JAIME: Welcome to Outgrowth: A Slice of Pro Beauty with your hosts Jaime Schrabeck.

ASHLEY: And Ashley Gregory Hackett. If a beauty product is on the shelf, we assume it has been safety tested and approved, but is that reality?

JAIME: To understand how the government protects our safety, we’re joined by Dr. Linda Katz, Director of the FDA’s Office of Cosmetics and Colors. Let’s grow together.

JAIME: Welcome to Outgrowth, Dr. Katz.

DR. KATZ: Thank you very much, Jaime, for inviting me to speak today about cosmetics at the FDA.

JAIME: By way of introduction, would you please share with us your training and background and how you came to serve in your current position?

DR. KATZ: Sure. I am the director for the Office of Cosmetics and Colors. My background is as a physician. I’m board certified in internal medicine, rheumatology,  and I have been with the Food and Drug Administration for over 30 years, first starting on the drug side, and now in the Center for Food Safety and Applied Nutrition in my current position for the last 17 years.

ASHLEY: Would you be able to help us by describing the role of the Food and Drug Administration in regulating cosmetics?

DR. KATZ: Sure. The Food and Drug Administration regulates cosmetics under the authority of the federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act. Under these laws, the cosmetics have been regulated and under the law cosmetics must not be adulterated, meaning that they cannot contain poisonous or deleterious substances making them harmful or injurious under labeled or customary conditions of use, or misbranded which means that they must be truthfully labeled, not contain false or misleading information, and that they must contain all of the information that is required by law for them to be used safely. The FDA does not have the legal authority to approve cosmetic products or their ingredients before they go on the market with the exception of color additives other than coal-tar hair dyes. Thus, our authority is all post-market. Cosmetics must be safe for consumers when used according to directions on the label or in the customary or expected way. And they must also be properly labeled as I’ve mentioned before. Companies and individuals who market cosmetics have a responsibility for the safety and the labeling of their products. The FDA can take action within our legal authority against a cosmetic on the market if we have reliable information showing that it is adulterated or misbranded, and the FDA can take enforcement actions such as issuing warning letters or requesting a product recall for violative products. The law does not provide for FDA to have a mandatory recall authority, but we can request a voluntary recall of problem products.

JAIME: Dr. Katz, why is it that color additives receive this special consideration in terms of the regulatory process?

DR. KATZ: Basically, color additives that are used in FDA-regulated products including cosmetics are subject to a strict system of pre-market approval under the Food, Drug and Cosmetic Act. Each color additive must be listed in the Code of Federal Regulations for its intended use before it may be used in products marketed in the United States regulated by the FDA. A color additive, thus, can only be used for the product commodity for which it’s allowed and stipulated in the CFR itself, or again, the Code  Federal Regulations. Failure to do so may make the product adulterated.

ASHLEY: So Dr. Katz, what exactly is the color additive approval process? 

DR. KATZ: The color additive approval process is accomplished through the FDA’s color additive petition process. A batch certification is required of certain color additives  because their composition needs to be controlled to protect the public health. The exception of cold-tar hair dyes, which are exempted from pre-market approval requirements by law, failure to meet US color additive requirements causes the cosmetic to be adulterated. Color additive violations aren’t common cause or reason for detaining imported cosmetic products offered for entry into the country.

ASHLEY: I’d like to know a little bit more about the importance of product labeling. We know that federal law requires an ingredient list for products sold to consumers, but not necessarily for salon use which is really pertinent to our listeners’ interest. So if you could tell us a little bit more about the Fair Packaging and Labeling Act and why it applies to some products and not others.

DR. KATZ: The Fair Packaging and Labeling Act basically applies to cosmetic products  that are sold via retail. It does not provide for stipulations for labeling for products that are deemed as, or identified as, being professional products. So under the Fair Packaging and Labeling Act, that there are certain types of ingredients, it stipulates what kind of ingredients as far as the labeling of these ingredients, and also provides for certain modifications, such as for fragrances and flavors. Under the FPLA, they get special treatment with regard to labeling by virtue of those provisions. Well, in most cases, each ingredient must be listed individually and in a cosmetic, it’s listed by descending order of predominance in the ingredient declaration itself. Flavors or fragrance may also be labeled, but they can simply be labeled as fragrance or flavor. That is because both fragrance and flavors may consist of up to several hundred different distinct ingredients in very small quantities and because some companies may regard these mixtures to be trade secrets. However, the labeling system may also pose some problems for individuals themselves, particularly those who are sensitive or have allergic reactions to certain ingredients. We have been working with industry and the major cosmetic trade organizations, such as Personal Care Products Council, an international beauty association formerly known as ICMAD, to have manufacturers voluntarily label their products with known allergen ingredients that might be contained within them. Some firms that market their cosmetics in the United States do list the fragrance ingredients on their product labels, especially, again, if they know that one of these ingredients is a known allergen. We’ve also developed on our own webpage information about potential allergens and ingredients commonly associated with allergic reactions.

JAIME: As beauty professionals, we’re always trying to be aware of the ingredients that are contained in the products that we’re using in the salon setting. Does the FDA require that every product have a safety data sheet?

DR. KATZ: With regard to the safety data sheet that you’re referencing, the FDA does not require the presence of the safety data sheet. This is actually something that is required by the Occupational Safety and Health Administration or OSHA, and they require that products with hazardous chemicals have a safety data sheet, SDS, or formerly known as the material safety data sheet MSDS, to communicate information on hazards associated with these products. So that, again, this is an OSHA requirement.

ASHLEY: Why hasn’t the FDA defined some commonly used marketing terms that we hear all the time in beauty like organic or cruelty-free?

DR. KATZ: The term organic has been defined for agricultural products and it’s regulated by USDA’s National Organic Program, also referred to as NOP which certifies agricultural products. Any cosmetic product labeled with organic claims must comply with both USDA regulations for the organic claim and FDA regulations for labeling and safety requirements for cosmetics. Claims such as natural, green, clean, cruelty-free or not tested on animals, hypoallergenic for sensitive skin, or allergy testing have essentially no regulatory meaning. The FDA is aware of the frequent use of these kinds of terms and is considering how best to address them.

JAIME: Given your long history with the agency, has the preponderance of these claims really proliferated more recently?

DR. KATZ: The use of these claims has been proliferating over the last probably 15 years or more, and we see this not only for cosmetics, but in other FDA-regulated commodities.

JAIME: Dr. Katz, how do problematic products even come to your agency’s attention?

DR. KATZ: Potentially problematic products come to our attention in a variety of ways, including information from consumer complaints, adverse event reports, published literature, media, other regulators from different jurisdictions, industry complaints, et cetera. Basically, when the agency’s aware of a potential problem, which may include contaminants such as lead or harmful microorganisms that are found within the product  or other concerns about a particular ingredient, the FDA will analyze the products further to see what’s in them. We also review for patterns to help us to do our job a little bit better. When the FDA performs the surveillance testing, products are selected either randomly or more focused and as such, when we suspect a problem with the ingredient or the product, as I’ve mentioned before. If a problem is suspected based on surveillance testing, adverse events reports, or other factors, we may elect to further investigate with a formal investigation and this would include an inspection of manufacturing and other facilities, evaluation of the manufacturer safety data is provided, and further testing of products. In addition, we do encourage consumers and other salon professionals who have experienced a problem with an FDA-regulated product to contact us. Problems can be reported to the FDA by completing an electronic voluntary MedWatch form online, by completing a paper voluntary MedWatch form, or by calling an FDA consumer complaint coordinator in the area where the problem may have occurred. The information that we obtain is often used to help us to support our actions including consumer alerts, the issuance of guidance for industry, as well as any enforcement actions that might be appropriate including warning letters or requesting a product recall if there are specific safety concerns.

JAIME: If it were to get to that point, who’s held responsible for any of those dangerous or, I suppose the agency could outright ban a product, is it the manufacturer, the distributor, or perhaps an individual selling it?

DR. KATZ: Manufacturers, packers, distributors, and retailers are responsible for assuring that he or she are not dealing with products that are adulterated or misbranded  even if someone else caused the adulteration or misbranding in the first place. FDA is responsible for regulating the products subject to interstate commerce. The vast majority of cosmetic products being sold would fall under FDA’s jurisdiction or authority. Thus, anyone introducing a cosmetic product into interstate commerce or receiving it in interstate commerce is responsible for the safety of the product and can be held accountable. The law applies to components and packaging as well as to finished products. And in addition, for those of your listeners wanting more information regarding manufacturing, I would recommend that they refer to our draft guidance for good manufacturing practices that can be found on our website.

ASHLEY: So does it make a difference then where a product is manufactured or where it’s packaged or sold? Many in our industry, we know the evolution of beauty. You start out as a beauty provider, you open your own salon, and then it seems like the pinnacle is having your own brand. So if we aspire to formulate and manufacture our own products, what is our level of exposure or what advice do you have for someone in that position?

DR. KATZ: Basically, in terms of what to do, I do recommend that you have your  salon professionals pay attention to what’s available on the FDA’s website. Look at our good draft good manufacturing practices, but in terms of the liability issues, that actually goes beyond what I can actually discuss at this time.

JAIME: Ashley, if you would agree with me, I think a lot of our colleagues would feel shielded from any of this if they’re just mixing something up in their kitchen.

ASHLEY: Definitely, which is very common in the beauty industry, but I would love to know since a lot of beauty products are manufactured outside of the United States, Dr. Katz, if you could share with us, does that make any difference in the amount of regulation or penalties something could receive?

DR. KATZ: Let me kind of go back a little bit again and just to kind of reinforce or re-emphasize. The companies and individuals who manufacture or market cosmetics are responsible for the safety of their products. If the FDA does become aware of a cosmetic product that is contaminated or otherwise shown to be adulterated, or if the product has labeling violations making it misbranded, then the FDA can take regulatory action. When taking enforcement action, the FDA must prove that the cosmetic is adulterated or misbranded. And that situations, again, regarding liability, as I mentioned before, are beyond the scope of FDA’s regulatory authority. With regard to products coming in from outside of the country, the FDA works closely with the US Customs and Border Protection to monitor cosmetic products. Imported cosmetics are subject to examination by the Customs and Border Protection as well as FDA at the time of entry. Imported cosmetics that appear to be adulterated or misbranded may be refused entry into the United States. They must be brought into compliance, destroyed, or re-exported if there are significant problems. Import refusals are listed in the FDA’s website, and are updated monthly, and so that we have a full listing of all of the import alerts, and why different products would be detained.

JAIME: Dr Katz, there are some broad categories of products that we’re most interested in getting your feedback on, and not to mention any brand names, but the category of product that first comes to my mind are lash and brow tints. Is there anything that you can share about that?

DR. KATZ: Currently, there are no FDA-approved color additives for the dying or tinting of eyebrows or eyelashes, either by professionals or consumers at home. The FDA cautions consumers about the potential health hazards that can result from engaging in this practice and using these products. One ingredient in particular, paraphenylenediamine PPD, which is an ingredient found in many coal-tar hair dyes, particularly those of dark colors, is a potent sensitizer known to cause severe allergic reactions as well as cross-sensitivity reactions, and as a result, is not recommended for tinting. In 2018, a color additive petition was submitted for the use of silver nitrate in professionals-use-only cosmetics to color eyebrows and eyelashes and this is still currently under review.

JAIME: So, if I’m to understand correctly, up until this point, there hasn’t been an ingredient that would be approved that would accomplish this task of tinting lashes and brows because of the proximity to the eye, that’s the concern?

DR. KATZ: That’s the concern and some of the ingredients that have been used  actually contain ingredients that might be harmful potentially if they get into the eye during the process of dying or tinting.

JAIME: And does henna fall into this same category?

DR. KATZ: Henna falls into the same category. In fact, henna is approved for use only as a hair dye, not for coloring the skin or the lashes with the dyes. Often, you can see black henna that’s used for temporary tattoos and again, the same problem as I mentioned with the tinting for the brows and the eyelashes. Black henna contains PPD or paraphenylenediamine, and again, by it being a very potent sensitizer, it’s not recommended that it be used, particularly for tinting or dying.

JAIME: Not to leave out any of our colleagues in other parts of the industry, what about products that are intended to straighten hair, but then release formaldehyde.

DR. KATZ: This is another area that we’ve been following very closely and that we know that it is of interest to the salon professionals as well as many consumers. That not all hair smoothing or straightening products do contain formaldehyde, but those that can release formaldehyde do so when heated, when applied to the hair and then the hair is heated with a heating iron. What is released is formaldehyde into the air, and formaldehyde again is a known carcinogen. Breathing in formaldehyde can be harmful and cause immediate reactions including irritation of the eyes, scratchy throat,  coughing, wheezing, and other things that may also cause or nausea, vomiting, skin rashes, as well as chronic problems. Since about 2010, FDA has regularly been communicating with the public and salon professionals about the potential of formaldehyde for skin sensitivity reactions and certain types of cancers, and how to recognize products containing formaldehyde or its liquid form formalin and ethylene glycol. Formaldehyde containing hair products, if used, should be used in a well-ventilated area. Salon workers and their customers should also be careful to avoid formaldehyde, especially if they are sensitive to it, have asthma or other respiratory concerns. Additionally, we have recommended that consumers or customers ask their salon professionals about the ingredients in these products prior to use in order to help them make a better informed decision as to what kind of a product they may or may not want to use. We have a website which contains information that was useful for salon workers, as well as consumers. And more information about these products can also be found on OSHA’s website, which include some specific information and advice,  specifically for salon workers and salon owners.

JAIME: Not to leave out the nail professionals who are using gel polish products, and in order to remove them, may be using products that contain methylene chloride, is this  something that’s come to the attention of the FDA?

DR. KATZ: It has, and we’ve been monitoring, and also again, putting information on our website to make sure that consumers and the salon professionals are aware of it.

ASHLEY: Outside of what we’ve addressed here in these last few questions, Dr. Katz, are there any other trends or emerging product categories that the FDA has taken notice of and that are concerning to you?

DR. KATZ: Some other categories that we’ve been looking at have included tattoo inks,  as well as following talc use in cosmetic products for asbestos contamination. In both of these areas, we have updated our website to provide useful information to consumers, and we have recalled a number of products that we found have been contaminated with microbial contamination for the tattoo inks, and a full listing can also be found on our website for the talc products. There have been some voluntary recalls as well and these are also listed on our website. Our webpages are kept up to date and are a useful source of information for consumers as well as for salon professionals.

JAIME: To facilitate the access to that information, we’ll make sure to include all of that information in our show notes, Dr. Katz.

DR. KATZ: Sounds great. And the other thing is that I want to encourage again consumers and the salon professionals is that if they see an adverse event reaction or they know of someone that has had one to please report that information to us. The more information we have the better. It helps us to do our job to make sure that safe products stay on the marketplace and those that may have problems can be dealt with appropriately. I also want to mention that we do have a presence in social media, that we have an OCAC Twitter account and that you can also find us via Facebook through FDA’s USFDA page.

ASHLEY: Well, you have given us so much to think about and I’m very excited that there are resources accessible to the public as well as the professional community that we make up. And I just want to thank you very much on behalf of Jaime, as well, Dr. Katz for your time today and for all of your great knowledge. Thank you.

DR. KATZ: Sure and thank you very much. I hope that that’s helpful for the salon professionals as well.

JAIME: Thank you, Dr Katz. If you’re enjoying Outgrowth, leave us a review on Apple podcasts with just one click. Visit bit.ly/outgrowthpodcast.

ASHLEY: And as always, you can follow us in comment on recent episodes on Instagram at @outgrowthpodcast.

JAIME: Ashley, I need to go read some labels. 

ASHLEY: I think this just drives home the importance of knowing what kind of products you’re using especially on clients and what types of ingredients they contain.

JAIME: And if you’re not sure about a particular ingredient, those resources from the FDA are going to prove really useful.

ASHLEY: Definitely. Well until next week, be smart.

JAIME: Be safe.

ASHLEY: Bye.

JAIME: Bye