DOES THE FDA REGULATE COSMETICS?
I hear time and time again..."The FDA doesn't regulate cosmetics."
"Beware! Beauty products are unsafe and unregulated."
False and false.
In the U.S.., to ensure the safety of cosmetic products, the U.S. Food and Drug Administration (FDA) regulates the cosmetics industry. Using science-based information, the FDA has broad regulatory authority under the Food, Drug and Cosmetic Act (FD&C Act) passed by Congress in 1938 and amended many times since.
Here is where the confusion occurs. Unlike drugs, the FDA does NOT approve cosmetics (see Cosmetic vs. Drug). It is the legal obligation and responsibility of the manufacturer to assure that their cosmetic product is safe when used under customary conditions and that the product is appropriately labeled. The law states that it is illegal to sell adulterated or misbranded cosmetics.
What is an adulterated cosmetic?
An adulterated cosmetic is one that...
- contains any poisonous or harmful ingredient, which may be harmful when the product is used as described on the label.
- contains any filthy, putrid, or decomposed substance.
- is packaged, prepared or manufactured in unsanitary conditions where it may be contaminated with microbial organisms or any substance that renders the product harmful to the consumer.
- is packaged in a container that is composed of poisonous or harmful substances that renders the product harmful to the user.
- is not a hair dye but contains an unsafe color additive as determined by the FD&C Act.
What is a misbranded product?
The FD&C Act defines a misbranded product as ont that...
- contains misleading or false information on the label.
- does not contain the name and place of the business of the manufacturer, packer or distributor on the label, the quantity of contents in terms of weight or measure.
- does not contain any prominently displayed required information in an easy to read and understood fashion by an ordinary individual under customary condition of use.
- is packaged in a misleading container.
- is a color additive and does not fulfill the packaging and labeling requirements of such color additives.
- has packaging and labeling in violation of the Poison Prevention Packaging Act of 1970.
The FDA has the right to enforce any of these regulations. FDA inspectors can inspect any cosmetic manufacturing plant or office at any time without notice. The FDA has the authority to:
- Restrict or ban cosmetic ingredient usage for safety reasons.
- Mandate warning labels on cosmetic products.
- Issue warning letters to manufacturers, packagers or distributors.
- Seize illegal products.
- Stop unlawful activities.
- Prosecute violators of these laws.
- Collaborate with companies to implement product recalls.
Although the FDA doe not "approve" cosmetics, the FDA absolutely regulates the industry. Enjoy your cosmetics!
IS SUNSCREEN BURNING YOUR EYES?
The skin around the eyes is the thinnest skin on the body (approximatley 0.5 mm thick.) It also happens to be a common site for non-melanoma, sun induced skin cancers, like basal cell carcinomas. Although the concave areas of the corners of the eyes may seem protected from direct sun exposure, light that reflects off of the brow and other orbital bones, ultimately hits this area which may explain the propensity for skin cancer formation at this site.
Many users simply forget to apply sunscreen around the eyes. Others opt not to due to burning or stinging in the eyes when the sunscreen is applied in that area.
Sunscreens commonly contain ingredients that may irritate the eye itself. Fragrance, the active ingredients in sunscreens, especially the chemical filters, preservatives, and other ingredients may cause eye stinging and burning if applied too close to the eye. The best eye protection is seeking shade, a wide brimmed hat and 100% ultraviolet protective sunglasses. Other alternatives include applying a fragrance-free sunscreen stick, or lip balm, around the eyes, one that is formulated with titanium dioxide and/or zinc oxide as the active ingredients. (You can select one using the Product Selector.) Sunscreen sticks and lip balms have a high wax content which may prevent the sunscreen from spreading into the eyes with sweating or increased physical activity. Although SPF facial foundation, concealers, and powdered eye makeup applied around the eye does not offer adequate sun protection, it may prevent some of the sun's ultraviolet light from hitting this sensitive area.
"Free-from" Skincare Products
We've all seen ads proclaiming that a skincare product is "free-from" some particular ingredient: a brilliant scare tactic that implies that the product is now safer because it is "free-from" that particular ingredient. Let's take the commonly used, most studied class of preservatives called parabens, for example.
To prevent contamination, all water-based products (which include the vast majority of facial and body moisturizers) require a preservative. Without one, mold and bacteria spoils the product in less than two weeks.
Stories in the media accuse parabens of having negative health effects, of being harmful endocrine disrupting chemicals. Yes, parabens may have estrogenic activity. But their estrogenic activity is magnitudes weaker that the natural phytoestrogens found in soy products, flaxseed, and tomatoes - foods we consume every day. Fact is, parabens have not been proven to be toxic in human beings when used in approved doses of less than 1%.
A poorly designed 2014 British study found parabens in breast tumor tissue samples. The author herself clarified that the study never concluded that the parabens caused the tumors. Media and consumer advocacy groups created a firestorm, perpetuating this erroneous conclusion. Fake news! A completely unnecessary consumer demand for paraben-free products was born.
But the one important question remains, one that consumers are unlikely to even think to ask. What alternative preservative is being used in those skincare products that are "free-from" parabens? Has the paraben preservative been replaced with DMDM Hydantoin, a formaldehyde-releasing preservative (not terrible unless you have an allergy to it or are eczema-prone)? Or is phenoxyethanol or iodopropynl butylcarbamate being used? The safety of these chemicals is not as well documented at that of parabens as they are all less studied alternatives.
A skincare product with "free-from" on the label may tell you what's NOT in the product, but it says nothing about the safety of the product. Don't be fooled!
ARE SILK PILLOWCASES GOOD FOR SKIN?
Silk pillowcases are lovely. They feel soft and smooth on the skin. Advice from "skincare experts" regarding the benefits of silk pillowcases on social media, on-line blogs, and in health and beauty magazines is ubiquitous. Claims include they prevent acne and wrinkles. The use of a silk pillowcase supposedly prevents split ends on hair. They are reported to help the skin retain moisture and minimize chemical exposure (from what particular chemicals I do not know.) Most of these "experts" are well-intentioned but are simply misinformed. Others financially benefit from their claims by selling silk pillowcases although they may still believe such claims to be true. Let's be clear: There are no scientific studies that correlate the use of a silk pillowcase with improved skin or hair health. There is no evidence that sleeping on a silk pillowcase minimizes acne breakouts, minimizes the formation of facial wrinkles, prevents split ends or chemical exposure. So don't expect healthier skin or hair from making such a purchase.
However, silk pillowcases are beautiful. They are a true luxury!
THE BEST ANTI-AGING PRODUCT
Other than sun avoidance, sunscreen application is the single most effective anti-aging preventative. Ultraviolet rays from the sun cause discoloration and wrinkling of the skin. Compare the skin on the face or chest with skin on unexposed areas of the body, like the breast or buttocks. Unexposed and exposed skin are the same age but unexposed skin always appears less wrinkled and more evenly pigmented, it has better tone and texture. Sunscreen prevents the skin discoloration and wrinkling and, as recent studies suggest, may even improve skin tone and texture.
Skincare moisturizers that claim to be "anti-aging" or "age defying" fill drugstore shelves. They often contain "marketing tool" ingredients that have never proven to rid of wrinkles or fine lines, certainly not at the concentrations used in the over-the counter (OTC) formulations. The fact remains, science has yet to find a single ingredient or product that can reverse or slow the aging process. In addition, by law, any skincare product sold in the United States that claims to actually change the skin is classified as a drug and must get FDA pre-market approval. It cannot be sold as an OTC cosmetic. (Cosmetic vs. Drug) Terms like "anti-aging" and "age defying" seen on skincare product labels are brilliant marketing phrases. The true benefit of including these terms on facial moisturizer labels, increased sales!
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Welcome to Fully Exposed
Hello, and welcome to FryFace!
I've been a New York based dermatologist for over 25 years. I love music. I love triathlons. I love chemistry. (I love petroleum jelly.) I study skincare ingredients and product formulation. I listen to skincare "advice" from self-proclaimed ......Read More