In recent months, companies such as Novartis and Clarins have begun to roll out retinoidal skin care products with retinols (such as retinyl palmitate and retinyl rosmarinic acid) as well as other types of retinogenic ingredients.
However, the FDA has been reluctant to allow these products to be marketed, with a recent decision requiring manufacturers to have labeling that specifically describes their ingredient list.
Now, the agency has issued an advisory saying that there may be an exception for these retinogens, but it’s not clear how.
In a statement to TechCrunch, the Department of Health and Human Services (HHS) said that the FDA did not have a position on whether or not retinoins could be marketed.
“However, we are not currently aware of a situation where retinone is the only available retinogen,” the statement reads.
It continued, “Although the FDA does not have regulatory authority to regulate the use of retinyl-x-tocopherol or retinones, we believe that the agency should be able to regulate their use in products for patients, which are considered to be medical care products, with labeling that explains the ingredient list.”
According to the FDA, a product that includes retinoxins must have a label stating that it contains “all natural ingredients, without artificial coloring, emulsifiers, preservatives, colorants, or fragrances,” as well a warning that “products may contain retinoyl hydroxyl esters.”
The agency added that it is also concerned about ingredients used in retinonoids that have been shown to cause toxicity and damage to the skin, as well the risk of skin reactions such as skin cancer.
The FDA also noted that retin-x retinolyl-sulfonyl moiety can also be added to certain retinodide-based formulas.
The agency said that this ingredient should be added “to the product ingredients list to ensure its safety and to prevent the use or misuse of retinal-x products by consumers.”
According the agency, manufacturers must also provide their labeling to consumers.
“Consumers should be aware that these ingredients can cause serious health risks and should not be used in products marketed to treat conditions of the skin,” the FDA said.
The agency also noted there are two other categories of retinoic acid, the retinoleic and the retinoin-containing.
According to the agency’s statement, both of these are still classified as drugs.