It may surprise the average consumer to know that skin care products — with their immaculate package designs, breathless marketing campaigns, and glossy magazine ads — are largely unregulated by the FDA.
Cosmetics and skin care products are a big business.
Each year, moisturizers, wrinkle creams, dark-spot removers, and other skin enhancement products bring in billions of dollars.
So it may surprise the average consumer that those products — with their immaculate package designs, breathless marketing campaigns, and glossy magazine ads — are largely unregulated.
Congress passed the Federal Food, Drug, and Cosmetic Act more than 80 years ago, putting cosmetics under the purview of the Food and Drug Administration (FDA).
Since then, the law has largely been untouched while the cosmetics industry has grown dramatically.
Today, only color additives in cosmetic products require FDA approval. The regulatory body is hands-off, so long as the language around a product’s promises is worded correctly.
“The FDA defines a drug as any article that intends to ‘change the actual function or structure of an organ’ — in this case, the skin. As a drug, the product must get premarket FDA approval, prove safety, and efficacy,” said Dr. Fayne Frey, a dermatologist and dermatological surgeon in West Nyack, New York.
“A cosmetic, however, cannot intend to actually change the skin but rather change the ‘appearance’ of or adorn the skin,” Frey added.
Frey cites products that increase water content to make skin more hydrated — or rather, to make skin appear more hydrated.
“Increasing water content, for example, temporarily improves the appearance of skin — think of a raisin being pumped with water appearing more like a grape. The FDA considers products that temporarily increase water content of skin, or moisturizes, [as] cosmetics,” Frey said. “They do not require FDA approval, and do not need to prove safety or efficacy.”
Indeed, Frey says the “overwhelming majority” of over-the-counter skin care products — the things you buy to moisturize or reduce wrinkles, hide dark circles, or reduce sun damage — are cosmetics.
“As such, they cannot, legally, claim to change the skin,” Frey said. “For this reason, marketing of products is limited to phrases like ‘decreases the appearance of fine lines’ rather than ‘gets rid of fine lines.’”
How, then, is the average consumer meant to filter through the stream of claims that are used to promote the myriad of products?
The first step is to know what they mean, says Dr. Manish Shah, a board-certified plastic surgeon in Denver, Colorado.
“As with most marketing, the claims hit customers the right way emotionally,” he said. “If a customer can identify with a problem, and the product claims to improve the problem, sales will increase.”
Shah added, “The claims aren’t lies, but they aren’t really truths either. Some patients will actually see the intended improvements.”
Here, we explain the most common marketing claims, what they really mean, and what you need to know about finding products that are right for you.
This claim may mean one or more of the ingredients is derived from a plant, Shah says.
It could also mean something in the product is synthetic but acts similar to a plant-based ingredient. It’s a feel-good claim, especially as people are seeking out more “natural” products over synthetic.
“‘Natural’ ingredients may imply where the ingredients come from but discloses nothing about the safety of the ingredient,” Frey said. “While most consumers can apply personal care products that claim to be ‘all natural’ without any ill effects, some plant-derived ingredients can cause severe reactions in those with allergies.”
“That’s a way to show that perhaps their product is unique compared to their competitors,” said Dr. Susan Bard, a board-certified general and procedural dermatologist in Brooklyn, New York.
“Unique, however, doesn’t necessarily mean better or even effective.”
Any product can provide a temporary boost of moisture or have a quick “firming” effect, but those results may fade shortly, Shah says.
You want products with long-term results, which isn’t as sexy a claim as “instant.”
You pick up a bottle of firming night cream because you want your skin to look tauter, but that claim means essentially nothing, Shah says.
“There is no objective way to measure firming. When a brand says their product has been shown to firm your skin, that claim can only be based on very subjective consumer perception,” he said.
“Maximum strength refers to products that provide a higher concentration of the active ingredient than the regular strengths,” said Dr. Erum Ilyas, a board-certified dermatologist in Pennsylvania. “However, this is not necessarily referring to buying the highest strength available.”
Ilyas says this claim can be misleading for people looking to get more effectiveness from high strengths.
“After trying a ‘maximum strength’ without a response, there can be an assumption that even that didn’t work,” she said.
A step up from “maximum strength” might be “clinical strength.”
But “this is still likely going to fall short of prescription strength,” Ilyas said.
Package designers may try to trick you into thinking their product is more legitimate by using clever design elements like test tubes or even a first-aid cross.
This can suggest to you that this product has a prescription-strength formula, even though it’s sold over the counter.
Anti-aging or age-defying
“‘Anti-aging’ in my opinion is the most brilliant marketing term on skin care product labels,” Frey said.
Over-the-counter anti-aging, age-defying, or revitalizing products may increase hydration and temporarily reduce the appearance of very fine lines, “but pronounced wrinkles and skin folds cannot be corrected by moisturizer application,” Frey noted.
If they could change the structure of the skin, she adds, they’d be classified as drugs, and they would need approval from the FDA.
The FDA only approves products that are drugs and make claims that they will change the function of the skin.
Beyond that, the FDA approves no element or claim of skin care products before they hit the market. They just stipulate that the product being sold is safe to use in the manner in which the manufacturer says.
“FDA approval is not a credential that shows the superiority of results,” Shah said.
Bard says looking for this faux stamp of approval isn’t necessary. “Just because something may not be approved doesn’t necessarily mean it’s bad and vice versa,” she said.
For all skin types
You may want to steer clear, Bard says. “Rarely is anything truly for all skin types. But as with any product, trial and error is key.”
Deciphering claims and promises will help set expectations for what your skin care products can do. Then, you can learn to understand what the product is actually telling you.
“I educate my patients to look at ingredient labels more so than the front of the package,” Ilyas said. “Look for products to contain certain ingredients that we know based on medical studies are effective. Look for percentages as well.”
Your dermatologist can direct you to products and ingredients that will help address your skin concerns.
“There’s a big difference between a product that has salicylic acid versus one that says it has 2 percent salicylic acid. It could be just a splash or sprinkle of an ingredient you use but not enough to have a clinical effect.”
You can — and should — look for results, too.
Some brands will offer “clinical studies” that show significant results in just a few weeks. Those don’t mean much, Shah says.
“The best thing that companies can do when marketing their consumer-targeted skin care products is to show visually accurate ‘before and after’ photos of patients who’ve used the products consistently for more than six months, especially if claiming improvements in collagen content or complexion correction,” Shah said.
“A picture is worth a thousand words, and consumers can feel comfortable knowing that a product actually works by seeing actual results.”