FDA's Role FAQs
Cosmetics are “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance” (FD&C Act, sec. 201(i)). Cosmetics include skin moisturizers, makeup, perfume, nail polish, deodorants, permanent waves, and hair colors. Cosmetics and their ingredients (with the exception of color additives) are not regulated or overseen by the FDA.
Under the current laws, the FDA does not substantiate or approve efficacy or safety claims of cosmetics. Furthermore, the terms ‘hypoallergenic,’ ‘non-comedogenic,’ ‘gluten-free,’ ‘natural,’ ‘fragrance-free,’ and ‘dermatologist recommended or tested’ are not regulated or overseen by the FDA.
Cosmetics generally do not contain any ingredients that treat or prevent disease, or that affect the structure or function of the body.
Unlike cosmetics, drugs and medical devices are products that are intended for the treatment or prevention of disease, or that affect the structure or function of the body, and require FDA approval.
Drugs may be OTC (over-the-counter) or prescription.
FDA monographs are specific ingredients that have been approved in OTC drugs to prevent or treat medical conditions by self-medication. OTC drugs do not require a prescription from a physician. Examples include benzoyl peroxide for acne, colloidal oatmeal for eczema, or sunscreen ingredient for photoaging. OTC drugs that make a claim to treat or prevent a medical condition must contain a monographed ingredient. If an OTC drug makes a claim to prevent or treat disease but product doesn’t contain a monographed ingredient, it must first be approved by the FDA as a new drug.
No. Cosmetics and their ingredients (with the exception of color additives) are not regulated or overseen by the FDA. There are regulations, however, that prohibit or restrict the use of certain dangerous cosmetic ingredients, including mercury, vinyl chloride, chloroform, and methylene chloride, among others.
Under the current laws, the FDA does not substantiate or approve efficacy or safety claims of cosmetic products. Furthermore, the terms ‘hypoallergenic,’ ‘non-comedogenic,’ ‘fragrance-free,’ ‘gluten-free,’ ‘natural,’ and ‘dermatologist recommended or tested’ are not regulated or overseen by the FDA.
Cosmetic companies and manufacturers have the responsibility to ensure the safety of their products. They are not, however, required to submit safety information or product formulation to the FDA. Safety recalls of cosmetics are voluntarily taken by manufacturers or distributors to remove products that are hazardous or deceptive to the public. The FDA is not authorized to order recalls of cosmetics.
No. Under the current law, cosmetics and their ingredients (with the exception of color additives) do not require FDA approval or specific safety testing prior to sales.
Allergic Contact Dermatitis FAQs
Absolutely not! Allergic contact dermatitis is typically limited to the skin. Anaphylaxis, however, is a severe, potentially-life threatening, whole-body allergic reaction characterized by hives, throat tightness, swelling of the eyes, face, lips or tongue, or difficulty breathing. For example, peanuts and shellfish may cause anaphylaxis in people who are allergic to these foods. Anaphylaxis requires immediate medical attention. Our evaluation process only determines the risk of allergic contact dermatitis, NOT the risk of anaphylaxis.
The more exposure you have to certain high-risk ingredients, the more likely you are to develop ACD. So, the best way to avoid ACD is to use hypoallergenic, or minimally allergenic products, whenever possible.
Anyone can develop allergic contact dermatitis, even if they have had no prior allergic reactions or history of sensitive skin. The more exposure you have to certain high-risk ingredients, the more likely you are to develop ACD. The best way to avoid ACD is to use hypoallergenic, or minimally allergenic products, whenever possible.
The T.R.U.E Test® is an FDA approved diagnostic tool that may be used by your dermatologist to determine whether you have developed a skin allergy to cosmetic ingredients. It consists of a panel of the most common skin allergens which are applied directly on your back and then removed on the 3rd day. The skin is checked by your dermatologist on the 5th day to look for the development of an allergic skin reaction. While the T.R.U.E Test is a good starting point, several studies have shown that it may fail to diagnose up to 1/3 of cases of allergic contact dermatitis.
ACD is an acquired, allergen-specific, Type IV, immune reaction that develops with repeated exposure to certain high-risk ingredients in cosmetics, the so-called sensitization phase. The disease phase is characterized by recurrent, intensely itchy, inflamed, red rashes in response to exposure to even minimal amounts of the allergen. The disease phase is without alterable factors and only improves with strict allergen avoidance, which can be very challenging.
Example: Poison ivy causes an allergic skin reaction which is characterized by an intensely itchy red rash, blisters, and swelling. The only way to prevent this allergic skin reaction is to avoid poison ivy completely. Avoiding plant allergens is often much easier to do than avoiding certain skin care ingredients, which are found in numerous products.
There are several, medically recognized, high-risk skin allergens including nickel, topical antibiotics (neomycin, bacitracin), and other skin care ingredients such as fragrance, formaldehyde, and methylchloroisothiazolinone, among others.
No product is completely allergen-free. Currently, there is no universal definition for the term hypoallergenic. Its definition varies by skin care company and is not overseen by the FDA. The Skin Trust Society offers the first industry-wide, dermatologist developed definition for the term hypoallergenic. Per our definition, hypoallergenic means that a skin care product has the least number of high-risk skin allergens is less likely to cause an allergic skin reaction. Our database of dermatologist approved products is not patient-specific and you should consult with your physician for guidance if you have known skin allergies to specific ingredients.
No. While some products that are certified hypoallergenic by the Skin Trust Society may also have been certified organic by the U.S. Department of Agriculture (USDA), there is not necessarily an overlap between these two categories. The Skin Trust Society is committed to producing a database of the least-allergenic skin care products, which may include both conventional and organic products.
Irritant Contact Dermatitis
Irritant contact dermatitis is NOT immune-mediated and often results from the inappropriate use of the product. Irritant contact dermatitis may be improved by using the product less frequently, in lower concentration, or in combination with moisturizers. Examples of irritants include ingredients found in synthetic soaps or cleansers, benzoyl peroxide, salicylic acid, and vitamin A derivatives.
On the other hand, allergic contact dermatitis is an immune-mediated skin reaction and only improves with strict allergen avoidance.
Acne is an inflammatory skin condition that usually starts with plugged pores (= comedones = blackheads). The bacterium Propionibacterium acnes is also thought to make acne worse by activating white blood cells, which leads to more inflammation. Uncontrolled acne may result in permanent scarring.
There are several factors that may cause acne including hormones, genetics, medications, and occupational exposures.
Endocrine abnormalities including polycystic ovarian syndrome and insulin resistance may predispose affected individuals to develop acne. Certain hereditary traits may make people more likely develop acne in association with other medical conditions. Certain medications such as steroids, and lithium, among others, can make acne worse. Occupational acne is due to exposure to industrial substances that clog pores such as chlorinated hydrocarbons, petroleum, and coal tar.
The bacterium Propionibacterium acnes is also thought to make acne worse by activating white blood cells, which leads to more inflammation.
FDA approved ingredients for OTC acne treatment include benzoyl peroxide (BP), salicylic acid (SA), and sulfur. Prescription medications such as vitamin A creams or oral antibiotics may be needed for moderate to severe acne that doesn’t improve with OTC products. Consult with your dermatologist to determine which treatment is best for you.
It is possible for acne products to be hypoallergenic, per our definition, if they have the least number of high-risk skin allergens. Most of the active ingredients used to treat acne such as benzoyl peroxide (BP), salicylic acid (SA), and vitamin A derivatives often cause dryness or irritant contact dermatitis if used inappropriately or in combination. Since irritant contact dermatitis is not an immune-mediated reaction, these ingredients are not currently considered to be sensitizing skin allergens. Skin irritation from these ingredients may actually be reduced by using the products less frequently, in lower concentration, or in combination with moisturizers. However, it’s important to realize that one or more inactive ingredients in acne products may be high-risk skin allergens.