Inside Out Quality

The Beauty of Regulations

November 16, 2021 Aaron & Diane
Inside Out Quality
The Beauty of Regulations
Show Notes Transcript

The FDA stands for The Food and Drug Administration, but they are also key in regulating the cosmetic industry.  In 1938, The Federal Food, Drug, and Cosmetic Act gave the FDA the responsibility for regulating cosmetics and protecting customers. 

To explore how cosmetics are regulated, Charmain Rodriques, Regulatory Affairs Manager at LVMH joins us to explore how the FDA, FTC, and even customers shape the cosmetic industry. Hope you enjoy!

Aaron Harmon:

The following is an excerpt from Ruth lambs book called The American chamber of horrors written in 1936. Your government has not the legal right under the present Food and Drugs Act to protect you against dangerous cosmetics. The law does not apply to toilet preparations, and those which are harmful, not be taken off the market no matter what pain and disfigurement they inflict. tragedies from the use of such products are by no means of uncommon occurrence. On the morning of May 17 1933, a charming lady whom we shall know is Mrs. Brown, drove downtown to have her picture taken. She'd worked hard all winter as secretary of the local Parent Teachers Association, and as a chairman of the Entertainment Committee. That evening, her associates were giving her banquet in her honor. They had asked for a picture of her to put in the state PTA magazine, so she was having a made an hour later, she stopped a birds beauty shop to get shampoo and haircut. But since this was to be a special occasion, and she naturally wanted to look her best, she let herself be persuaded to have her brows and lashes touched up. Hi, I'm Aaron Harmon, and this is inside out quality, a podcast about real life events and experiences shared by our guests of when things have gone wrong, and how we can learn from them to build better products, companies and improve lives through an effective quality system. The year before the elixir sulfanilamide disaster, two years before the first Food Drug and Cosmetic deck. Ruth was the chief educational officer for the FDA. Her book was written to warn customers of the potential dangers of marketed products at that time. Here's that excerpt. Ruth was describing what happened to Hazel Fay, who ended up being permanently blinded from a cosmetic name Lafleur. The beauty industry continues to flourish in 2021. With social influencers, cosmetic brands and even drugstore sellers offering millions of ways to alter one's appearance. People regularly pick up a tube of mascara at their local store without questioning. Will this make me go blind? Am I going to have a life threatening reaction? We don't ask these questions thanks for the work of agencies like the FDA. In a world before the 1938 Food, Drug and Cosmetic Act, products like lash there could be sold and marketed without any oversight. The company marketed this product as an eyelash and eyebrow dye, which boasted permanence and the coveted dark color fashion at that time. What it didn't share was that it was all banks to paratha aniline dynamin from aniline, a coal tar component and known allergen, according to the American Academy of Ophthalmology. In 1933. several cases of severe reactions to the die were reported, including blindness blisters, and in one case even deaths from the infection. The incidents were highly publicized, including an FDA exhibit in the 1933 Chicago World's Fair, as they in proponents petitioned for the revision of the 1906 Food and Drugs Act. After a few years of industry resistance, the Food Drug and Cosmetic Act finally emerged as the first federal regulation of cosmetics. It provided a list of safe approved ingredients and gave the government power to pull harmful products from the shelves. And what was the first product that the FDA withdrew from the market. It was Lafleur the Food and Drug cosmetics Act has spent the last 80 years holding cosmetic producers accountable for bringing safer beauty products to consumers. Now it's time to learn more and a previous intermission, I introduced Jenny elstead, one of the interns with Inside Out quality. In this episode. She joins me as a co host and help us with that is Charmaine Rodriquez. She is the Regulatory Affairs Manager for perfumes, Christian Dior, welcome to Inside Out quality Charmaine.

Charmaine Rodriques:

Thank you, Aaron. I'm really excited to be here. Thank you for inviting me.

Aaron Harmon:

I am glad I got to speak to you and convince you to be on the show with us. Pretty excited as well. So first, how did your career path bring you the role that you're in now with Christian Dior?

Charmaine Rodriques:

I'm gonna say Aaron that the past my current role is regulatory manager for advertising compliance has been one that has been fairly progressive, I would say it wasn't a path that I deliberately set out on. But I now happily find myself in this position based upon my prior experiences. One of my first jobs was actually in the cosmetic industry. I worked as a lab tech for a company that formulated lip liners and eyeliners. So I was involved in the batch formulation then. And in addition, I got, I was introduced to color matching. So the company that I worked for was a contract manufacturer, we would match colors for clients. So it was just, you know, one of my first introduction to the beauty industry. But after that I worked in the pharmaceutical area as a QC chemist for a number of years. And while I was in that field, I started and finished a graduate degree in environmental studies. I thought my intent was to have a career in the environmental space. And so after graduating, I took a position at the Good Housekeeping Research Institute as a chemist In their beauty lab, and the that role involved chemistry and environmental studies, so or environmental science, so it was one that was, you know, really perfect for me. And I worked there for a number of years, testing beauty products against the or efficacy as well as evaluating product ingredient and label claims. I was able to contribute to a number of blogs and worked with the editors, their magazine articles on safety issues in the beauty industry. Good Housekeeping magazine has a very rich history of consumer safety and advocacy, and in fact, was one of the few magazines or maybe the only magazine at that time that reviewed advertising on its pages to ensure claims were supported. My next role after that was research editor at NBC Universal, there was responsible for reviewing clinical studies and other support documents for advertising that you see on TV. I did that for about three years, then moved on to racket, where I worked on the legal team as an advertising claims review manager. And there I worked on a wide variety of brands, including personal care, beauty OTC and dietary supplements. And they're worked closely with the regulatory department, the r&d as well as clinical to make sure that the claims from my brands were validated. And now at Dior, I validate advertising claims for several of the beauty brands there under the LVMH umbrella. So that's pretty much my journey in a nutshell. That's a fabulous journey. I would never expect someone could have a farmer job working for NBC. Exactly.

Aaron Harmon:

Some totally blew my mind. Oh, you said that. Yeah. And just out of curiosity, you said you did efficacy testing for some of the products early on? What does that look like in the cosmetic space.

Charmaine Rodriques:

So in the cosmetic space, there are like a whole bunch of tests that you can do. So when you see a product that says it hydrates the skin and moisturizes the scan, that's a really common claim in this space. And so we would do corny geometry studies. It involves capacitance measurements, where you apply a product to the skin, and see how well it hydrates the skin. That's one test that we would do, we'd also to Cutometer. To see if a product from the skin, we had another instrument called the Vizio complexion analyzer. Without we took photos of panelists in a control light setting. And so we'd send them home with products to use for, you know, several weeks, and then we would take after photos to look at to see if their wrinkles were less visible, that type of thing if their dark spots were less visible or minimized. So it's quite a lot. And we did a lot of hair testing to where we actually tested on here swatches. We did a cone test to see how well conditioners performed. So it's a whole variety of tests.

Aaron Harmon:

Amazing. Yeah. So Lash Lure caused skin irritation caused ulcerations of the cornea. And the result of that was women being blinded. So how does this prevented now in the cosmetic product development?

Charmaine Rodriques:

So first of all, I just want to say that story is one that's extremely sad and disheartening, and I'd never heard of it before. I was just kind of like blown away. And a story like this should never be repeated in this Age of Information and Technology. And now we have the FDA. When it comes to product development. Every cosmetic manufacturer selling in the US has a legal requirement to make sure that their products are safe for consumers under the Food, Drug and Cosmetic Act. The FDA prohibits the marketing of adulterated or misbranded cosmetics. And what they will do is that they will enforce actions against companies that do not comply. One thing is that the FDA does not approved cosmetics before they hit the market. And neither do they prescribe a set of testing methods that manufacturers need to abide by. So it's really up to the responsibility of that manufacturer to make sure that they're producing a product that is safe for consumers. The manufacturers will do cosmetic safety tests. They will assess toxicology data for their ingredients and the products that they sell. Because if they don't comply the agency which is the FDA will take enforcement actions against brands and you really don't want the government to come down on you. And in terms of safety protocols there like a wide variety of established methods that a formulator can use Now, big companies will have teams of scientists in their research labs that are dedicated to safety testing. Or another option is to have like a third party lab that will conduct your safety tests. And many of these labs are accredited to the FDA will actually do inspections as well here. And in the product development phase, companies will conduct tests like stability, which you're going to assess. And with this test, you're going to assess how your product stands up over time. So you look at the cosmetics and the the integrity of the product. Is it separating? Is the color changing? Does it smell bad, so you're gonna do this stability test after specific intervals, like a week or two weeks or two months, you know, however you set that up. And then another test that a formulator can do is microbiological evaluation, to ensure that your product is not contaminated, while it's on the shelf for when it's being transported to the consumer. And even when they actually evaluating it as to how a consumer would use it. Because a lot of folks will dip their hands you know, the wet hands into a cream. So you want to make sure that microbes don't grow in your product. So a lot of companies will test how the product will uphold in situations like that. And in fact, the PC PC which personal care products Council just came out with updated guidelines a couple of weeks ago, maybe not a week ago, but a couple weeks ago. And in addition to this companies will also conduct clinical trials, such as the human repeat in South patch test. And again, they can either do this in house or via a third party. And then with this test evaluates a product's potential to cause irritation on the skin or sensitization. So all of this testing will be done in the product development phase prior to a cosmetic hitting the market just to ensure that safety has been established. And then I mentioned earlier that the FDA conducts inspection of manufacturing and research facilities just to make sure that all these safety protocols are in place during formulation and production. And a couple other things that I want to mention is that the the FDA has a list of prohibited and restricted ingredients for cosmetics on the website. And then they're really extensive restrictions when it comes to color additives like I make up for eye makeup that are used, used on the skin, especially for the eyes. So formulators can familiarize themselves with these lists when developing new products. And in addition to the FDA, the FDA works with the PCPC to publish what's called the cosmetic ingredient review. And this is really, really an important and fabulous website because it lists the safety profiles of cosmetic ingredients that are based on scientific and independent expert assessments. So if you're a new manufacturer in the industry, and you want to use a specific ingredient in your new serum, or your new moisturizer, you can go on there and you can identify any potential hazard for that ingredient. And again, these findings are based on peer reviewed scientific literature. And what the database will do it, we'll establish certain limits for certain ingredients. So you have this particular ingredient, but you shouldn't use it more than 2%. Or you know, or even point oh 1% in your formula. So you can look at that and get your safety data and your toxicology data. And then just across the border Health Canada, where a lot of American brands do business, they also have a very rigorous system and strict set of guidelines. They have what they publish the hot list. And you can find that on the Health Canada website. And it's just a list of ingredients that have restrictions for use in beauty products. And this is constantly being updated as new information comes out about ingredients and possible allergic reactions. And then a manufacturer or formulator can actually get some data from the ingredient suppliers themselves, they will have they should have saved MSDS is and relevant safety data for the ingredients that they're going to be selling to their clients. And then in terms of the for consumers. If the consumer experiences an adverse reaction to a an ingredient in a cosmetic, they can report that to the FDA or they can reach out to the manufacturer as well. The more You know, you know, that's what's going to help you. So they're pretty much three pillars that really keep brands accountable and formulators accountable. The regulator, the industry experts in the consumers. So I hope that answers your question. I know it was kind of long winded. It's so yeah, hear that? Yeah. Now we'll

Aaron Harmon:

take a quick break to hear from one of our sponsors.

Joni Ekstrum:

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Jeni Fjelstad:

I was just curious, like how does like public view and popular demands like maybe taking parabens out or like vegan in organic formulations? How does that affect that quality production side of making cosmetic products and making them safe?

Charmaine Rodriques:

Right, so let me first start with parabens. I mean, parabens are used in cosmetics as preservative. But I am not aware of any data that supports that a periban free formula will perform better than one without parabens. As I said, they've been used as effective preservatives for many years. And in the last decade or so there have been implications around the safety of parabens. And so many brands have chosen not to include parabens in their formula because of the uncertainty. And you know, I can understand that. So what gets around about parabens so consumers don't want parabens in their products either. There is nothing conclusive yet, the FDA does have a statement on on parabens on their website. And they're still investigating the health effects. But a formula without parabens, I don't think the data is there that say, you know, if you have the screen with Paramount and one without, you know, the one without is going to perform better. I know that parabens are very good in terms of being an effective preservative system, I don't know in terms of the actual efficacy of the product, if that makes a difference with the non periban formulations. But manufacturers are required to have a formula formulations that are safe and adequately preserved. I think like vegan and organic and naturals are some of the other terms that consumers are looking for. For those formulas that are vegan, organic or natural. I think that has more to do with ethics and sustainability rather than quality. These claims are based more on a brand's ethical values, then I would say establish product efficacy. I don't know of any research that says a vegan versus you know, a vegan formula is better than a non vegan one, it's more or less just what consumers want now, or where the ethics with the animal testing, and all that how a brand wants to present itself. When

Aaron Harmon:

you described all the stuff you guys work through to make sure that a product is safe before it goes out the door. That works. Like blew me away the amount of detail like what you're describing is what we do in the pharmaceutical industry. Right? And that's to other people. Are they surprised when they hear how much goes into into making sure these products are safe? Yeah,

Charmaine Rodriques:

a lot of people are very surprised. Because then you think about a cosmetic. And it's like fun and exciting. But your skin is the largest organ. So you know you have to take care of it and it has whatever you put on your skin has to be safe. So even though the industries itself is fun and exciting, but it is serious, because medics can do harm from the story that you mentioned earlier. So you know, you still have to have very scientific way about formulating your products and making sure that they're safe.

Aaron Harmon:

Yeah, no, that's that's pretty impressive. In terms like we talked about the FDA, there are other ways that cosmetics are regulated.

Charmaine Rodriques:

Yeah, so as I mentioned the FDA, through the Food, Drug and Cosmetic Act as well as the fair packaging and labeling act. These two acts are what the FDA use to regulate cosmetics. And as I mentioned, a lot of the responsibility lies with the manufacturers themselves. The Federal Trade Commission, in addition to the FDA regulates advertising for cosmetics, so the FTC will make ensure that companies are not making say medical claims on their cosmetics or claims that are misleading, like you can say this skin cream is going to cure your acne, there is an FDA monograph, Acme products are OTC products. So even though they have a cosmetic element in them, they're regulated as drugs. And so a cosmetic should never go into that space. You can say your cosmetic will heal your skin or make your skin clearer or something like that. So the FTC regulates cosmetics in that way, in terms of like, advertising, you see on TV advertising you see on the web, anywhere, cosmetic company will advertise this claim that the FTC will have jurisdiction over the advertising part of it. And the FDA does that too. In addition to the FDA and the FTC, you have the individual states that will have their own set of regulations. And that becomes a bit of a problem for a lot of brands, for example, a claim sorry, states like California, they're constantly adding new restrictions, when it comes to ingredients, or even issues like sustainability claims, they will have their own set of rules, say you can't use over a certain percentage of this ingredient, your product in say, if you want to sell in California, I'm just kind of making that out. So if you do that, you know a formula, or formulator has to decide, okay, you know, if I have more than that, does it mean I can sell in California, you know, and so they'll have to reformulate according to these updated guidelines. So regulatory folks like me and have to be knowledgeable, and the on top of the new regulations that are coming out with the individual states, especially if the brand wants to do business nationwide, when it comes to advertising, which is what I deal with a lot. We have the national advertising division, which is a self regulatory body that also governs advertising. And they kind of work closely with the FTC, even though they're self regulatory. There's a team of lawyers and they will do their own routine monitoring, if they see a cosmetic that's making a medical or health claim, they can pretty much challenge that advertiser and review the claims. Or, if the brand doesn't want to comply, they'll actually refer them to the FTC. And so that's happened before. And then the PCPC, which I mentioned before, the personal care products Council, they're also an industry group. And it's probably it's a, it's a trade organization that I would say represents most of the beauty brands, especially the big ones here in the US. And the PCPC helps to establish policies, and they advocate for cosmetic safety through scientific evaluations, and you know, they'll have meetings and they'll inform their brands of new regulations and just helping them to comply. And then last but not least, are consumers, consumers actually play a very big role in keeping beauty brands you know, they're like the quote unquote regulator. Keep beauty brands in line because they'll file class action lawsuits against brands if they feel like a brand is making a misleading claim, or if the brand is failing to provide a safe product for them. So consumers fall class action lawsuits if they experience hair loss with a hair product or if they use a product that burnt their skin or that irritated their skin. If they could find an attorney that could file a class action if they feel that especially if the product especially if the brand is making a claim on packaging that it's safe or hyper allergenic, then they will challenge those claims in a class action lawsuit. So that's pretty much it in terms of regulation here in the US.

Aaron Harmon:

How do you keep this all straight?

Charmaine Rodriques:

I know it's it's quite a bit that's why there are teams of you know, regulatory people working Yeah, just being on top of everything all the time. It's your scouring and making sure that nothing misses you. Wow, you're

Jeni Fjelstad:

so so knowledgeable That is so awesome. Thank you for sharing that. You mentioned something about like products being hypoallergenic like allergy tested the active ingredient in lash slur actually is like a well known allergen now. I'm so I'm just curious like how people should approach products to safely check if there may be allergic at all. Do it or perhaps there's like some allergy testing that goes into cosmetic quality testing nowadays pretty regularly.

Charmaine Rodriques:

Yeah, so that's a good question. If you go to say, a Sephora or an OTA, you'll see and you pick up a product, you'll see some of the claims are like hypoallergenic or allergy tested, you'll see those claims on some of the products. And that means that the products have been safety tested, and should cause fewer allergic reactions than other products. So this is typically done through some form of patch testing. And the product is applied repeatedly to the skin over a period of time to see if the consumer experiences irritation, or sensitization. And then so some brands will do this prior to a product hitting the market just to make sure that it's not going to cause an allergic reaction. Of course, there is no guarantee you right, because a consumer, you can develop an allergy anytime to ingredient in the product. The FDA legally requires cosmetics to have ingredient lists on their labels, so that consumers can you know, if you you know that you're allergic to a specific chemical, you can quickly check the ingredient list on your product to see if there are ingredients in there that you potentially be harmful for you or risk for you. All products, all products out there on shelves should have these ingredient lists, you can check the website to a lot of companies are putting have their ingredient list on the website, there's something there that you think could be of harm to you, then you shouldn't use that product. Or if Surprise, surprise, I used to scream free day. And now Hey, it's given me a rash, what do I do? So you can notify the manufacturer, you can reach out, you can look on your packaging, there should be an 800 number, some number where you can contact the brand. Or you can even go to the FDA website, they have a link there where consumers can report adverse events. it's importa t for consumers. And I kn w a lot of consumers are do ng this now they're reading ingr dient list. They're very knowle geable these days. So that's go d practice.

Aaron Harmon:

We're definitely in an age where it's very easy to transfer information, both customers to manufacturers and back and forth.

Charmaine Rodriques:

Absolutely. Absolutely. Now with the QR codes, too, you know, you can? Yeah, I mean, nothing should be hidden anymore. Yeah, it's all it's all out there.

Aaron Harmon:

So in the case of like lash lawyer, there wasn't many barriers at that time to keep that product off the market. And I say barriers, because I'll hear entrepreneurs refer to regulations and quality systems, like a barrier sometimes. But with everything you described, you know, what does that view a business that's well established and eventually gets products on the market?

Charmaine Rodriques:

Yeah, I mean, I would say, you know, you really don't have much of a choice these days, you just really have to have a safe product, regardless of the the barriers that are there. I mean, in this age of social media, I would say word gets around really fast about products. So if you don't adhere to the guidelines, and God forbid, somebody has a rash to your product, that's basically or an adverse event. That's basically it for you. I'm, I am part of a mommy group. And they actually do their own like, brand or product reviews, sometimes, you know, they recommend products. And it's back and forth, where you'll hear, you know, when mom say, oh, no, I don't like that, my my child to give my child a rash, or it smells bad, or it didn't work. So you shouldn't really view these regulations as barriers, I would say because you know, as especially for product safety, because when the age of social media, you really don't want consumers saying anything about it. Because pretty much reputation is what a lot of brands have, especially in a market that is so competitive means so many people are making moisturizers and serums. And, you know, how do you stand out? It's your reputation, really.

Aaron Harmon:

And like you mentioned earlier, the story of last year you hadn't heard about that? That's the case where someone died from a cosmetic and now that idea of someone dying from a cosmetics unheard of.

Charmaine Rodriques:

Exactly, exactly. Yeah. Yeah. Yeah. You really just have to be on top of it and and Think that nobody, no companies out here now you know, wanting to hurt consumer, that's where you're getting your you know that they're the ones who are keeping you in business. So, um, people, I would say, are vigilant. And I would say trying to be careful. So this like two way communication kind of between the producer of the product and then their consumers and the regulators, does that mean that the regulations or the standards for cosmetics are like changing more quickly these days? Or how often are they changing? I would say that they're changing pretty. I mean, I don't know, if quickly would be a term, but I know they're there. There's consistent change. As I mentioned, before, a couple of weeks, the PCPC just published new guidelines for the safety test that's being done. So I mean, when it comes to companies that do business in Canada, you know, Health Canada, they're constantly updating their hot lists. They're constantly updating their regulations there to make products safer. And so if a company wants to do business across the border, they're constantly having to change companies that do business in Europe, it's the same things, too. You know, a lot of brands here sell in Europe and China, and those regulations are changing quite quickly. The FDA is actually looking to change some regulations with sunscreen and sunscreen safety. So that's going to be updated soon. So I would send and one more thing, there's a I believe there are four new bills, I believe those are in California, don't quote me on that, that are coming out about cosmetic safety. And so we don't know if those are going to be passed yet. But they were introduced. So yeah, I would say it's, it's changing. It's constant. It's constant. That's a good thing. Yeah, it is a good thing. As we learn more. Yeah, it may not be such a good thing for you know, companies, because you're constantly having to form you know, reformulate. And so it can be challenging. But as we get new information, you know, it's it's important that in terms of like keeping your consumers safe, that's really important. Jenny, was there any other questions you want to ask? I think that pretty much got it all covered from what I was really curious about. I'm so glad that you came here today to share all your knowledge, you know, so, so much about the cosmetics industry. So I'm so glad to have a couple moments to learn from you today. Thank you, Jenny. It was a pleasure being here. Yeah. Yeah, it's a it's a wonderful industry. I enjoy being in it. I actually can't see myself in another industry right now. But you know, it's really exciting and good to be able to work in an area where you actually use the products. So it's, it's exciting. It's fun. That's great. That's, I think there's a certain amount of joy you get as somebody who works in the space of bringing products to market when you can go into a store and see your product on the shelf. Absolutely. Yes. That is that that's that's a big deal for me. Yeah. When you can walk into this for Neiman Marcus, and then you see the brands that you work on on the shelves. Yeah, it's like gives you a little bit of joy. Thank you for being on the episode. Thank you, Erin. Thank you for having me. Thanks for listening to this episode, and stay tuned for our next one. We hope you enjoyed this episode. This is brought to you thanks to South Dakota biotech Association. If you have a story you'd like us to explore and share, let us know by visiting www.sd bio.org. Also, if you live in the Sioux Falls area, check out quit a local Quality Assurance Professionals Network. You can find out more about QUIBIT by clicking on the link on our website too. Thanks for listening