Is Your Skincare Routine Subject To False Advertising?
Updated: Sep 15, 2019
Have you ever bought a skincare product that claimed to do amazing things, like make your skin perfect or erase your wrinkles, only to have it do nothing special or even make your skin worse? I know I have! You may have a sense that there are laws to govern what a company can claim about its products. Drug makers have to go through many hoops and spend a lot of money to prove to the FDA that a drug does what it’s intended to do and that it’s safe, though perhaps with known side-effects that must be disclosed. Cosmetics makers don’t have to test their products the way drug makers do and they’re allowed to use controversial ingredients that are banned in other countries, including formaldehyde, talc, and hydroquinone.
While the FDA regulates the manufacturing of prescription drugs, it only regulates the labeling and marketing of cosmetics products (and addresses adulterated or contaminated cosmetics). It is illegal for the labeling and marketing materials associated with a cosmetic product to include what are called “drug claims.” A drug claim is a claim that a product does something to alter a function of the human body. Some examples of drug claims are “antiperspirant, anti-wrinkle, and “treats eczema.”
The Handcrafted Soap and Cosmetics Guild sells a book by Marie Gale, an expert in FDA regulations for cosmetics and author of the book “Soap and Cosmetics Labeling.” According to Ms. Gale it's a drug claim to say that a cosmetic is “antioxidant.” When you buy skincare products you often see the word “antioxidant” on labels and in ads. Phrases like “anti-redness”and “anti-bacterial” are also drug claims and should not be used in reference to cosmetics and skincare products.
I was in a beauty store not long ago that specializes in non-toxic and natural products. I counted six products with "antioxidant" on the label, and a couple which claimed to be “age defying”and “anti-wrinkle.” There were also claims of “cellular repair,” and some which said a product was “anti inflammatory,” or “reduces pigmentation.” Even if these claims were true based on testing, they would still be illegal to put on a product being sold as a cosmetic. Some natural ingredients that are often used in cosmetics have benefits that are widely acknowledged, but that can’t legally be mentioned because they would be drug claims. For example, raspberry seed oil is thought to provide a low level of sun protection and chamomile essential oil may reduce redness.
If the intention of a product is to do something that by definition would make it a drug, then by law it needs to be marketed as a drug or as a cosmetic that contains approved drugs - in which case the drug ingredients would have to be listed separately as “active ingredients,” the way you see on products with sunscreen. Now that I know about these laws, I’m quickly turned off as a consumer by companies that are not compliant, and as a cosmetics maker it’s upsetting to see the competition get away with breaking the law and in many cases deceiving the public. The FDA does not have the resources to enforce these regulations, which is one reason there are so many violations that don't get addressed.
I recently had the opportunity to interview Marie Gale about some of the nuances related to the FDA regulations of cosmetics labeling. Here's our full Q&A:
SP: I've read your book, Soap and Cosmetic Labeling, and understand that FDA regulations prohibit makers from putting drug claims on cosmetic product labels or marketing materials. I also understand that in some cases a cosmetic product may contain FDA-approved drugs and that in those cases the ingredients which are approved need to be listed as "active ingredients" on the product label to meet the FDA regulations. I have a few questions related to this: MG: A cosmetic can, occasionally, be both a drug and a cosmetic. An example would be a cream for treating acne. In that case, the "drug" part must be an approved drug and it must be manufactured by an approved drug-manufacturer. SP: Are there any other conditions under which it would be compliant with FDA regulations for a cosmetic product to have drug claims on its labeling or marketing material, such as the product had certain tests performed on it? (A reason I ask is that it was suggested to me that this could be so when I shared an example of a company making drug claims on a cosmetics product with some fellow makers) MG: No. In order for the product to be intended to treat, cure, mitigate, prevent or diagnose a disease or physical ailment, it must be approved as a drug OR meet the exact specifications for an over-the-counter drug. In either case, it must be manufactured by a registered drug manufacturer in an approved facility. SP: Can a retailer be liable for selling products that violate the FDA laws? If so, do you know any examples of a retailer being held accountable by the FDA for this? MG: No. The responsibility falls to the manufacturer. That would be the person/company whose name is on the label. SP: Can a beauty blogger or magazine be held accountable for talking about a cosmetic product in a way that promotes drug claims? Do you know any examples of a blogger or magazine being held accountable by the FDA for this? MG: No. It's possible that the manufacturer might be held accountable if the FTC determined that it was "false or misleading" advertising for the product. Note: unapproved drug claims are considered false or misleading. SP: Is a cosmetics maker liable for customer comments (on product webpages) that contain drug claims?
MG: Yes. The manufacturer is responsible for what consumers view as the intended use of the product. If the manufacturer allows comments that show that the intended use is as a drug (that is, to treat, mitigate, prevent or diagnose disease or to alter the function or structure of the body) and that's what informs new consumers, then the manufacturer is promoting their product as a drug - even though someone else said it for them. SP: As a consumer and maker of skincare products, I notice a lot of companies putting drug claims on their labeling and marketing materials. I understand the FDA has limited resources to keep up with monitoring the industry and enforcing its regulations. If a consumer notices a company selling a cosmetic product with drug claims on the labeling or marketing material, do you think that should raise a red flag against using that company’s products? Can you talk about why or why not? MG: First, keep in mind that many of the large cosmetic companies do, in fact, make products that are legally both a drug and a cosmetic. You can tell because it is appropriately labeled as a drug (with the active ingredients, and other required statements). That said, when a product is marketed as a cosmetic but clearly the intended use is as a drug, the product is an unapproved new drug, and so illegal. I consider any company operating illegally and selling an unapproved new drug to be suspect. I personally wouldn't buy from them. Obviously there is a difference between "tea tree oil treats acne" to "this blend of essential oils cures cancer" .... but they are both on the same scale and are both illegal. An educated consumer can make informed decisions based on the ingredients in the product. If I think that a product with tea tree oil will be good for my skin and will be a good antibacterial, then I look for a product that contains tea tree oil. But I am informed, and I know the difference between when tea tree oil might be appropriate and when a proven antibiotic would suit. The other side of that coin is that an UNeducated consumer, when told that tea tree oil is "antibiotic," would be unable to determine if a trip to the doctor for a proven antibiotic would be the better course. It is unfortunate that in our society there are those that can't tell the difference --- and those are the people who could be harmed by products that make unproven drug claims. SP: Do you think that companies which violate the FDA regulations intend to deceive consumers?
MG: Sometimes. There are those that actively seek to deceive for as long as they can to make the biggest profit they can before they are shut down. An example (although not a cosmetic) are the "dietary supplements" to enhance "male vigor" that actually contain Cialis or Viagra. The intent there is obviously to deceive and make a quick buck. Then there are those that "don't see any harm" in making "supposedly true" statements (like tea tree oil being an antibiotic, or lavender curing insomnia). They know it's illegal, but it's "harmless". Unfortunately, it isn't harmless to the person who tries to treat an infected cut or a systemic infection with tea tree oil. However, much of the time it is lack of education. Most (but not all) of the handcrafters I have dealt with are sincerely trying to stay legal and are more than willing to correct errors. Not only do they want to serve their customers well, they want the peace of mind to be able to sleep at night knowing they don't have to be watching over their shoulder for the inspector to come knocking. SP: I'm also curious about the process that takes place when the FDA pursues a cosmetics maker for violations and have a couple related questions: What happens when a cosmetics company gets an FDA warning (for violating labeling or marketing regulations)? Can they continue selling the same products with the same labels and marketing? At what point would a company get fined by the FDA? MG: Generally, the first step is that the FDA contacts the company in question and often performs an inspection. If the issue (whatever it is) is resolved, no further action is taken. If it doesn't resolve (or maybe if it's a big issue), a warning letter is issued. The warning letters are public - so any customer could look it up (often they come up in a google search for a company name). The company has a set time to resolve the issue(s). After that point, the FDA has to resort to the courts for fines, misdemeanor or criminal charges (usually related to something other than the actual label). Misbranded or adulterated products (that is, mislabeled or contaminated products) cannot be sold ... so you can't continue selling with the same labels. Also keep in mind that each STATE has similar regulations. A great deal of the time it is the STATE that comes knocking, not the FDA. States may have different methods of enforcement. SP: How would a consumer know if a company had received a letter from the FDA? MG: A google search for the company name, "warning letter site:fda.gov" would likely pull it up. All of the warning letters issued by the FDA are available to view by date on the FDA website as well. Each state may have some method for looking up their warning letters, but that varies from state to state, so I can't give any suggestions there. SP: Do you have a sense of how much the fines are that the FDA levies against cosmetic companies which violate the regulations? MG: It is my understanding that actual fines have to go through the court. I don't have any data on amounts or the process.
Additional commentary from Marie on the topic of "anti-aging" claims: " the FDA has recently backed off on their stance for "anti-aging" and "age defying" type claims. They used to be something that the FDA would look for in imported products and would reject the import if the claims were made. That guideline has been quietly removed. Once legal article I read pointed out that the view of consumers is changing, so there is an argument that a consumer "knows" that a cosmetic isn't a true fountain of youth and so just consdiers that type of claim to be "marketing hype" rather than an actual medical claim."
Thanks again to Marie Gale for participating in this interview with me!