July 2004 from another product containing Vitamin K1 – 11 cases and 4 products over two years. The Cosmetics Directive that was in force at the time did not ban Vitamin K1 and the SCCS opinion was not even issued and adopted until late 2007. At the time, I worked for a cosmetics company that sold face cream with Vitamin K1 throughout the European Union. This ban created chaos in the supply chain ensuring that the product was not shipped to France. Vitamin K1 is not an isolated case, and what resulted was a patchwork of regulations that became increasingly difficult with which to comply and the motivation to pass the Cosmetics Regulations (1223/2009).
Going back to the myth around EU-style safety assessments as support for the safety of a product and using the Vitamin K1 example, at the time that Vitamin K1 was reviewed by SCCS, the recommended CIR level was 5% and the recommended SCCS level was 3%. Which is the correct data to be used in a safety assessment to further support testing in the US – CIR or SCCS? As stated earlier, CIR data is what the FDA relies on, and that data is not in the EU software that many safety assessors use. Despite many EU Responsible Persons and Safety Assessors stating they can write a US Safety Assessment as support for product safety, they truthfully cannot answer this question because the FDA guidance is too vague and as discussed earlier, the FDA prefers actual testing.
The last myth to be debunked in this section is around the idea of the US Responsible Person. The similarities between the US and the EU systems end with the name. In the US, a designated employee of the brand may be the responsible person. It does not require any special education, course, or certification as in the EU. It could be a person who is designated to hold all the safety testing that has been conducted on a product or raw material. It can be supplemented with an EU safety assessment for good measure. Adverse events can be collected by this designated person as well. The requirement is that they must be reported to the FDA within 15 days. The FDA has stated publicly that their preferred method for collecting adverse events is through the existing system, MedWatch, and that debunks another myth I have heard which is that reporting adverse events is a new concept for the US. Nope, that one is false too. What is new is FDA’s expanded oversight of adverse events and their new recall authority. Brands located outside of the US are required to have either a US phone number or a website where adverse events are collected and a US Agent to report these to the FDA. To be clear, brands can be their own US Responsible Person.
Regulatory Definitions and Consumer Confusion
The final area for discussion and another real miss for MoCRA is around regulatory definitions. As an industry we are not helping ourselves and this is definitely an area that needs government intervention. Brands are creating their own definitions of clean, non-toxic, safe, and natural. Either because they do not know better or they think it costs too much, brands are self-certifying and making up symbols that are designed to look like those from independent, third-party certifying bodies. These terms are often used interchangeably by brands, each giving the term a different meaning and the result is consumer confusion and a false sense of safety. To out “clean” each other, retailers are adding to the confusion by creating unique clean definitions based on “blacklists” of banned substances that brands must comply with to be considered clean. I have had new clients come to me and state that they have not conducted any safety testing because none of their ingredients are on a retailer’s “blacklist” except, in one example, the brand had 5% glycolic acid in their formula. I have heard from other brands that testing of their products wasn’t required because all their ingredients have been assigned a 1 or 2 by EWG. This is clearly false and in the absence of real definitions, both brands and consumers will continue to rely on this deceptive terminology.
EWG, in my opinion, is the most problematic for two reasons other than their state initiatives. EWG profits from consumer ignorance which they stoke, and it has an amateurish certification program. It is a pay to play scheme that basically says a brand is compliant with the EU Annex II and FDA regulations. In 2018, they took in $14 million USD in donations and a few additional millions as part of this certification program. Add to the fear mongering and the state legislative incitement, the rating system that many small brands have relied on for safety is not based on sound science. In the Journal of the American Medical Association there was an article about this and in it Drs. Rubin and Brod wrote the following, “the EWG’s skin safe database scores thousands of products based on the putative toxicity of their ingredients, but these claims are not always uniformly agreed on by a broad consensus of experts and can cause confusion to consumers. For example, the EWG assigned a hazard score of 5 to PEG-2 Soyamine, despite acknowledging that there is no available data. Although the EWG remains a powerful force driving the clean beauty dialogue, their method for assessing risk does not seem to be data driven. The EWG also profits from participating in affiliate programs where they receive a percentage of the sales when a consumer makes a purchase through their website, which may be a notable conflict of interest.”
In summary, while the US needed updated cosmetic regulations, the combination of the lack of Congressional knowledge about the cosmetic industry coupled with the selfish interests of fear mongering lobbyists like EWG, MoCRA falls woefully short of the intended goals of product safety. It is filled with loopholes, intentional ambiguity, unintended, negative consequences, and disproportionate financial costs. I would be willing to bet that anyone who thinks that MoCRA is a good piece of legislation is from a multinational, large company, an NGO or someone who will profit from its passage.
For European brands selling in the US to be successful and comply with MoCRA, I strongly suggest that they educate themselves on the elements of the Act and regulation once promulgated. As I have said, there are many myths being used as advertising to turn a profit from MoCRA. I have had brands ask me to be their US RP and my answer is the same, “Save your money! You are your own US Responsible Person. I can help you write an SOP for adverse event reporting if you do not have one, but you should already and if you do, it will need to be more robust. And I will tell you when the portal opens so you can upload your ingredient lists and contract manufacture’s registration numbers by December 29, 2023.” Obviously, this is overly simplified, however, the point is that a brand does not need to hire someone to straighten their files and add data into a portal.
I suggest European brands attend the Independent Beauty Association’s FDA Workshop which will be held virtually on September 20–21, 2023, as Dr. Linda Katz, Director of FDA’s Office of Colors and Cosmetics and Dr. Namandje Bumpus, FDA’s Chief Scientist will be providing insight into the anticipated regulations. There is also a session dedicated to the requirements for non-US manufacturers and brands, entitled, MoCRA: International Brands and Manufacturer Obligations & U.S.
Businesses Working with International Manufacturers on September 20th. More information can be found on their website https://independentbeauty.org/.
