8 things about formulating products

Dermatologist and cosmetic surgeon Joel Schlessinger M.D., is formulating his 20th skincare product. The President of LovelySkin.com, an established international online skincare marketplace, shares what dermatologists who want to formulate skincare products should consider before making what can be a hefty investment in money and time.

Satisfaction

Dermatologists are in-the-know when it comes to skin. They have a built-in potential customer base (their patients). And dermatologists make up the specialty that would get the most satisfaction from making a better product for their patients, Dr. Schlessinger says.

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“Clearly, there are a lot of products out there that have dermatologists’ names on them that have zero input by the dermatologist other than picking the color of the label and deciding on a name,” Dr. Schlessinger says. “There’s a big difference [in satisfaction] when it comes to actually going inside the bottle and working on the composition of ingredients, in an honest start-to-finish production.”

The costs, risks can be huge, too

Dr. Schlessinger says it costs about $50,000 or more to formulate and produce one product, which includes not only the formulation but also the minimum that most manufacturers require for production.

“If you’re formulating something brand new, you can’t just make 100 or 200 of them. You have to do this in lots of 5,000, 10,000 and more depending on the manufacturer,” Dr. Schlessinger says.

While the formulating process should always start with the dermatologist and includes a manufacturer, it usually also requires input from a cosmetic chemist and, possibly, an FDA advisor. FDA advisors are professionals that help guide dermatologists through FDA’s regulating processes for over-the-counter products.

“There are several companies that act as FDA advisors,” Dr. Schlessinger says. “While they don’t accept responsibility for the issues, they give the best advice that they can. At that point, the formulator has to make decisions based on their preferences for the product and the best advice given.”

Another factor that drives up product formulation costs is based on whether the formulator promotes active ingredients and makes claims on the packaging. So, a simple acne topical with salicylic acid could incur tens of thousands of dollars in extra costs in order to claim that salicylic acid is the active ingredient and the effect it has on acne, according to Dr. Schlessinger.

After all that work and expense, if there’s a recall on the product or formulation issues that lead to harm from use, the formulator, or dermatologist, and manufacturer are the responsible parties and are at risk for lawsuits.

And problems do happen. Dr. Schlessinger says that some newer forms of preservatives used to mitigate concerns about parabens and other ingredients have proven to cause allergic reactions.

Start simple

The easiest place to start is with a simple skincare product that has ingredients that are commonplace or just coming to the forefront. These include moisturizers, anti-aging and acne formulations that don't contain any active ingredients that would be FDA regulated.

“Things such as peptides, stem cell extracts and hyaluronic acid are now fairly commonplace in most products, but there are still opportunities to either adjust these ingredients or form a more perfect balance of these in the desired products,” Dr. Schlessinger says. “And there are other opportunities to refine products in a more elegant manner--either adjusting fragrances or going without fragrances, [for example]. There are only a handful of companies that really take the time and effort to craft a product that is not only useful but clever in its approach. Therefore, there is a great deal of opportunity for dermatologists who have the knowhow, wherewithal and desire to form their own products.”

Save some things for later

Sunscreens are highly regulated and sunscreen formulators are likely to face costly regulatory hurdles as a result, Dr. Schlessinger says.

“That’s the reason most sunscreens are formulated by larger companies,” he says.

Take packaging seriously

Packaging determines customer acceptance, according to Dr. Schlessinger.

“Something as simple as the use of a jar versus a pump can make or break a product. We’re heading away from jars for creams because of the problems of contamination. But, on the other hand, patients generally accept jars a lot more than pumps. These are decisions everybody has to make when formulating products,” he says.

Control costs by spending wisely

It’s easy and tempting to add active ingredients to products because they’re “sexy,” but those ingredients can increase the cost significantly, without improving quality, according to Dr. Schlessinger.

“Additionally, their level of excitement can abate very quickly, leaving you with an expensive product that is 'so-2016,’” he says. “Think carefully about which active ingredients you want and try to make a hit list of which ingredients you’re willing to sacrifice if the price of the product turns out to be astonishingly high.”

Manufacturers don't know everything

Manufacturers tend not to be board certified dermatologists. And they have a lot less experience with allergens than dermatologist formulators. Have complete medical oversight on what goes into the product and how it’s produced.

Don’t quit your day job

The pros of skincare product formulation generally don’t include a huge profit stream.

“This is almost always going to be an incredibly expensive undertaking and one that doesn’t usually lead to a mega blockbuster sales experience,” Dr. Schlessinger says. “But you’ll end up with a significant amount of satisfaction and the knowledge that you’ve actually done something that can help your patients and has your personal stamp of approval.”

Dr. Schlessinger’s flagship product and the one that he says has given him the most satisfaction as a formulator is Fix My Skin 1% hydrocortisone healing balm, which he formulated and patented with his son, Daniel Schlessinger, now a second year medical student at Northwestern's Feinberg Medical School.

The healing balm is on Walmart shelves and sells internationally. Dr. Schlessinger says he receives letters from people around the world about what a difference Fix My Skin has made on their eczema, dry skin and psoriasis.

Despite the product’s widespread use, however, it still hasn't turned a profit due to the expensive nature of the patent process, but the dermatologist says he expects that it will be in the black soon.