Warning Required: Products Containing Beta Hydroxy Acids
This article applies to cosmetic products containing beta hydroxy acids which are sold in the United States.
Beta hydroxy acids (BHAs) are a class of ingredients which are commonly used in exfoliants and skin peels for both professional and at-home use. They are similar to alpha hydroxy acids but are oil soluble compared to AHAs which are water soluble. They also function similarly, however BHAs are tend to be less irritating. Salicylic acid is the most common ingredient known as a BHA although technically, from a chemistry view, it’s not actually a BHA.
The Cosmetic Ingredient Review Expert Panel reviewed the safety of salicylic acid and its derivative salicylates in 2003.1 At that time, they found that salicylic acid and derivatives were safe in cosmetic products as used (less than 5%) and when formulated to avoid skin irritation and increasing the skin’s sun sensitivity. When increased sun sensitivity would be expected, directions for use include the daily use of sun protection.
In 2019, the Cosmetic Ingredient Review Expert Panel revisited their safety assessment of salicylic acid and its derivative salicylates and expanded the assessment to include 3 additional salicylates.2 The final conclusion in 2019 was the same as in 2003.
The FDA has not published any specific guidelines for warning statements for cosmetic products containing BHAs. They have, however, published a web page about Beta Hydroxy Acids in which they state that cosmetic manufacturers should test products containing BHAs to determine whether they cause an increase in sensitivity to the harmful UR radiation in sunlight.
Where a product does increase sensitivity to UV radiation (or where testing has not been carried out) the directions for use should include the daily use of sun protection.3
This is quite similar to the recommendations for the sunburn alert which should be placed on products containing alpha hydroxy acids.4 Using the sunburn alert for BHAs would be very appropriate.
Sunburn Alert: This product contains a beta hydroxy acid (BHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.
The sunburn alert is not specifically required for BHAs. However, the statutes do state that a cosmetic is misbranded if its labeling is false or misleading5 and “misleading” can be based on a failure to provide material facts regarding results of normal or customary use of a product.6 In other words, if you fail to tell the customer something important about what might happen if they use the product, that would be misleading … and make the product misbranded (and therefore illegal to sell in the United States).
In the case of products containing BHAs, including information on the necessity to protect from sunburn would be a material fact that should be provided to the consumer. Placing the sunburn alert on the package is highly recommended.
See also Alpha Hydroxy Acids
1 Andersen, FA. (2003). Safety assessment of salicylic acid, butyloctyl salicylate, calcium salicylate, C12-15 alkyl salicylate, capryloyl salicylic acid, hexyldodecyl salicylate, isocetyl salicylate, isodecyl salicylate, magnesium salicylate, MEA-salicylate, ethylhexyl salicylate, potassium salicylate, methyl salicylate, myristyl salicylate, sodium salicylate, TEA-salicylate, and tridecyl salicylate. International Journal of Toxicology. 22. 1-108. doi:10.1080/10915810390239487
2 Cosmetic Ingredient Review Expert Panel. (2019). Amended Safety Assessment of Salicylic Acid and Salicylates as Used in Cosmetics.
3 FDA. Beta Hydroxy Acids
4 FDA. Guidance for Industry: Labeling for Cosmetics Containing Alpha Hydroxy Acids
5 21 USC 362(a) – Misbranded Cosmetics
6 21 USC 321(n) – Definitions Generally
