Dear Valerie: We’re trying to formulate something for atopic dermatitis, but we’re torn—should it be an OTC or just a really good personal care product? 

—Itchy & Scratchy

Dear Itchy & Scratchy:

As you surely already know, making claims related to relieving symptoms of (or completely resolving) atopic dermatitis is considered a drug claim in the US and Canada. Any product treating such a malady would therefore be treated as an over-the-counter (OTC) drug, requiring more hurdles in formulating, manufacturing and labeling compliance.

As an OTC-drug product, only monographed ingredients may be used for treating atopic dermatitis (AD) in formulation. Ingredients such as colloidal oatmeal, dimethicone or zinc oxide (to name a few) can be used as a skin protectant, while hydrocortisone can be used to relieve itching associated with AD. Corresponding allowed use levels and combinations are listed in the FDA monograph for skin protectant drugs.¹ The benefit of using monographed materials is that you can make strong claims that make product efficacy clear to the consumer. For example, being able to claim colloidal oatmeal temporarily protects and helps relieve minor skin irritation and itching due to rashes is a strong statement.

The other ingredients in the formula? Those can be whatever you want, but you can’t attribute those to drug claims. For this reason, they are called inactive ingredients.

This incredible product you’re formulating can’t be produced just anywhere; it must be manufactured in an FDA-registered establishment that is authorized by the FDA to produce such products. Just the facility having a facility entity identification number (a MoCRA requirement) isn’t adequate.

It’s also not as simple as compounding and filling the product; extensive steps are required to ensure adequate control of incoming raw materials, processes and testing. Documentation must be a strength of any OTC-drug facility—the paperwork is a paper workout! It’s important to ensure all T’s are crossed and I’s are dotted to avoid future headaches when the FDA audits the facility and your product. It’s easy to assume your manufacturer is doing all the correct steps, but sometimes that’s not the case. (Peek into FDA Warning Letters for insight into what the FDA flags.) 

Beware of Paperwork

One downside of manufacturing a product where even the paperwork has paperwork is that it takes time and personnel to execute the job to the degree of satisfaction required for compliance. As they say, time is money. This often leads to high unit costs and/or high MOQs for the brand.

There is also the burden of labeling compliance. The FDA is very particular about product labeling requirements for both the primary and secondary packaging for OTC drug products. You can’t say whatever you want; the required text and even how it should be laid out in a Drug Facts panel is scripted. While some feel this is stifling, I think it’s a blessing because all the rules are spelled out, and there is an even playing field across brands.

Manufacturing OTC-drug products isn’t cheap or easy, and I suspect that for these reasons, you are considering making a super-efficacious, high-performing personal care product without the drug actives. While this can be done, you won’t necessarily end up with the same product. (And you certainly won’t end up with the same claims!)

The challenge is both what you say and how you say it. If your product is intentionally designed to address AD (or eczema or some other physiological ailment), you won’t be able to talk about it. Doing so would classify your product as a drug product. You wouldn’t have the active ingredients, manufacturing strategy or labeling compliance to support that. The product would be misbranded, and the FDA would not be pleased. 

If you were to avoid any and all claims related to treating AD (ensuring compliance as a cosmetic product), you essentially just have a nice moisturizer. How many moisturizers on the market soothe dry skin or calm sensitive skin? In my opinion, no matter how high performing the moisturizer is, or how excellent your product education is, it’s difficult to stand out in a crowded marketplace when there are actual OTC products that can use terms like relief and treatment. That’s way more powerful than the ubiquitous soothing and calming language used on most mainstream moisturizers.

To make the decision to OTC or not to OTC, you must consider your budget, aptitude for managing the regulatory burden, and willingness of your customer to accept a product that can’t make the claims, even if the formulation could support it.

Valerie George

askvalerie@icloud.com

Valerie George is a cosmetic chemist, science communicator, educator, leader, and avid proponent of transparency in the beauty industry. She works on the latest research in hair color and hair care at her company, Simply Formulas, and is the co-host of The Beauty Brains podcast. You can find her on Instagram at @cosmetic_chemist or showcasing her favorite ingredients to small brands and home formulators at simply-ingredients.com