Dear Stephen, thank you for answering my last question! I have another. Can you explain why some skincare topicals are available only by prescription while others are available OTC?

For example, why does tretinoin cream require a prescription while retinol does not? I realize the easy answer is because “the FDA says so,” but I don’t really understand how one could abuse tretinoin, even though it is more potent, and so I don’t understand *why* the FDA says so. Lobbying? Patents? Random? Thanks!

Hi Jechristine, sorry it’s taken so long to get to these questions!

This is a great question and what you need to look at is the regulations of what the FDA considers a “cosmetic” vs. a “drug”.

The main thing that differentiates the two is the claims that the product can make. For example tretinoin can claim to treat acne as well as photoageing.

Even though retinol is a similar compound and may have similar effects as tretinoin, can’t claim the same. This is because retinol hasn’t been submitted for drug approval.

If a company wants to make claims like treating acne or treating photoageing for a retinol product, they’d have to submit it as a new drug. This would involve conducting human clinical trials to establish efficacy and data, just like any drug the FDA considers for approval. This is a lengthy and costly process.

Keeping to acne treatments, benzoyl peroxide, salicylic acid, and sulfur are approved by the FDA to treat acne. An over-the-counter product with these active ingredients can make the claim that it treats acne. Other acne treatment ingredients without FDA approval can only allude to treating acne, but can’t directly claim it.

This is why a lot of the marketing copy on cosmetics are very flimsy or elude to a treatment. “Purify skin” vs. “Acne treatment”.

This isn’t just for cosmetics. For example, you have prescription fish oil supplements and over-the-counter ones. The company manufacturing the prescription fish oil supplements submitted it as a new drug, and went through the process to get it approved as a treatment for a condition. They can make claims that over the counter fish oil supplements are unable to.

Under the FDA regulations any cosmetic that claims to alter or change the functioning of the skin, treat or cure a disease, or provide photoprotection is no longer a cosmetic – but a drug, and requires all the clinical trials and approval that any other drug would require.

Not all companies follow these regulations and you do see products that imply that they change the way the skin functions. It’s a blurry line, and a lot of these products get a pass. Not because the FDA approves them, but because the regulations arm of the FDA is probably underfunded.